Scorpion Therapeutics and Pierre Fabre Laboratories Initiate Phase 1/2 Clinical Trial
Wednesday, October 11, 2023
Scorpion Therapeutics, Inc. and Pierre Fabre Laboratories have jointly announced the commencement of a Phase 1/2 clinical trial for STX-721, a groundbreaking tyrosine kinase inhibitor tailored to target epidermal growth factor receptor (EGFR) and ERBB2 (HER2) Exon 20 insertion mutations. These mutations are well-established as oncogenic drivers in non-small cell lung cancer (NSCLC), the most prevalent form of lung cancer.
This clinical trial signifies a significant advancement in the realm of precision medicine for NSCLC. It aims to evaluate STX-721 as a standalone treatment for patients diagnosed with locally advanced or metastatic NSCLC carrying EGFR Exon 20 insertion mutations. EGFR mutations are widely recognized as the primary drivers of NSCLC, with Exon 20 insertion mutations accounting for up to 10% of this subgroup.
Dr. Axel Hoos, CEO of Scorpion, conveyed his enthusiasm for the clinical assessment of STX-721. He emphasized its potential as a leading EGFR Exon 20 insertion inhibitor for NSCLC treatment, underlining its exceptional selectivity and therapeutic potential, which may surpass existing treatments.
Eric Ducournau, CEO of Pierre Fabre Laboratories, expressed his satisfaction with the progress achieved through their partnership with Scorpion and the promise that STX-721 holds for benefiting patients.
STX-721 has been meticulously designed as an oral therapy that offers selectivity and optimized tolerability and efficacy when compared to presently available commercial treatments. It aims to address the limitations associated with the inhibition of wild-type EGFR in healthy tissues, which often lead to adverse events and necessitate dose adjustments.
Dr. Michael Streit, Chief Medical Officer of Scorpion, emphasized STX-721's unique quality in sparing wild-type cells and highlighted its potential as a best-in-class product. The Phase 1/2 trial seeks to demonstrate the advantages of this distinctive profile by potentially enhancing response rates.
The Phase 1/2 clinical trial, conducted in partnership with Pierre Fabre Laboratories, is an open-label, multi-center study. It aims to assess the safety and tolerability of STX-721 at various doses for patients diagnosed with EGFR-mutated NSCLC. The trial's objectives include establishing the maximum tolerated dose or an optimal biologically active dose, known as the recommended Phase 2 dose (RP2D), for STX-721 as a monotherapy. Once the RP2D is determined, Scorpion will proceed to evaluate its safety, tolerability, and overall efficacy. Additionally, the trial will measure various pharmacokinetic and pharmacodynamic effects, as well as clinical responses using established criteria.
