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

The PFL-002/VERT-002 Phase I/II trial is a multi-center, international study aimed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of PFL-002/VERT-002 in NSCLC patients with MET alterations, including those acquired as resistance mechanism to other treatments. The FDA will review the application and determine its acceptability.

"We are looking forward to initiating the first-in-human trial of PFL-002/VERT-002 later this year. We are confident that this new drug holds significant promise, as a novel therapeutic option with a differentiated mechanism of action, for patients facing MET-altered solid tumors, including NSCLC" said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

About PFL-002/VERT-002

PFL-002/VERT-002 is a monoclonal antibody developed by Vertical Bio, offering a unique and differentiating mechanism of action, acting as a degrader of c-MET, a known disease driver in patients with solid tumors, including non-small cell lung cancer (NSCLC) presenting mutations or amplification of MET. The antibody has been optimized preclinically by Vertical Bio, which has been acquired by Pierre Fabre Laboratories.

Pierre Fabre Laboratories is progressing PFL-002/VERT-002 into clinical development and hope to enroll a first patient in the FIH trial by end 2024.

About Pierre Fabre R&D Pipeline and Portfolio

Pierre Fabre Laboratories has expanded its efforts in precision oncology by adding several assets to its R&D pipeline. In partnership with Scorpion Therapeutics, PFL-241/STX-241 and PFL-721/STX-721, two mutant-selective EGFR inhibitors, will be developed for the treatment of EGFR-driven non-small cell lung cancer (NSCLC) patients. Through the acquisition of Vertical Bio, PFL-002/VERT-002 will undergo clinical testing in solid tumors driven by MET genetic alterations.  More recently, the pan-RAF inhibitor exarafenib was acquired from Kinnate Biopharma with the aim to expand targeted therapy options for RAS/RAF-driven solid tumors. These new additions to its clinical development portfolio complement Pierre Fabre Laboratories' existing precision oncology portfolio targeting BRAF, MEK, HER2, with encorafenib, binimetinib and neratinib, respectively.

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Press contact:

Laurence Marchal

laurence.marchal@pierre-fabre.com