In an oral presentation at ESMO (European Society for Medical Oncology), Five Prime Therapeutics (FPRX) recently provided updated data from the ongoing Phase 1B trial of FP-1039, a drug in development for use in mesothelioma patients (MPM), notes biotech expert John McCamant, editor of The Medical Technology Stock Letter.
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The mesothelioma arm of the open-label Phase 1B trial evaluated weekly infusions of FP-1039, an FGF ligand trap, in combination with first-line pemetrexed and cisplatin chemotherapy in patients with untreated, unresectable MPM.
The primary study endpoints are safety and overall response rate (ORR), disease control rate (DCR) at 6 months, progression free survival (PFS) and exploratory translational objectives. The poster includes data from MPM patients who had received FP-1039 as of the 17-Mar-17 cut-off.
In the 27 patients evaluable as of March 17, 2017, who had received FP-1039 at or below the 15 mg/kg MTD dose level: Preliminary ORR was 48%, with six-month DCR of 81%.
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Safety was also good with the most common adverse events across all dose levels (AEs; all grades) observed were: nausea (56%), decreased appetite (36%), fatigue (33%) and infusion reaction (36%). The vast majority of events were Grades 1-2.
Toxicities associated with small-molecule FGFR inhibitors, such as hyperphosphatemia, retinal detachment and nail bed changes, have not been observed.
FPRX also presented an oral poster discussion featuring preclinical data for FPA150, a novel B7-H4 antibody. B7-H4 shares significant homology with other B7 family members, including PD-L1 and PD-L2.
B7-H4 is expressed in several human tumors such as carcinomas of the breast, ovary and endometrium, and its expression tends to correlate with poor prognosis.
While the receptor for B7-H4 is unknown, it is believed to be expressed on T cells because B7-H4 is described as a ligand capable of directly inhibiting T cell activity.
FPA150 is a high affinity, afucosylated B7-H4 monoclonal antibody that has demonstrated potent antibody-dependent cell-mediated cytotoxicity (ADCC) and T cell checkpoint blockade activity in vitro and significant dose-dependent anti-tumor efficacy in vivo. FPA150 is an exciting drug development candidate and IND-enabling studies are currently ongoing.
FPRX is a leader in developing new targeted cancer drugs with their proprietary platform technology continuing to flesh out the company’s pipeline with novel drug development candidates.
In our view, FPRX is positioned to be a major player in I/O as their protein based platform is both unique and patent protected. FPRX is a buy under $42 with a target price of $55.
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