Board Change • May 21
High number of new directors There are 6 new directors who have joined the board in the last 3 years. CEO & Director Marc Le Bozec was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Announcement • Apr 23
OSE Immunotherapeutics Announces Presentation Of Tedopi Phase 2 Topline Results In Ovarian Cancer OSE Immunotherapeutics SA announced that topline results from the TEDOVA Phase 2 international clinical trial of Tedopi in Ovarian Cancer sponsored by ARCAGY-GINECO have been selected for an oral presentation at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, United States (May 29 - June 2, 2026). The TEDOVA trial evaluates Tedopi as a maintenance treatment of ovarian cancer. The neo-epitope-based vaccine OSE-2101 with or without pembrolizumab versus best supportive care as maintenance in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy: The academic randomized TEDOVA/GINECO-OV244b/ENGOT-ov58 trial. Rapid Oral Abstract. Session: Gynecologic Cancer – Subtrack: Ovarian Cancer. Abstract 5510. Room: E450. May 30, 2026, 8:06-8:12am CDT (3:06-3:12pm EST). TEDOVA is a three-arm Phase 2 study evaluating Tedopi as a maintenance treatment, alone or in combination with anti-PD1 immune checkpoint inhibitor Keytruda (pembrolizumab), versus best supportive care in 185 patients in platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor. The primary endpoint is the Progression Free Survival (PFS) of the maintenance of Tedopi, with a PD1 inhibitor, after platinum-based chemotherapy in relapsed ovarian cancer. (NCT04713514). Announcement • Apr 16
OSE Immunotherapeutics SA Announces Appointment of Thomas Gidoin as Deputy CEO and Aurore Morello as Chief Scientific Officer OSE Immunotherapeutics SA announced the appointment of Thomas Gidoin as Deputy Chief Executive Officer (Directeur Général Adjoint), in addition to his current duties, to support Marc Le Bozec in implementing OSE’s strategic plan. In his new role as Deputy CEO and CFO, he will notably drive the Company’s financial strategy, develop investor relations, and oversee corporate communications, as well as legal and corporate affairs. Thomas Gidoin is an experienced biopharma executive with a strong expertise in strategic financial leadership, capital markets and corporate affairs, both in private and listed companies on Euronext Paris and the US NASDAQ. He joined OSE Immunotherapeutics in June 2025 and has demonstrated significant contribution to defining and implementing the new 2026-2028 strategic plan. OSE Immunotherapeutics SA also announced the appointment of Aurore Morello, PhD, previously Head of Research and Director of R&D Programs, as Chief Scientific Officer. In her new role, she will oversee OSE’s research strategy, drive R&D innovation, and lead the Company’s scientific teams developing monoclonal antibodies, immunocytokines, and RNA-based immunotherapies. Dr Morello will also lead OSE’s Scientific Advisory Board, contributing to the strategic guidance of the Company’s scientific roadmap. Dr. Morello earned her PhD in Immunology and Oncology from the University of Bordeaux, France and completed a prestigious postdoctoral fellowship at Memorial Sloan Kettering Cancer Center (MSKCC) in New York, where her work focused on CAR T-cell therapies for solid tumors. She is the author of numerous publications in high-impact journals, and recipient of several scientific awards, including the MSKCC Young Researcher Award. Dr Morello joined OSE Immunotherapeutics in 2016. Announcement • Mar 17
OSE Immunotherapeutics SA, Annual General Meeting, Jun 24, 2026 OSE Immunotherapeutics SA, Annual General Meeting, Jun 24, 2026. Announcement • Mar 10
OSE Immunotherapeutics SA Confirms Marc Le Bozec as Chief Executive Officer ,Effective March 10, 2026 OSE Immunotherapeutics SA announced the transition of Marc Le Bozec from interim to permanent Chief Executive Officer, effective March 10, 2026. Mr. Le Bozec had served as interim CEO since October 2, 2025. Following a thorough review of internal and external candidates and upon recommendation of the Nomination and Compensation Committee, the Board of Directors unanimously confirmed Marc Le Bozec's transition from interim to permanent CEO. New Risk • Jan 10
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 92% per year for the foreseeable future. Minor Risk Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Board Change • Dec 30
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO & Director Marc Le Bozec was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 03
OSE Immunotherapeutics SA Announces Management Changes OSE Immunotherapeutics announced the termination of the position as chief executive officer of Mr. Nicolas Poirier and the appointment of Mr. Marc Le Bozec as interim CEO, as decided on October 2, 2025 by the Board of Directors. The Board of Directors has commenced a formal search for a new permanent Chief Executive Officer. The Board of Directors has empowered Marc Le Bozec to lead a strategic evaluation of OSE's business, with a focus on maximizing value across partnerships, finances, and clinical development programs. Nicolas Poirier will retain his position as Chief Scientific Officer at OSE. The termination of Mr. Nicolas Poirier's duties as Chief Executive Officer will not result in the payment of any compensation or indemnity, given that Mr. Nicolas Poirier is remunerated exclusively under his employment contract with the Company. The compensation of the new Chief Executive Officer will be reviewed by the Nomination and Compensation Committee and submitted to a vote at the next shareholders' general meeting, given the absence of a compensation policy for the Chief Executive Officer. Marc Le Bozec currently advises numerous biotech companies as a consultant, board member, and investor. He has extensive experience in interim management. Between 2015 and 2023, he created and managed two biotech investment funds at Financière Arbevel. He made 11 investments and facilitated two exits: TransCure bioServices, sold to Cathay Capital in early 2022, and Imactis, sold to GE Healthcare in early 2023. Previously, he was CFO of Cellectis, where he raised €120 million and prepared the company for its Nasdaq listing. He also led and successfully restructured CYTOO. A graduate of HEC Paris (1992), Marc Le Bozec began his career in organizational consulting (Bossard Consultants), then in strategy consulting (Arthur D. Little). He founded his first biotech company, BioProtein Technologies, in 1998. Announcement • Oct 01
OSE Immunotherapeutics Approves Board Appointments OSE Immunotherapeutics at its Annual General Meeting held on September 30, 2025, shareholders notably voted in favor of the appointment of the following directors: Caroline Mary, as representative of employee shareholders. Pascale Briand, Markus Cappel, Jonathan Cool, Marc Le Bozec, Shihong Nicolaou and Alexis Peyroles. Following the General Meeting, the new Board of Directors held its first meeting and elected Dr. Markus Cappel as Chairman. Biographical highlights on Dr. Markus Cappel: Dr. Markus Cappel has over thirty years of experience in the biotechnology sector. He is widely recognized for his entrepreneurial spirit and for his outstanding achievements. As Chief Business Officer of ChemoCentryx, he led product development and key initiatives supporting the commercialization of TAVNEOS® across seven market countries. He also led multi-party negotiations with major pharmaceutical companies, securing agreements that preserved commercial rights and development control in the United States. He played a pivotal role in the acquisition of ChemoCentryx by Amgen for $4 billion, representing a 116% premium, after having raised $435 million at the IPO, $138 million through private equity fundraising, and over $250 million in non-dilutive financing. Prior to ChemoCentryx, Dr. Cappel served as Vice-President of Business Development at Advanced Inhalation Research (AIR), where he negotiated an exclusive agreement with Eli Lilly and built a strategic alliance with GlaxoSmithKline, securing an upfront payment of $125 million. Dr. Cappel holds an MBA from Harvard Business School and a PhD in Pharmaceutical Sciences from J.W. Goethe University in Germany. Announcement • Sep 13
OSE Immunotherapeutics and the FoRT Foundation Announces Completion of Enrollment in Combi-TED, a Phase 2 Clinical Trial Evaluating Tedopi in Combination with Nivolumab or Docetaxel in Patients with Non-Small Cell Cancer OSE Immunotherapeutics SA the FoRT Foundation (Fondazione Ricerca Traslazionale) today announced the completion of patient enrollment in a Phase 2 clinical trial evaluating the neoepitope-based therapeutic cancer vaccine Tedopi® in combination with nivolumab or docetaxel in patients with Non-Small Cell Lung Cancer (NSCLC). The clinical trial (NCT04884282) is sponsored and conducted by the Italian Foundation FoRT across sites in Italy, France and Spain. Combi-TED is an open label, randomized, three-arm Phase 2 study evaluating Tedopi® in combination with the anti-PD1 immune checkpoint inhibitor Opdivo® (nivolumab) or Tedopi® plus docetaxel or docetaxel alone (reference arm) as second-line treatment in HLA-A2 positive patients with metastatic NSCLC and no evidence of EGFR mutations or ALK or ROS1 rearrangement, after first-line chemo-immunotherapy. The primary endpoint is 1-year survival rate. As planned, 105 patients were enrolled in the clinical study, and the readouts are expected in the second half of 2026 (Presentation at the ESMO 17-21 Oct. 2025: 2085eTrial in Progress (TiP): OSE2101 plus docetaxel or nivolumab as second line therapy in metastatic non-small-cell lung cancer (mNSCLC) progressing after first line chemoimmunotherapy (Combi-TED). Announcement • Sep 10
OSE Immunotherapeutics SA to Report First Half, 2025 Results on Sep 30, 2025 OSE Immunotherapeutics SA announced that they will report first half, 2025 results on Sep 30, 2025 Announcement • Aug 21
OSE Immunotherapeutics SA Announces Chief Financial Officer Changes OSE Immunotherapeutics SA announced the appointment of Thomas Gidoin as Chief Financial Officer. Thomas joins the Executive Committee, bringing over 15 years of deep international expertise in capital markets, financial strategy, and governance to the company. Thomas Gidoin is an experienced biopharma finance executive with a strong track record in strategic financial leadership, both in private and public companies. Prior to joining OSE Immunotherapeutics, he served as Chief Financial Officer at Advesya, a privately held Franco-Swiss clinical-stage biotech company in oncology and autoimmune diseases, after having spent 8 years as CFO of GenSight Biologics, where he led the company’s financing strategy from the Series B to the IPO on Euronext Paris and a number of follow-on transactions and structured financings. Previously, Thomas was Vice President of Finance at DBV Technologies, where he led the Corporate Finance team and contributed to public offerings and private placements, including the dual listing of the company on the US NASDAQ. Prior to this, Thomas served as Northern Europe Business Controller at PregLem in London, held several positions at Ipsen, including UK Operations Controller in London and Senior Financial Analyst in the Global Operations division in Paris. He started his career in audit at Ernst & Young in Paris. He holds master’s degrees in international finance from ESGF Paris and in international management from NEOMA Business School. Thomas succeeds Anne-Laure Autret-Cornet, marking a new phase in the company’s financial leadership. Announcement • Jun 02
