Annonce • Mar 25
BioInvent International AB (publ), Annual General Meeting, Apr 29, 2026 BioInvent International AB (publ), Annual General Meeting, Apr 29, 2026, at 16:00 W. Europe Standard Time. Location: elite hotel, ideon on scheelevagen 27 in lund, Sweden Annonce • Mar 17
BioInvent International AB (publ) to Report Fiscal Year 2025 Final Results on Mar 31, 2026 BioInvent International AB (publ) announced that they will report fiscal year 2025 final results on Mar 31, 2026 Annonce • Jan 05
Bioinvent Reports Promising Data from Ongoing Phase 2A Study for Bi-1808 with Keytruda®(Pembrolizumab) in Recurrent Ovarian Cancer BioInvent International AB announced encouraging interim results from its ongoing Phase 2a signal-seeking study evaluating BI-1808, a novel immuno-oncology candidate, in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with recurrent ovarian cancer who have progressed following platinum-based therapy. The interim data from the signal-seeking cohort of patients with recurrent ovarian cancer demonstrates an overall response rate (ORR) of 24%, which represents a meaningful improvement over pembrolizumab monotherapy. Some responses have been observed after several months of treatment, suggesting that additional responses with potentially important impact on PFS (Progression Free Survival) may be observed. The combination was generally safe and well-tolerated, and all adverse events were manageable with standard medical treatments. Exploratory analyses indicate strong activity in both high-grade serous and clear cell ovarian cancer subtypes. The Phase 2a expansion will enroll an additional 20 patients focusing on these subtypes to validate and quantify the signal with an expected readout in H2 2026. Clinical trial collaboration and supply agreement. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, NJ., USA, to evaluate the combination of BI-1808 and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizum AB). This Phase 2a trial (NCT04752826) is designed to assess BI-1808 administered as a single agent (Part A) and in combination with pembrolizumab (Part B) at the respective recommended Phase 2 dose (RP2D) determined in Phase 1. Phase 2a expansion is being conducted in indication specific cohorts of subjects. The aim of the Phase 2a is to further assess the safety and tolerability of BI-1808 as a single agent (PartA) and in combination with p Embrolizumab (PartB), characterize its PK and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR (duration of response), and progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST. BI-1808 is a ligand-blocking FcgR-engaging antibody that depletes immunosuppressive Treg cells and reprograms myeloid cells. BI-1910 is a pure agonist antibody that directly co-stimulates T and NK cells through partially FcgR-independent mechanisms. Annonce • Mar 26
BioInvent International AB (publ), Annual General Meeting, Apr 29, 2025 BioInvent International AB (publ), Annual General Meeting, Apr 29, 2025, at 16:00 W. Europe Standard Time. Location: elite hotel ideon, scheelevagen 27 in lund, Sweden Annonce • Mar 22
BioInvent International AB (publ) to Report Fiscal Year 2024 Final Results on Apr 04, 2025 BioInvent International AB (publ) announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Apr 04, 2025 Annonce • Dec 03
Bioinvent International AB Appoints Ashley Robinson as SVP Strategy & Finance to Lead U.S. Expansion Bioinvent International AB announced the appointment of Ashley Robinson as SVP Strategy & Finance, effective as of December 3, 2024. In this role, Mr. Robinson will spearhead efforts to strengthen BioInvent’s presence and strategy in the US. Ashley Robinson is an accomplished biotechnology business leader and joins BioInvent with 25 years in capital markets and corporate strategy experience. Most recently, he served as Managing Director at LifeSci Advisors, where he established a Life Sci office in Boston, advising key clients in the healthcare sector. Prior roles have been healthcare product specialist, sector head at Guggenheim Securities, Managing Director and Senior Partner at Leerink Partners, Vice President at Lehman Brothers in the ECM division. Annonce • Sep 16
Bioinvent and Transgene’S Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase 1/2A Trial in Solid Tumors That Failed Previous Treatments BioInvent International AB and Transgene announced new initial data from their ongoing Phase 2/2a study on the multifunctional oncolytic virus BT-001, demonstrating antitumor activity in patients with refractory solid tumors. The data presented at the2024European Society for Medical Oncology (ESMO) Annual Meeting, showed that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as a monotherapy and in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab).
