Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, announced that it has entered into a clinical supply agreement with Coherus Oncology, Inc. (“Coherus”) to evaluate Oncolytics’ investigational oncolytic virus immunotherapy, pelareorep, in combination with Coherus’ next-generation PD-1 inhibitor, LOQTORZI^® (toripalimab-tpzi), in a clinical study in patients with squamous cell anal carcinoma (“SCAC”).

The study is expected to be conducted at a premier cancer center in the United States, which will be named once the study commences, and is anticipated to begin in the first quarter of 2027. It is expected to enroll patients who have progressed on the current standard-of-care first-line treatment of chemotherapy and checkpoint inhibition. Importantly, there is no approved therapy for second-line patients in this indication.

Under the terms of the clinical supply agreement, Coherus will provide LOQTORZI^® to Oncolytics, which is expected to partner with the institution sponsoring the planned clinical study.

“This agreement supports a focused clinical evaluation of pelareorep with a marketed PD-1 inhibitor in a difficult-to-treat patient population,” said Jared Kelly, Chief Executive Officer of Oncolytics. “The planned study is designed to build upon the previous efficacy signals pelareorep has shown in second-line or later SCAC patients while getting data in a patient population that has progressed on the new first-line standard of care. If the results are supportive, we believe SCAC could provide an important first step toward evaluating this combination more broadly across HPV-associated cancers.”

Rationale for the Pelareorep and Toripalimab Combination

Pelareorep is designed to activate toll-like receptor 3, stimulating innate and adaptive antitumor immune responses, and to promote the formation of tertiary lymphoid structures within the tumor, which have been associated with improved responses to checkpoint inhibitor therapy. Through these mechanisms, pelareorep promotes tumor-directed T-cell activation and infiltration and induces inflammatory signaling within the tumor microenvironment. Recent translational data presented at the Society for Immunotherapy of Cancer Annual Meeting showed that pelareorep combined with a checkpoint inhibitor increases human papillomavirus (“HPV”)-16-specific T cell clones and tumor-infiltrating lymphocyte clones in SCAC patients. Toripalimab blocks the PD-1 pathway, a mechanism tumors can use to suppress activated T cells. The planned study will evaluate whether pelareorep-mediated immune activation can enhance the antitumor activity of PD-1 blockade in SCAC patients who have progressed on chemo-immunotherapy treatment.

SCAC is an HPV-associated cancer with limited treatment options for patients whose disease progresses after available therapy. Because HPV-associated tumors express viral antigens that may provide recognizable immune targets, the SCAC study may also inform a potential broader development strategy across HPV-associated cancers.