Pelareorep(Oncolytics Biotech, Inc.)

New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /PRNewswire/ -- 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." About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and 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 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 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 PDAC 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 or later 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; continued enrollment in the GOBLET study and the expansion thereof to additional participants; our belief that pelareorep is poised to advance 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] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 26, 2024 /PRNewswire/ -- USA News Group News Commentary – Immunotherapy is transforming oncology by harnessing the immune system's power to fight cancer like never before. Notable advancements include a bioengineered therapeutic platform that boosts immune responses, providing targeted solutions for challenging cancer types. Researchers have also introduced an mRNA-based immunotherapy platform capable of selectively targeting cancer cells while preserving healthy tissue. These innovations underscore the relentless pursuit of breakthroughs in oncology to enhance patient outcomes. Among the key players driving recent progress in the field are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Erasca, Inc. (NASDAQ: ERAS), Allogene Therapeutics, Inc. (NASDAQ: ALLO), Context Therapeutics Inc. (NASDAQ: CNTX), and Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX). The article continued: The oncology field continues to advance, with MarketsAndMarkets forecasting the Artificial Intelligence in Oncology Market to reach $11.52 billion by 2030, driven by a 29.4% CAGR. Similarly, Nova Advisor predicts the Personalized Cell Therapy Market will grow at a 23.53% CAGR, reaching $251.37 billion by 2034. Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently released a recap of major accomplishments from 2024 and a preview of anticipated milestones for the next 12 months. Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across its clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities. "This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study," said Wayne Pisano, Interim CEO and Chair of Oncolytics Biotech's Board of Directors. "In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep's potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy—and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the ASCO GI Symposium—an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert 'cold' tumors to 'hot,' pelareorep's unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients' immune responses—making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of Oncolytics Biotech who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey." Oncolytics Biotech continues to advance pelareorep, its innovative immunotherapy for multiple cancer indications. Final efficacy results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer demonstrated a median overall survival benefit exceeding one year and a two-year survival rate nearly double that of paclitaxel monotherapy. These findings, supported by earlier IND-213 data, further reinforce pelareorep's transformative potential. With FDA alignment on a planned registration-enabling study, Oncolytics Biotech aims to offer improved treatment options for approximately 55,000 U.S. patients annually. Significant progress has also been made in pancreatic cancer, with plans for a registration-enabling study supported by collaborations with the Global Coalition for Adaptive Research (GCAR) and Roche. This follows the GOBLET study's outcomes, which more than doubled response rates in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Additionally, the PanCAN-funded GOBLET cohort evaluating pelareorep plus mFOLFIRINOX, with or without atezolizumab, has completed safety run-in enrollment, receiving positive feedback from the Data Safety Monitoring Board. Key findings from this cohort, alongside progress in anal cancer, will be presented at the ASCO GI Symposium in January 2025. Looking ahead, Oncolytics Biotech will present at the Biotech Showcase on January 13, 2025, and host investor meetings during the J.P. Morgan Healthcare Conference that same week. These events will provide a platform to highlight its clinical advancements and reinforce its commitment to addressing critical unmet needs in oncology. