Pierre Fabre SA

PFL-002/VERT-002 is a monoclonal antibody with a novel and differentiated mechanism of action, acting as a degrader of c-MET, with the potential to be a best-in-class treatment for cancer driven by MET alterations CASTRES, France I October 24, 2024 I Pierre Fabre Laboratories announced today that the first patient has been dosed with PFL-002/VERT-002, a monoclonal antibody acting as a degrader of c-MET, in a phase I/II first-in-human dose-escalation, dose-optimization and dose-expansion trial, for patients with Non-Small Cell Lung Cancer (NSCLC) harbouring MET alterations. Pierre Fabre Laboratories Announce First Patient Dosed in Phase I/II Clinical Trial of PFL-002/VERT-002, an Innovative Targeted Therapy Intended to Treat NonSmall Cell Lung Cancer with MET Alterations The PFL-002/VERT-002 phase I/II trial is an open label, multi-centre study that aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of PFL-002/VERT-002, as a monotherapy for patients with MET-dependent tumors, including those emerging with acquired resistance to other treatments. Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, accounting for approximately 85% of newly diagnosed lung cancer cases, and MET, also known as hepatocyte growth factor receptor (HGFR), is an oncogene driver in subsets of patients suffering from NSCLC. 1-4 MET exon 14 skipping mutation and MET amplification are found as primary oncogenic drivers and MET amplification as a resistance mechanism to selected targeted therapies. “PFL-002/VERT-002 targets a clinically validated oncogenic driver with a unique and differentiated mechanism of action, triggering the degradation of the c-MET oncogene. Thus, it provides the opportunity to test a novel therapeutic approach for patients with MET driven tumors. We are looking forward to collaborating with the investigators participating in the first-in-human trial to assess the safety and efficacy of this new agent.” said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories. SOURCE: Pierre Fabre

LAKE FOREST, Ill., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, announced that Ajay Patel, Chief Financial Officer, will host investor meetings at two investor conferences taking place in New York City during September 10-12, 2024. Assertio will participate in the HC Wainwright Conference, which will take place September 10-11, 2024 at the Lotte New York Palace Hotel. Investors can register and request meetings via their HC Wainwright representative. The Company will also participate in the Lake Street Capital Markets BIG8 Conference, taking place September 12, 2024 at the Yale Club. Investors can register and request meetings through their Lake Street representative. About Assertio Assertio is a commercial pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our commercial portfolio through acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. To learn more about Assertio, visit www.assertiotx.com. Investor Contact Matt Kreps, Managing DirectorDarrow AssociatesM: 214-597-8200mkreps@darrowir.com

European approval is based on results from the Phase II PHAROS trial, which showed a meaningful clinical benefit to BRAF V600E mutated advanced NSCLC patients with an objective response rate (ORR) of 75% in treatment-naïve patients and 46% in previously treated patients. [ 1-3] The safety pro consistent with that observed in the approved metastatic melanoma indication. [ 1] The approval follows a positive opinion issued on July 25 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) CASTRES, France , Aug. 30, 2024 /CNW/ -- Pierre Fabre Laboratories announced today that the European Commission (EC) has approved BRAFTOVI ® (encorafenib) in combination with MEKTOVI ® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. The approval is based on the results from the Phase II PHAROS trial, a global, open-label, multicentre, non-randomised trial to determine the efficacy and safety of BRAFTOVI ® + MEKTOVI ® in treatment-naïve and previously treated patients with BRAF V600E mutant metastatic NSCLC. [ 1] “We are pleased to be able to extend the treatment of BRAFTOVI ® (encorafenib) in combination with MEKTOVI ® (binimetinib) to adult patients with advanced NSCLC with a BRAF V600E mutation in Europe ” said Eric Ducournau , Chief Executive Officer of Pierre Fabre Laboratories. “There are currently limited targeted treatment options for BRAF V600E mutant NSCLC patients, so this approval is a significant milestone as BRAFTOVI ® + MEKTOVI ® will give patients the option of an additional effective targeted therapy.” The EC decision, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued on 25 July, is based on the results from the Phase II PHAROS trial. [ 1-3] At primary analysis (cut-off date: September 22, 2022 ), the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. In the treatment-naïve population (n=59), the ORR was 75% (95% CI: 62, 85), including 15% complete responses (CRs) and 59% partial responses (PRs). [ 1-3] Updated results with an additional 10-month follow-up showed that 64% of patients maintained a response for at least 12 months, with a median duration of response (mDOR) per IRR of 40 months (95% CI: 23.1, not estimable [NE]). [ 2,3] * CONTACT: Laurence MARCHAL, laurence.marchal@pierre-fabre.com PDF - Logo - SOURCE PIERRE FABRE LABORATORIES