Flare Therapeutics Presents FX-909 Phase 1 Dose Escalation and Expansion Clinical Trial Design at the 2024 ASCO Genitourinary Cancers Symposium
–First-in-human trial evaluating safety, tolerability, and clinical activity of FX-909 in patients with advanced solid malignancies including advanced urothelial carcinoma–
Excerpt from the Press Release:
CAMBRIDGE, Mass., Jan. 26, 2024 /PRNewswire/ — Flare Therapeutics Inc., a biotechnology company targeting transcription factors (TF) to discover precision medicines for cancer and other diseases, today announced a poster presentation outlining the Phase 1 clinical trial design of FX-909, a highly potent and selective inhibitor of PPARG, at the 2024 ASCO Genitourinary Cancers Symposium taking place from January 25-27, 2024 in San Francisco, CA.
“FlareTx has built a robust body of preclinical evidence that supports investigation of FX-909 in clinical trials in patients,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Flare Therapeutics. “Results shown to date reveal that FX-909 eradicates tumors in urothelial cancer (UC) animal models at low oral doses. Our scientists have also leveraged high PPARG expression as a defining feature of luminal muscle-invasive UC (MIUC) to identify genetically defined populations and select the patients that may be more likely to benefit from a treatment like FX-909. In addition, we recently shared novel translational data correlating increased PPARG expression with an immunosuppressive tumor microenvironment (TME) and shorter real-world progression-free survival to anti-PD1 treatment.”
PPARG drives luminal cell identity and accounts for two-thirds of all advanced cases of UC. Targeting PPARG offers a novel approach to treating advanced UC that could pave the way to improved clinical outcomes in patients with a luminal subtype. Treatment of genetically defined UC xenografts with FX-909 has shown an 84% tumor growth inhibition at a dose expected to be equivalent to a 50 mg dose in humans – the starting dose in the Phase 1 clinical study.
FX-909-CLINPRO-1 (NCT05929235) is a first-in-human, multicenter, open-label Phase 1 study designed to assess the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FX-909 given orally to patients with advanced solid malignancies.
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