Pharma Focus Asia

Oncorus Announces Clinical Trial Collaboration with Merck to Evaluate the Combination of Oncorus’ ONCR-177 with Merck’s KEYTRUDA®

Friday, July 17, 2020

Oncorus Announces Clinical Trial Collaboration with Merck to Evaluate the Combination of Oncorus’ ONCR-177 with Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients with Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors

Oncorus, Inc., a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, today announced a clinical trial collaboration agreement with Merck (NYSE:MRK), known as MSD outside of the United States and Canada, through a subsidiary to evaluate the combination of Oncorus’ ONCR-177 with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as part of an ongoing Phase 1 study of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. ONCR-177, Oncorus’ lead product candidate, is an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy being developed for the treatment of multiple solid tumor indications.

“We are pleased to enter into this clinical collaboration with Merck, as we believe the mechanisms of ONCR-177 and KEYTRUDA are highly complementary,” said Theodore (Ted) A. Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. “KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, to activate T cells, while ONCR-177 is designed to elicit an immunogenic cell death and stimulate T cells and additional key cells within both the innate and adaptive immune systems to drive a lasting and systemic anti-tumor response. Combining these two approaches has the potential to enhance antitumor immunity, and form immunologic memory against tumors. It also may help more patients become responders to immunotherapy.”

As announced today by Oncorus, the Phase 1 study underway is an open-label, multi-center, dose escalation and expansion trial designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with KEYTRUDA.

Upon determination of the recommended Phase 2 dose, the study will then enroll patients to histology- specific expansion cohorts to demonstrate safety and initial efficacy of ONCR-177 as a monotherapy and in combination with KEYTRUDA, in addition to enabling biomarker exploration. The expansion cohorts will enroll patients with solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists, including patients with breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and melanoma.

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