Preliminary translational data suggest that BT-001 replicates in the tumor where the payloads are expressed with undetectable systemic exposure. BT-001 alone or in combination with pembrolizumab was well tolerated and showed first signs of efficacy with clinical responses in 2 of 6 refractory patients when given in combination with pembrolizumab. BT-001 treatment turned "cold" tumors to "hot" inducing T cell infiltration, a higher M1/M2 ratio, and a shift toPD(L)-1 positivity in the tumor microenvironment. Annonce • Sep 12
Bioinvent International AB Announces the Enrollment of the First Patient in Triple Combination Arm of Phase 1/2A Study, Bi-1206, Rituximab and Calquence(R) for the Treatment of Non-Hodgkin's Lymphoma BioInvent International AB announced it has enrolled the first patient in the triple combination arm of the Phase 1/2a study of its anti-FcgRIIB antibody, BI-1206 in non-Hodgkin's lymphoma (NHL). The Phase 2a study arm will combine the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib), a selective inhibitor of Bruton's tyrosine kinase (BTK). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. Preliminary data are expected by the end of 2024. In February 2024BioInvent signed a clinical supply agreement with AstraZeneca to provide Calquence® for the combination arm. Annonce • Jul 30
BioInvent Receives Notice of Allowance from USPTO for BI-1910 Patent Application BioInvent International AB announced that the US Patent and Trademark office (USPTO) has issued a Notice of Allowance for a patent application relevant to the anti-TNFR2 antibody BI-1910 by the - The patent, once granted, provides a composition-of-matter protection for BI-1910 and the use of the antibody for the treatment of cancer. Annonce • Jun 26
Bioinvent International AB Presents Poster Highlighting Model-Informed Early Clinical Development of Anti-TNFR2 Agent BI-1808 At PAGE 2024 BioInvent International AB announced the presentation of a poster highlighting the model-informed early clinical development of the company's anti-TNFR2 program BI-1808 at the Population Approach Group in Europe (PAGE) 2024 meeting, being held in Rome, Italy from June 26 to 28, 2024. BI-1808 could represent a new class of immunomodulatory agent with the potential to improve efficacy of cancer therapy. As earlier communicated, initial efficacy and safety data from the ongoing Phase 1/2a study show so far: One complete response (CR), one partial response (PR) that is still improving, and nine patients with stable disease (SD) of 26 evaluable patients in the single agent arm of BI-1808; Promising signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA® (pembrolizumab). Poster summary: The objective was to characterize the population pharmacokinetics (PK), receptor occupancy (RO), and concentrations of the target engagement biomarker soluble tumor necrosis factor receptor 2 (sTNFR2) at different BI-1808 doses, to support the dose selection for the dose expansion trial. Data and methods: Data was available from patients in the ongoing Phase 1/2a dose escalation trial. Model building and application proceeded in a sequential manner: Development of a joint PK-RO model to simultaneously characterize BI-1808 concentrations and TNFR2 receptor occupancy. Extension of the PK-RO model with a sTNFR2 PD model. Typical value simulations for RO as well as PK and sTNFR2 (not shown) considering different doses and dosing frequencies. Conclusions: A simultaneous model of the BI-1808 PK, RO, and sTNFR2 successfully explained the observed profiles across a wide dose range. Simulations provided insights into the expected PK, RO, and sTNFR2 levels across potential dose levels and dosing frequencies and will support the selection of doses for further exploration. Poster Title: Model-informed early clinical development of BI-1808, a novel monoclonal antibody to tumor necrosis factor receptor 2; Abstract Number: 10786; Session: Drug/Disease Modelling - Oncology; Date: June 27, 2024; Time: 9:50 - 11:20 AM CEST. Annonce • Jun 25
BioInvent International Gains Patent for BI-1808 in China BioInvent International AB announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-TNFR2 antibody BI-1808 will be granted. The patent provides composition-of matter protection for BI-1808 and the use of the antibody for the treatment of cancer. Annonce • May 16
