CAMBRIDGE, Mass., July 16, 2020 – 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 subsidary 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.
For more information on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT04348916.
Oncorus has designed its proprietary oHSV Platform to develop improved intratumorally administered viral immunotherapies that have enhanced potency without sacrificing safety, a challenge that has been encountered by earlier generation programs in this class. ONCR-177 is designed to mount a powerful, multidimensional attack on cancer; it induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to its oncolytic activity, ONCR-177 is armed with five immunomodulatory transgenes: IL-12, CCL4, FLT3LG, and antagonists of clinically proven immune checkpoints PD-1 and CTLA-4. This represents a greater payload capacity than viral immunotherapies that are either currently approved or in clinical development.
In preclinical studies, ONCR-177 was shown to stimulate multiples arms of the immune system, drive abscopal activity and prolong survival while limiting systemic exposure to transgene products, such as IL-12, that cannot be safely dosed systemically due to toxicities.
ONCR-177 retains full replication competency to enable potent tumor cell killing. It also incorporates two highly innovative approaches — the use of microRNA target sequences and a proprietary mutation engineered in an HSV-1 protein, known as UL37 — to allow for tumor-specific replication, which restricts viral activity to tumor cells while sparing normal tissues.
At Oncorus, we are focused on driving innovation to deliver next-generation viral immunotherapies to transform outcomes for cancer patients. We are advancing a portfolio of intratumorally and intravenously administered viral immunotherapies for multiple indications with significant unmet needs based on our oncolytic Herpes Simplex Virus Platform and Synthetic Virus Platform. Please visit www.oncorus.com to learn more.