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F-star Therapeutics to Present FS120 Phase 1 Trial-in-Progress Update at ESMO 2021

Excerpt from the Press Release:

Preclinical Data Indicates a Broad Therapeutic Window for F-star’s First-in-Class Tetravalent Dual T cell Agonist

CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., Sept. 16, 2021 (GLOBE NEWSWIRE) — F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, today announces that the Company will present a trial in progress update on FS120, a first-in-class OX40 and CD137 tetravalent dual T cell agonist, at the European Society for Medical Oncology 2021 Conference, taking place virtually, September 16th-21st.

The poster, entitled “A First-in-Human Phase 1 Study of FS120, an OX40/CD137 tetravalent bispecific antibody, in patients with advanced malignancies” is presented by Kyriakos P. Papadopoulos (START, San Antonio, Texas) and describes the design of a first-in-human Phase 1 clinical trial (NCT04648202) to assess the safety, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of FS120 in patients with advanced malignancies.

This study comprises an Accelerated Dose Titration (ADT) component followed by a 3+3 design. Enrollment of the ADT portion of the study is complete, and the Company anticipates providing a further update on the study progress later this year.

Key findings include:

  • Preclinical data from pivotal GLP Non-Human primate (NHP) study indicate a wide therapeutic window supporting the clinical study design. FS120 was well tolerated in NHP with a HNSTD (highest non-severely toxic dose) of 30mg/kg with limited and minimal changes in clinical chemistry measurements relating to liver model function.
  • Pharmacodynamic biomarkers indicative of FS120 pharmacology, including increases in proliferation of CD4+ and CD8+ T cell and NK cell models, were observed in the NHP study and plateaued at the highest dose level. These pharmacodynamic markers are being used in the clinical study to determine a pharmacologically active dose in humans.

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