CEACAM6

Trial-in-progress abstract highlights new cohort that could expand the company's pancreatic cancer program Pelareorep's ability to expand TILs highlights its immunotherapeutic mechanism of action and potential as a backbone immunotherapy for multiple indications SAN DIEGO and CALGARY, AB, May 24, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. One is a trial-in-progress abstract discussing cohort 5 of the GOBLET study, which will evaluate the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The second describes pelareorep's ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) across multiple cancers and the correlation between TIL expansion and tumor response. The ASCO annual meeting will take place from May 31 – June 4, 2024, in Chicago, Illinois. "The two abstracts that we are sharing at ASCO this year are in synch with our mission of advancing pelareorep towards registrational trials. The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy. This cohort is being funded by a US$5 million grant in the form of the Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN). We anticipate enrollment in this cohort will begin this quarter." Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics stated, "Pelareorep stimulates a proinflammatory response that primes tumors for immunologic killing and also activates both innate and adaptive immune responses. Our second ASCO abstract provides additional support for pelareorep's immunotherapeutic mechanism of action by describing its ability to stimulate the expansion of pre-existing and new TIL clones in the blood, which correlate with treatment response. These results build upon previously reported data from the AWARE-1 study in breast cancer to expand our understanding of pelareorep's immune-based mechanism of action, and it supports further investigation of TIL expansion as a potential biomarker of clinical activity in patients treated with pelareorep." Details on the abstracts and poster presentation are shown below. Title: Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma. Presentation Type: Poster Abstract Number: TPS4203 Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Session Date and Time: June 1, 2024, 1:30 – 4:30 p.m. CT A copy of the ASCO presentation will be available on the Media page of Oncolytics' website (LINK) following the conclusion of the meeting. Highlights from the GOBLET cohort 5 abstract and poster include: The study utilizes a Simon two-stage design to evaluate patients with newly diagnosed metastatic PDAC. In Stage 1, 15 evaluable patients per arm will be randomized to receive either: 1) pelareorep + mFOLFIRINOX, or 2) pelareorep + mFOLFIRINOX + atezolizumab. The co-primary endpoints are objective response rate and safety. Secondary and exploratory endpoints include additional efficacy assessments (e.g., progression-free and overall survival), and biomarker evaluations. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples are being collected for translational evaluations. Title: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer. Presentation Type: Online abstract Abstract Number: e14625 Highlights from the abstract include: The presence and expansion of TILs are associated with a better prognosis and response to treatment in cancer patients. Pelareorep treatment increased TIL expansion in the blood in all pancreatic, breast, and colorectal cancer patients evaluated after one cycle of treatment. Pre-existing TIL clonal expansion in the blood appears to correlate with tumor responses in pancreatic cancer patients. The addition of the PD-L1 inhibitor avelumab, unlike atezolizumab, eliminated pre-existing TIL expansion in the blood and reduced pelareorep's clinical activity. These data suggest that pelareorep offers a simple, reliable way to expand TILs to provide clinical benefit. About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated mission of advancing pelareorep towards registrational trials; our belief that should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to such events outside of our control, including public health crises such as pandemics and epidemics, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Logo: SOURCE Oncolytics Biotech® Inc.

US$5 million PanCAN grant provides important support for the fifth cohort of the GOBLET study Study of modified FOLFIRINOX/pelareorep/atezolizumab (Tecentriq®) combination expands existing pancreatic cancer program First patient expected to be enrolled in Q2 2024 SAN DIEGO and CALGARY, AB, May 9, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals. This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq®) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a US$5M Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer.1 Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel (link to the PR, link to the poster) that surpassed historical outcomes.2-5 Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer. "Oncolytics is pleased to announce receipt of regulatory clearance to initiate the mFOLFIRINOX cohort in patients with newly diagnosed metastatic PDAC. We appreciate the opportunity to collaborate with PanCAN, Roche, and AIO on this cohort, which is expected to initiate enrollment in the second quarter," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We believe that working with PanCAN will help to further enrich Oncolytics' clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN's Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy." "The Therapeutic Accelerator Award program has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer. We incorporated input from leading scientists and clinicians in the field of pancreatic cancer to select Oncolytics as a recipient of this award," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN. "Increasing patient access to clinical trials is vital to developing improved treatment options, so we are pleased that Oncolytics has received regulatory clearance for the pelareorep/mFOLFIRINOX combination and is poised to enroll the first patient in this cohort. We hope that the results from this study lead to improved outcomes for patients with pancreatic cancer." Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, "Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens. My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the mFOLFIRINOX cohort." "We previously reported very encouraging results in pancreatic cancer patients for the combination of pelareorep, gemcitabine/nab-paclitaxel, and atezolizumab, and we plan to begin a registration-enabling study of this regimen later this year. The new pelareorep/mFOLFIRINOX cohort offers the opportunity to expand pelareorep's role in pancreatic cancer. If the mFOLFIRINOX combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "In addition, translational research studies planned for this cohort will help to further elucidate pelareorep's mechanism of action, including its ability to shape the tumor microenvironment (TME). Notably, we will evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect that was observed in earlier pancreatic cancer studies. We look forward to initiating enrollment into the mFOLFIRINOX/pelareorep study cohort in the second quarter of this year." References Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369 O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005 Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684 Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070 About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon-two stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated goals, objectives and mission; the commencement of enrollment into our new GOBLET study pancreatic cancer cohort and the timing thereof; our belief that positive results from a combination of pelareorep and mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer, including potentially advancing the approach to a registration-enabling study; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Logo: SOURCE Oncolytics Biotech® Inc.

US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab Testing with the most common therapies could facilitate broad use of pelareorep in pancreatic cancer patients SAN DIEGO and CALGARY, AB, March 5, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI; Germany's regulatory body) for approval before patient enrollment can begin. The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being supported by the US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. Evaluation of this novel treatment approach will complement Oncolytics' ongoing development of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in PDAC, which is expected to advance to a registrational study later this year. "We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFOLFIRINOX or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy1. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel (link to the PR, link to the poster). This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible." Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, "One of the reasons for pancreatic cancer's poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumor microenvironment (TME)2. Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems while driving the remodeling of the tumor microenvironment. Positive results from the Phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer." "This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients," commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The mFOLFIRINOX cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumor responses. We look forward to building on PanCAN's strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the GOBLET study." References Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. . Yoon JH, et al. Immunotherapy for pancreatic cancer. World J Clin Cases. 2021 May 6;9(13):2969-2982. doi: 10.12998/wjcc.v9.i13.2969. PMID: 33969083; PMCID: PMC8080736. About GOBLET cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm - pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen patients may be randomized to each arm in Stage one of the Simon-two stage design. The co-primary endpoints of the cohort are objective response rate and safety. The success criteria for Stage 1 is defined as six or more responses in one or both of the treatment groups. Successful completion of Stage one will support expansion into Stage two, which can include one or both treatment regimens, and would enroll 17 additional evaluable patients. A total of 13 or more responses from Stage 1 and 2 combined are required to achieve the success criteria. Translational data will also be generated. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated goals, objectives and mission; our belief that pelareorep in combination with mFOLFIRINOX could improve outcomes for pancreatic cancer patients and advance the development of new treatment options for patients with pancreatic cancer; our plans to build on PanCAN's strong relationships with the pancreatic cancer community and further our collaboration with AIO-Studien-gGmbH on our GOBLET study; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Logo - SOURCE Oncolytics Biotech® Inc.