Bioinvent to Present Additional Promising Phase 1/2A Data At EHA 2024 for BI-1206 with rituximab in NHL BioInvent International AB (publ) announced that promising clinical data for BI-1206 in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), dosed in combination with rituximab, will be presented in a poster at the European Hematology Association congress held in Madrid, Spain from June 13-16, 2024. Overview: While anti-CD20 antibodies such as rituximab are a cornerstone of NHL care, approximately 15% of patients are refractory to treatment and 25% relapse within 3 years after treatment. The inhibitory Fc receptor CD32b (Fc?RIIB) promotes resistance by triggering tumor cells to internalize and destroy rituximab. BI-1206 has been designed as an anti-Fc?RIIB mAb to block rituximab internalization. Methods: BioInvent conducted a Phase 1/2a trial in several R/R B-cell NHL subtypes to evaluate safety and tolerability of BI-1206 in combination with rituximab. Dose expansion is ongoing for the IV formulation since the recommended Phase 2 dose (RP2D) of IV BI-1206 has been established. Phase 1 dose escalation is still ongoing for the SC formulation. Annonce • Mar 28
BioInvent International AB (publ), Annual General Meeting, May 03, 2024 BioInvent International AB (publ), Annual General Meeting, May 03, 2024, at 16:00 Central European Standard Time. Location: Elite Hotel Ideon on Scheelevägen 27 Lund Sweden Agenda: To consider opening of the meeting; to consider election of Chairperson of the meeting; to consider preparation and approval of the voting list; to consider election of persons to approve the minutes; to consider determination of compliance with the rules of convocation; to consider approval of the agenda; and to consider other matters. Annonce • Feb 21
BioInvent International AB (publ) to Report Fiscal Year 2023 Results on Feb 22, 2024 BioInvent International AB (publ) announced that they will report fiscal year 2023 results at 8:00 AM, Central European Standard Time on Feb 22, 2024 Annonce • Dec 06
BioInvent International AB (publ) Presents Positive First Clinical Data on Anti-FcyRIIB Antibody BI-1607 BioInvent International AB presented the first clinical data from a Phase 1/2a trial of its second FcyRIIB-blocking antibody BI-1607. BioInvent pipeline currently includes five drug candidates progressing through six clinical trials. The Phase 1 data, presented in a poster at the San Antonio Breast Cancer Symposium, covered 18 patients treated at doses ranging from 75 mg up to 900 mg flat dose. Treatment was well tolerated and no serious adverse events related to BI-1607 were observed. The best clinical response reported in the poster was stable disease (SD) in 4/11 evaluable patients, with disease control lasting up to 7 cycles (21 weeks). To date two additional SDs have been observed, adding to 6/11 evaluable patients. Pharmacokinetic and pharmacodynamic data allowed identification of a wide dose range, where complete target engagement throughout a 3-week dose interval can be achieved, and this will provide the basis for further investigation in a Phase 2a trial, which planned to start 2024. BI-1607 is developed to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. The reported trial is a first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors. Annonce • Dec 05
Bioinvent Enrolls First Patient in Phase 1/2A Clinical Trial with TNFR2 Antibody BI-1910 BioInvent International AB announced it has enrolled the first patient in its Phase 1/2a trial of the monoclonal antibody BI-1910, the company's second anti-tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development. The Phase 1/2a clinical trial will be conducted in the US and Europe and is using an innovative, adaptive design for dose escalation. The first phase of the trial will enroll all solid cancer entities initially as single agent, followed by a dose escalation phase with BI-1910 in combination with pembrolizumab. Subsequently, Exploratory expansion cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent's first-in-class anti-TNFR2 antibody which is currently in a Phase 1/2a trial. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent's proprietary F.I.R.S.T™? technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline or for additional licensing and partnering. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. Annonce • Nov 04
