Oncolytics Biotech® Begins Enrollment Expansion for GOBLET Anal Cancer Cohort

Successful stage 1 data support expansion, with nearly three times the objective response rate compared to checkpoint inhibitor monotherapy, including complete responses.

san diego and Calgary, Alberta, February 14, 2024 /CNW/ — Oncolytic biotechnology^® Inc. (NASDAQ: ONCY) (TSX: ONC), an oncology-focused clinical-stage immunotherapy company, today announced the enrollment of the anal cancer cohort in the GOBLET study evaluating the combination of perolep and atezolizumab (Tecentriq). Announcing expansion.^®) Patients with unresectable squamous cell carcinoma of the anal canal (SCCA) after second-line treatment. This study expanded on positive data from Stage 1 of the study, which was presented at the 2nd Research Conference.^n.d. International Interdisciplinary Anal Cancer Conference (IMACC) November 2023 (Link to PR, Link to poster).

“These exciting clinical data, exceeding Simon’s two-step success criteria, provide strong support for expanding the evaluation of peraleolep in patients with advanced anal cancer. Results reported at IMACC 2023 show that peraleolep Combination with atezolizumab demonstrated a 37.5% treatment efficacy. These data demonstrate that post-second-line anal cancer patients treated with checkpoint inhibitor therapy experienced responses. This is in significant contrast to recent clinical trial results. 10-14% interest rate.^1-3” said the doctor. matt coffey, President and CEO of Oncolytics. ”

“Given the early efficacy signals observed with peraleolep-based therapy, particularly in pancreatic cancer, we have a fairly optimistic outlook for our patients and the potential of peraleolep for stage 2 expansion. Currently, there is no established standard of care for patients with anal cancer who have failed the first line of therapy. Opportunities could expand and open the door to expedited regulatory pathways in this rare and grossly underserved patient population,” Dr. Coffey continued.

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dark arnold“One of the most difficult challenges in my practice is the limited number of treatment options available for patients with advanced anal cancer,” said Dr. M.D., director of the Asklepios Oncology Center in Hamburg and principal investigator of the GOBLET trial. “It’s about being there,” he commented. This will allow continued evaluation of Pelaorep and atezolizumab combination therapy, as it may provide important confirmatory data that may lead to better treatment options for patients with this late-stage treatment drug. I’m working hard on growing this cohort. gradual disease. ”

“We look forward to building on the oncology community’s enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal cancer cohort and incorporating additional sites into the study.” did. thomas heineman, MD, Ph.D., Chief Medical Officer, Oncolytics. “Careful consideration of recently published clinical trial results suggests that even modest expansion of the number of patients to less than 20 patients would solidify the efficacy signal observed to date and provide guidance for future studies targeting this population. We find that this is sufficient to lay the foundation for a potential registration study. We hope to continue our excellent collaboration with AIO clinical sites and researchers and report additional results in 2025. Masu.”

References

1. Rao S, et al. A phase II study of retifanlimab in patients (pts) with squamous cell carcinoma of the anal canal (SCAC) who progressed after platinum-based chemotherapy. Annals of Oncology. September 2020. Doi: https://doi.org/10.1016/j.annonc.2020.08.2272.

2. Marabelle A et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: Results from the nonrandomized, multicohort, multicenter, phase 2 KEYNOTE-158 study. Lancet Gastrointestinal Roll Hepatol. May 2022;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4.

3. Randomized phase II study of avelumab alone or in combination with cetuximab in patients with previously treated locally advanced or metastatic squamous cell anal cancer: caracas study. J Immune Cancer. 2021 Nov;9(11):e002996. doi:10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452.

About the goblet

Goblet (Ggastrointestinal tract○Explore Treatment Com rsBInfection with oncolytic reovirus peLAruEOrep andTThe i-PD-L1) study is a Phase 1/2 multi-indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers across the country. Germany Managed by AIO-Studien-gGmbH. The study’s co-primary endpoints are objective response rate (ORR) and safety assessed at week 16. Important secondary and exploratory endpoints include additional efficacy assessments and assessment of potential biomarkers (T cell clonality and CEACAM6). This study employs Simon’s two-stage design, with stage 1 consisting of his four treatment groups.

