Merck & Co has added another clinical-stage drug to its oncology pipeline via a licensing agreement with Finland’s Orion for ODM-208, a prostate cancer candidate currently in phase 2 testing.
Merck – known as MSD outside the US and Canada – is paying $290 million upfront for global co-development and co-marketing rights to ODM-208, a steroid synthesis inhibitor, as well as follow-up compounds in the same class. Further financial terms have not been disclosed.
ODM-208 targets an enzyme called cytochrome P450 11A1 (CYP11A1) that is central to the production of steroids in the body from cholesterol, including androgens that can stimulate the growth of prostate cancer.
It is currently in a phase 2 trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), said Merck.
The big pharma is already a player in mCRPC with AstraZeneca-partnered PARP inhibitor Lynparza (olaparib), which was approved for that indication in 2020, although its efforts to position cancer immunotherapy Keytruda (pembrolizumab) have so far resulted in failure.
A combination of Keytruda and Lynparza proved to be ineffective in mCRPC in the KEYNOTE-365 trial, but Merck is still evaluating the pairing of its immunotherapy with Eisai-partnered VEGF/FGFR inhibitor Lenvima (lenvatinib) in this setting.
Meanwhile, Merck is also working with Seagen on the development of antibody-drug conjugate ladiratuzumab vedotin – both alone and in combination with Keytruda – for prostate cancer as well as other solid tumours. It is rumoured to be near to announcing a $40 billion takeover bid for the biotech.
“Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones,” said Dean Li, president of Merck Research Laboratories.
“We believe ODM-208 has the potential to complement our existing programme in prostate cancer,” he added.
The terms of the ODM-208 deal allow for the current terms to be upgraded to a full, worldwide license for Merck, which would add in multiple regulatory and sales milestones that, according to the partners, would “represent a substantial opportunity for Orion.”
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