The dose escalation and expansion study is evaluating the safety and tolerability of ONCR-177 in patients with cancer and determining the recommended phase 2 dose.
Oncorus announced that it has initiated a phase 1 study of ONCR-177, an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy being developed for multiple solid tumor indications.
The open-label, multi-center, phase 1 dose escalation and expansion study is designed to evaluate the safety and tolerability of ONCR-177 and to determine the recommended phase 2 dose. In addition, the study will assess the anti-tumor activity of ONCR-177 alone and in combination with pembrolizumab (Keytruda) in patients with advanced and/or refractory cutaneous, subcutaneous, or metastatic nodal solid tumors.
In preclinical studies, ONCR-177 was shown to stimulate multiples arms of the immune system, drive abscopal activity, and prolong survival while simultaneously limiting systemic exposure to transgene products, such as IL-12, that generally cannot be safely dosed systemically due to toxicities.
“Initiating our first-in-human study of ONCR-177 is a significant milestone, bringing us a major step closer to delivering on our mission to realize the full promise of viral immunotherapy for cancer patients across multiple indications, including some of the most notoriously difficult-to-treat types of cancer,” Theodore A. Ashburn, MD, PhD, president and chief executive officer of Oncorus, said in a press release. “Our oHSV platform represents a potential breakthrough for the viral immunotherapy class due to the multiple proprietary innovations our team has developed to activate multiple arms of the immune system to enhance potency while balancing safety.”
The first part of the phase 1 study involves a monotherapy dose escalation of ONCR-177 and is anticipated to enroll approximately 21 patients with cancer with advanced or metastatic solid tumors for whom surgical resection or locoregional therapy is not indicated, and 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. The phase 1 trial will escalate the dose of ONCR-177 until the recommended phase 2 dose is determined.
Once the recommended phase 2 dose has been determined, 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 pembrolizumab, 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, head and neck squamous cell carcinoma (HNSCC), and melanoma.
“While we have seen great success with immuno-oncology as an approach in some patients, these therapies have not benefited all patients with cancer and new strategies are needed,” Shiraj Sen, MD, PhD, associate director of the Drug Development Unit at the Sarah Cannon Research Institute at HealthONE in Denver, Colorado, said in a press release. “Given its differentiated profile, ONCR-177 has the potential to enable more patients to respond to, and realize the benefits of, immuno-oncology treatment. We are pleased to be part of this important first-in-human study of this next-generation viral immunotherapy.”
Sen is a site investigator for the ONCR-177 Phase 1 study, and his site enrolled and dosed the first patient in this trial.
ONCORUS INITIATES FIRST-IN-HUMAN PHASE 1 STUDY OF ONCR-177 FOR THE TREATMENT OF ADULT SUBJECTS WITH ADVANCED AND/OR REFRACTORY CUTANEOUS, SUBCUTANEOUS OR METASTATIC NODAL SOLID TUMORS [news release]. Cambridge, Massachusetts. Published July 16, 2020. oncorus.com/news-items/2020/07/16/oncorus-initiates-first-in-human-phase-1-study-of-oncr-177-for-the-treatment-of-adult-subjects-with-advanced-and-or-refractory-cutaneous-subcutaneous-or-metastatic-nodal-solid-tumors/. Accessed July 16, 2020.