The Phase 1 trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (PSA and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy and have been treated with at least one potent anti-androgen therapy.
This is an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information.
FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor. In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and reductions in androgen receptor expression.
FT-7051 also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models.
Prostate cancer is the second leading cause of cancer death for men in the US, and mCRPC is the most advanced form of this disease.
Prostate cancer cell growth is driven by activity of the androgen receptor. Primary treatments of mCRPC include therapies that reduce androgen synthesis or inhibit androgen binding and activation of the AR.
Studies have shown that approximately 20% to 40% of mCRPC patients demonstrate primary resistance to enzalutamide and abiraterone acetate, two commonly used therapies, and virtually all patients who demonstrate initial clinical responses eventually acquire resistance.
There are currently no approved therapies specifically aimed at mCRPC over-expressing AR variants, including AR-v7; therefore, a novel inhibitor of AR co-activator CBP/p300 may play a role in the suppression of mCRPC driven by AR aberrations.
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.
GSK releases decade-long data on Shingrix efficacy
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients