Arvinas Releases Updated Dose Escalation Data from Clinical Trial of PROTAC Protein Degrader ARV-110 in Patients with Metastatic Castration-Resistant Prostate Cancer

- Clear efficacy signal with two ongoing confirmed PSA responses, including one associated with a confirmed RECIST response -

- Data represent the first demonstration of PROTAC-mediated degradation of a disease-causing protein in humans -

NEW HAVEN, Conn., May 29, 2020 (GLOBE NEWSWIRE) --  Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated data from the dose escalation portion of the company’s Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer (mCRPC), to be shared as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020. ARV-110 is a potent, selective, orally available androgen receptor (AR) degrader, and the ASCO presentation highlights promising clinical activity, including both efficacy and AR degradation, in a heavily pretreated patient population. ­

“For ARV-110 to show signs of efficacy in these patients at this early stage of development is strong validation of our PROTAC technology,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “In addition, seeing AR degradation demonstrates that ARV-110 is acting on-mechanism to achieve this result, and we are excited to continue clinical development in the hope of bringing a new therapeutic option to patients with significant unmet need.”

“The responses we see are the first powerful examples in patients of the potential benefits of protein degradation pharmacology compared to classic inhibition or antagonism, which failed in these patients while degradation showed clinical benefit,” added Ron Peck, M.D., Chief Medical Officer at Arvinas. “This is a patient population where other therapies would be expected to have little to no benefit, and we are very pleased with the early clinical efficacy data and safety profile we are seeing and think it bodes well for both ARV-110 and the PROTAC platform.”

The dose escalation portion of Arvinas’ Phase 1/2 clinical trial of ARV-110 is designed to assess safety, tolerability, and pharmacokinetics (PK) in men with mCRPC who have progressed on standard of care therapies, as well as to identify a recommended Phase 2 dose. To date, ARV-110 has shown a favorable safety profile, and PK have been generally dose proportional, reaching exposures associated with tumor inhibition in preclinical models at 140 mg. In the data released today, Arvinas also shared evidence of in-tumor AR reduction, the first demonstration of successful targeted protein degradation by a PROTAC protein degrader in humans.