Pelareorep(Oncolytics Biotech, Inc.)

Pelareorep combination therapy shows continued meaningful improvement over checkpoint inhibitors alone in anal cancer patients Pelareorep-based therapy demonstrates strong safety profile with new chemotherapy regimen in pancreatic cancer patients SAN DIEGO and CALGARY, AB, Jan. 22, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today provided details from the abstracts featuring pelareorep that are being presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech, commented, "The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers. In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients. Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab. In pancreatic cancer, pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel and atezolizumab. Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer. We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available." "I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm." Abstract Number: 6 Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab. Presentation Type: Poster Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: January 25, 2025, 7:00 - 7:55 a.m. PT The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The treatment combination met the pre-defined efficacy success criteria for Stage 1 of its Simon two-stage design, and Stage 2 enrollment of 18 additional evaluable patients has begun. Updated results from this cohort show that four of twelve evaluable patients achieved a partial response for an objective response rate of 33%. This includes one patient with a prolonged complete response that persisted for over 15 months. This is notable because historical response rates to checkpoint inhibitor monotherapy are low, generally 10-24%1-3. There continue to be no safety concerns with the treatment regimen. At treatment cycle four, tumor-infiltrating lymphocyte (TIL) clonal expansion has been observed in the three responding patients for which data is available. It is anticipated that the additional data from Stage 2 of this cohort will provide a sufficiently strong efficacy signal to move this treatment regimen into a registration-enabling study. Abstract Number: 730 Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. Presentation Type: Poster Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT A promising efficacy signal in metastatic pancreatic ductal adenocarcinoma (PDAC) was previously observed for the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab. To expand the potential of pelareorep to benefit PDAC patients, and after discussion with key opinion leaders, a cohort was added to the GOBLET study to evaluate pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab. This cohort is being funded by a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN). The three-patient safety run-in for each treatment arm has completed enrollment, and patients have completed the necessary evaluation period. The safety data have been reviewed by the Data Safety Monitoring Board (DSMB) and Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and they have recommended patient enrollment continue without modification. Abstracts from the ASCO Gastrointestinal Cancers Symposium are currently available on the event website, which can be accessed by clicking here. References Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: . Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4. Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452. 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 17 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. The study comprises 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 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. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. 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 plans to provide updates on the safety and efficacy of pelareorep-based combinations therapy; our expectation that additional data from the fourth cohort of our Stage 2 GOBLET study will provide a sufficiently strong efficacy signal to move the treatment regimen into a registration-enabling study; our plans to advance pelareorep to registration-enabling studies for the treatment of breast and pancreatic cancers; 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 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. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo - SOURCE Oncolytics Biotech® Inc. 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Issued on behalf of Oncolytics Biotech Inc. USA News Group News Commentary VANCOUVER, BC, Jan. 15, 2025 /PRNewswire/ -- As 2025 begins, the American Association for Cancer Research (AACR) recently published forecasts from experts showcasing transformative advances in cancer research, including cutting-edge AI technologies, novel targeted therapies, and innovative cancer vaccines. With over 50 oncology drug approvals in 2024, including the first tumor-infiltrating lymphocyte cell therapy, this year holds great promise for precision medicine and immunotherapy. Amid growing expectations for an active year for biotech stocks in 2025, developers of new cancer therapies are already releasing important developments, with recent news coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Adaptive Biotechnologies Corporation (NASDAQ: ADPT), NeoGenomics, Inc. (NASDAQ: NEO), Elevation Oncology, Inc. (NASDAQ: ELEV), and ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC). The article continued: Statista analysts project that the oncology drugs market will generate an estimated revenue of $208.9 billion in 2025. Meanwhile, Global Market Insights reports that the global oncology market, valued at approximately $320.3 billion in 2024, is expected to grow at a compound annual growth rate (CAGR) of 10.8% from 2025 to 2034, reaching $866.1 billion. Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year. "Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed." The Phase 1/2 GOBLET study is testing pelareorep, an oncolytic reovirus, in combination with other treatments for advanced gastrointestinal cancers, including pancreatic, colorectal, and anal cancers. Conducted at 17 centers in Germany, the study aims to evaluate response rates, safety, and biomarkers across multiple treatment arms, with promising cohorts advancing to further testing. AIO is a non-profit organization that evolved from the medical oncology working group within the German Cancer Society (DKG). Dedicated to advancing science and research in medical oncology, AIO has grown into a prominent sponsor and study management company. Over the years, it has established a strong reputation both within Germany and on the international stage for its contributions to oncology research and study development. Oncolytics Biotech's work represents a significant step forward in the fight against metastatic pancreatic cancer, addressing a critical need for more effective treatment options in this aggressive disease. By leveraging the innovative potential of pelareorep in combination with established therapies, the company is paving the way for breakthroughs that could transform outcomes for patients and unlock value for investors. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, recently announced a multi-year exclusive strategic commercial collaboration that will advance minimal residual disease (MRD) monitoring options for patients with select blood cancers. Adaptive's clonoSEQ® is the first and only FDA-cleared test for detecting minimal residual disease (MRD) in lymphoid cancers, while NeoGenomics' COMPASS® and CHART® offer comprehensive and personalized testing for complex blood cancers. By combining clonoSEQ with these advanced services, oncologists can develop tailored treatment plans, assess patient risk more accurately, and gain real-time insights into disease progression, enhancing care for blood cancer patients. "As a leader in oncology testing with an extensive menu of precision oncology offerings, NeoGenomics is a natural partner for us," said Chad Robins, CEO and Co-Founder of Adaptive Biotechnologies. "We are proud of this collaboration, which expands access to the valuable insights that clonoSEQ MRD results offer, ultimately helping more providers and patients benefit from knowing their MRD status." Under a new agreement, clinicians using NeoGenomics' COMPASS diagnostic tool for blood cancers like multiple myeloma, B-ALL, CLL, and DLBCL can now include Adaptive Biotechnologies' clonoSEQ Clonality (ID) test at diagnosis to identify patient-specific DNA sequences for ongoing MRD (minimal residual disease) tracking. This integration allows seamless monitoring of disease burden throughout treatment using CHART, giving patients access to clonoSEQ insights and increasing eligibility for clinical trials that rely on MRD testing to guide therapy decisions. All clonoSEQ testing will be conducted at Adaptive's specialized laboratory, ensuring accurate and consistent results. Adaptive and NeoGenomics are preparing to implement the infrastructure for their partnership, with cross-promotional efforts expected to launch later this year, though financial terms remain undisclosed. iBio, Inc. (NYSE-American: IBIO) an AI-driven innovator of precision antibody immunotherapies, in collaboration with AstralBio Inc., recently announced they've developed a breakthrough antibody targeting Activin E, a key protein linked to cardiometabolic disorders and obesity. This achievement demonstrates the strength of iBio's platform in tackling challenging targets and advancing innovative therapies, with plans for rapid testing of this and other candidates in advanced disease models. "Developing a functional antibody against Activin E, an achievement we believe to be an industry first, is a significant milestone for iBio," said Martin Brenner, Ph.D., DVM, iCEO and Chief Scientific Officer of iBio. "This breakthrough strengthens our efforts to expand our therapeutics pipeline for the treatment of cardiometabolic disorders and obesity with innovative next-generation solutions." Elevation Oncology, Inc. (NASDAQ: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, recently announced program updates and upcoming milestones. The company is advancing its pipeline with EO-3021, a potentially best-in-class antibody drug conjugate targeting Claudin 18.2 in advanced gastric/GEJ cancer, showing promising early results with a 42.8% overall response rate and a differentiated safety profile. The ongoing Phase 1 trial includes monotherapy and combination studies, with additional data expected in 2025 and 2026, while EO-1022, a HER3-targeting ADC for solid tumors, is progressing toward preclinical data release in 2025 and an IND filing in 2026. "We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and CEO of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings." ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, recently provided early Phase 1b combination data for ORIC-944, operational highlights for 2024, and anticipated upcoming milestones. ORIC-944, a potent PRC2 inhibitor, has shown strong potential in treating metastatic castration-resistant prostate cancer (mCRPC), with deep and durable PSA responses and a favorable safety profile in early Phase 1b combination trials with apalutamide and darolutamide. Alongside advancements in ORIC-114 for NSCLC, ORIC's 2024 milestones include promising clinical data, strategic collaborations with Johnson & Johnson and Bayer, and a robust cash position expected to support operations into late 2026, positioning the company for continued progress in oncology drug development. "We made strong progress on multiple fronts in 2024, most notably with the initiation of multiple cohorts for ORIC-114 in NSCLC and ORIC-944 in mCRPC," said Jacob M. Chacko, M.D., President and CEO of Oric. "We also forged three strategic collaborations with leading pharma partners, strengthened our leadership team to expand functional capabilities, and completed a $125 million PIPE financing, extending our cash runway into late 2026. These accomplishments position us well for 2025 and beyond, with seven anticipated data readouts over the next 18 months as we advance toward potentially initiating registrational studies for ORIC-114 in the second half of 2025 and for ORIC-944 in early 2026." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. 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