On April 24, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported that clinical data from the dose escalation portion of the Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer have been selected for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois (Press release, FibroGen, APR 24, 2024, View Source [SID1234642279]).
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Details for the poster presentation are as follows:
Session: Poster Session – Genitourinary Cancer – Prostate, Testicular, and Penile
Title: A Phase 1b dose escalation study of FOR46, a novel antibody-drug conjugate targeting a tumor-specific epitope of CD46, in combination with enzalutamide (Enza) in patients with metastatic castration resistant prostate cancer (mCRPC).
Presenter: Nonna Shakhnazaryan and Dr. Rahul Aggarwal, MD from the UCSF Helen Diller Family Comprehensive Cancer Center
Abstract number: 5066
Poster number: 472
Date and Time: June 2, 2024 at 9:00-12:00 AM CDT
About FG-3246
FG-3246 (also known as FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and other tumor types. FG-3246 binds to a tumor-specific epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types, and demonstrates limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing investigator-initiated Phase 1b/2 study being conducted at UCSF to evaluate it in combination with enzalutamide with initial data expected in mid-2024, and a biomarker trial using a PET biomarker for CD46 using the same antibody backbone. We anticipate the initiation of a Phase 2 monotherapy dose optimization study of FG-3246 in metastatic castration-resistant prostate cancer in 2H 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.