On July 13, Merck and Orion announced that they have reached a cooperation agreement to jointly develop and commercialize Orion’s drug ODM-208 and other drugs targeting cytochrome P450 11A1 (CYP11A1). ODM-208 is a novel, oral, non-steroidal, selective CYP11A1 inhibitor currently in Phase II clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Under the terms of the agreement, Orion will receive an upfront payment of $290 million and milestone payments related to the development and commercialization of ODM-208. In addition, the agreement gives both parties the option to convert co-development and commercialization into Merck’s exclusive global development. If this option is exercised, Merck will bear all development and commercialization costs associated with the program.
Globally, prostate cancer is the second most common cancer in men, with an estimated 1.4 million diagnosed in 2020. Approximately 10-20% of advanced prostate cancers develop castration-resistant prostate cancer (CRPC) within 5 years, and at least 84% of CRPC patients have metastases at diagnosis. The prognosis for patients with advanced prostate cancer is poor, and the five-year survival rate remains low.
The androgen receptor (AR) plays a central role in prostate cancer, and increased AR expression also induces castration-resistant prostate cancer (CRPC). Several steroid precursors, such as testosterone and dihydrotestosterone, activate AR. CYP11A1 (cytochrome P450scc) is a mitochondrial enzyme that catalyzes the conversion of cholesterol to pregnenolone (Preg), the first rate-shifting step in steroid hormone biosynthesis. ODM-208 is a novel, oral, non-steroidal selective CYP11A1 enzyme inhibitor discovered and developed by Orion, which can inhibit the synthesis of steroid hormones and their precursors that can activate the AR receptor signaling pathway, thereby achieving treatment purpose. In addition, Orion also has an investigational drug ODM-209 for the CYP11A1 target, which is currently undergoing Phase I clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and breast cancer.
Orion is a globally operating Finnish drug discovery company whose core therapeutic areas are oncology and central nervous system diseases. Orion and Bayer jointly developed a new drug, dalotamide, for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), which be approved by the NMPA in 2021.