Ose Immunotherapeutics Sa Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi®? in Pancreatic Cancer and Non-Small Cell Lung Cancer OSE Immunotherapeutics SA provided clinical updates on Tedopi®?, the "off-the-shelf" neo-epitope-based therapeutic cancer vaccine under evaluation in both monotherapy and combination therapy across five clinical trials in several cancer indications. Tedopi®? combines 10 neo-epitopes derived from five tumor antigens, selected for their presence in a range of tumors, offering a multi-target "pipeline in a product" approach for HLA-A2 positive patients to address unmet needs in oncology. The positive results for Tedopi®? in pancreatic cancer are promising for this devastating disease with a poor progosis. In lung cancer, patient recruitment is progressing per plan in the Artemia Phase 3 registration study, a key milestone bringing one step closer to the registration of Tedopi®? for NSCLC. As previously communicated, the readouts of the combination Phase 2 trials, CombiTED for NSCLC and TEDOVA for ovarian cancer, are expected in 2026. TEDOPaM - An oral communication, titled "Maintenance with OSE2101 plus FOLFIRI vs FOLFIRI alone after FOLFIRI reduction in patients with advanced pancreatic ductal adenocarcinoma (PDAC): Primary endpoint results of a randomized randomized TEDOPAM GERCOR D17-01 PRODIGE 63 trial" (abstract 4009) featuring positive topline Phase 2 results for the clinical trial TEDOPaM was presented by the GERCOR Oncology Group at ASCO 2025. TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI1 (Arm A) and cancer vaccine Tedopi®? (OSE2101) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patient with advanced or metastatic Pancreatic Ductal Adenocarcinoma (PD AC) with no progression after eight cycles of FOLFIRI reduction chemotherapy2. No new safety signal was observed. Prof. Cindy Neuzillet, MD, PhD (Curie Cancer Research Institute, Saint-Cloud), Principal Investigator of the Tedopi®? in combination therapy in advanced pancreatic cancer. The company now need more mature data on overall survival over a longer period. ARTEMIA - A "Trial in Progress" poster titled: Phase 3 trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy" was also presented at ASCO 2025. The Phase 3 pivotal clinical trial aims to support the registration of Tedopi as a second-line treatment in HLA-A 2 positive NSCLC patients with secondary resistance to anti-PD-(L)1 immunotherapy. This pivotal trial is conducted in 14 countries across the United States, Canada, Europe, and United Kingdom. However, long-term survival rates remain low, underscores the need for continued research and development of more effective systemic therapies to improve outcomes for patients with resected PD-PD-(L)1. Announcement • May 22
OSE Immunotherapeutics SA, Annual General Meeting, Jun 25, 2025 OSE Immunotherapeutics SA, Annual General Meeting, Jun 25, 2025. Location: hotel drawing house, 21 rue vercingetorix, paris France Announcement • May 06
OSE Immunotherapeutics SA Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab OSE Immunotherapeutics SA announced that over >90% of people living with ulcerative colitis (UC) who achieved a clinical response after 10 weeks of treatment with Lusvertikimab maintained symptomatic remission for an additional 24 weeks. Of the participants who did not reach symptomatic remission in the first 10 weeks of treatment with either dose of Lusvertikimab, 61% had achieved remission after a further 24 weeks on the 850 mg dose. Lusvertikimab was well tolerated over the 24-week extended treatment period. These findings from the open-label extension (OLE) of the Phase 2 CoTikiS study of the anti-IL-7 receptor monoclonal antibody Lusvertikimab in UC were presented at Digestive Disease Week in San Diego (May 3 - 6, 2025). These build on results from the earlier induction phase presented at the ECCO 2025 congress in February. Findings from the OLE period, extending from Week 10 to Week 34, complete the CoTikiS dataset which provides a compelling Phase 2 efficacy and safety data package for Lusvertikimab In UC. OverVIEW OF COTIKIS EXTENSION PERIOD (OLE) FINDINGS1 Lusvertikimab demonstrated a deepening of treatment response and durable response, with a high rate of symptomatic remission. 89% of participants entered the OLE period and 87% of them completed the study. Rates of symptomatic remission6 improved for all dose groups in the OLE period, suggesting a deepening of efficacy. For participants who had received the 850 mg dose from the beginning of the study, rates plateaued already after Week 14; rates of symptomatic remission continued to improve through week 26 for the 450 mg induction group (10 weeks of 450 mg, 16 weeks of 850 mg dosing) and through week 34 for the group receiving placebo in the induction phase (10 weeks of placebo, 14 weeks of 850 mg Lusvertikimab). A 24-week OLE period in which all participants received Lusvertikimab 850 mg infusions every four weeks; and A 16-week safety follow-up period without treatment. Findings from the induction phase of the CoTikiS study were presented in February at the 2025 ECCO congress. Both doses met the primary efficacy endpoint (improvement in Modified Mayo Score at Week 10) and demonstrated statistically significant and clinically meaningful results on secondary clinical, endoscopy and histology endpoints. Announcement • Apr 30
Ose Immunotherapeutics Sa Reports on an Oral Presentation from Research Collaboration with the Leon Berard Cancer Center At the American Association for Cancer Research Annual Meeting Held April 25 - 30, 2025 OSE Immunotherapeutics SA reported on an oral presentation from a research collaboration with the renowned Leon Berard Cancer Center in Lyon at the American Association for Cancer Research (AACR) Annual Meeting held April 25 - 30, 2025, in Chicago. Immune checkpoint blockade (ICB) therapies, targeting PD-1, PD-L1, and CTLA-4, have revolutionized cancer treatment by helping the immune system recognize and attack cancer cells more effectively. These therapies offer lasting responses and significant survival benefits across various cancers. However, current biomarkers like PD-L1 expression and tumor mutational burden (TMB) are not always reliable. PD-L1 expression can vary within tumors and between patients, making predictions inconsistent. Therefore, more universally applicable biomarkers are needed to predict patient responses and guide treatment decisions. While RNA sequencing has created detailed gene expression signatures (GES) that describe the tumor environment, their use in everyday clinical practice is limited due to their specificity and lack of widespread adoption. The presentation, entitled "A tumor agnostic composite gene expression signature identifies three groups of patients treated with immune checkpoint blockade with distinct clinical outcome", reported on the development and validation of a robust and tumor-agnostic composite gene expression signature (cGES) that can predict overall survival and progression free survival in cancer patients treated with immune checkpoint blockers (e.g. Anti PD-L1, Anti PD-1 and Anti CTLA-4). This signature could be useful in clinical practice to better stratify patients on risk and potentially guide treatment decisions of multiple cancer types. Announcement • Mar 12
OSE Immunotherapeutics SA and GERCOR Announce Positive Topline Phase 2 Result for Clinical Trial TEDOPaM Evaluating OSE2101 in Advanced Pancreatic Cancer OSE Immunotherapeutics SA and the GERCOR Group announced that the primary endpoint has been reached in TEDOPaM (GERCOR D17-01 PRODIGE 63 trial), a Phase 2 clinical trial sponsored and conducted by the French GERCOR Oncology Clinician Group, evaluating OSE2101 (Tedopi), the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, in advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC). TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI (Arm A) and cancer vaccine OSE2101 (Tedopi) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patients with PDAC with no progression after eight cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial was the one-year overall survival (OS) rate in the experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha: 2.5%, power: 90%). 107 patients were enrolled with a 1:1 ratio. The TEDOPaM trial met its primary objective, showing positive outcomes according to the predefined statistical hypothesis, with minimal toxicity for OSE2101 (Tedopi®) combined with FOLFIRI as maintenance treatment. Further follow-up and translational analyses are ongoing, with detailed results to be presented at upcoming medical congresses. PDAC is a highly aggressive form of cancer originating in the ducts of the pancreas. It represents about 95% of all pancreatic cancers. The global burden of pancreatic cancer has more than doubled in recent decades. It is now the sixth leading cause of cancer-related death worldwide, with an estimated 510,922 new cases and 467,409 deaths in 2022. The incidence of the disease continues to rise annually, with projections indicating a 95.4% increase in new cases by 2050. The overall five-year survival rate for pancreatic cancer is 10% worldwide, showing only a modest improvement over the past decade. More than 67,000 Americans will be diagnosed with pancreatic cancer in 2025, which is the equivalent of 184 people being diagnosed every day. Pancreatic cancer is now the 10 most found cancer in the US and represents about 3.5% of all new cancer diagnoses, and 7.1% of all cancer deaths in the EU. Announcement • Jan 14
OSE Immunotherapeutics SA Appoints Dr. Sonya Montgomery as Chief Development Officer OSE Immunotherapeutics SA announced the appointment of Dr. Sonya Montgomery as Chief Development Officer. Sonya will serve on the OSE Immunotherapeutics Executive Committee in a strategic move that will enhance the company’s development capabilities. Dr. Montgomerybrings over two decades of experience leading R&D strategies at major life science companies. She will oversee development activities for the company’s key assets and the strategic development of the preclinical and clinical product portfolio, and coordinate development efforts across manufacturing, supply, translational & biomarker development, alliance, and medico-marketing teams. Dr. Montgomery’s expertise extends to defining and executing development strategies across various therapeutic areas and modalities. She is skilled in designing innovative and efficient development plans for biologics, advanced therapies, and small molecules. She has successfully partnered various clinical assets to large pharma, secured financing for pipeline programs, and led programs from discovery through registration in Europe and the United States. Dr. Montgomery started her career in Canada, later holding various global leadership positions, including Director and Clinical Lead at Pfizer (Connecticut and Cambridge, US), Executive Director Clinical Development at Relypsa (California, US), Vice President Clinical Development at ProQR (Netherlands), Vice President and Head of Clinical Development at Gyroscope Therapeutics (London, UK), and more recently Chief Medical Officer at Evox Therapeutics (Oxford, UK). She has also been an advisor on development strategy for early-stage biotech companies and supported their financing strategy. Valuation Update With 7 Day Price Move • Oct 24
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to €10.36, the stock trades at a forward P/E ratio of 5x. Average trailing P/E is 25x in the Biotechs industry in Europe. Total returns to shareholders of 12% over the past three years. Valuation Update With 7 Day Price Move • Oct 09
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to €9.08, the stock trades at a forward P/E ratio of 3x. Average trailing P/E is 24x in the Biotechs industry in Europe. Total loss to shareholders of 14% over the past three years. Reported Earnings • Sep 29
First half 2024 earnings released: EPS: €2.63 (vs €0.64 loss in 1H 2023) First half 2024 results: EPS: €2.63 (up from €0.64 loss in 1H 2023). Revenue: €82.6m (up €81.2m from 1H 2023). Net income: €57.2m (up €69.0m from 1H 2023). Profit margin: 69% (up from net loss in 1H 2023). The move to profitability was driven by higher revenue. Revenue is expected to decline by 46% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 20%. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. New Risk • Sep 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 58% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 58% per year for the foreseeable future. Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). New Risk • Jul 02
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 9.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 9.1% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-€20m). Shareholders have been diluted in the past year (18% increase in shares outstanding). Revenue is less than US$5m (€2.2m revenue, or US$2.4m). Announcement • Jun 20
OSE Immunotherapeutics Presents Preclinical Data on Mrna Therapeutic Platform for the Treatment of Inflammatory and Autoimmune Disorders At the Focis Annual Meeting, San Francisco OSE Immunotherapeutics SA presented a poster on preclinical data on its mRNA (messenger RiboNucleic Acid) therapeutic platform for the treatment of inflammatory and autoimmune disorders at the Federation of Clinical Immunology Societies (FOCIS) annual meeting held in San Francisco (June 18 – 21, 2024). IL-35 (Interleukin-35) is an immunosuppressive cytokine capable of potently inhibiting immune- related inflammation by acting on multiple immune cells (T cells, Myeloid cells, B cells). IL-35 can promote differentiation of T and B cells into regulatory functional state to limit inflammatory response. IL-35 has demonstrated in preclinical studies a key role in controlling several immune related disorders including autoimmune diseases, infectious diseases, and cancer. OSE Immunotherapeutics’ mRNA therapeutic platform has been designed for the local delivery of mRNA into inflammatory tissue using lipid nanoparticles. mRNA encodes for immunotherapy to locally suppress immune response for the treatment of inflammatory and autoimmune diseases. This platform has the potential to deliver innovative immunotherapeutic drugs and to address new biology that cannot be targeted with standard biologic treatments. Breakeven Date Change • Jun 06
