Pierre Fabre & Scorpion Therapeutics announce new Phase I/II clinical trial for an innovative treatment in oncology.
Pierre Fabre Laboratories and Scorpion Therapeutics Announce First Patient Dosed in Phase I/II Clinical Trial of PFL-241/STX-241, a Mutant-Selective Inhibitor Intended To Treat Locally Advanced or Metastatic Non-Small Cell Lung Cancer Driven by EGFR Exon 19 or 21 and Co-occurring C797S Mutations
PFL-241/STX-241 is a highly selective, and potentially best-in-class fourth generation epidermal growth factor receptor (“EGFR”) inhibitor
One of two EGFR programs being developed with Scorpion Therapeutics
CASTRES, France and BOSTON, Massachusetts – October 8, 2024 – Pierre Fabre Laboratories, a global player in oncology, and Scorpion Therapeutics, Inc. (“Scorpion”), a pioneering clinical-stage oncology company dedicated to transforming the lives of cancer patients by redefining the frontier of precision medicine, today announced that the first patient has been dosed in a Phase I/II, first-in-human dose-escalation, dose-optimization and dose-expansion trial. This clinical trial evaluates PFL-241/STX-241, a highly differentiated, orally bioavailable, highly selective tyrosine kinase inhibitor ("TKI") targeting epidermal growth factor receptor ("EGFR") Exon 19 or 21 mutations with the co-occurring C797S mutation, a known resistance mechanism to 3rd generation EGFR inhibitors.
The PFL-241/STX-241 Phase I/II trial is an open label, multi-center study that aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical efficacy of PFL-241/STX-241 as a monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring EGFR Exon 19 or 21 mutations with the co-occurring C797S mutation.
NSCLC is the most common form of lung cancer and EGFR mutations are one of its most common disease drivers, occurring in up to 38 percent of tumors, depending on geography1,2,3.
We are eager to begin the clinical evaluation of PFL-241/STX-241, our mutant-selective 4th generation EGFR inhibitor, a molecule with differentiated properties that we believe has the potential to become a best-in-class therapeutic option for patients developing resistance to current targeted therapy. The initiation of this clinical trial highlights our team’s engagement and execution in strong partnership with Scorpion Therapeutics, and we look forward to demonstrating how patients could potentially benefit from this targeted therapy.
Francesco Hofmann
Head of Research and Development for Medical Care at Pierre Fabre Laboratories
PFL-241/STX-241 is an oral treatment designed to selectively inhibit the C797S resistance mutation co-occurring with EGFR exon 19 deletion or exon 21 mutation (“double mutant”). Those “double mutants” are emerging as an on-target resistance mechanism in a subset of NSCLC patients. Most recent data suggest that the C797S mutation emerges in approximately 12.5%4-8 of patients undergoing therapy with 3rd generation EGFR inhibitors. There are currently no approved therapeutic options for patients who develop this “double mutant” EGFR NSCLC.
The initiation of the second clinical trial in partnership with Pierre Fabre Laboratories is an important milestone as we work together to enable the rapid, global advancement of our next-generation EGFR inhibitors for difficult-to-treat NSCLC patients. PFL-241/STX-241 is a novel, CNS-penetrant and highly potent and selective treatment option for patients who develop ‘double mutant’ disease for which there is currently no approved treatment, and it’s a pleasure to partner with Pierre Fabre Laboratories, a company who shares our commitment to bringing innovative treatments to this underserved patient population. We look forward to demonstrating how PFL-241/STX-241’s differentiated preclinical profile translates into clinical benefit for patients.
Mark Chao
M.D., Ph.D., Chief Medical Officer of Scorpion
About Pierre Fabre Laboratories R&D pipeline
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 tumours 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 tumours. 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.
About Scorpion Therapeutics
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully-integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly-owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets. For more information, visit www.scorpiontx.com.
Media Contact
Media Contact
Les laboratoires Pierre Fabre
Laure Bregeon-Sgandurra
+33 6 32 54 92 01
Laure.sgandurra@pierre-fabre.com
Contacts
Scorpion Therapeutics
Contact médias : Ethan Metelenis Precision AQ ethan.metelenis@precisionaq.com
Contact investisseurs : Emiley Demick Precision AQ emiley.demick@precisionaq.com
