Annuncio • Dec 07
F-star Therapeutics, Inc. Presents Clinical Data on FS222, a CD137/PD-L1 Tetravalent Bispecific Antibody, at ESMO-IO 2022 Congress F-star Therapeutics, Inc. announced new clinical data from its potentially best-in-class clinical asset FS222, a CD137/PD-L1 targeting tetravalent bispecific antibody, at the European Society of Medical Oncology Immuno-Oncology (ESMO-IO) Annual Congress which is being held from December 7 - 9, 2022, in Geneva. FS222 targets critical tumoral immune-suppressing pathways via PD-L1 checkpoint blockade and has exhibited important costimulatory effects through potent clustering and activation of CD137, which in turn, synergistically promotes T cell activation and enhanced cytotoxic T cell responses. In preclinical models, engagement of PD-L1 and CD137 by FS222 induced T cell proliferation and cytokine production that was associated with significant tumor regression compared to the combination of CD137 and PD-L1 targeting monospecific antibodies. Phase 1 Interim Efficacy and Safety Results on FS222 as of the Cut-Off Date of July 20, 2022: 33 patients had been treated to date with FS222 at dose levels of: 300 µg (n=1), 1 mg (n=1), 3 mg (n=1), 10 mg (n=1), 30 mg (n=5), 0.75 mg/kg (n=15), and 1 mg/kg (n=9); Median time on study was 58 days (range 19-359 days) with 11 patients ongoing; One non-squamous NSCLC, PD-L1 naïve patient experienced a complete response (CR) at 8 weeks, at a dose of 1mg/kg. The CR has remained persistent for 40.9 weeks as of 20th July 2022. 6 patients had disease stabilization (SD), 16 had progressive disease (RECIST 1.1), 2 were discontinued before week 8, and 8 were awaiting their week 8 evaluation. FS222 showed a manageable safety profile with most adverse events (AEs) Grade 1-2. One patient experienced a DLT of Grade 3 febrile neutropenia. No patients discontinued FS222 due to an AE. Maximum tolerated dose was not reached, and dose escalation is ongoing. The pharmacological activity was demonstrated by increased peripheral soluble target receptors and proliferating CD4+ and CD8+ T cells. Details of the poster presentation are as follows: Abstract Title: “First-in-human study to evaluate the safety and activity of FS222, a tetravalent bispecific antibody targeting PD-L1 and CD137, in patients with advanced solid tumors”; Abstract Number: 173P; Presenter: Dr. Guillermo De Velasco, Hospital Universitario 12 de Octubre, Madrid, Spain; Session Date: December 8, 2022; Dr. Neil Brewis, F-star’s Chief Scientific Officer will have an oral presentation on Multi-specific Antibody-like Platforms on December 8 at 16:50 CET in Room C. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Todd Brady was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Annuncio • Nov 08
F-star Therapeutics, Inc. Announces Publication of Phase 1 Dose-Escalation Trial of FS118 in Patients with Advanced Cancer and PD-L1 Resistance in Clinical Cancer Research F-star Therapeutics, Inc. announced the publication of safety and efficacy results from Phase 1 trial of FS118 in patients with advanced cancer and PD-L1 resistance in Clinical Cancer Research, a journal of the American Association for Cancer Research. FS118 is a first-in-class tetravalent bispecific antibody binding to LAG-3 and PD-L1, resulting in the reversal of immune suppression. The Phase 1 trial is the first-in-human study of FS118 that is evaluating forty-three patients with locally advanced/metastatic cancer with a median of three prior regimens therapy and at least one anti-PD-L1 regimen. Patients received intravenous FS118 monotherapy weekly with an accelerated dose titration design followed by 3+3 ascending dose expansion. Weekly administration was well tolerated, with no dose-limiting toxicities, and no serious adverse events relating to FS118. The recommended Phase 2 dose of FS118 was established at 10 mg/kg weekly. The pharmacodynamic activity was prolonged throughout dosing as demonstrated by sustained, increased levels of both soluble LAG-3 and peripheral effector cells. A disease control rate (DCR) of 54.8% was observed in patients receiving 1 mg/kg or greater who had acquired resistance to PD-L1-targeted therapy. Board Change • Oct 18
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Todd Brady was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 14