Forecast breakeven date moved forward to 2024 The 3 analysts covering OSE Immunotherapeutics previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of €17.5m in 2024. Earnings growth of 79% is required to achieve expected profit on schedule. Announcement • May 09
OSE Immunotherapeutics SA, Annual General Meeting, Jun 19, 2024 OSE Immunotherapeutics SA, Annual General Meeting, Jun 19, 2024. Location: 21 rue vercingetorix, paris France Reported Earnings • Mar 31
Full year 2023 earnings released: €1.18 loss per share (vs €0.96 loss in FY 2022) Full year 2023 results: €1.18 loss per share (further deteriorated from €0.96 loss in FY 2022). Net loss: €23.0m (loss widened 30% from FY 2022). Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 30% per year, which means it is performing significantly worse than earnings. Breakeven Date Change • Mar 28
Forecast to breakeven in 2025 The 3 analysts covering OSE Immunotherapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €46.6m in 2025. Average annual earnings growth of 64% is required to achieve expected profit on schedule. Announcement • Feb 27
OSE Immunotherapeutics Provides Update on Clinical Results With OSE-279 in Advanced Solid Tumors OSE Immunotherapeutics SA presented an update on the positive results of OSE-279 in the Phase 1/2 clinical evaluation in advanced solid tumors at the 2024 ESMO Targeted Anticancer Therapies Congress [1] (ESMO TAT) held in Paris, France (February 26 – 28, Abstract #368; FPN 30P). The ESMO-TAT communication reported on the positive results from the Phase 1/2 clinical trial (NCT05751798 [2]) evaluating OSE-279 monotherapy in patients with advanced solid tumors, with no therapeutic option available. The updated data show a good pharmacokinetic/pharmacodynamic (PK/PD) and manageable safety profile in line with previous anti-PD1 development and with a high signal of efficacy in the first 20 patients representing 13 different tumor types. Four confirmed ongoing partial responses (PR) with 600 mg every six weeks (q6w), with a response rate of 36%, were reported in patients with anal squamous cell carcinoma, undifferentiated pleomorphic sarcoma, oncocytic thyroid cancer, and alveolar soft part sarcoma. One still ongoing confirmed PR (81% reduction of target lesions) has been observed in a patient with hepatocellular carcinoma after one single dose of OSE-279 300 mg. Five stable diseases (SD) were reported at multiple dose levels. Treatment is ongoing in seven patients. Pharmacokinetic (PK) showed dose-proportionality and favorable exposure. Receptor occupancy (RO) was maintained. At 600 mg q6w, no dose-limiting toxicities (DLTs) were reported in 10 patients. Further to the recommendation of a Phase 2 dose (RP2D) of 300 mg q3w, the dose of 600 mg q6w has been selected as the second RP2D. OSE-279 is a high affinity humanized anti-PD1 monoclonal antibody blocking both PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells and tumor microenvironment. Overexpression of PD-L1 and PD-L2 on tumor and myeloid cells in the tumor microenvironment is a mechanism of tumor immune escape. The first-in-human open label Phase 1/2 dose escalation and expansion study, initiated in December 2022, aims to determine the Maximum Tolerated Dose (MTD) and/or the RP2D of OSE-279 as a monotherapy in advanced solid tumors with two possible administration regimens. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile. New Risk • Jan 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 17% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-€28m free cash flow). Minor Risks Share price has been volatile over the past 3 months (7.2% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$3.9m). Market cap is less than US$100m (€83.8m market cap, or US$91.3m). Announcement • Dec 11
OSE Immunotherapeutics SA and Nantes University Hospital Presents Positive Interim Data Analysis from the FIRsT Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplant OSE Immunotherapeutics SA and Nantes University Hospital presented positive interim data analysis from first use of anti-CD28 FR104/VEL-101 in kidney transplantation at the Annual Meeting of the Francophone Society of Transplantation(SFT, Société Francophone de Transplantation) held in Brest, France (December 5 – 8, 2023). The oral communication, entitled “First use of FR104, an anti-CD28 molecule in human kidney transplantation, interim analysis”, reported on the first data from the Phase 1/2 clinical trial FIRsT evaluating FR104/VEL-101(emerging locally from the ITUN/CR2TI*) in patients undergoing renal transplant. This study is sponsored and conducted by the University Hospital of Nantes as part of a collaboration agreement with OSE Immunotherapeutics. The purpose of the FIRsT Phase 1/2 clinical trial is to investigate the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as well as its potential clinical efficacy on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors (NCT number: NCT04837092). A longer-term follow-up assessment is performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 is evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events. Ten patient candidates to a first kidney transplant at low risk of rejection, as planned in the protocol, have been included in the FIRsT study for eight analyzable patients (two patients were screened and enrolled but not transplanted for technical reasons). Tacrolimus (a calcineurin inhibitor) was withdrawn after 6 months post-transplantation. Seven patients completed 1-year treatment with FR104/VEL-101 and one is ongoing (Month 4). At this interim analysis, no safety alert was detected for FR104/VEL-101. Adverse events were those conventionally observed in kidney transplantation. Pharmacological monitoring made it possible to optimize exposure to FR104/VEL-101 and to maintain high receptor occupancy during the one-year follow-up. No acute rejection under FR104/VEL-101 was observed, especially after discontinuation of Tacrolimus. One of the key challenges in organ transplantation remains to replace calcineurin inhibitors with efficient immunosuppressive treatments with minimal side effects, particularly on renal function in order to preserve patients’ quality of life, and long-term control of post-transplant immune reaction. Announcement • Oct 24
Ose Immunotherapeutics Sa Announces First Clinical Results for Bi 770371, A Novel Anti-Sirpa Monoclonal Antibody OSE Immunotherapeutics SA announced that first Phase 1 results for BI 770371, a novel anti-SIRPa monoclonal antibody evaluated in advanced solid tumors, have been presented, at the European Society for Medical Oncology conference, held in Madrid, Spain (October 20 - 24, 2023). The BI 770371 development program will extend the therapeutic potential of selective SIRPa antagonists in various diseases or disorders, covering the most prevalent allelic variants of SIRPa, V1 SIRPa and V2 SIRPa expressed on myeloid cells. Boehringer Ingelheim is currently evaluating BI 770371 as monotherapy and in combination with ezabenlimab, a PD1 inhibitor (BI 754091), in an open-label, dose escalation/dose expansion Phase I clinical trial (NCT05327946) conducted in Canada, USA and Japan in patients with advanced solid tumours. The first clinical results of BI 770371 presented at ESMO 2023 conference (Madrid, Abstract #697P) showed that adverse events were manageable during the on-treatment period, Maximal Tolerated Dose (MTD) has not been reached. This clinical trial is ongoing. Boehringer IngELheim is also evaluating BI 765063 (formerly OSE-172) in different combinations with patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC) in a Phase 1b trial conducted in the United States, Europe and Asia (NCT05249426). Reported Earnings • Sep 29
First half 2023 earnings released: €0.64 loss per share (vs €0.11 loss in 1H 2022) First half 2023 results: €0.64 loss per share (further deteriorated from €0.11 loss in 1H 2022). Net loss: €11.9m (loss widened 499% from 1H 2022). Revenue is forecast to grow 103% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 12% per year, which means it is performing significantly worse than earnings. New Risk • Sep 28
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€19m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€19m free cash flow). Share price has been highly volatile over the past 3 months (25% average weekly change). Minor Risks Revenue is less than US$5m (€3.6m revenue, or US$3.8m). Market cap is less than US$100m (€84.4m market cap, or US$89.3m). Breakeven Date Change • Sep 28
Forecast breakeven date moved forward to 2024 The 2 analysts covering OSE Immunotherapeutics previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of €3.57m in 2024. Average annual earnings growth of 135% is required to achieve expected profit on schedule. Announcement • Jul 22
OSE Immunotherapeutics SA Announces Publication in Frontiers in Immunology on Ose-230, Its Novel Agonist Therapy in Chronic Inflammation OSE Immunotherapeutics SA announced the publication of its latest peer-reviewed results on pro-resolutive monoclonal antibody OSE-230, a novel and innovative approach in the management of the resolution of chronic and severe inflammation, in the leading journal Frontiers in Immunology. The article, entitled: "ChemR23 activation reprograms macrophages toward a less inflammatory phenotype and dampens carcinoma progression", reports on ChemR23 expression by Tumor-Associated Macrophages (TAM) and the use of tumor models to explore OSE-230's pro-resolutive and non-immunosuppressive activity in a chronic severe inflammatory situation associated with cancer and metastasis. OSE-230's target, ChemR23, also known as chemerin chemokine-like receptor 1 (CMKLR1), a G-protein coupled receptor (GPCR), is expressed by human TAM, the most frequent infiltrating immune cells in tumors known to modulate pro-tumoral chronic inflammation. The research demonstrated the reprogramming of TAM through the activation of ChemR23 by OSE-230. ChemR23 receptor strongly controls macrophage phenotype and its activation by OSE-230 results in major remodeling of the tumor immune microenvironment by limiting macrophages' immunosuppressive functions, activating T lymphocyte activity as well as modifying the metastatic niche. The research conducted jointly with the CRCI2NA laboratory (Nantes, Principal investigators: Christophe Blanquart and Sophie Barille) has demonstrated the long-term efficacy of OSE-230 based on the strong expression of ChemR23 in a high inflammatory and severe chronic model. With occurrence of metastases reduced and overall survival extended, these data support the durability of OSE-230's agonist effect on chronic and severe inflammation. This makes OSE-230 a first-in-class candidate for IND-enabling studies and opens its development pathway in various chronic inflammatory diseases with significant advantage over immunosuppressive therapies". ChemR23 activation reprograms Macrophages toward a less inflammatory disease and dampens carcinoma progression, Frontiers Immunology Frontiers, Front. Immunol., 19 July 2023, Sec. Cancer Immunity and Immunotherapy, Volume 14 - 2023. Announcement • Jul 12
OSE Immunotherapeutics and Nantes University Hospital Announce Completion of Patient Enrollment in the FIRsT Clinical Trial, a Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplantation OSE Immunotherapeutics and Nantes University Hospital announced the completion of patient enrollment in the FIRsT Study. This Phase 1/2 clinical trial is the first study to evaluate the immunotherapy FR104/VEL-101, a monoclonal antibody fragment CD28 antagonist, in patients undergoing renal transplant. This study is sponsored and conducted by the University Hospital of Nantes as part of a collaboration agreement with OSE Immunotherapeutics. The purpose of this Phase 1/2 clinical trial is to investigate the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as well as its potential clinical efficacy on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors (NCT number: NCT04837092). A longer-term follow-up assessment will be performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 will be evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events. Board Change • Jul 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Employee Shareholder Representative Director & CFO Anne-Laure Autret-Cornet was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Jun 30
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Bernard Malissen was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Announcement • Jun 06
