Flare Therapeutics Inc. announced that it will present a poster detailing the correlative biomarker analysis from its FX-909 Phase 1A clinical trial at the upcoming 40th Anniversary Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025). This event is set to take place from November 5-9, 2025, in National Harbor, Maryland.
The SITC presentation will expand on previously disclosed data from Part A of the ongoing Phase 1 study of FX-909, which was recently shared at the AACR-NCI-EORTC International Conference. The new insights will delve into FX-909″s immune modulatory mechanisms.
FX-909 stands out as a pioneering orally available small molecule inhibitor of peroxisome proliferator-activated receptor gamma (PPARG), a key regulator of the luminal lineage. Currently, it is in a Phase 1B study aimed at treating locally advanced or metastatic urothelial carcinoma (UC).
Details of the SITC poster presentation include:
- Abstract Title: Phase 1 Clinical Data Show FX-909, a First-in-Class Oral PPARG Inhibitor, Drives Immune Modulation and Pro-Inflammatory Cytokine Induction in IO-Experienced Patients with Advanced Urothelial Carcinoma
- Abstract Number: 1318
- Session: Exhibits & Poster Viewing
- Presenter: Matthew L Milowsky
- Date and Time: Saturday, November 8, 2025, from 10:00 AM to 6:35 PM ET
- Location: Lower Level Atrium, Prince George”s ABC
Flare Therapeutics is dedicated to developing therapies that target transcription factors, which have historically been difficult to drug. The company”s lead program, FX-909, has shown clinical proof-of-concept as a monotherapy in its Phase 1A study and is currently assessing the recommended Phase 2 dose in a biomarker-defined population during its Phase 1B study.
Another promising program from Flare, FX-111, is a selective degrader of the hormone-bound androgen receptor (ARON), which could potentially address the limitations of traditional therapies targeting AROFF, making it relevant for all stages of prostate cancer. FX-111 is in the process of undergoing Investigational New Drug (IND)-enabling studies for its initial development aimed at treating metastatic castration-resistant prostate cancer (mCRPC).
These initiatives, alongside an earlier-stage portfolio that focuses on transcription factors across various therapeutic areas, utilize Flare Therapeutics” comprehensive discovery platform designed to identify novel, validated ligands for previously undrugged targets.
For additional information, visit www.flaretx.com and follow the company on LinkedIn.
Contacts:
- Investors: Sarah McCabe, [email protected]
- Media: Timothy Cockroft, [email protected]
