Orion grants exclusive prostate cancer therapy rights to MSD

Merck & Co (MSD) has revealed an update to its collaboration with Orion Corporation regarding the co-development and co-commercialization of the investigational cancer drug, opevesostat (MK-5684/ODM-208). The modified agreement now grants MSD exclusive rights to the development and commercialization of this hormone-dependent cancer treatment.

Initially, the agreement allowed both MSD and Orion the option to transition the licensing arrangement into an exclusive global license for MSD. Under this updated agreement, MSD now holds exclusive global rights for the development and commercialization of opevesostat and any other candidates targeting the CYP11A1 enzyme. In return, Orion stands to receive financial benefits including up to $30 million for developmental milestones, as much as $625 million for regulatory milestones, and up to $975 million linked to sales milestones.

This strategic shift enables Orion to focus its resources on advancing other projects, all while benefiting from the potential developmental and commercial successes of opevesostat in treating specific prostate cancers. Orion’s President and CEO, Liisa Hurme, highlighted these advantages in a press release dated July 1. Despite the change in rights, Orion will continue to be responsible for manufacturing the drug for both clinical trials and commercial supply for MSD.

Opevesostat is a non-steroidal, selective inhibitor of the CYP11A1 enzyme, which is designed to inhibit the production of steroid hormones that could activate the androgen receptor signaling pathway involved in hormone-dependent cancers, such as prostate cancer. The drug is currently being assessed in two major Phase III clinical trials, named OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650).

The OMAHA1 trial is a randomized, open-label study comparing the combination of opevesostat and hormone replacement therapy (HRT) against a next-generation hormonal agent (NHA) such as abiraterone acetate or enzalutamide. The study is focused on patients with metastatic castration-resistant prostate cancer (mCRPC) who have not responded to a prior line of NHAs or two previous taxane treatments. Abiraterone is marketed as Zytiga by Johnson and Johnson, while enzalutamide is sold as Xtandi by Pfizer and Astellas Oncology. The primary endpoints of this study include overall survival and radiographic progression-free survival (rPFS) in patients with androgen receptor ligand-binding domain (AR LBD) mutations.

The OMAHA2a trial aims to evaluate the safety and efficacy of the combination therapy compared to Xtandi or Zytiga for treating patients with front-line mCRPC who have failed a prior NHA treatment.

Earlier this year, MSD entered into a clinical trial collaboration and supply agreement with Lava Therapeutics to investigate a potential combination treatment involving Lava’s prostate cancer therapy, LAVA-1207, and MSD's well-known drug Keytruda (pembrolizumab).

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