Second quarter 2022 earnings released: US$0.88 loss per share (vs US$0.91 loss in 2Q 2021) Second quarter 2022 results: US$0.88 loss per share. Revenue: US$0 (flat on 2Q 2021). Net loss: US$19.0m (loss widened 23% from 2Q 2021). Profit margin: (in line with 2Q 2021). Over the next year, revenue is expected to shrink by 88% compared to a 11% growth forecast for the industry in Germany. Reported Earnings • May 11
First quarter 2022 earnings released: US$0.57 loss per share (vs US$1.08 loss in 1Q 2021) First quarter 2022 results: US$0.57 loss per share. Revenue: US$2.55m (down 13% from 1Q 2021). Net loss: US$12.1m (loss widened 23% from 1Q 2021). Over the next year, revenue is expected to shrink by 75% compared to a 37% growth forecast for the industry in Germany. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Todd Brady was the last director to join the board, commencing their role in 2020. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Annuncio • Apr 23
F-star Therapeutics, Inc., Annual General Meeting, Jun 16, 2022 F-star Therapeutics, Inc., Annual General Meeting, Jun 16, 2022, at 09:00 US Eastern Standard Time. Agenda: To elect two (2) Class I directors of the Corporation to serve three-year terms expiring in 2025; to hold a non-binding advisory vote on approval of the compensation of named executive officers as disclosed in this proxy statement; to hold a non-binding advisory vote on the frequency of holding an advisory vote on the compensation of named executive officers; to ratify the appointment of RSM US LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business that is properly presented at the Annual Meeting and any adjournments or postponements thereof. Annuncio • Apr 09
F-Star Therapeutics Presents A Novel Lag-3 Reduction and Shedding Mechanism with Fs118 At AACR 2022 F-star Therapeutics, Inc. announced that preclinical, mechanistic data on FS118, a bispecific antibody targeting LAG-3 and PD-L1, will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 8-13, 2022, in New Orleans, Louisiana. FS118 is a dual checkpoint inhibitor developed to overcome tumor evasion mechanisms promoted by two highly immunosuppressive pathways, LAG-3 and PD-L1. In addition to simultaneously blocking both inhibitory pathways, FS118 demonstrated a highly differentiated, novel mechanism of action in preclinical models and in the clinic that translated into prolonged disease control in patients with cancer. The data presented in the poster reveals that the tetravalent and unique structure of FS118 plays a critical role in driving LAG-3 shedding and cell surface reduction by TILs, enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade. Reported Earnings • Mar 16
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: US$1.88 loss per share (up from US$2.82 loss in FY 2020). Revenue: US$21.2m (up 88% from FY 2020). Net loss: US$31.3m (loss widened 22% from FY 2020). Revenue exceeded analyst estimates by 38%. Over the next year, revenue is expected to shrink by 71% compared to a 76% growth forecast for the pharmaceuticals industry in Germany. Annuncio • Mar 04
F-star Therapeutics, Inc. to Report Q4, 2021 Results on Mar 14, 2022 F-star Therapeutics, Inc. announced that they will report Q4, 2021 results on Mar 14, 2022 Annuncio • Mar 03
F-Star Therapeutics Appoints James Sandy as Chief Development Officer F-star Therapeutics, Inc. announced that James Sandy has been appointed as Chief Development Officer, effective today. Mr. Sandy will lead the clinical development and advancement of F-star’s pipeline. James brings over 35 years of experience in the pharmaceutical and biotechnology industries across all phases of drug development. Before joining F-star Therapeutics James served as Chief Development Officer at Ellipses Pharma, Immunocore, and Creabilis Pharmaceuticals. Earlier in his career, James held senior positions with Pfizer, including Head of Development Operations and Project Management, Europe and Asia. James holds a MPhil in Statistics and Operational Research from Imperial College London. Annuncio • Jan 22