BioInvent Presents Positive Data at SITC from Clinical Phase 1/2a Trial of BI-1808 as Single Agent BioInvent International AB presents the latest data from a Phase 1/2a trial of its first-in-class anti-tumor necrosis factor receptor 2 (TNFR2) antibody BI-1808 as a single agent, at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting in San Diego, California. The poster presentation, entitled "Phase 1/2a Clinical Trial of BI-1808, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2) as Single Agent and in Combination with Pembrolizumab" include data from the BI-1808 monotherapy arm of the Phase 1 study and display encouraging results in the form of early efficacy signals. Furthermore, BI-1808 exhibited a favorable safety profile with no dose-limiting toxicity observed in the monotherapy arm and no maximum tolerated dose could be found. BI-1808 was well tolerated across all dose levels studied. The data strengthens the outlook for the ongoing Phase 2 part of the clinical trial and positions BI-1808 as the best-in-class. BI-1808 administered as single agent induced a robust partial response (PR) in a patient with a gastrointestinal tumor (GIST) who had received 12 previous lines of treatment. Immune checkpoint inhibitors have previously shown very limited activity in this tumor type. The patient is still receiving BI-1808 treatment, and the most recent scan showed a tumor burden reduced to 48% compared to baseline, with 2/4 target lesions no longer detectable. There are a further 7 cases of stable disease out of 21 evaluable patients and pharmacokinetic/pharmacodynamic data has enabled identification of a wide dose range where complete target coverage can be achieved with a remarkable safety profile. The title and number of the SITC poster presentation is as follows: Title: Phase 1/2a Clinical Trial of BI-1808, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2) as Single Agent and in Combination with Pembrolizumab Number: 757. BI-1808 and the second anti-TNFR2 antibody BI-1910, are part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be determinant for tumor growth and survival, representing a new and promising target for cancer immunotherapy. The dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label trial of BI-1808 is investigating it as a single agent and in combination with MSD's (Merck & Co. Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in subjects with advanced malignancies, whose disease has progressed after standard therapy. It consists of Phase 1 Parts A and B (dose escalation as single agent and in combination with pembrolizumab, respectively), and Phase 2a Parts A and B (dose expansion cohorts with treatment as single agent and in combination, respectively). The efficacy of BI-1808 as single agent is currently further explored in an ongoing Phase 2a trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer and cutaneous T cell lymphoma (CTCL), BioInvent plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas. This is driven by the exciting data observed so far. Phase 1 data on the combination of BI-1808 with pembrolizumab is due in H1 2024. Annonce • Nov 01
BioInvent Presents Preclinical Data at SITC Providing Clear Evidence of the Potential of Anti-TNFR2 Antibody BI-1910 BioInvent will present preclinical data on its anti-tumor necrosis factor receptor 2 (TNFR2) agonistic antibody BI-1910 at the Society of Immunotherapy for Cancer (SITC) 38th Annual Meeting in San Diego, California. The presentation, scheduled for November 4, 2023, entitled "Preclinical development of an agonistic anti-TNFR2 antibody (BI-1910) for cancer immunotherapy," demonstrates that BI-1910 has broad anti-tumor activity, activating T cells and natural killer (NK) cells and showing antitumor activity independent of Fc gamma receptor (FcyR) expression. BI-1910 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor growth and survival, representing a new and promising target for cancer immunotherapy. BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, and both monoclonal antibodies were chosen as potential best-in-class from a large collection of fully characterized binders generated through BioInvent's proprietary F.I.R.S.T™ technology platform. The latest data from the other Treg program, i.e. the BI-1808 single agent Phase 1 study, will be presented at SITC on November 3, 2023. Annonce • Sep 22
Bioinvent International AB Recruits First Patient in Single Agent Phase 2a Part of its Phase 1/2a Trial of its First-in-Class Anti-TNFR2 Antibody BI-1808 in Advanced Malignancies BioInvent International AB announced recruitment of the first patient in the single agent Phase 2a part of its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies. In June 2023, the company reported strong interim safety data on BI-1808 as a single agent, from the dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study. The trial is investigating the use of BI-1808 as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. Stable disease as best response was observed in six subjects during the single agent dose escalation part. The efficacy of BI-1808 as single agent will now be further explored in the Phase 2a part of the trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer and cutaneous T cell lymphoma (CTCL), the company plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas. This is driven by the exciting data observed so far. Annonce • Sep 08
