FX-111 / Flare Therap - LARVOL DELTA

A Study in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Flare Therapeutics Inc.

First-in-human • New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Discovery of FX-111, a first-in-class heterobifunctional degrader of transcriptionally active androgen receptor (ARON), to treat patients with AR-driven prostate cancer (AACR 2026) - "Targeting ARON in PC could potentially treat all forms of PC that are driven by AR signaling without the need for androgen deprivation. FX-111 is currently in IND-enabling studies with plans to initiate clinical studies in 2026."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CRBN

AR copy number amplification and AR/KLK3 expression patterns reveal mechanisms of AR signaling inhibitor (ARSI) resistance and highlight the need for AR-directed therapeutic innovation in metastatic castration resistance prostate cancer (mCRPC) (AACR 2026) - "From the Caris Prostate Cancer Database (N=17,429), 511 mCRPC patients treated with ARSI (Abiraterone and/or Enzalutamide) were identified. FX-111, a selective degrader of transcriptionally active, hormone-bound AR (ARON) in IND-enabling studies by Flare Therapeutics, offers a promising strategy to address this resistance. Ongoing analyses of AR/KLK3 subgroups aim to elucidate biological drivers of differential ARSI response."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK3

Flare Therapeutics Announces Three Upcoming Poster Presentations at AACR Annual Meeting 2026 (The Manila Times) - "The poster presentations will include preclinical data for the company’s two lead programs, FX-909, a first-in-class, orally available PPARG inhibitor designed to target the underlying luminal lineage biology of urothelial cancer and FX-111, a novel and highly differentiated potent and selective degrader for ARON, the transcriptionally active, hormone-bound androgen receptor for prostate cancer."

Clinical data • First-in-human • Preclinical • Bladder Cancer • Castration-Resistant Prostate Cancer • Urothelial Cancer