OSE Immunotherapeutics SA Presents Clinical Abstracts on Tedopi at the ASCO 2023 Annual Meeting OSE Immunotherapeutics SA presented a poster and a publication in abstract book featuring Tedopi, an immunotherapy activating tumor specific T-cells, in non-small cell lung cancer (NSCLC) and in ovarian cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6. AddITIONAL data from the POSITIVE PHASE 3 CLINICAL TRIAL IN NSCLC, ATALANTE-1 randomized trial", reported an analysis performed to identify the prognostic factors of overall survival (OS) in each treatment group of the Phase 3 clinical trial of Tedopi®? (Atalante-1) in HLA-A2+ patients with advanced or metastatic non-small cell lung cancer, led by Pr. Benjamin Besse, Gustave Roussy cancer center, Principal Investigator of the study. Tedopi®? is the first cancer vaccine that has shown positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in third line with secondary resistance to immune checkpoint inhibitors in advanced or metastatic NSCLC (Phase 3 trial ATALANTE-1). Classical baseline factors (disease stage, histology) and treatment effect including best response, safety and ECOG Performance Status (PS) deterioration were studied in this analysis and correlated to OS. These results support the mechanism of action of Tedopi®? in improving OS by controlling tumor growth regardless of best response. Announcement • Jun 01
OSE Immunotherapeutics SA, Annual General Meeting, Jun 22, 2023 OSE Immunotherapeutics SA, Annual General Meeting, Jun 22, 2023. Announcement • May 25
OSE Immunotherapeutics and GERCOR Oncology Clinician Group Announces Completion of Patient Enrollment in TEDOPaM Phase 2 Clinical Trial with Tedopi in Advanced Pancreatic Cancer OSE Immunotherapeutics SA announced completion of patient enrollment in the Phase 2 clinical trial TEDOPaM sponsored and conducted by the GERCOR Group and evaluating Tedopi in advanced or metastatic pancreatic ductal adenocarcinoma. This randomized, non-comparative Phase 2 trial is designed to evaluate Tedopi plus FOLFIRI chemotherapy versus FOLFIRI as maintenance treatment in patients (HLA-A2 genotype) with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with no progression after 8 cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial is the one-year overall survival (OS) rate (Fleming- futility analysis; null hypothesis =25%; alternative hypothesis = 50%), and the key secondary endpoint is the progression-free survival [TEDOPaM GERCOR D17-01 PRODIGE 63 study: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma NCT03806309]. The interim results from the TEDOPaM Phase 2 trial presented at the 2022 ASCO (American Society of Clinical Oncology) meeting referred to the first 29 randomized HLA-A2 positive patients with no progression after 8 cycles of FOLFIRINOX: 9 patients included in standard arm A (FOLFIRI) with a 1-year OS rate of 44% and one partial response (11%); 10 patients in experimental arm B (Tedopi monotherapy) with a similar 1-year OS rate of 40% and one partial response (10%); and 10 patients in experimental arm C (nivolumab + Tedopi) with a 1-year OS rate of 30% and no partial response. Tedopi as maintenance monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. Nivolumab + Tedopi was associated with poorer outcomes leading to the closing of this arm. Following an Independent Data Monitoring Committee (IDMC) recommendation, the study continued with an amended protocol comparing a maintenance treatment Tedopi in combination with FOLFIRI versus FOLFIRI chemotherapy after treatment with FOLFIRINOX. A total of 107 patients were enrolled in this second part. Breakeven Date Change • May 23
Forecast to breakeven in 2025 The analyst covering OSE Immunotherapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of €37.2m in 2025. Average annual earnings growth of 34% is required to achieve expected profit on schedule. Reported Earnings • Apr 30
Full year 2022 earnings released: €0.96 loss per share (vs €0.93 loss in FY 2021) Full year 2022 results: €0.96 loss per share (further deteriorated from €0.93 loss in FY 2021). Revenue: €18.3m (down 30% from FY 2021). Net loss: €17.8m (loss widened 5.4% from FY 2021). Revenue is expected to decline by 50% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Germany are expected to grow by 18%. Over the last 3 years on average, earnings per share has fallen by 10% per year whereas the company’s share price has fallen by 9% per year. Announcement • Feb 16
OSE Immunotherapeutics SA Provides Regulatory Update on Tedopi®, a Cancer Vaccine at a Late-Stage Clinical Development in Lung Cancer After Failure to Immunotherapies OSE Immunotherapeutics SA provided a regulatory update on the clinical development plan of Tedopi®, an immunotherapy activating tumor specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure. Both Agencies supported the continuation of the clinical development for Tedopi® through a new confirmatory phase 3 clinical trial versus standard of care in second line treatment for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC). OSE Immunotherapeutics is thus progressing on the protocol development for the next confirmatory phase 3 pivotal trial to support the regulatory registration of Tedopi® in second line. This upcoming phase 3 is planned for HLA-A2+ patients with secondary resistance to immunotherapy (IO) after a first line of chemo-IO followed by failure to maintenance IO of at least 12 weeks (defined as the threshold for secondary/acquired resistance by international expert consensus recommendations). The protocol design is developed with the support of the international NSCLC clinician experts’ group which were already involved in the previous phase 3 ATALANTE trial. Tedopi® is the first cancer vaccine to show positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in third line with secondary resistance to ICI in advanced or metastatic NSCLC. Significant overall survival (primary endpoint) (p=0.017) with 44.4% overall survival rate at 1 year with Tedopi® versus 27.5% with chemotherapy; - Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi® versus 35% with chemotherapy, p<0.05); - Significant better quality of life (Global health status: p=0.045; Role Functioning: p=0.025). The results from the first phase 3 trial (ATALANTE) in a clearly defined target population are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi®’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi® differs from ICI releasing the break of immune response. OSE Immunotherapeutics is committed to provide Tedopi® through cohort early access and nominative compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement. The French National Authority for Health issued a negative decision on the cohort early access program in third line treatment related to the COVID crisis which led to the suspension of patient inclusion in the previous phase 3 ATALANTE and the consecutive primary analysis on a population of interest with secondary resistance. Patients can benefit from Tedopi® through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France, Italy and Spain, confirming thereby the significant medical need for new therapeutic alternatives. Announcement • Dec 22
OSE Immunotherapeutics SA Announces First Patient Dosed with Anti-PD1 Monoclonal Antibody OSE-279 in Phase 1/2 Clinical Trial in Advanced Solid Tumors or Lymphomas OSE Immunotherapeutics SA announced that the first patient has been dosed in the Phase 1/2 clinical trial evaluating OSE-279, a high affinity anti-PD1 blocking monoclonal antibody, in patients with advanced solid tumors or lymphomas. This first-in-human open label Phase 1/2 dose escalation and expansion study aims to determine the Maximum Tolerated Dose and/or the recommended Phase 2 dose of OSE-279 as a monotherapy in advanced solid tumors or lymphomas. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile. OSE-279 is a high affinity humanized anti-PD1 monoclonal antibody blocking both PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells and tumor microenvironment. Overexpression of PD-L1 and PD-L2 on tumor cells and other cell types of the tumor microenvironment is a mechanism of tumor immune escape. OSE-279 is the key anti-PD-1 backbone component of OSE’s bifunctional checkpoint inhibitor BiCKI® platform that is targeting PD1 and other new immune targets. The first cytokine selected to be paired with the anti-PD1 in the bispecific antibody is Interleukin-7 (IL-7), which has been shown at preclinical stage to improve long-term immune functions and cancer immunotherapy efficacy. BiCKI®-IL-7 has potential to address the needs of a patient population in immune escape from checkpoint inhibitor treatment. Given the advantages of owning a proprietary and protected anti-PD1 antagonist antibody in the new era of immuno-oncology, OSE Immunotherapeutics has developed a global intellectual property strategy protecting OSE-279 until at least 2039. This has been achieved through the grant in 2022 of patents for the US, Europe, China, Japan, Korea, Australia and Mexico to date. These patents protect the antibody sequences of OSE-279 associated with its innovative biological and manufacturing properties. Announcement • Dec 12
OSE Immunotherapeutics SA Announces Latest Preclinical Efficacy Data on its Anti-IL-7 Receptor Antagonist OSE-127 in Acute Lymphoblastic Leukemia at the 2022 American Society of Hematology (ASH) Annual Meeting OSE Immunotherapeutics SA presented the latest preclinical data on the use of its anti-IL-7 receptor (IL-7R) antagonist OSE-127 for the treatment of B- and T-Cell Acute Lymphoblastic Leukemia (B- and T-ALL) at the American Society of Hematology (ASH) annual meeting(1) on December 11, 2022 (New Orleans, Louisiana). This oral presentation has received the merit-based “Abstract Achievement Award” from the peer-review committee. The preclinical data on OSE-127 presented at ASH was generated from a collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany). This collaboration is using patient-derived samples and in-vivo xenograft models to evaluate the therapeutic potential of anti-IL-7R antagonist OSE-127 in targeting and blocking the high and dysregulated IL-7R-expression observed in 84% of B- or T-Acute Lymphoblastic Leukemia (ALL) patients. The 2022 ASH presentation, entitled “The IL7R-Antagonist OSE-127 Blocks Acute Lymphoblastic Leukemia Development Via a Dual Mode of Action” (2), reported on the preclinical efficacy of OSE-127 in ALL and on the mechanism of action underlying its anti-leukemic efficacy: In a large prospective ALL patient cohort, IL-7R positivity was detected in more than 84% of cases; Mechanistically, OSE-127 efficiently targeted leukemic cells not only via its IL-7R antagonist activity but also through macrophage-mediated antibody dependent phagocytosis (ADCP); In vivo efficacy of OSE-127 treatment correlated with IL-7R expression levels on patient leukemic cells, independently of IL-7R pathway activity, highlighting IL-7R as a potential predictive biomarker for OSE-127 efficacy in ALL; High preclinical efficacy has been observed both in minimal residual disease (MRD) as well as in overt-leukemia patient derived xenograft (PDX) models; OSE-127 demonstrated preclinical in vivo efficacy as monotherapy in 96% of tested B- and T-ALL Patient Derived Xenografts (PDXs), including samples from relapse and refractory patients; Standard of Care (SOC) poly-chemotherapy synergized with OSE-127 treatment, resulting in increased survival in overt-leukemia settings, with clearance of the disease in 56% of SOC + OSE-127 treated cases; Additional patent applications were filed in 2021 and 2022 to strengthen the global intellectual property of OSE-127 by covering the use of anti-IL-7R antagonist antibodies with macrophage-redirected phagocytic activity for the targeted treatment of IL-7R-positive cancers. Announcement • Nov 23
Ose Immunotherapeutics Announces Publication of Peer-Reviewed Data on Clec-1 OSE Immunotherapeutics SA announced the publication of data in the peer-reviewed journal Science Advances on a first-in-classpreclinical program with CLEC-1, its novel myeloid immune checkpoint target for cancer immunotherapy. Overall, CLEC-1 genetic deletion leads to a profound reinvigoration of the tumor immune microenvironment by enhancing infiltrates of dendritic cell (antigen presenting cells), increasing memory and activated T lymphocyte infiltrates, decreasing infiltrates of exhaustion marker PD1-expressing T lymphocytes and limiting the recruitment of immunosuppressive cells such as myeloid derived suppressor cells (MDSCs). - Importantly, CLEC-1 blockade using monoclonal antibody treatment demonstrates robust anti-tumor activity, also by reinvigorating the tumor immune microenvironment in several preclinical oncology models, thereby faithfully recapitulating the effect of CLEC-1 genetic deletion in the context of human CLEC-1-expressing mice. Proprietary anti-CLEC-1 mAbs increase survival in monotherapy in orthotopic model of hepatocellular carcinoma while combination with chemotherapy increases preclinical tumor eradication in colon carcinoma model. Announcement • Nov 03