BioInvent International AB Initiates Subcutaneous Arm of Phase 1/2 Trial with BI-1206 in Solid Tumors BioInvent International AB announced the enrollment of the first patient in a Phase 1/2 trial (NCT04219254; KEYNOTE-A04) in combination with KEYTRUDA® (pembrolizumab), MSD's (Merck & Co. Inc., Rahway, NJ., USA) anti-PD-1 therapy, investigating a subcutaneous (SC) formulation of its lead drug candidate, the novel anti-FcyRIIB antibody BI-1206, in solid tumors. SC administration provides a significant improvement in terms of convenience and flexibility to both patients and healthcare professionals when compared to intravenous (IV) administration. In the ongoing Phase 1/2 trial of BI-1206, in combination with rituximab in non-Hodgkin's lymphoma (NHL), pharmacokinetically equivalent doses to IV have already been administered improving exposure and receptor engagement as had been predicted. Furthermore, there have been no safety or tolerability concerns. The trial is recruiting patients with advanced solid tumors who had progressed after prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients will receive three-week cycles of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. As reported on June 7, 2023, the IV part of the study has already generated early signs of efficacy, e.g., two partial responses and two patients displaying stable disease, out of a total of 18 evaluable patients having received BI-1206+pembrolizumab. Annonce • Jun 21
BioInvent International AB (publ) Reports Strong Interim Safety Data and Early Signs of Efficacy in Phase 1/2a Trial with Anti-TNFR2 Antibody BI-1808 in Advanced Malignancies BioInvent International AB announced strong interim safety data from its Phase 1/2a trial of its first-in-class anti-TNFR2 antibody BI-1808 in advanced malignancies. The dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study is investigating use of BI-1808 as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. No significant safety concerns were observed in relation to the administration of BI-1808 as single agent in Phase 1, Part A of the trial. A total 24 subjects were dosed with a range of 25-1000 mg with 22 patients evaluable for efficacy. The BI-1808 infusions were well tolerated and no dose limiting toxicity or serious adverse events related to BI-1808 were observed, at any dose level. Stable disease was observed in six patients subjects so far - 1 in the 25 mg cohort, 3 subjects at 75 mg, 1 at 225 mg and 1 at 1000 mg. The efficacy of BI-1808 As single agent and in combination with Pembrolizumab will be further explored in the subsequent Phase 2a part of the trial, which is intended to enroll pre-defined malignancies and a larger sample size. Phase 2a Part A (single agent) is planned to start during H2 2023. Annonce • Jun 13
BioInvent International AB Announces Abstract Presentation of BI-1206 At the 17th International Conference of Malignant Lymphoma 2023 BioInvent International AB announced that an abstract reporting the clinical profile of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, has been accepted at the International Conference of Malignant Lymphoma (ICML) Annual Meeting 2023. In the ongoing Phase 1/2a study of BI-1206 in combination with rituximab for the treatment of non-Hodgkin's lymphoma (NHL), the dose escalation phase of intravenously (IV) administered BI-1206 has been completed and the recommended IV Phase 2 dose (RP2D) has been identified. A subcutaneous (SC) formulation is being developed in parallel to the IV and the first results will be available during H1 2023. The SC formulation should allow a great deal of flexibility in dosing and regimen to assure the best development of BI-1206. All patients in the ongoing study of BI-1206 have previously been treated with one or multiple rituximab containing treatments and classified as refractory or relapsed. In the IV dose escalation cohort, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients. Among the CR population, responses have been long-lasting, three of them lasting years after end of treatment, while the 4th is still on treatment. As of June 12th, 2023, the median duration of complete response was 2.5 years, with three patients still ongoing. No maximum tolerated dose has been defined, and Phase 2a dose expansion cohort is currently enrolling patients. Annonce • Jun 08
