{"id":3649,"date":"2024-06-05T15:01:43","date_gmt":"2024-06-05T08:01:43","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=3649"},"modified":"2024-06-05T15:01:43","modified_gmt":"2024-06-05T08:01:43","slug":"pierre-fabre-laboratories-announce-ind-filing-for-pfl-002-vert-002-a-potential-treatment-for-patients-with-solid-tumors-including-non-small-cell-lung-cancer-with-met-alterations","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=3649","title":{"rendered":"Pierre Fabre Laboratories Announce IND Filing for PFL-002\/VERT-002, a Potential Treatment for Patients with Solid Tumors, Including Non-Small Cell Lung Cancer with MET Alterations"},"content":{"rendered":"

CASTRES, France<\/span>, June 5, 2024<\/span> \/PRNewswire\/ — Pierre\u00a0Fabre 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\u00a0for solid tumors including\u00a0non-small cell lung cancer (NSCLC).<\/p>\n

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\u00a0MET\u00a0alterations, including those acquired as resistance mechanism to other treatments. The FDA will review the application and determine its acceptability.<\/p>\n

“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\u00a0MET-altered solid tumors, including NSCLC” said Francesco Hofmann<\/span>, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.<\/p>\n

About PFL-002\/VERT-002<\/p>\n

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\u00a0c-MET, a known disease driver in patients with solid tumors, including non-small cell lung cancer (NSCLC) presenting mutations or amplification of\u00a0MET.\u00a0The antibody has been optimized preclinically by Vertical Bio, which has been acquired by Pierre Fabre Laboratories.<\/p>\n

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.<\/p>\n

About Pierre Fabre R&D Pipeline and Portfolio<\/p>\n

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.<\/p>\n

PDF – https:\/\/mma.prnewswire.com\/media\/2430129\/Pierre_Fabre_filing.pdf\u00a0<\/a><\/p>\n

Press contact:
Laurence Marchal<\/span>
laurence.marchal@pierre-fabre.com<\/a>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

CASTRES, France<\/span>, June 5, 2024<\/span> \/PRNewswire\/ — Pierre\u00a0Fabre 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\u00a0for solid tumors including\u00a0non-small cell lung cancer (NSCLC).<\/p>\n

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\u00a0MET\u00a0alterations, including those acquired as resistance mechanism to other treatments. The FDA will review the application and determine its acceptability.<\/p>\n

“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\u00a0MET-altered solid tumors, including NSCLC” said Francesco Hofmann<\/span>, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.<\/p>\n

About PFL-002\/VERT-002<\/p>\n

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\u00a0c-MET, a known disease driver in patients with solid tumors, including non-small cell lung cancer (NSCLC) presenting mutations or amplification of\u00a0MET.\u00a0The antibody has been optimized preclinically by Vertical Bio, which has been acquired by Pierre Fabre Laboratories.<\/p>\n

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.<\/p>\n

About Pierre Fabre R&D Pipeline and Portfolio<\/p>\n

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.<\/p>\n

PDF – https:\/\/mma.prnewswire.com\/media\/2430129\/Pierre_Fabre_filing.pdf\u00a0<\/a><\/p>\n

Press contact:
Laurence Marchal<\/span>
laurence.marchal@pierre-fabre.com<\/a>\u00a0<\/p>\n

<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-3649","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/3649","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3649"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/3649\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3649"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3649"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3649"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}