Bispecific antibodies, which feature two different antigen-binding sites in one molecule, have promising applications in cancer immunotherapy. Only 3 bispecific antibodies have received FDA approval – Janssen Pharma’s Rybrevant to treat adults with locally advanced or metastatic non-small cell lung cancer; Amgen’s Blincyto for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL); and Roche’s Hemlibra for the treatment of patients with hemophilia.
F-star Therapeutics Inc. (FSTX), a clinical-stage biopharmaceutical company, is developing next generation bispecific immunotherapies to transform the lives of cancer patients. The lead drug candidate is FS118, a tetravalent bispecific antibody targeting lymphocyte-activation gene 3 (LAG-3; CD223) protein and programmed cell death ligand 1 (PD-L1; CD274).
A proof-of-concept phase II study of FS118 in patients with PD-1 resistant head and neck cancer is ongoing. An update on this study is expected in mid-2022.
The other compounds in the pipeline are FS222, FS120, and SB 11285.
— FS222, a bispecific antibody targeting CD137 and PD-L1, is under a phase I study in patients with advanced malignancies. An update on this trial is anticipated in the second half of 2021.
— FS120 is a dual-agonist tetravalent bispecific antibody targeting CD137 and OX40. This compound is currently being explored in a phase I trial as a monotherapy in dose escalation including the evaluation of pharmacokinetics and pharmacodynamics in patients with advanced cancer.
The company expects to provide an update on the FS120 monotherapy accelerated dose titration cohorts later this year and plans to initiate the KEYTRUDA combination cohort in the second half of 2022.
— SB 11285 is an intravenously administered STimulator of INterferon Genes (STING) agonist in development for patients with advanced solid tumors.
A phase Ia/Ib multicenter, dose-escalation, and cohort expansion study of SB 11285 alone and in combination with Roche’s Tecentriq in patients with advanced solid tumors is underway. An interim update on this study, provided in July of this year, showed that SB 11285 was well tolerated both alone and in combination with Tecentriq across all dose levels tested to-date, with pharmacokinetics (PK) being in line with the predicted profile for rapid cellular uptake.
A further clinical update on SB 11285 is expected to be shared in mid-2022.
In July of this year, the company inked a licensing agreement with AstraZeneca plc (AZN), under which AstraZeneca was granted exclusive access to F-star’s novel preclinical STING inhibitors.
Last month, F-star Therapeutics entered into a clinical trial collaboration and supply agreement with Merck & Co (MRK) to evaluate the combination of FS120 with Keytruda. (Keytruda is Merck’s approved blockbuster cancer drug).
As of June 30, 2021, the company’s cash and cash equivalents were $81.6 million.
Cambridge, U.K.-based F-star Therapeutics was listed on the Nasdaq Capital Market under the ticker symbol “FSTX.” on November 23, 2020, following a reverse merger with Spring Bank Pharmaceuticals Inc.
FSTX closed Tuesday’s trading at $7.92, up 6.88%.
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