BioInvent International AB Announces Additional Efficacy Data from Intravenous Part of Phase 1/2 Trial with BI-1206 in Solid Tumors BioInvent International AB announced six additional patients have been treated in the intravenous (IV) arm of its Phase 1/2 trial (NCT04219254; KEYNOTE-A04) of the novel anti-FcyRIIB antibody BI-1206 in combination with KEYTRUDA®? (pembrolizumab), MSD's (Merck & Co. Inc., Rahway, NJ., USA) anti-PD-1 therapy, in solid tumors. The additional patients have been treated at a dose of 1 mg/kg. Previous observations had revealed that BI-1206 may enhance the activity of pembrolizumab in patients who have previously progressed on PD-1/PDL-1 targeting therapies. In addition to the patients previously reported, (1 case of pseudo progression and 1 partial response (PR), new data now show one patient experiencing a long-lasting stable disease, with more than 80 weeks of treatment in the study, and another patient experiencing a PR. Both patients have melanoma, and both had previously been treated with immune checkpoint inhibitors. The latter had progressed after previous lines of those agents. The first PR observed is still responding and has been on treatment for more than 90 weeks. BioInvent will share additional updates from the IV arm of the trial during the second half of 2023. The study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination With rituximab in non-Hodgkin's lymphoma (NHL), is also continuing. Annonce • Jun 07
BioInvent Ready for Combination Studies with BT-001 BioInvent and its partner Transgene have reported positive results in the phase I/IIa study with the oncolytic virus BT-001. In 11 of the 18 included patients, the lesions were stabilised. In two patients, objective antitumour activity was also seen. This means that both partners can continue the evaluation as planned with the part of the study where BT-001 will be studied in combination with pembrolizumab. Annonce • May 24
BioInvent International AB (Publ) Appoints of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs BioInvent International AB ("BioInvent") announced the appointment of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs. Lindvig, an experienced regulatory affairs leader who has worked across all stages of product development and has hands-on experience of the US and EU regulatory systems, will join on June 12, 2023, be part of the BioInvent management team and report to CEO Martin Welschof. Lindvig joins from Norwegian biotech company Circio, where she was Vice President and Head of Regulatory Affairs since 2019. She was previously Head of Regulatory Affairs at Nordic Nanovector and also held senior regulatory positions at Photocure and Nycomed/GE Healthcare. She holds a PhD in biology from the University of Oslo. Annonce • Dec 09
Bioinvent International AB Provides Update on Its Clinical and Pre-Clinical Pipeline, Including an Update on Its Lead Drug Candidate, the Novel Anti-Fc?RIIB Antibody Bi-1206 BioInvent International AB provided an update on its clinical and pre-clinical pipeline, including an update on its lead drug candidate, the novel anti-Fc?RIIB antibody BI-1206. BI-1206 is currently being studied in two Phase 1/2 trials, in combination with rituximab in non-Hodgkin's lymphoma (NHL) and in combination with pembrolizumab in solid tumors. Latest data from the Phase 1/2 trial with BI-1206 in combination with rituximab in NHL first half 2023. BioInvent is also moving several other drug candidates through clinical and preclinical development. The latest updates include: Recruitment to both the single agent and combination arms of the Phase 1/2 a trial with the anti-TNFR2 drug candidate BI-1808 is progressing well, with two patients already dosed with 1000mg. Interim results from the trial, which is evaluating BI-1808 as a single agent and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) in patients with ovarian cancer, non-small cell lung cancer and cutaneous T-cell lymphoma (CTCL), have reinforced the very favorable tolerability profile, no safety concerns and early signs of efficacy; A joint paper on BT-001, a vectorized anti-CTLA-4 antibody co-developed with Transgene and currently in a Phase 1/2 a trial, has won this year's Journal for ImmunoTherapy of Cancer (JITC) Best Oncolytic and Local Immunotherapy Paper Award. The trial assessing BT-001 as a single agent and in combination with Keytruda against solid tumors is progressing well, and BioInvent and Transgene plan to present results from Part A at a scientific conference H1 2023; The U.S. Food and Drug Administration (FDA) has approved BioInvent's Investigational New Drug (IND) application for its FcyRIIB-blocking antibody BI-1607. This allows for the ongoing Phase 1/2a trial of BI-1607 in combination with trastuzumab in HER2+ solid tumors to be extended to U.S. centers. The ongoing clinical study is progressing well with the first dose cohort (75 mg) completed with no safety or tolerability concerns and no infusion-related reactions observed; Preclinical development of the anti-TNFR2 antibody BI-1910 continues as planned. While BI-1808 is a ligand blocking FcyR-engaging anti-TNFR2 antibody, BI-1910 has FcyR-independent intrinsic agonist activity. Annonce • Nov 18
