Results from an Ongoing Phase I/II CYPIDES Trial of ODM-208 Presented at ASCO-GU

Results from an Ongoing Phase I/II CYPIDES Trial of ODM-208 Presented at ASCO-GU

Clinical phase I data on Orion Corporation’s ODM-208, a first-in-class oral, non-steroidal and selective inhibitor of CYP11A1, the first and rate-limiting enzyme of steroid biosynthesis, were presented today at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). CYPIDES phase 1 data shows that ODM-208 effectively blocked the production of all steroid hormones in men with metastatic castration-resistant prostate cancer (mCRPC) and showed promising anti-tumor activity in men progressing despite extensive prior treatment with both novel hormonal therapies (NHT’s) and taxanes. Treatment responses to ODM-208 especially occurred in men with activating androgen receptor (AR) mutations.

ODM-208 is a complete blocker of steroid biosynthesis that suppresses the production of all steroid hormones and their precursors that may activate the androgen receptor (AR) signalling pathway. This is particularly relevant in patients with AR ligand binding domain (LBD) activating somatic point mutations, a mechanism of resistance to hormone-based therapies in metastatic castration-resistant prostate cancer (mCRPC). During treatment the patients receive hormone replacement therapy to ensure sufficient adrenal function.

In CYPIDES phase I, a total of 44 patients with median age of 70 years received ODM-208. Overall, 32% of the patients achieved a PSA (prostate specific antigen) decrease of ≥50%. Of patients with AR LBD mutation (17), 68% achieved a PSA decrease of ≥50%. Also, prolonged treatment responses were observed especially in patients with AR LBD mutation. Although tolerated by most patients, the main safety finding was adrenal insufficiency (AI). Overall, 14 (32%) patients experienced severe adrenal insufficiency despite the replacement therapy requiring further adrenal supplementation after which the ODM-208 treatment commonly continued. Non-adrenal adverse events were unremarkable.

Taru Blom (MD, PhD), Vice President, Global Development and CMO, Orion R&D comments:

“ODM-208 is a first-in-class CYP11A1-inhibitor and we are excited that this novel approach works in some of the patients who have only a few effective treatment options available. The first results of CYPIDES are encouraging, and more studies are needed to confirm the potential of ODM-208 as a treatment option for men with advanced prostate cancer. In addition, we are focusing on the safety findings of the study as well as are looking into the optimization of the adrenal balance of the patients through appropriate replacement therapy.”

More information about the CYPIDES trial: www.clinicaltrials.gov, Identifier: NCT03436485

The Phase II dose expansion part of CYPIDES is ongoing.

Phase I/II clinical trial CYPIDES

The Phase I/II trial CYPIDES investigates the safety, pharmacokinetics and anti-tumor activity of ODM-208 in men with mCRPC. The Phase I started in 2018 and has recruited 44 patients. More information about the trial: www.clinicaltrials.gov, Identifier: NCT03436485

ODM-208 investigational drug

ODM-208 is a novel, oral, non-steroidal and selective inhibitor of CYP11A1 enzyme developed by Orion for the treatment of prostate cancer. CYP11A1 is the rate-limiting enzyme of the steroid biosynthesis. By inhibiting CYP11A1 enzyme activity, ODM-208 suppresses the production of all steroid hormones and their precursors that may activate AR signalling pathway. Orion is the first pharmaceutical company to develop a selective drug that works by this mechanism.

Contact persons:

Taru Blom

Vice President, Global Development and CMO, Orion R&D, Orion Corporation

taru.blom@orionpharma.com

Tel. +358 50 966 7836

Contact person for the media:

Terhi Ormio

Vice President, Communicatios, Orion Corporation

terhi.ormio@orion.fi

Tel. +358 50 966 4646

Publisher:

Orion Corporation

http://www.orion.fi/en

http://www.twitter.com/OrionCorpIR

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion’s pharmaceutical R&D are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion’s net sales in 2021 amounted to EUR 1,041 million and the company had about 3,350 employees at the end of the year. Orion’s A and B shares are listed on Nasdaq Helsinki.