F-star Announces Issuance of U.S. Patent Protecting FS118, a Bispecific Antibody Targeting PD-L1 and LAG-3 F-star Therapeutics, Inc. announced that the United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors. U.S. Patent is entitled “Binding Molecules Binding PD-L1 and LAG-3“ and is expected to provide F-star with exclusivity for FS118 out to at least August 2038. F-star currently has over 500 granted and pending patents covering its platform technology and product pipeline. Reported Earnings • Nov 11
Third quarter 2021 earnings released: US$0.52 loss per share (vs US$0.67 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$10.8m (loss widened 76% from 3Q 2020). Annuncio • Jul 29
F-star Therapeutics, Inc. Provides Interim Update on Sb 11285 First-In-Human Dose-Escalation Study in Patients with Advanced Solid Tumors F-star Therapeutics, Inc. is providing an interim update on the first-in-human dose-escalation study of SB 11285, a second generation STING agonist. The ongoing multicenter clinical trial (NCT04096638) is evaluating the safety and efficacy of intravenously (IV) administered SB 11285 alone and in combination with the anti-PD-L1 monoclonal antibody, tezolizumab, in patients with advanced solid tumors. SB 11285 was well tolerated both alone and in combination with atezolizumab across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. Initial analysis showed that pharmacokinetics (PK) were in line with the predicted profile for rapid cellular uptake, a characteristic of second generation STING agonists. A further clinical update will be shared in 2022. Stimulator of interferon genes (STING) is a transmembrane protein located in the endoplasmic reticulum (ER) in cells and plays a key role in the immune system’s defense against pathogens via the production of type I interferon. The activation of STING, via binding of its ligand, has also been associated with durable anticancer immune responses. Agonists targeting STING signaling, including SB 11285, are therefore being investigated as anticancer treatments. In clinical trials, the first generation of these compounds were typically injected intratumorally in patients with solid cancers. F-star’s SB 11285 is differentiated from the first generation of STING agonists, as it is delivered systemically, enabling access to hard-to-reach tumors. Additionally, SB 11285 may facilitate migration of newly activated immune cells from the periphery into the tumor site. Importantly, SB 11285 is active against common STING variants and has demonstrated, in vivo, uptake into the targeted immune cells and has shown long lasting and complete tumor regression in preclinical models. The dose-escalation portion of the study has progressed as planned and the “part 1a/1b study database lock”, as defined in the contingent value rights agreement (CVR1) entered into as part of the business combination with Spring Bank Pharmaceuticals, has been completed. Based on the emerging clinical data, dose escalations beyond those contemplated by the CVR1 agreement are ongoing. The company continues to explore strategic options for progressing SB 11285 in parallel with clinical development activity. Reported Earnings • May 19
First quarter 2021 earnings released: US$1.08 loss per share (vs US$1.59 loss in 1Q 2020) The company reported a solid first quarter result with improved revenues and control over costs, although losses increased. First quarter 2021 results: Revenue: US$2.92m (up 205% from 1Q 2020). Net loss: US$9.87m (loss widened 53% from 1Q 2020). Annuncio • May 18
F-Star Therapeutics Provides Corporate Update F-star Therapeutics provided corporate update. Clinical validation of LAG-3: Aligning with F-star’s promising internal data, new headline phase 3 data reported during the quarter by a global pharmaceutical company has potentially validated LAG-3 as an immuno-oncology target. Importantly for FS118, these data also confirm the necessity of co-targeting the LAG-3 and PD-1/PD-L1 pathways to achieve efficacy in patients. FS118 European patent protection granted: The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule giving protection until June 2037. The phase 2 proof-of-concept trial of FS118 is proceeding on plan and the Company plans to provide an update on progress in the first half of 2022. FS222 Poster presented at the American Association for Cancer Research (AACR) Annual Meeting in 2021: F-star presented a poster at AACR 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies. The ongoing phase 1 clinical trial is proceeding on plan and the Company plans to provide an update on progress before the end of 2021. SB 11285 in Nature publication: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications [2]. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The Company plans to provide an update on the progress of SB 11285 in the phase 1 clinical trial in mid-2021. Merck, KGaA, Darmstadt, Germany exercised third target option: F-star continued to deliver on the collaboration with Merck, KGaA, Darmstadt, Germany. The third option to license an F-star preclinical immuno-oncology program was exercised in the ongoing collaboration in March 2021. The companies entered into the agreement in 2019 with the first option to license. In July 2020, Merck KGaA, Darmstadt, Germany brought the second program from the collaboration into its pipeline, and has recently exercised its third option, taking over future development and commercialization of the program. Reported Earnings • Mar 31
Full year 2020 earnings released: US$9.69 loss per share (vs US$12.56 loss in FY 2019) The company reported a soft full year result with weaker revenues and control over costs, although losses reduced. Full year 2020 results: Revenue: US$11.3m (down 61% from FY 2019). Net loss: US$25.6m (loss narrowed 41% from FY 2019). Is New 90 Day High Low • Mar 09
New 90-day low: €6.45 The company is down 4.0% from its price of €6.72 on 08 December 2020. The German market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. Annuncio • Jan 05
F-star Therapeutics, Inc. Announces First Patient Dosed in FS222 Phase 1 Clinical Trial F-star Therapeutics, Inc. announced that the first patient has been dosed in its Phase 1 trial evaluating FS222, a potentially best-in-class bispecific antibody targeting CD137 and PD-L1. This multicenter, open-label, first-in-human trial will evaluate the safety, tolerability, and clinical activity of FS222 in adult patients diagnosed with advanced malignancies. The adaptive study design will allow for the early exploration of clinical activity of FS222 in a range of selected solid tumor types that will guide further targeted future clinical development. FS222 targets critical tumoral immune-suppressing pathways via PD-L1 checkpoint blockade and has exhibited in preclinical studies important costimulatory effects through potent clustering and activation of CD137, which in turn, synergistically promote T cell activation and enhance cytotoxic T cell responses. In preclinical models, engagement of PD-L1 and CD137 by FS222 induced T cell proliferation and cytokine production associated with significant tumor regression, significantly better than that observed with a combination of CD137 and PD-L1 targeting antibodies. Annuncio • Dec 04
F-star Therapeutics Announces First Patient Dosed in First-in-Class FS120 Phase 1 Clinical Trial F-star Therapeutics, Inc. announces that the first patient has been dosed in its Phase 1 trial evaluating FS120, a first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 (4-1BB, TNFRSF9) and OX40 (CD134, TNFRSF4). The adaptive Phase 1 trial will explore FS120 as a monotherapy in dose escalation including evaluation of PK/PD in patients with advanced cancer. FS120 will also be evaluated in combination with a PD-1 monoclonal antibody with the potential for early demonstration of efficacy in specific tumor subtypes. FS120 has the potential to show activity in "cold" tumors and improve outcomes of existing immunotherapies by simultaneously agonizing CD137 and OX40. These two receptors are part of the Tumor Necrosis Factor Receptor family ("TNFRSF") and are widely expressed on activated T cells and NK cells in tumors. Many TNFRSF-targeting antibodies require crosslinking via Fc? receptors ("Fc?Rs") to show activity, but this engagement can limit their clinical activity and lead to significant toxicity. FS120 has been designed to be Fc?R-null and instead uses bispecific crosslinking to drive robust receptor clustering and activation, without engaging the Fc?R. FS120 preclinical data demonstrated delays in tumor growth, activation and proliferation of CD4+ and CD8+ T cells, and synergies with PD-1 monoclonal antibodies and chemotherapies.