Servier and OSE Immunotherapeutics Announce Completion of Patient Enrollment in the Phase 2a Clinical Trial of OSE-127/S95011 in Primary Sjögren’s Syndrome OSE Immunotherapeutics SA announced the completion of patient enrollment in the Phase 2a clinical trial evaluating the efficacy and safety of monoclonal antibody OSE-127/S95011 in primary Sjögren’s syndrome. This international, randomized, double-blind, placebo-controlled, Phase 2a study is designed to evaluate the efficacy and tolerance of the monoclonal antibody named OSE-127/S95011 in primary Sjögren’s syndrome. The study includes 48 patients across a score of centers located in the United States, Australia and Europe. Results are expected in 2023. OSE-127/S95011, for which Servier has worldwide rights, is being developed in partnership between OSE Immunotherapeutics and Servier via a collaboration agreement, with the possibility for Servier to exercise a licensing option. Two clinical studies evaluating OSE-127/S95011 are ongoing: a Phase 2a study conducted by Servier in primary Sjögren’s syndrome and a Phase 2 study conducted by OSE Immunotherapeutics in ulcerative colitis. Announcement • Oct 21
OSE Immunotherapeutics SA Updates on Tedopi®, Cancer Vaccine as Potential New Standard of Care in Non-Small Cell Lung Cancer After Failure to Immunotherapies OSE Immunotherapeutics SA provides an update on Tedopi®, an immunotherapy activating tumor specific T-cells, developed in advanced or metastatic non-small cell lung cancer (NSCLC), ovarian cancer and pancreatic cancer. Authorizations for compassionate use of Tedopi® in NSCLC have recently been granted by Health Agencies in Europe. Regulatory meetings are planned to validate the confirmatory Phase 3 clinical trial in NSCLC. Tedopi® is the first cancer vaccine to show clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) post-immune checkpoint inhibitors (ICI) failure in advanced or metastatic NSCLC: Significant overall survival (primary endpoint) (p=0.017, HR=0.59) with 44.4% overall survival (OS) rate at 1 year with Tedopi® versus 27.5% for chemotherapy and a meaningful gain of median OS of 3.6 months (ESMO 2021); Improved post-progression survival benefit in the Tedopi® arm (7.7 months versus 4.6 months, p=0.004, HR=0.46) (ESMO 2021); Significant delayed median time to worsening ECOG performance status with a difference of 5.3 months (p<0.01, HR=0.43) (ASCO 2022); Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi® versus 35% with chemotherapy, p<0.05) (ESMO 2021); Significant better Quality of Life (Global health status: p=0.045; Role Functioning: p=0.025) (ASCO 2022) and positive Net Treatment Benefit (p=0.032) with Tedopi® compared to chemotherapy (ESMO 2022). These positive clinical results in a clearly-defined target population for this first Phase 3 trial are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi®’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi® differs from ICI releasing the break of immune response. The significant medical need for new therapeutic options in NSCLC patients post-ICI failure associated with promising efficacy, safety and quality of life data resulted in authorizations for compassionate use of Tedopi® from Health Agencies in Europe - in France, Italy and Spain -in third line post-chemotherapy and immunotherapy. The medical need in this targeted population with high mortality previously led to an orphan drug designation by the FDA, while Tedopi® was recognized as a precision medicine in Europe for the treatment of HLA-A2 positive NSCLC patients. Announcement • Oct 08
OSE Immunotherapeutics SA Appoints Nicolas Poirier as Chief Executive Officer OSE Immunotherapeutics SA announce the appointment of Dr. Nicolas Poirier as new Chief Executive Officer, effective immediately. This appointment follows the decision of the Board of Directors to terminate the mandate of Alexis Vandier. Throughout his career, Dr. Nicolas Poirier has demonstrated both his expertise as an international scientific leader, pioneering the discovery and development of innovative immunotherapies, and in-depth knowledge of the biotech sector through various strategic leadership roles. He has been instrumental in the development of OSE Immunotherapeutics, notably as the initiator of 5 programs in the Company's portfolio that are now in clinical stage. He also played a major role in the signature of 4 strategic pharmaceutical partnerships for OSE Immunotherapeutics. Nicolas Poirier holds a PhD in Immunology (European Center for Transplantation and Immunotherapy Sciences, Nantes), a double master's degree in Biotechnology from the University of Nantes and in Pharmacology from the University of Louis Pasteur in Strasbourg and a certification in Global Management from INSEAD. Nicolas Poirier has been Chief Scientific Director and member of the management team of OSE Immunotherapeutics since 2016. He started his career at Tcl Pharma in 2009 as a researcher, became Project Manager at Effimune in 2012, then Director of R&D programs in 2014. In addition, Nicolas Poirier in an active member of the Strategic and Scientific Advisory Committee (COSSF) of the French biomedical industry association (MabDesign). Over the past fifteen years, he has authored more than 50 peer-reviewed international scientific publications and holds over 40 issued patents in the field of immunotherapy. Nicolas Poirier and his team have obtained more than 45 million euros in French and European public funding to co-finance OSE Immunotherapeutics’ research and development programs. Reported Earnings • Sep 24
First half 2022 earnings released: €0.11 loss per share (vs €0.64 loss in 1H 2021) First half 2022 results: €0.11 loss per share (improved from €0.64 loss in 1H 2021). Revenue: €16.0m (up 79% from 1H 2021). Net loss: €1.98m (loss narrowed 83% from 1H 2021). Revenue is expected to decline by 25% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 19%. Over the last 3 years on average, earnings per share has fallen by 31% per year but the company’s share price has increased by 18% per year, which means it is well ahead of earnings. Announcement • Sep 07
Ose Immunotherapeutics to Present New Data on Tedopi® from Phase 3 Clinical Trial in Patients with Advanced Non-Small Cell Lung Cancer After Failure to Immune Checkpoint Inhibitors At Esmo Congress 2022 OSE Immunotherapeutics SA announces the presentation of two new analyses from the Phase 3 Atalante-1 study of immunotherapy Tedopi®, in patients with advanced non-small cell lung cancer (NSCLC) in secondary resistance after failure of previous checkpoint inhibitor treatments, at the 2022 European Society for Medical Oncology (ESMO) Congress, being held September 9-13, in Paris. The first analysis compared Tedopi® to the Standard of Care (SoC) in patients with advanced NSCLC after secondary resistance to sequential use of chemotherapy followed by immunotherapy (CT-IO). The results have shown that in advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (n=118), overall survival (OS) was longer with Tedopi® versus SoC regardless of the use (or not) of post progression anticancer treatment (with 13.5 months versus 10.6, HR=0.71; without 6.3 months versus 4.5, HR=0.76). This analysis will be presented by Dr. Maria Rosario Garcia Campelo (Head of Medical Oncology Department, Thoracic Tumors Unit, Investigator of Atalante-1 study, University Hospital A Coruña, Spain). The second analysis assessed the overall benefit/risk of Tedopi® versus SoC chemotherapy in patients with NSCLC who failed therapy with immune checkpoint inhibitors. The Net Treatment Benefit (NTB), a new statistical method combining efficacy, safety and quality of life, was assessed in the overall population (n=219). NTB of Tedopi® was of 19% and reached statistical significance (p=0.035). This analysis will be presented by Dr. Marc Buyse, (Founder and Chief Scientific Officer, International Drug Development Institute (IDDI), Brussels, Belgium). Announcement • Jul 14
OSE Immunotherapeutics SA Appoints Alexis Vandier as Chief Executive Officer OSE Immunotherapeutics SA announced the appointment of Alexis Vandier as Chief Executive Officer, effective immediately. Alexis Vandier brings an impressive track record of successes in Pharma across a range of international roles and therapeutic areas, including oncology. Alexis served as Vice-President – Global Asset Lead at Ipsen, heading their efforts to build a leading oncology platform, including their lead tyrosine kinase inhibitor (Cabometyx®, cabozantinib) which Alexis helped launch and reach its full commercial potential in various solid tumor indications and across 40 countries. Alexis also managed partnerships with Exelixis in the U.S., as well as with Roche and BMS (co-development in combination with nivolumab and atezolizumab). Alexis’ broad international and proven leadership experience were acquired over the last 20 years in various pharma positions. First at Sanofi where he spent 11 years in Corporate Strategy and Business Development, in Finance and Marketing, then 12 years spent at Ipsen working directly with Marc de Garidel in different global roles in Strategy, Business Development, Alliance management and Innovation/Marketing across multiples geographies (EU, Asia and U.S.). Alexis also became General Manager of Ipsen France where he accelerated the development of Ipsen around medical, market access and external affairs, driving successful launches in oncology and rare diseases. Alexis is a graduate of Ecole Centrale de Lyon and holds a master’s degree in engineering from the University of Economics, Lyon II. Announcement • Jun 24
OSE Immunotherapeutics SA, Annual General Meeting, Jun 23, 2022 OSE Immunotherapeutics SA, Annual General Meeting, Jun 23, 2022. Agenda: To consider the approval of the annual and consolidated financial statements as of December 31, 2021; to consider the renewal of the term of office as director of Maryvonne Hiance, Didier Hoch and Nicolas Poirier (director representing the employee shareholders), which expired at this General Meeting, for three years and to consider the appointment of Alexandre Lebeaut as a new independent Director. Announcement • May 04
Boehringer Ingelheim and OSE Immunotherapeutics Announce First Patient Dosed in a Phase 1 Expansion Trial of SIRPa Antagonist Monoclonal Antibody BI 765063, Targeting Myeloid Cells in Immuno-Oncology Boehringer Ingelheim and OSE Immunotherapeutics SA announced a new step achieved through their global collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063, a first-in-class SIRPa inhibitor on the SIRPa/CD47 myeloid pathway. In particular, a milestone has been achieved upon the first patient dosed in the Phase 1 expansion trial conducted by Boehringer Ingelheim in difficult to treat advanced cancers. This international Phase 1 aims at evaluating BI 765063 in patients with recurrent/metastatic hepatocellular carcinoma (HCC) or head and neck squamous cell carcinoma (HNSCC). BI 765063 is being evaluated in parallel in Europe in combination with Ezabenlimab in a Phase 1 expansion clinical trial in patients with microsatellite stable (MSS) advanced colorectal cancer and MSS advanced endometrium cancer whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors. The study is being conducted by OSE Immunotherapeutics. Announcement • May 03
OSE Immunotherapeutics SA Announces New European Patent Granted Covering CLEC-1, Novel Myeloid Immune Checkpoint Target for Cancer Immunotherapy OSE Immunotherapeutics SA announced the grant of a new patent from the European Patent Office strengthening the protection covering its novel myeloid cell immune checkpoint target, CLEC-1 (a C-type lectin receptor), and its use in cancer treatment. This patent provides a protection until 2037. CLEC-1 is a C-type lectin receptor with demonstrated potential to inhibit the functions of myeloid cells and to block anti-tumor responsiveness of T-lymphocytes. Myeloid cells have the ability to accumulate in the tumor microenvironment and deregulate the immune activation of T-lymphocytes. CLEC-1 is a new therapeutic target of interest in immuno-oncology. Announcement • Apr 06