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Erasca, Inc. (NASDAQ: ERAS), a clinical-stage precision oncology company, recently provided updates on its R&D advancements targeting RAS/MAPK pathway-driven cancers. In October 2024, the company presented promising Phase 1b SEACRAFT-1 data for naporafenib plus trametinib (MEKINIST®), showing potential for an NRAS-mutated melanoma indication and supporting the ongoing Phase 3 SEACRAFT-2 trial. Erasca also announced progress on its pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 programs, confirming best-in-class potential and preparing for IND submissions in 2025. Key milestones include data from SEACRAFT-2 in 2025 and initial Phase 1 monotherapy data for ERAS-0015 and ERAS-4001 in 2026. "We made significant progress across our pipeline programs and are pleased with the pace of our execution," said Jonathan E. Lim, M.D., Chairman, CEO, and co-founder of Erasca. "Positive preliminary data from SEACRAFT-1, which we reported at the 36th EORTC-NCI-AACR (ENA) Symposium last month, has refined our clinical development focus of naporafenib plus trametinib on patients with NRAS-mutant (NRASm) melanoma, and importantly, heightens our conviction in the ongoing SEACRAFT-2 registrational trial targeting a similar patient population. SEACRAFT-2 has the potential for approval based on the high unmet need of these patients as well as the alignment with US and European regulators on the NRASm melanoma indication. We expect randomized dose optimization data from Stage 1 of this Phase 3 trial in 2025." Allogene Therapeutics, Inc. (NASDAQ: ALLO), a clinical-stage biotechnology company, recently announced new data from the Phase 1 TRAVERSE trial evaluating ALLO-316, its first AlloCAR T™ product candidate, for advanced or metastatic renal cell carcinoma (RCC). Presented at the 2024 IKCS and SITC Annual Meetings, the data demonstrated a 50% overall response rate (ORR) and a 33% confirmed response rate (CRR) in patients with CD70 Tumor Proportion Scores (TPS) ≥50%. ALLO-316 showed robust CAR T cell expansion, manageable safety, and durable tumor responses, supporting the FDA's RMAT designation for advanced RCC. Additional data from the ongoing Phase 1b expansion cohort is expected in mid-2025. "ALLO-316, the leading "off-the-shelf" CAR T product candidate currently in development for solid tumors, continues to show remarkable potency in the TRAVERSE trial," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer of Allogene. "Data from the Phase 1 study demonstrating significant anti-tumor activity in patients with metastatic disease resistant to multiple therapeutic classes, even with standard lymphodepletion, potentially marks a major advancement in the field. The unprecedented cell expansion and persistence driven by CD70 CAR-intrinsic Dagger® technology, along with strong evidence of tumor infiltration by CAR T cells, highlights the distinctive features of ALLO-316. We believe these findings from our Phase 1 trial lay the groundwork for a new generation of allogeneic cell therapies." Context Therapeutics Inc. (NASDAQ: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, recently announced advancements in its T cell-engaging bispecific antibody pipeline, including CT-202, a Nectin-4 x CD3 antibody licensed in September 2024, with an IND filing expected in mid-2026. Context also acquired CT-95, a Mesothelin x CD3 antibody, set to begin Phase 1 trials in Q1 2025. Additionally, Context will present data on its Claudin 6-targeting antibody CTIM-76 at the SITC Annual Meeting. " Context executed on its strategy to build a pipeline of T cell engaging bispecific antibodies through its acquisitions of CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody," said Martin Lehr, CEO of Context. "We continue to activate additional sites for our Phase 1 trial for CTIM-76, a Claudin 6 x CD3 bispecific antibody, and expect to dose our first patient by the end of this year. We also expect to advance CT-95 into the clinic soon and expect to enroll our first patient in our CT-95 Phase 1 study in the first quarter of 2025." Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), a clinical stage TechBio company, recently announced interim data from the Phase 1/2 ELUCIDATE trial of REC-617, a selective CDK7 inhibitor, in advanced solid tumors. The trial showed REC-617 was well-tolerated with no discontinuations due to adverse events, and one patient with platinum-resistant ovarian cancer achieved a confirmed partial response lasting over six months, while four others had stable disease for up to six months. With plans to continue dose escalation and initiate combination studies in early 2025, REC-617 demonstrates potential as a safe and effective therapy in heavily pre-treated cancer patients. "Cell cycle dysregulation and transcriptional 'addiction' are both hallmarks of many aggressive cancers," said David Hallett, Ph.D., Chief Scientific Officer of Recursion. "By inhibiting CDK7, we have the potential to target both mechanisms while fine tuning the therapeutic index. Using our precision design platform, we created a molecule with rapid oral absorption to reduce GI tissue exposure, a suitable half life to manage side effects, and target engagement covering the IC80 level." 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