Thomas Civik, the new CEO at Five Prime (FPRX) is not wasting any time and is refocusing the company. The firm is now prioritizing the development of bemarituzumab and FPT155, asserts John McCamant, editor of The Medical technology Stock Letter.
Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) being studied in the FIGHT trial as a targeted cancer therapy for tumors that over-express FGFR2b.
FPRX believes that a Phase II trial is the fastest path to generating informative data about bemarituzumab to target FGFR2b overexpressing gastric and gastroesophageal junction cancer (GEJ). Importantly, this decision will allow the company to generate Phase II data sooner.
Positive proof-of-concept data will allow Five Prime to design a smaller and more efficient pivotal trial, while also stimulating a potential partnership. Gastric cancer is a devastating cancer from a patient perspective, life expectancy with advanced stage disease remains 12 months or less in the U.S., and this hasn’t changed appreciably in a decade.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting T cell activation in the tumor microenvironment.
In the ongoing Phase 1 dose escalation study, a dose-dependent expansion of memory T-cells has been identified, consistent with the mechanism of action of FPT155 observed in preclinical studies.
A combo arm has been added to the ongoing trial to test the combination of escalating doses of FPT155 and pembrolizumab in patients with PD-1 treated non-small cell lung cancer.
Overall, FPRX has made important decisions to refocus their pipeline and deliver potential value creating catalysts. Bemarituzumab has interesting potential to treat gastric cancer which basically remains a large unmet medical need with advanced stage patients having a life expectancy of less than 12 months.
The Phase II FLIGHT trial should read out late this year or early 2021 and positive data would serve a significant catalyst. FPT155 will also have data by year end and any signs of activity with PD-1 treatment would also serve as a catalyst. Our initial impression of new CEO Thomas Civik is quite positive.