OSE Immunotherapeutics Invited to Present Preclinical Data on its PD-1/IL-7 Bifunctional Program BiCKI®-IL-7 Cancer Immunotherapy OSE Immunotherapeutics SA announced that the Company is invited to present the latest progress on its bispecific antibody checkpoint inhibitor BiCKI® platform, and in particular on its bifunctional therapy targeting PD-1 and the Interleukin-7 (IL-7) cytokine, BiCKI®-IL-7, during a plenary oral presentation in an educational session dedicated to immunocytokines at the American Association Cancer for Research (AACR) annual meeting to be held on April 8 – 13, 2022 in New Orleans, Louisiana. BiCKI®-IL-7 is a bifunctional therapy which targets PD-1 and at the same time provides IL-7 cytokine to restore exhausted T cell function, to disarm Treg suppressive activity and to extend stem-like memory T cells able to reconstitute the memory and effector T cells. This immunotherapy has potential to address the high medical need of patients with cancers with primary or secondary resistance (1) or that are refractory to immune checkpoint inhibitor treatments. In parallel to the ongoing late-stage preclinical testing, the industrial development of BiCKI®-IL-7 has been recently initiated, representing another critical step in the product’s development. The BiCKI® platform, and in particular the bifunctional therapy BiCKI®-IL-7v, preferentially delivers the IL-7 cytokine at the heart of the tumor microenvironment (TME) where T PD1+ lymphocytes accumulate in response to immunotherapy. This TME-driven IL-7 immunocytokine has a well differentiated biodistribution compared to other cytokines being currently developed. In addition, the BiCKI®-IL-7v immunocytokine significantly improves the quality and durability of memory T lymphocytes in the tumor microenvironment (with T lymphocyte stem cells without immune exhaustion), this IL-7 T cell-specific profile is very different from other cytokines developed which increase the quantity of T cells while accelerating the exhaustion process of the immune response. Breakeven Date Change • Apr 01
No longer forecast to breakeven The 4 analysts covering OSE Immunotherapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €3.45m in 2023. New consensus forecast suggests the company will make a loss of €13.3m in 2024. Announcement • Mar 31
OSE Immunotherapeutics SA to Report Fiscal Year 2021 Results on Mar 30, 2022 OSE Immunotherapeutics SA announced that they will report fiscal year 2021 results on Mar 30, 2022 Announcement • Mar 10
Boehringer Ingelheim and OSE Immunotherapeutics to Present Biomarker Analyses From the Phase 1 Clinical Trial With First-in-Class SIRPa Inhibitor BI 765063 in Advanced Solid Tumors OSE Immunotherapeutics announced that early biomarker analyses from the ongoing Phase 1 clinical trial with SIRPa inhibitor BI 765063 in patients with advanced solid tumors have been selected for presentation (1) in an in-person poster session at the American Association Cancer for Research (AACR) annual meeting to be held on April 8 – 13, 2022 in New Orleans, Louisiana. The goal of the biomarker analyses from the Phase 1 trial with first-in-class SIRPa inhibitor BI 765063 was to characterize the impact of the product on peripheral blood immune cells (PBMCs), as well as on the tumor microenvironment. The early biomarker analyses of paired tumor biopsies from patients with a wide range of solid tumors and treated with BI 765063 show encouraging signs of mode-of-action related changes, both in peripheral blood and in the tumor, in particular an increase in CD8 T-cell infiltration and activation. These new data confirm preclinical results showing that T lymphocytes initially blocked at the tumor’s margin could penetrate efficiently into the tumor when blocking SIRPa in parallel. Crossing this barrier is associated with positive modulation of macrophage expression and secretion of chemokines allowing the penetration of T lymphocytes into the heart of the tumor. The Phase 1 clinical trial with BI 765063 is being conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063. BI 765063, a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPa selectively blocks the SIRPa/CD47 interaction and thus increases the function of myeloid cells: phagocytosis of tumor cells by macrophages and presentation of tumor antigens by dendritic cells. BI 765063 is also a selective inhibitor of SIRPa that by virtue of this specificity and lack of binding and blocking of a very similar receptor called SIRP?, ensures that response of T lymphocytes is retained to enable T cell-mediated tumor killing. BI 765063 (OSE-172, anti-SIRPa mAb on CD47/SIRPa pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy and in combination with ezabenlimab (PD-1 antagonist); ongoing expansion Phase 1. Announcement • Feb 19
OSE Immunotherapeutics SA Appoints Alexandre Lebeaut as Independent Member of the Board of Directors OSE Immunotherapeutics SA announced the appointment by cooptation of Alexandre Lebeaut as an independent Director of the Company. Alexandre Lebeaut has more than 25 years of a valuable experience and leadership both in innovation, research and development, from preclinical to post-marketing stage and with major achievements in particular in immunology, oncology, immuno-inflammation and infectious diseases. He has held various global positions, notably in the United States at Bluebird Bio, Sanofi, Novartis and Schering Plough Research Institute. Most recently, Alexandre Lebeaut served as Executive Vice-President R&D and Chief Scientific Officer at Ipsen in the US. He currently heads I-ACT for Children (Institute for Advanced Clinical Trials), an American non-profit organization based in Maryland which is dedicated to pediatric drug development. Announcement • Feb 01
OSE Immunotherapeutics SA Announces Acceptance of the US Investigational New Drug Application Obtained by Veloxis Pharmaceuticals, Inc., Its Partner in Transplantation, for CD28 Antagonist VEL-101/FR104 OSE Immunotherapeutics announced acceptance of the IND obtained by Veloxis Pharmaceuticals Inc. from the Food & Drug Administration for a clinical trial with VEL-101/FR104, a CD28 antagonist monoclonal antibody fragment. This trial will be sponsored and conducted by Veloxis Pharmaceuticals Inc. in the United States. This important milestone has been achieved by Veloxis Pharmaceuticals Inc. as part of the global license agreement signed in April 2021 under which Veloxis Pharmaceuticals Inc. obtained from OSE Immunotherapeutics worldwide rights to develop, manufacture and commercialize FR104, a CD28 antagonist monoclonal antibody fragment, for all transplant indications. Under this agreement, acceptance of the US IND application has triggered a milestone payment of €5 million from Veloxis Pharmaceuticals Inc. to OSE Immunotherapeutics. In parallel, OSE Immunotherapeutics retains all product rights to develop FR104 in autoimmune diseases. Announcement • Jan 26
OSE Immunotherapeutics Receives First Notice of Allowance of a Patent for Use of Tedopi after Failure with PD-1 or PD-L1 Immune Checkpoint Inhibitor Treatment in HLA-A2 Positive Cancer Patients OSE Immunotherapeutics SA announced that the Japanese Patent Office has issued the notice of allowance for a new patent covering Tedopi, a combination of neoepitopes, for use after failure with PD-1 or PD-L1 immune checkpoint inhibitor treatment in HLA-A2 positive cancer patients. This patent, which will further strengthen Tedopis global intellectual property portfolio in immuno-oncology, will provide the product with a new protection until 2037. This new patent recognises the innovation of a multiepitope composition (all peptides included in Tedopi) administered after immune checkpoint inhibitor (progression of the cancer), in particular in secondary resistance situation. In addition, it further supports the products clinical development focus and the positive results of the Atalante 1 Phase 3 trial of Tedopi in patients with advanced non-small cell lung cancer (NSCLC) with secondary resistance to PD-1/PD-L1 immune checkpoint inhibitor, a hard-to-treat patient population with high unmet medical need. Based on the finalized positive results of Atalante 1, company are preparing discussions with regulatory agencies on optimal paths for potential approval of Tedopi in patients with NSCLC in secondary resistanceafter immune checkpoint inhibitor treatment. The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial. Tedopi demonstrated a favourable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2 positive NSCLC patients with secondary resistance to PD-1 or PD-L1 immune checkpoint inhibitors. Announcement • Nov 30
OSE Immunotherapeutics Provides an Update on the First Positive Results and Clinical Development of CoVepiT, Its Multi-Target T-Cell Anti-COVID Vaccine OSE Immunotherapeutics announced the positive analysis of the first data of CoVepiT, its prophylactic vaccine candidate against COVID-19, in particular positive interim immunological results on T cell response obtained in 100% of the treated population, with in parallel a resolution of local indurations observed during vaccination. Last July, the company voluntarily suspended the recruitment and administration of CoVepiT in the Phase 1 clinical trial as a precaution due to a limited number of adverse reactions (nodule-like indurations at the injection site) grade 1 and a grade 2 adverse reaction in one participant. Since then, the data have been analyzed regularly with the Independent Safety Monitoring Committee in charge of evaluating the safety of the trial and the Ghent (Belgium) investigation center. The indurations were resolved within a few weeks for most of the participants (without systemic reaction, without fever, nor inflammation, without local ulceration) and the follow-up continues to show a good safety profile. This profile, with frequent indurations, is close to that of vaccines inducing T cell responses (1;2;3) and is regularly linked to this T cell mechanism of action. The immunological response was measured on the eight healthy volunteers who received CoVepiT, showing the expected efficacy at six weeks after the injection, the primary endpoint of the phase 1 trial, with good immunogenicity of the T cells against the viral epitopes. Interferon-gamma responses measured by Elispot was observed in 100% of participants, from the 22nd day to the 6th week. These immunological results are significantly better than those obtained in convalescent patients and confirm the interest and the mechanism of action of the vaccine on the T cell response. In addition, new preclinical studies have shown that the intensity and the quality of the immunogenicity of the T cells induced by the CoVepiT vaccine were not altered by concomitant immunosuppressive treatments such as antimetabolites (mycophenolate mofetil, MMF, inhibiting immunosuppressant proliferation of B and T cells) or by a strong depletion of B cells producing antibodies (observed with rituximab, used in autoimmune diseases and certain cancers). The interest in generating T cells is enhanced especially for immunocompromised patients with weak antibody responses despite repeated administration of current registered vaccines. Reported Earnings • Sep 23
First half 2021 earnings released: €0.64 loss per share (vs €0.21 loss in 1H 2020) The company reported a mediocre first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: €8.98m (up 53% from 1H 2020). Net loss: €11.5m (loss widened 269% from 1H 2020). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 151 percentage points per year, which is a significant difference in performance. Announcement • Sep 13
OSE Immunotherapeutics SA to Present Phase 1 Results with First-In-Class Sirpa Inhibitor Bi 765063 in Advanced Solid Tumors At Esmo 2021 OSE Immunotherapeutics SA announced that promising data from dose escalation Phase 1 of selective SIRPa inhibitor BI 765063 in patients with advanced solid tumors (ePoster 983P) will be presented at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference to be held on September 16 –21, 2021. This Phase 1 clinical trial aims to evaluate the safety and efficacy of BI 765063 as monotherapy and in combination with ezabenlimab (BI 754091; anti-PD-1 mAb) in patients with advanced solid tumours. The dose escalation part (Step 1) of the Phase 1 trial has enrolled SIRPa V1/V1 homozygous or V1/V2 heterozygous patients with advanced solid tumours who failed or were not eligible for standard therapies. Two dose levels of BI 765063 (18 and 24 mg/kg IV every 3 weeks) were evaluated in combination with BI 754091 (240 mg IV every 3 weeks). Micro Satellite Instable (MSI) biomarkers are recognized as effective for immunotherapy by checkpoint inhibitor alone. The majority of colorectal and endometrial cancers are MSS and achieve limited benefit from immune checkpoint inhibitor monotherapy. Updated data of June 2021 on this dose escalation part of Phase 1 will be featured in an ePoster presentation at the upcoming 2021 ESMO meeting. The Phase 1 clinical study of BI 765063 is being conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to the product. Announcement • Aug 27
OSE Immunotherapeutics and ARCAGY-GINECO Announce First Patient Randomized in Phase 2 Clinical Trial Evaluating Tedopi in Combination with Pembrolizumab in Ovarian Cancer OSE Immunotherapeutics and ARCAGY-GINECO announced that the first patient has been randomized in the Phase 2 clinical trial evaluating Tedopi alone and in combination with MSD’s Keytruda (pembrolizumab) as maintenance treatment in patients with recurrent ovarian cancer after chemotherapy (the TEDOVA trial). The three arm TEDOVA study aims at evaluating the neo-epitope-based vaccine Tedopi as a maintenance treatment, alone or in combination with anti-PD-1 immune checkpoint inhibitor Keytruda, versus best supportive care in patients with first or second platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy and who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor. Patients with ovarian cancer do not respond to checkpoint inhibitors (ICI) alone because these tumors are ‘immune cold’. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor using a combination of tumor associated neo-epitopes that have been optimized to break immunological self-tolerance. This Phase 2 trial, sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)” on behalf of GINECO, is designed to enroll 180 patients and will be conducted at approximately 30 sites in France and around 12 sites in Germany and Belgium. Announcement • Aug 26
