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.
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary Data Management
Click the image or button below to explore our interactive infographic which illustrates the comprehensive and unique capabilities of the TrialStat eClinical Suite.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?