Pharma Focus Europe

Pierre Fabre Laboratories Files IND for PFL-002/VERT-002, Targeting Treatment of Solid Tumors and MET-Altered Non-Small Cell Lung Cancer

Thursday, June 06, 2024

Pierre Fabre Laboratories has submitted an application for investigational new drug approval to the U.S. Food and Drug Administration to begin a Phase I/II clinical trial with PFL-002/VERT-002, aimed at treating solid tumors, including non-small cell lung cancer (NSCLC).

This international, multi-center study will focus on evaluating the drug's safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and initial effectiveness in patients with NSCLC who have alterations in the MET gene, particularly those who have developed resistance to previous therapies. The FDA will review this application to decide whether the trial can proceed.

Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories, stated, "We are excited to start the first-in-human study for PFL-002/VERT-002 later this year. We see great potential in this novel therapy, which targets MET-altered solid tumors, including NSCLC."

PFL-002/VERT-002 is a monoclonal antibody created by Vertical Bio, designed to degrade c-MET, a significant driver of disease in solid tumors such as NSCLC with MET mutations or amplification. The antibody has been preclinically optimized by Vertical Bio, now part of Pierre Fabre Laboratories.

Pierre Fabre Laboratories plans to begin clinical trials for PFL-002/VERT-002 and hopes to start enrolling patients in the Phase I/II trial by the end of 2024.



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