On July 16, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported it initiated dosing of ORIC-944, a potent and selective allosteric inhibitor of PRC2, in combination with darolutamide as well as in combination with apalutamide, in the first half of 2024 as part of the ongoing Phase 1b trial in patients with metastatic prostate cancer (Press release, ORIC Pharmaceuticals, JUL 16, 2024, View Source [SID1234644891]). Each combination cohort includes a dose escalation and expansion portion, evaluating the combination of ORIC-944 and NUBEQA (darolutamide) or ORIC-944 and ERLEADA (apalutamide).
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The company also announced that it has entered into clinical trial collaboration and supply agreements with Bayer and Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-944 in combination with NUBEQA, Bayer’s androgen receptor (AR) inhibitor, and ERLEADA, Johnson & Johnson’s AR inhibitor.
Under the terms of the collaborations, ORIC will continue to conduct and sponsor the ongoing Phase 1b trial, and Bayer and Johnson & Johnson will provide darolutamide and apalutamide, respectively, for the study. ORIC maintains full global development and commercial rights to ORIC-944.
"We are pleased to enter into these clinical collaborations to investigate the broader potential of ORIC-944 in combination with AR inhibitors, a combination approach that we believe is particularly promising based on our preclinical findings as well as emerging clinical data," said Jacob M. Chacko, M.D., president and chief executive officer. "As reported at the AACR (Free AACR Whitepaper) Annual Meeting earlier this year, the combination of ORIC-944 and AR inhibitors demonstrated synergy in multiple prostate cancer models with a unique mechanism of reprogramming prostate cancer to revert to an AR-dependent state. Together with the emerging clinical profile of ORIC-944, which has already demonstrated superior clinical half-life, robust target engagement and favorable safety as a monotherapy, the combination of ORIC-944 with an AR inhibitor has the potential to become a novel treatment paradigm for patients with prostate cancer."
About ORIC-944
ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile.