F-star Therapeutics Announces Clearance of Clinical Trial Application for FS222

CD137/PD-L1 Bispecific Antibody for Patients with Advanced Malignancies to Enter the Clinic

First-in-Human Adaptive Trial to Evaluate Safety, Pharmacology and Anti-tumor Activity

CAMBRIDGE, UK and CAMBRIDGE, MA, USA I November 24, 2020 I F-star Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, today announces the authorization of the Clinical Trial Application (CTA) in Spain for the initiation of a Phase 1, open label, first-in-human clinical study of FS222. FS222 is a potentially best-in-class bispecific antibody targeting CD137 (4-1BB) and PD-L1.

FS222 has a natural antibody structure and a unique tetravalent bispecific mechanism of action. It has the potential to overcome cancer resistance by combining PD-L1 blockade with tumor-targeted, potent CD137 agonism. Most patients do not respond or have a short duration of response to currently approved immune checkpoint inhibitors such as PD-1 or PD-L1 antibodies. In preclinical studies, FS222-mediated PD-L1 blockade that synergized with conditional CD137 agonism stimulated lymphocyte activation and showed antitumor responses beyond that achieved with PD-L1 inhibition alone. FS222 is Fcg receptor null and was well tolerated in preclinical toxicology studies using animal models.

Dr. Louis Kayitalire, CMO of F-star said: "With this CTA authorization we are excited to bring this novel immunotherapy into the clinic for patients with cancer. We are eager to investigate its safety and potential differentiated benefit in partnership with immuno-oncology leaders in Spain.  As our third wholly-owned bispecific to enter the clinic, we believe that F-star's novel platform technology can be the answer that so many patients have been waiting for."

About F-star Therapeutics Inc
F-star is a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. By developing medicines that seek to block tumor immune evasion, the Company's goal is to offer patients greater and more durable benefits than current immuno-oncology treatments. Through its proprietary tetravalent, bispecific natural antibody (mAb²™) format, F-star generates highly differentiated drug candidates that are expected to be best-in-class, using monoclonal antibody-like manufacturability. For more information visit www.f-star.com.

SOURCE: F-star Therapeutics

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