BioInvent International AB (publ) Receives FDA IND Approval for Anti-FcyRIIB Antibody BI-1607 BioInvent International AB announced the U.S. Food and Drug Administration has approved its Investigational New Drug application for its FcyRIIB-blocking antibody BI-1607. BI-1607 is intended to enhance efficacy and overcome resistance to existing cancer treatments such as trastuzumab. The IND approval allows for a Phase 1/2a trial with BI-1607, in combination with trastuzumab in HER2+ solid tumors, to be extended to U.S. centers. The study is currently in the dose-escalation phase, with the selected dose of BI-1607 to be studied in the subsequent Phase 2a part of the trial along with trastuzumab in advanced breast, metastatic gastric and gastroesophageal junction HER2+ cancers. The Phase 1 part of the study is expected to recruit between 12 and 26 subjects. The Phase 2a part aims to recruit 30 patients in two cohorts of 15 subjects each. The study will be carried out at 7-12 sites in Spain, the UK, Germany, and in the U.S. HER2 is a driver of tumor formation and growth and is overexpressed in approximately 20% of breast cancers, the most common cancer worldwide in women, and in gastric and gastroesophageal junction adenocarcinoma. Like BI-1206, BioInvent's lead FcyRIIB antibody, BI-1607 is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. Trastuzumab alone or in combination with chemotherapy significantly improves overall survival of HER2+ breast cancer patients but many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to FcyRs. This alteration generates a major differentiating factor between the two antibodies, and specifically with respect to the best combination partners. Annonce • Sep 09
BioInvent International AB (publ) Completes Dose Escalation Part of the Phase I/IIa Study with Anti-TNFR2 Drug Candidate BI-1808 BioInvent International AB (publ) has completed the dose escalation part of the phase I/IIa study with the anti-TNFR2 drug candidate BI-1808. Supported by the positive safety and tolerability profile that the company has observed so far, BioInvent will also study the effect of a higher dose with BI-1808 as monotherapy. Also, the company has, in collaboration with CASI Pharmaceuticals, dosed the first patient in China for the phase I clinical trial evaluating BI-1206 for the treatment of non-Hodgkin's lymphoma. Annonce • Aug 02
BioInvent International AB (publ) Enrolls First Patient in Phase 1/2A Trial of Bi-1607 in HER2 Positive Solid Tumors BioInvent International AB (publ) announced treatment of the first patient in a Phase 1/2a trial of its second anti-FcyRIIB antibody BI-1607 in combination with trastuzumab in HER2+ solid tumors. The first-in-human Phase 1 trial is a dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors. The selected dose of BI-1607 will be studied in a subsequent Phase 2a part of the trial along with trastuzumab in advanced breast, metastatic gastric and gastroesophageal junction HER2+ cancers. The first patient has been recruited to the Phase 1 part of the study which is expected to recruit between 12 and 26 subjects. The Phase 2a aims to recruit 30 patients in two cohorts of 15 subjects each (one cohort in breast and one in gastric and gastroesophageal cancers). The study will be carried out at 7-12 sites in Spain, the UK, Germany, and in the U.S. Like BI-1206, BioInvent's lead FcyRIIB antibody, BI-1607 is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. Trastuzumab alone or in combination with chemotherapy significantly improves overall survival of HER2+ breast cancer patients. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to FcyRs. This alteration generates a major differentiating factor between the two antibodies, and specifically with respect to the best combination partners. Preclinical data presented at this year's AACR, indicate that treatment with BI-1607 enhances the efficacy of current anti-HER2 regimens such as trastuzumab. HER2 is a driver of tumor formation and growth in approximately 20% of breast cancers, the most common cancer worldwide in women, and in gastric and gastroesophageal junction adenocarcinoma. 