Servier and OSE Immunotherapeutics SA Announces Enrollment of First Patient in OSE-127/S95011 Phase 2 Clinical Trial in Sjögren’s Syndrome Servier and OSE Immunotherapeutics SA have announced enrollment of the first patient in the Phase 2 clinical trial of OSE-127/S95011 in Sjögren’s syndrome, with Servier sponsorship. This international, randomized, double-blind, placebo-controlled Phase 2 study aims to evaluate the efficacy and safety of OSE-127/S95011 in patients with Sjögren's syndrome. Sjögren's syndrome is an autoimmune disease characterized by lymphoid infiltration of the salivary and lacrimal glands leading to dry mouth and eyes. Sjögren's syndrome is one of the most common chronic systemic autoimmune diseases, with an incidence of 60.82 per 100,000 people, according to a meta-analysis of epidemiological studies in Sjögren’s syndrome. OSE-127/S95011 is being developed in partnership with OSE Immunotherapeutics as part of a collaboration agreement with license option upon completion of two Phase 2 clinical studies, and exercise of the option by Servier. An initial Phase 2 study under the sponsorship of OSE Immunotherapeutics is currently underway in ulcerative colitis. As part of the agreement, two milestone payments are planned in favor of OSE Immunotherapeutics: An initial payment of EUR 5 million upon enrollment of the first patient in the Phase 2a clinical study and, if Servier exercises the option, a EUR 15 million payment upon completion of the two Phase 2 clinical studies. Announcement • Jul 20
OSE Immunotherapeutics SA Announces Voluntary Pause of Enrollment in the CoVepiT Phase 1 Study OSE Immunotherapeutics SA announced a voluntary and temporary pause of enrollment and dosing in its ongoing Phase 1 clinical trial for CoVepiT, the company’s investigational prophylactic COVID-19 vaccine candidate. OSE Immunotherapeutics notified the Belgian Health Authorities that the Company is voluntarily pausing its Phase 1 clinical study of CoVepiT in healthy volunteers. This pause was decided after receiving a preliminary update by the trial’s principal investigator at the Center for Vaccinology, Ghent University, regarding a limited number of Grade 1 and one Grade 2 adverse events, in particular, persistent nodules around injection points (subcutaneous, with no pain, no inflammation, no fever, no impact on everyday life and without any systemic symptoms). Out of an abundance of caution, and in agreement with the independent Safety Monitoring Committee (SMC), the Company has decided to voluntarily pause dosing in its ongoing clinical study and assess the evolution of these nodules before determining the best way forward for this product and its target population. The Company will carefully review all available data to determine the future clinical development strategy of CoVepiT. About CoVepiT: CoVepiT is a next-generation multi-target, multi-variant vaccine against SARS-CoV-2 designed to generate robust CD8 T cell responses and supported by Bpifrance1,2 and in clinical Phase 1 (EudraCT 2021-000572-11 and clinicaltrials.gov identifier: NCT04885361). The study seeks to assess CD8+ T Cell responses to spike and additional non-spike antigens from SARS-CoV-2 with aim of augmenting clinical protection against spike variants of concern. The vaccine candidate was designed using optimized epitopes selected after screening more than 67,000 global SARS-CoV-2 genomes, as well as those of previous human-infective CoVs, SARS and MERS, to identify vaccine targets with the lowest chance of natural mutation. Targeting 11 virus proteins including Spike, M, N and several nonstructural proteins, this second-generation vaccine covers all initial and novel SARS-CoV-2 variants identified globally to date. In preclinical testing, CoVepiT demonstrated the ability to activate T cell defenses through CD8 T-cell multi-epitope responses for long-term T memory cell immunity. Announcement • May 28
Ose Immunotherapeutics and the Fort Foundation Announce Initiation of A Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Opdivo® (Nivolumab) in Non-Small Cell Lung Cancer OSE Immunotherapeutics and the FoRT Foundation(Fondazione Ricerca Traslazionale) announced that the Italian Medicines Agency (AIFA) and the Italian Ethics Committee approved the initiation of a new Phase 2 clinical trial evaluating Tedopi® in combination with Opdivo® or chemotherapy as second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC). This three-arm Phase 2 study will evaluate neo-epitope-based vaccine Tedopi® in combination with Bristol Myers Squibb’s Opdivo® (nivolumab), an immune checkpoint inhibitor, or Tedopi® plus chemotherapy or chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy. The clinical trial will be sponsored by the Italian oncology Foundation FoRT. It will be supported by Bristol Myers Squibb, which will provide Opdivo®, and by OSE Immunotherapeutics, which will provide Tedopi® for the study as well as a partial financial support. This clinical trial will be sponsored and conducted by the Italian Oncology Foundation FoRT and supported by Bristol Myers Squibb and OSE Immunotherapeutics. The study will explorethe strategy of combining a PD-1 targeted checkpoint inhibitor with Tedopi® as a second-line treatment in patients with metastatic non-small cell lung cancer after first-line chemo-immunotherapy. Announcement • May 26
OSE Immunotherapeutics Announces Dosing of the First Healthy Volunteer in Phase 1 Clinical Trial of its Multi-Variant Second-Generation COVID-19 Vaccine OSE Immunotherapeutics announced that the first healthy volunteer has been enrolled and dosed in the Phase 1 clinical trial evaluating its COVID-19 vaccine, named CoVepiT. This Phase 1 clinical trial is evaluating the safety, reactogenicity and immunogenicity of two dose regimen of CoVepiT in 48 healthy adult volunteers, previously vaccinated or not by an authorized COVID-19 vaccine (NCT04885361). The Phase 1 clinical trial of CoVepiT is based on the results from preclinical and human ex vivo studies demonstrating its potential to generate sentinel memory T cells with long-term protective effect against COVID-19. Targeting 11 virus proteins (including Spike, M, N and several non-structural proteins), this second-generation vaccine is designed to cover all initial and novel or upcoming SARS-CoV-2 variants. Announcement • May 21
OSE Immunotherapeutics SA and Boehringer Ingelheim to Present Positive Phase 1 Results with First-In-Class Sirpa Inhibitor Bi 765063 in Advanced Solid Tumors At Asco 2021 OSE Immunotherapeutics SA announced acceptance of an upcoming poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 4 – 8, 2021, covering promising initial data from Phase 1 dose escalation of selective SIRPa inhibitor BI 765063 in patients with advanced solid tumors (Abstract #2623). The data to be presented at ASCO 2021 indicate that OSE Immunotherapeutics’ first-in-class signal regulatory protein a (SIRPa) inhibitor BI 765063 was well-tolerated, showed sustained receptor occupancy (RO) saturation and monotherapy activity. Clinical benefit was observed in 45% of patients evaluable per RECIST* criteria. A durable partial response was observed in an advanced hepatocellular carcinoma (HCC) patient, and the on-treatment biopsy of the responder showed an increase in CD8 T-cell infiltration and activation. Furthermore, the on-treatment biopsy also showed an increase in PD-L1 expression on tumor cells. A BI 765063 dose escalation study in combination with Ezabenlimab (PD-1 antagonist) is ongoing and will help determine the recommended dose for further Phase 2 clinical development in patients with advanced solid tumors. Announcement • Apr 27
Veloxis Pharmaceuticals, Inc entered into a global license agreement to acquire Worldwide Rights to FR104 from OSE Immunotherapeutics SA (ENXTPA:OSE). Veloxis Pharmaceuticals, Inc entered into a global license agreement to acquire Worldwide Rights to FR104 from OSE Immunotherapeutics SA (ENXTPA:OSE) on April 26, 2021. Pursuant to the transaction, OSE Immunotherapeutics will receive up to €315 million in potential milestones from Veloxis, including a €7 million upfront payment. Reported Earnings • Mar 29
Full year 2020 earnings released: €1.06 loss per share (vs €0.31 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €10.4m (down 60% from FY 2019). Net loss: €16.6m (loss widened 256% from FY 2019). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 117 percentage points per year, which is a significant difference in performance. Announcement • Mar 15
OSE Immunotherapeutics Sa and ARCAGY - GINECO Announces Initiation of A Randomized Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Pembrolizumab in Ovarian Cancer OSE Immunotherapeutics and the French cooperative group ARCAGY-GINECO announced that the French National Agency for Medicines and Health Products Safety and the French Central Ethic Committee approved the initiation of a new Phase 2 clinical trial evaluating Tedopi® in patients with recurrent ovarian cancer (the TEDOVA trial). Tedopi® will be evaluated alone and in combination with Merck’s Keytruda® (pembrolizumab), an immune checkpoint inhibitor, as maintenance treatment in ovarian cancer patients after chemotherapy. The three arm TEDOVA study will evaluate neo-epitope-based vaccine Tedopi® as a maintenance treatment, alone or in combination with anti-PD-1 Keytruda®, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy. The clinical trial is sponsored by the “Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)” on behalf of GINECO, lead group for the TEDOVA trial of the European Network for Gynaecological Trial Groups (ENGOT). It will be supported in part by a research grant from the Investigator-Initiated Studies Program of MSD (Merck Sharp & Dohme Corp), a subsidiary of Merck & Co. Inc.”, which will provide Keytruda® (pembrolizumab), and by OSE Immunotherapeutics which will provide Tedopi® for the study as well as partial financial support. Announcement • Mar 13
OSE Immunotherapeutics SA to Present New Data Reflecting Expansion and Progress on Its Immuno-Oncology and Inflammation Preclinical Portfolio At the 2021 Aacr Annual Meeting OSE Immunotherapeutics SA announced that new preclinical data has been selected for e-poster presentations at the American Association of Cancer Research (AACR) Virtual Annual Meeting I, to be held on April 10 - 15, 2021. The presentations will include data on the novel “Don’t Eat Me” signal myeloid immune checkpoint target CLEC-1 (a C-type lectin receptor), BiCKI-IL-7 bifunctional therapy targeting PD-1 and IL-7 and OSE-230, a novel monoclonal antibody agonist therapy driving resolution of chronic inflammation. CLEC-1 is a recently identified C-type lectin receptor with demonstrated potential to block the suppressive functions of myeloid cells and to restore anti-tumor responsiveness of T-lymphocytes. Suppressive myeloid cells have the ability to accumulate in the tumor microenvironment and deregulate the immune activation of T-lymphocytes. CLEC-1 is a new therapeutic target of interest in immuno-oncology. BiCKI®-IL-7, a novel bispecific therapy combining anti-PD-1 and the cytokine IL-7, has potential to help in overcoming tumor resistance mechanisms to anti-PD(L)-1 therapies and will potentially address the high medical need of patients whose cancer is refractory to immune checkpoint inhibitor treatments. The combined research data collected to date validate the strong therapeutic potential of providing IL-7 signals to strengthen PD-1 therapy and prevent immuno-resistance by sustaining T cell response and overcoming Treg suppression. The bispecific BiCKI® IL-7 mutein can preferentially deliver and activate IL-7 pathway on tumor reactive T cells, limiting the risk of immunotoxicity resulting from combination immunotherapies. Is New 90 Day High Low • Feb 23
New 90-day high: €15.00 The company is up 119% from its price of €6.84 on 24 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €429 per share. Announcement • Feb 18
