On October 10, 2023 Scorpion Therapeutics, Inc. ("Scorpion"), a pioneering clinical-stage oncology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, and Pierre Fabre Laboratories reported that the first patient has been dosed in a Phase 1/2 first-in-human dose escalation and expansion clinical trial evaluating STX-721, Scorpion’s highly differentiated, orally bioavailable, irreversible highly selective tyrosine kinase inhibitor ("TKI") targeting epidermal growth factor receptor ("EGFR") and ERBB2 (HER2) Exon 20 insertion ("ex20ins") mutations, well-known, clinically validated oncogenic drivers in non-small cell lung cancer ("NSCLC") (Press release, Scorpion Therapeutics, OCT 10, 2023, View Source;301949595.html [SID1234635827]). The Phase 1/2 clinical trial will evaluate STX-721 as a monotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations.
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NSCLC is the most common sub-type of lung cancer and various EGFR mutations are the most frequent drivers of NSCLC, occurring in up to 38% of tumors, depending on geography.[1],[2],[3] Of this population, up to 10% have ex20ins mutations.[4]
"We are excited to begin the clinical evaluation of STX-721, our mutant-selective EGFR ex20ins inhibitor with a potentially best-in-class profile, for the treatment of non-small cell lung cancer," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion. "The initiation of our second clinical trial this year underscores our research team’s productivity and execution, as well as the confidence that Scorpion and Pierre Fabre Laboratories have in the quality, selectivity, and potential clinical differentiation of this compound. Based on preclinical data to-date, we believe that STX-721 is more selective and can provide a wider therapeutic window than other therapies currently on the market or in development and, as a result, has the potential to deliver superior efficacy to this highly underserved patient population."
"We are pleased to see STX-721 enter the clinic, and the overall progress we’ve achieved since we announced the partnership with Scorpion six months ago," said Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories. "Our two teams have been working closely on both of the EGFR candidates and we look forward to seeing how patients may benefit from this targeted therapy."
STX-721 is an oral treatment designed to be mutant-selective and optimized for tolerability and efficacy when compared to currently available commercial treatments. Existing therapeutic options face significant limitations that are associated with the inhibition of wild-type EGFR in healthy tissues, including serious adverse events often leading to dose reductions or interruptions.
"STX-721 is a wild-type-sparing, oral inhibitor of EGFR ex20ins mutations with a compelling preclinical selectivity profile," said Michael Streit, M.D., Chief Medical Officer of Scorpion. "In this Phase 1/2 trial, we will aim to demonstrate how these unique qualities translate into a potentially best-in-class product profile that increases response rates as a result of its optimized design. We look forward to partnering with study investigators, as well as our colleagues at Pierre Fabre Laboratories, to evaluate STX-721 in patients with EGFR ex20ins-mutated NSCLC."
About STX-721 Phase 1/2 Trial
Scorpion’s Phase 1/2 clinical trial, in collaboration with Pierre Fabre Laboratories, is a multi-center, open-label study designed to evaluate the safety and tolerability of STX-721 in multiple ascending doses for patients with locally advanced or metastatic NSCLC driven by EGFR mutations. The goal of the trial is to characterize the safety profile of STX-721 and determine a maximum tolerated dose or a lower optimal-biologically active dose, if appropriate, as the recommended Phase 2 dose ("RP2D") as a monotherapy for NSCLC driven by EGFR exon20ins mutations. Once the RP2D is established, Scorpion intends to continue to evaluate the safety, tolerability and overall efficacy of STX-721. Secondary objectives for this Phase 1/2 trial include assessing the pharmacokinetic profile, pharmacodynamic effects and clinical response as measured by Response Evaluation Criteria In Solid Tumors ("RECIST") version 1.1. To learn more about the first-in-human trial of STX-721, please visit this page.