FDA to Review IND of PFL-002/VERT-002 in MET-Altered NSCLC
An international, multicenter, first-in-human, phase 1/2 study of PFL-002/VERT-002 plans to enroll patients with NSCLC with MET alterations and expects to begin patient enrollment by the end of 2024.
- An investigational new drug application for PFL-002/VERT-002, targeting solid tumors like non–small cell lung cancer (NSCLC), has been submitted to the FDA.
- With this, a phase 1/2 trial plans to begin.
- The upcoming trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and initial efficacy of PFL-002/VERT-002.
An investigational new drug application for PFL-002/VERT-002 has been filed to the FDA, and a first-in-human, phase 1/2 trial will investigate the agent for the treatment of solid tumors, including NSCLC.1
The FDA plans to review the application and determine its acceptability.
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"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, in a press release.
PFL-002/VERT-002 is a monoclonal antibody being developed by Vertical Bio. The agent acts as a degrader of c-MET, a known disease driver in patients with solid tumors, including NSCLC presenting mutations or amplification of MET. Preclinically, PFL-002/VERT-002 has shown potential as a best-in-class agent in NSCLC harboring MET mutations or amplifications.
The study will be a multicenter, international study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PFL-002/VERT-002. Patients with NSCLC harboring MET alterations, including those acquired as resistance mechanisms to other treatments, will be included in the study.
PFL-002/VERT-002 continues to progress in clinical development, and the company anticipates enrolling its first patient in the first-in-human, phase 1/2 trial by the end of 2024.