OSE Immunotherapeutics SA Announces Granting of First European Patent Protecting Anti-Il-7 Receptor Antagonist OSE-127/S95011 OSE Immunotherapeutics SA announced that it has strengthened intellectual property rights for its anti-interleukin-7 receptor (IL-7R) antagonist OSE-127/S95011 through the granting of a first patent by the European Patent Office. The patent covers the product and its therapeutic applications in autoimmune and inflammatory diseases through 2037. OSE-127/S95011 is being developed in partnership with Servier under an option agreement up to the completion of both Phase 2 clinical studies and exercise of the option upon successful completion of at least one of these Phase 2 trials. The Phase 2 trial in ulcerative colitis is being conducted under OSE Immunotherapeutics’ sponsorship while in parallel, another Phase 2 in Sjögren’s syndrome is planned to start shortly under Servier’s sponsorship. OSE is eligible to receive a €5 million milestone payment from Servier upon enrollment of the first patient in the Sjögren’s syndrome Phase 2. Is New 90 Day High Low • Feb 03
New 90-day high: €10.00 The company is up 40% from its price of €7.16 on 05 November 2020. The German market is up 16% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €698 per share. Announcement • Jan 29
OSE Immunotherapeutics Expands its Collaboration with MAbSilico to Use Artificial Intelligence to Accelerate Drug Development of Novel Antibody Therapeutics OSE Immunotherapeutics announced a new collaboration agreement with MAbSilico to use artificial intelligence (AI)-based software for therapeutic monoclonal antibody drug development. OSE Immunotherapeutics and MAbSilico entered into an initial agreement early 2020 to apply innovative AI-based solutions to six programs aiming at accelerating the characterization and optimization of monoclonal antibodies and therapeutic proteins for OSE to investigate as therapeutic agents. Through this expanded agreement, both companies reinforce and extend the scope of the collaboration to use MAbSilico software for ten additional development programs of antibody drugs in immuno-oncology, inflammation and autoimmune diseases for OSE. Furthermore, both companies are bringing together their unparalleled expertise in the field of AI and antibody-based therapies to develop a disruptive computational in silico Antibody Discovery and Design platform combining OSE’s database and expertise with MAbSilico’s AI-tools. MAbSilico software, including AI, numerical simulation and data mining, is being used to guide therapeutic antibody discovery, help reduce the risk of failure and accelerate the preclinical development process of antibody drug candidates, with the objectives of speeding up the start of clinical testing. Announcement • Jan 26
OSE Immunotherapeutics Receives €1.3 Million Milestone Payment from Bpifrance for OSE-127/S95011 OSE Immunotherapeutics announced it received a milestone payment of €1.3 million from Bpifrance related to the Company’s collaborative program, EFFIMab, focused on evaluating interleukin-7 receptor antagonist OSE-127/S95011, partnered with Servier1. This new milestone payment of €1.3 million was triggered by achieving several key steps in the development of OSE-127/S95011 including reinforcement of preclinical and translational data in ulcerative colitis (UC), completion of the Phase 1 clinical trial, obtaining the Phase 2 regulatory authorization as well as specific manufacturing steps. OSE-127/S95011 Phase 2 in ulcerative colitis. The Phase 2 clinical trial with OSE-127/S95011 in UC started in December 2020 under OSE Immunotherapeutics’ sponsorship. This study aims to assess the efficacy and safety of OSE-127/S95011 versus placebo in patients with moderate to severe active UC who have previously failed or lost response or are intolerant to previous treatment(s). In parallel to the trial being conducted in UC, an independent Phase 2 clinical study is planned to start shortly in Sjögren’s syndrome under Servier’s sponsorship. Under the terms of the license option agreement, OSE is eligible to receive a €5 million milestone payment from Servier upon enrollment of the first patient in this Phase 2. OSE-127/S95011 is being developed in partnership with Servier under an option agreement up to the completion of both Phase 2 clinical studies. Ulcerative colitis background: UC is a debilitating inflammatory bowel disease that affects 3.3 million patients in the U.S., Europe and Japan. Despite multiple approved therapeutic options, remission rates are 25-30%, leaving most patients in therapeutic failure and in need of alternative new therapies. The current standard of care is largely comprised of two main therapeutic classes (5-ASAs and TNFa) with a total market size of $6.3 billion. Announcement • Dec 23
OSE Immunotherapeutics Announces Enrolment of First Patient with Ulcerative Colitis in Phase 2 Trial Testing Anti-IL-7 Receptor Antagonist OSE-127/S95011 OSE Immunotherapeutics announced enrolment of the first patient in its Phase 2 clinical trial evaluating the benefits of anti-IL-7 receptor antagonistOSE-127/S95011 for moderate to severe active ulcerative colitis patients. The first patient has been enrolled in the randomized, double-blind Phase 2 clinical trial aiming at assessing the efficacy and the safety of OSE-127/S95011 versus placebo in patients with moderate to severe active ulcerative colitis who have previously failed or lost response or are intolerant to previous treatment(s). The study population (patients with moderate to severe ulcerative colitis who have failed or are intolerant to immunosuppressors, anti-tumor necrosis factor (TNF)-a, anti-integrin, ustekinumab and/or corticosteroids) was selected since this population consists of patients who are in need of alternative new therapies to avoid for as long time as possible the complications linked to the disease and in whom the safety profile of OSE-127/S95011 can be reliably assessed. OSE-127/S95011 is being developed in partnership with Servier under an option agreement up to the completion of both Phase 2 clinical studies and exercise of the option upon successful completion of at least one of these Phase 2 trials. The Phase 2 in ulcerative colitis is being conducted under OSE Immunotherapeutics’ sponsorship while in parallel, another Phase 2 in Sjögren’s syndrome is planned to start shortly under Servier’s sponsorship. OSE-127/S95011 is a monoclonal immunomodulatory antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R) that induces a powerful antagonist effect on effector T lymphocytes. Interleukin-7 is a cytokine which specifically regulates the tissue migration of human effector T lymphocytes, especially in the gut. The blockage of IL-7R prevents the migration of pathogenic T lymphocytes while preserving regulator T lymphocyteswhich have a positive impact in autoimmune diseases. Announcement • Dec 19
OSE Immunotherapeutics Receives €5.2 Million in Public Funding for the Clinical Development of CoVepiT, its Second Generation COVID-19 Vaccine OSE Immunotherapeutics announced that the Company has obtained funding of €5.2 million under the PSPC-COVID call for projects, operated on behalf of the French government by Bpifrance as part of the Programme d’investissements d’avenir (PIA) and led by the Secrétariat général pour l’investissement (SGPI), to support its development program on CoVepiT, its second-generation multi-target vaccine against COVID-19. CoVepiT 1 was a human ex vivo clinical study, conducted in 120 convalescent COVID-19 subjects versus unexposed subjects, which enabled OSE to identify T memory immuno-dominant epitopes after infection with COVID-19, selected for their strong immunogenicity potential. New SARS-CoV-2 mutated variants spread rapidly across Europe, some of them bearing mutations in some key targets of the virus in particular the Spike protein and Nucleoprotein. Based on new analyses of up to 226,000 different virus sequences collected around the world, the OSE bioinformatic team confirmed that mutations did not emerge in the highly stable viral genome region of the 11 targets selected by OSE. This reinforces the multi-epitope approach against these virus proteins to generate a T lymphocyte response and the CoVepiT vaccine continues to cover all previous, novel and current SARS-CoV-2 strains and variants. The CoVepiT development program will be conducted within a consortium led by OSE Immunotherapeutics, in partnership with the teams of Prof. Eric Tartour, Head of the biological immunology department at the European Hospital Georges-Pompidou-APHP and Professor at University of Paris, in charge of immune-monitoring, and with the teams of Prof. Odile Launay, Professor of infectious and tropical diseases at University of Paris and Coordinator of the Clinical Investigation. The French State's funding, totaling €5.8 million for the entire consortium and including €5.2 million for OSE Immunotherapeutics, will in particular support the CoVepiT 1 study, the production of a clinical batch according to Good Manufacturing Practices and a Phase 1/2 clinical trial which will assess the safety and immunogenicity of CoVepiT in patients from at-risk populations. Announcement • Dec 04
OSE Immunotherapeutics and Nantes University Hospital Announce Initiation of a Phase 1/2 Clinical Trial to Evaluate CD28 Antagonist FR104 in Patients Undergoing Renal Transplantation OSE Immunotherapeutics and Nantes University Hospital announced that the French National Agency for Medicines and Health Products Safety and the French Central Ethics Committee approved the initiation of a Phase 1/2 trial evaluating first administration of FR104, a monoclonal antibody CD28 antagonist, in patients undergoing renal transplant. This study will be conducted as part of a collaboration agreement between OSE Immunotherapeutics and the University Hospital of Nantes. The purpose of this Phase 1/2 clinical trial is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of FR104 in renal transplant patients. A long-term follow up assessment will be performed one year after the end of the study. Long term safety and efficacy will be evaluated in terms of renal function, incidence of rejection and all suspected FR104 related adverse events. The study will be conducted under the sponsorship of Nantes University Hospital. Pr. Gilles Blancho, Head of the ITUN (Institute of Urology and Nephrology Transplantation) within the University Hospital, will serve as the coordinating investigator. OSE Immunotherapeutics will provide its product FR104 and a financial support. FR104 is a monoclonal antibody and an antagonist of CD28. This pegylated monovalent antibody selectively inhibits the CD28 receptor and has potential clinical applications in autoimmune diseases and transplantation. Due to its selective immunosuppressive activity directed at effector T cells, OSE plans to investigate FR104 for use in kidney transplantation. Selective CD28 blockage by FR104 might represent an effective immunomodulation strategy by reducing the activation of T lymphocytes, while sparing the activity of regulatory T lymphocytes. Announcement • Nov 07
OSE Immunotherapeutics Provides COVID-19 Vaccine Update on Covepit OSE Immunotherapeutics announced successful completion of its human ex vivo study with CoVepiT, a prophylactic vaccine based on optimized epitopes selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19. In parallel, OSE Immunotherapeutics gave an overview on the development of this multi-target vaccine at the World Immunotherapy Congress, or Festival of Biologics, held virtually November 2-6, 2020. This is the first presentation on a second-generation memory T cell COVID-19 vaccine at a scientific congress. The human ex vivo clinical study, named CoVepiT 1, was conducted in 120 convalescent COVID-19 subjects versus unexposed subjects. It aimed at assessing the memory T cell immune response at a distance from a resolving infection with SARS-CoV-2 adults. The main objective of the study was achieved: the identification of T memory immuno-dominant epitopes after infection with COVID-19 and incorporation in the vaccine composition. Scientists warn of new SARS-CoV-2 variants spreading rapidly across Europe and bearing mutation in some key targets of the virus, in particular the Spike protein and Nucleoprotein. Based on new analyses of up to 167 000 different virus sequences taken globally, the OSE Immunotherapeutics bioinformatic team confirmed that mutations did not emerge in the highly stable viral genome region of the 11 targets selected by OSE and that the CoVepiT vaccine continues to cover all initial and novel SARS-CoV-2 strains and variants. These results from both preclinical and human ex vivo studies as well as the expected emergence of new SARS-CoV-2 variants build a strong basis for supporting the development of CoVepiT as a novel and differentiated COVID-19 vaccine designed against multiple coronavirus targets with vaccinal technology known to induce long-lasting memory T lymphocytes. Is New 90 Day High Low • Nov 05
New 90-day high: €7.40 The company is up 33% from its price of €5.58 on 07 August 2020. The German market is down 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.56 per share.