Oncolytic therapy meets efficacy criteria in third-line colorectal cancer cohort of GOBLET study

The results met the efficacy criteria for expanded registration and supported Perolep’s mechanism of action.

san diego and Calgary, Alabama, October 23, 2023 /PRNewswire/ — Oncolytic Biotechnology^® Inc. (NASDAQ: Oncy(Oncolytics) (TSX: ONC), an oncology-focused clinical-stage immunotherapy company, today announced that microsatellite Discuss metastatic colorectal cancer (CRC) regardless of its instability status. madrid, spain.

“The results presented at ESMO met the criteria to advance the study to the next stage, with four of the 14 enrolled patients showing stable disease at week 16. “We demonstrated a 40% disease control rate, further encouraging data for Pelaolep,” said Dr. matt coffey, President and CEO of Oncolytics. “We continue to confirm the ability of perolep to synergize with atezolizumab by eliciting an immune response, including the expansion of T-cell clones, in a patient population that has not responded to multiple treatments. The clinical data are consistent with the observed clinical responses, further supporting Perolep’s mechanism of action as a potential backbone immunotherapy for patients with gastrointestinal and other forms of cancer. ”

“We are evaluating the ability of peraleolep to improve clinical outcomes in a variety of gastrointestinal cancers, including different disease stages, and generating strong translational data to better understand the mechanism of action of peraleolep. To do so, we designed the GOBLET study. Data from this arm of the study aim to better understand the mechanism of action of peraleolep.” In patients with well-pretreated colorectal cancer Even if present, it is taken up by tumor cells and stimulates T cell proliferation. ” thomas heineman, MD, Ph.D., Chief Medical Officer, Oncolytics. “These patients showed disease control of 40%, progression-free survival of 2.8 months, median overall survival of 8.0 months, and 12-month survival of 33%, exceeding previous results.^1-3. These findings are encouraging, given that the late stage of the disease and prior extensive chemotherapy may have depleted tumor-infiltrating lymphocytes, limiting their ability to expand in response to treatment. be. Of note, this is the second GOBLET study cohort to consecutively meet success criteria, further supporting Pelaorep’s ability to synergize with atezolizumab. These data also support Perolep’s immunological mechanism of action and will inform future development plans. ”

GOBLET Study 3L Metastatic CRC Patient Overview:

Patients in the CRC cohort presented at ESMO 2023 received third-line treatment with perolep, atezolizumab, and trifluridine/tipiracil combination. The 15 evaluable patients enrolled in the first phase of the study were evaluated based on the following criteria: September 18, 2023 Data deadline. The enrolled patient population included patients with confirmed colorectal cancer with an ECOG score of 1 or less, regardless of microsatellite instability status.

References

1. Mayer et al. N Engl J Med 2015; 372:1909-1919. DOI: 10.1056/NEJMoa1414325

2. Moriwaki et al. Oncologist 2018; 23(1):7-15. DOI: 10.1634/theoncologist.2017-0275

3. Batchett et al. Esmo open. 2020 June;5(3):e000698. doi: 10.1136/esmoopen-2020-000698

poster information

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). The study will employ Simon’s two-stage design, with Stage 1 consisting of four treatment groups, with a total of approximately 55 patients expected to be enrolled.

1. Peraleolep in combination with atezolizumab, gemcitabine, and nab-paclitaxel 1^cent Patients with advanced/metastatic pancreatic cancer (n=12).
2. Combination of peraleolep and atezolizumab 1^cent Line MSI (Microsatellite Instability) – Highly metastatic colorectal cancer patients (n=19).
3. Combination therapy of peraleolep with atezolizumab and TAS-102 (3)^rd Patients with metastatic colorectal cancer (n=14).and
4. Combination therapy of peraleorep and atezolizumab 2^n.d. Lines were patients (n=10) with advanced, unresectable anal cancer.

Cohorts that demonstrate an ORR above a prespecified threshold in Stage 1 are advanced to Stage 2, where additional patients can be enrolled.

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 statements regarding Oncolytics’ beliefs regarding the potential, mechanism of action, and benefits of perolep as a cancer treatment. Our established goals and objectives. And we plan to move forward with registration studies for metastatic breast cancer and pancreatic cancer. 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. Such 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 associated with pharmaceutical research and development, uncertainties associated with 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). It is unclear whether and how oncolytic therapy will be affected if the COVID-19 pandemic continues for an extended period of time. 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.

logo: https://mma.prnewswire.com/media/1808285/4295352/Oncolytics_Biotech_Grey.jpg

SOURCE Oncolytics Biotech® Inc.