On August 19, 2024 Scorpion Therapeutics, Inc. ("Scorpion"), a pioneering clinical-stage oncology company dedicated to transforming the lives of cancer patients by redefining the frontier of precision oncology, reported that it was selected to present initial, first-in-human clinical results from the Phase 1/2 study of STX-478, a mutant-selective PI3Kα inhibitor, in advanced solid tumor patients in a Proffered Paper late-breaking session at the European Society for Medical Oncology ("ESMO") Congress 2024, taking place September 13 – 17, 2024 in Barcelona, Spain (Press release, Scorpion Therapeutics, AUG 19, 2024, View Source [SID1234645996]).
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"The presentation of first-in-human clinical data for our lead candidate, STX-478, marks an important milestone for patients living with advanced solid tumors driven by PI3Kα mutations, especially HR+/HER2- breast cancer, and for Scorpion as we work to broaden the reach and impact of precision oncology for patients with high unmet medical need," said Mark Chao, M.D., Ph.D., Chief Medical Officer of Scorpion. "While PI3Kα has been one of the highest profile targets in cancer for years, current treatment options suffer from toxicity limitations and subpar efficacy due to a lack of mutant selectivity. These initial data will provide early insight into how STX-478’s differentiated profile translates to potentially superior outcomes in PI3Kα-mutated cancers, and we look forward to presenting initial assessments of safety, pharmacokinetic and pharmacodynamic data and preliminary efficacy data at the ESMO (Free ESMO Whitepaper) 2024 Congress."
Details of the Proffered Paper presentation are as follows:
Title: First-in-human Results of STX-478, a Mutant-selective PI3Kα Inhibitor, in Advanced Solid Tumor Patients
Presentation Number: LBA27
Session Name: Proffered paper session 2: Developmental therapeutics (ID 156)
Session Date & Time: Sunday, September 15, 2024, at 14:45 CEST – 16:15 CEST (8:45 a.m. – 10:15 a.m. ET)
Presentation Time: 14:55 CEST – 15:05 CEST (8:55 a.m. – 9:05 a.m. ET)
Location: Salamanca Auditorium – Hall 5
Presenter: Alberto J. Montero, M.D. (University Hospitals Cleveland, OH, USA)
According to ESMO (Free ESMO Whitepaper), the late-breaking abstract will be published via the ESMO (Free ESMO Whitepaper) website at 00:05 CEST on September 15 (6:05 p.m. ET on September 14). Data presented at the conference will be available to view in the "Publications & Presentations" section of the Scorpion website (View Source) following the ESMO (Free ESMO Whitepaper) 2024 Congress.
About STX-478
STX-478 was designed to improve outcomes in patients harboring PI3Kα mutations, one of the most prevalent drivers of cancer, occurring in over 166,000 patients per year with breast, gynecological and other solid tumors in the United States alone. In preclinical models, STX-478 demonstrated robust activity across a range of PI3Kα mutations while sparing wild-type PI3Kα inhibition in normal tissues; previous generations of non-selective PI3Kα inhibitors have limited patient benefit due to these on-target toxicities. Scorpion’s Phase 1/2 clinical trial is a multi-center, global, open-label study designed to evaluate the safety and tolerability of STX-478 in multiple ascending doses for patients with locally advanced or metastatic HR+/HER2- breast cancer and other solid tumors driven by PI3Kα mutations. The program entered the clinic in 2023 and has rapidly advanced, now in multiple expansion cohorts across a range of solid tumors and in breast cancer as monotherapy and in combinations with fulvestrant and CDK4/6 inhibitors. To learn more about the first-in-human trial of STX-478, please visit this page.