Oncolytics Biotech

ONCY

시가총액 US$6531만

Completion of enrollment earlier this year and expected final PanCAN grant payment this quarter mark successful completion of a key phase of Cohort 5 Final Cohort 4 results expected in Q4 2026; initial Cohort 5 results expected in the first half of 2027 The Company will use the clinical data to focus and guide its strategy to combine pelareorep with a checkpoint inhibitor in gastrointestinal and additional tumors SAN DIEGO, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced an update regarding the status of its GOBLET Phase 1/2 study, including timing for the release of certain clinical data. It also declared that it will receive the final payment under its grant from the Pancreatic Cancer Action Network (“PanCAN”) later this quarter, following the completion of certain activities in Cohort 5 of the study.

New method of use patent covering pelareorep as an immunotherapy for cancer has been issued in several countries, with U.S. issuance expected in the near term Three patent applications are pending, including two method of use with one expected to be converted to a Track One application this quarter Company expects to add a new composition of matter patent covering “next generation” pelareorep SAN DIEGO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today provided an update on its intellectual property strategy, outlining progress on new method of use patents and plans to expand its portfolio with composition of matter protection for a modified “next generation” pelareorep. These initiatives build on the Company's existing manufacturing patent protection through 2044 and are intended to extend protection for specified therapeutic uses and future innovations into the late 2040s, subject to patent issuance and applicable patent terms.

SAN DIEGO, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced data published in the Proceedings of the National Academy of Sciences show pelareorep's ability to change an immunologically inactive liver cancer tumor microenvironment into one that is immunologically active and potentially susceptible to immune-based therapy.

Substantially all planned REO 033 clinical sites are now activated, with multiple patients currently on study Company expects to have sufficient Part A data to provide an interim clinical update by year-end 2026 FDA alignment provides potential path to accelerated approval based on objective response rate and full approval based on progression-free survival SAN DIEGO, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced continued clinical and operational progress in REO 033, its randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”).

Oncolytics announced positive preclinical results evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.

FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full approval Pivotal expansion to follow initial clinical data from the ongoing randomized Part A SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design of a potential pivotal Part B expansion of REO 033, the Company's ongoing randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer (“REO 033”). The Company submitted a Type D meeting request to the FDA regarding the potential expansion of REO 033 into a pivotal study.

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics' regulatory momentum and continues to advance the Company's path toward registration SAN DIEGO, July 20, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (“SCAC”) who have progressed on or were intolerant to one or more prior lines of systemic therapy. Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious diseases and address significant unmet medical needs.

Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design Part B will be a randomized study designed to support potential accelerated and full approval SAN DIEGO, July 13, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today provided a clinical and regulatory update on REO 033, the Company's randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan (“FOLFIRI”) and bevacizumab for the second-line treatment of patients with Rat Sarcoma (“RAS”)-mutant, microsatellite stable (“MSS”) metastatic colorectal cancer. REO 033 builds upon the previously reported REO 022 study, which more than doubled historical standard-of-care benchmarks across progression-free survival, overall survival, duration of response, and objective response rate.1 -4 Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for this indication.

Intellectual property update confirms pelareorep's unique manufacturing process and scalability Previously filed method-of-use patent application expected to provide protection into 2046 Additional patent filings planned in 2026 to further expand the pelareorep intellectual property estate SAN DIEGO, June 16, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a new patent broadly protecting the Company's proprietary manufacturing process for pelareorep. The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide intellectual property protection into 2044.

SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, today announced the appointment of Steve Glover to its Board of Directors and the promotion of John McAdory to Chief Operating Officer (“COO”). Mr. Glover brings significant public company leadership and transaction experience to Oncolytics, including serving as Chairman of Ambrx Biopharma during its acquisition by Johnson & Johnson in a transaction valued at approximately $2 billion.