1. Peraleolep in combination with atezolizumab, gemcitabine, and nab-paclitaxel 1^cent Intended for patients with advanced/metastatic pancreatic cancer.

2. Combination of peraleolep and atezolizumab 1^cent Line MSI (Microsatellite Instability) – Highly metastatic colorectal cancer patients.

3. Combination therapy of peraleolep with atezolizumab and TAS-102 (3)^rd Line up patients with metastatic colorectal cancer.and

4. Combination therapy of peraleorep and atezolizumab 2^n.d. Patients with advanced, unresectable anal cancer are placed on the line.

Cohorts that meet prespecified efficacy criteria in Stage 1 can proceed to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) Internal Oncology Working Group Within the German Cancer Society (DKG). AIO operates with a not-for-profit purpose of advancing science and research with an emphasis in medical oncology. Since its inception, AIO has established itself as a successful sponsor and research management company nationally and internationally.

About Oncolytics Biotech Co., Ltd.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously administered immunotherapy. Peraleorep showed promising results in a phase 2 study in breast and pancreatic cancer. It acts by inducing anti-cancer immune responses, promoting an inflamed tumor phenotype through innate and adaptive immune responses, transforming “cold” tumors into “hot” and causing a variety of treatment.

Pelaolep has demonstrated synergy with multiple approved oncology treatments. Oncolytics is currently moving forward with registration studies in metastatic breast and pancreatic cancer, and is conducting and planning clinical trials in combination with perolep in solid tumors and hematologic malignancies. See below for more information. www.oncolyticsbiotech.com.

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act 1934 and as amendments and forward-looking information under applicable Canadian securities laws (such Forward-looking statements and forward-looking information are collectively referred to as “forward-looking statements”). (hereinafter referred to as “forward-looking statements”). Forward-looking statements contained in this press release include Oncolytics’ beliefs regarding the potential, mechanism of action, and benefits of perolep as a cancer treatment. Plans to expand evaluation of perolep in patients with advanced anal cancer. We believe that continued positive results could expand opportunities for perolep beyond its primary indications in breast and pancreatic cancer, opening the door to an expedited regulatory pathway. Expansion of the anal cancer cohort will allow continued evaluation of peralolep and atezolizumab combination therapy, providing important confirmatory data that may lead to better treatment options for patients with this terminal disease. We believe that it is possible. Our belief in the potential of future registry studies in anal cancer. We hope to continue our collaboration with clinical sites and researchers at AIO-Studien-gGmbH and report additional results in 2025. Plans to move forward with registry studies in metastatic breast cancer and pancreatic cancer. and other statements relating to anticipated developments in Oncolytics’ business and technology. In forward-looking statements in which Oncolytics expresses expectations or beliefs regarding future results, such expectations or beliefs are expressed in good faith and believed to have a reasonable basis; There is no guarantee that any expectation or belief will be certain. It will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties that could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to, the availability of funding and resources to pursue research and development projects, the effectiveness of Peraleorep as a cancer treatment, the success and timely completion of clinical studies and trials, and These include Oncolytics’ ability to successfully commercialize. uncertainties related to pharmaceutical research and development, uncertainties related to regulatory processes and general changes in the economic environment; In particular, we are experiencing delays and disruptions to our operations, manufacturing supply chain, clinical trials and project development, workforce shortages, travel and transportation disruptions, and closures (including due to government actions) resulting from COVID-19. may be affected by business interruption. Regulations and Precautions). We may incur costs and delays related to such events that are beyond our control, which could have a material adverse effect on our business, results of operations and financial condition. Investors should refer to Oncolytics’ quarterly and annual reports filed with the Canadian and U.S. securities commissions for additional information regarding the risks and uncertainties associated with forward-looking statements. Investors are cautioned not to place undue reliance on forward-looking statements. We undertake no obligation to update these forward-looking statements, except as required by applicable law.

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SOURCE Oncolytics Biotech® Inc.

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