Pierre Fabre Files IND for PFL-002/VERT-002 for Solid Tumors Including MET-Altered NSCLC

CASTRES, France, June 5, 2024 -- Pierre Fabre Laboratories has announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a first-in-human (FIH) Phase I/II clinical trial of PFL-002/VERT-002. This trial will focus on treating solid tumors, including non-small cell lung cancer (NSCLC).

The upcoming PFL-002/VERT-002 Phase I/II trial is an international, multi-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy of PFL-002/VERT-002. The study will specifically target NSCLC patients with MET alterations, which can emerge as a resistance mechanism to other therapies. The FDA's review of the IND application will determine the trial's acceptability.

Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories, expressed optimism about the trial: "We look forward to initiating the first-in-human trial of PFL-002/VERT-002 later this year. We believe this new drug offers significant potential as a novel therapeutic option with a differentiated mechanism of action for patients with MET-altered solid tumors, including NSCLC."

PFL-002/VERT-002 is a monoclonal antibody developed by Vertical Bio, acting as a degrader of c-MET, which is a known driver of disease in patients with solid tumors, including those with MET mutations or amplification in NSCLC. Pierre Fabre Laboratories acquired Vertical Bio and has optimized this antibody preclinically. The company aims to enroll the first patient in the FIH trial by the end of 2024.

Pierre Fabre Laboratories has been expanding its precision oncology research and development pipeline. In collaboration with Scorpion Therapeutics, the company is developing two mutant-selective EGFR inhibitors, PFL-241/STX-241 and PFL-721/STX-721, to treat NSCLC patients driven by EGFR mutations. Additionally, through the acquisition of Vertical Bio, PFL-002/VERT-002 will be tested clinically in solid tumors driven by MET genetic alterations. More recently, Pierre Fabre Laboratories acquired exarafenib, a pan-RAF inhibitor from Kinnate Biopharma, to broaden its targeted therapy options for RAS/RAF-driven solid tumors. These new assets complement the company's existing precision oncology portfolio, which includes BRAF, MEK, and HER2 targets, with drugs such as encorafenib, binimetinib, and neratinib.

Pierre Fabre Laboratories continues to push the boundaries of precision oncology, aiming to bring innovative and effective treatments to patients with challenging solid tumors. The company's strategic acquisitions and partnerships signify a robust commitment to expanding targeted therapy options for various cancer types, promising hope for improved patient outcomes in the future.

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