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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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AUSTIN, Texas--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that the first set of abstracts have been released from several studies that will be shared at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) taking place Jan. 23 – 25, 2025 in San Francisco, CA. BESPOKE CRC Study New data will be presented in an oral presentation on Jan. 25 from BESPOKE CRC, a multicenter, prospective, observational study in colorectal cancer (CRC). The study underscores Signatera’s capability as a prognostic and a predictive biomarker in a cohort of over 1,000 patients wherein post-surgical Signatera-positivity was predictive of inferior outcomes in stage II patients [disease-free survival (DFS) (HR=10.4; p<0.0001), and stage III patients (HR=10.1; p<0.0001)]. 24-month DFS estimates for stages II-III combined were 91.7% for Signatera-negative and 41.4% for Signatera-positive. Signatera-positive patients benefitted from adjuvant treatment while Signatera-negative patients did not, and clearance of ctDNA during and after treatment led to superior DFS outcomes. Additional data from the study will be shared during the symposium illustrating the impact of MRD detection on clinical decision-making. The data show that even in the early days of MRD commercialization, a significant number of oncologists escalated or de-escalated post-surgical chemotherapy plans based on Signatera results, and the vast majority of oncologists found that Signatera results strengthened the treatment plan under consideration. In addition, surveillance with Signatera enabled a high rate of curative-intent surgery among recurrent patients. Readouts in Tissue-Free MRD and Early Cancer Detection Initial results from a clinical performance study on Natera’s novel tissue-free MRD detection test will be presented, where high sensitivity and specificity were observed in patients evaluable for clinical outcomes. The study demonstrated that the tissue-free MRD assay was prognostic, with MRD-positive patients showing inferior recurrence-free survival. The data also showed that the test was predictive, as MRD-positive patients benefited from adjuvant therapy whereas MRD-negative patients did not. In addition, the data showed strong concordance between the tissue-free MRD test and the gold standard Signatera test, with a positive percent agreement of 86% (95% CI:77-93%) and a negative percent agreement of 98% (95% CI: 95-100%). Natera will also present case-control data in early cancer detection, including data from screen-detected colorectal cancer cases from the CIRCULATE study and controls from the PROCEED-CRC study, respectively. The data reports an overall sensitivity of 95% (95% CI: 92-99%) and a specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals. “ This data at ASCO GI demonstrates the ongoing strength of Signatera complemented by our exciting innovation pipeline,” said Adham Jurdi, MD, senior medical director in oncology at Natera. “ The results from BESPOKE CRC highlight the potential value of Signatera-based MRD detection for treatment-decision making, with strong findings in clinical utility. Our readouts in early cancer detection and tissue-free MRD offer great promise for expanding Natera’s portfolio to help millions of additional patients with cancer.” Full list of Signatera presentations and activities during ASCO GI Oral Presentations Jan. 25, 1:00 PM PT | Abstract # 15 | Stage II-III Colorectal Cancer (Oral Presentation) Presenter: Purvi K. Shah, MD, MBBS, Virginia Cancer Institute Circulating Tumor DNA for Detection of Molecular Residual Disease (MRD) in Patients (pts) with Stage II/III Colorectal Cancer (CRC): Final Analysis of the BESPOKE CRC sub cohort Jan. 25, 1:00 PM PT | Abstract # LBA14 | Colon Cancer (Oral Presentation) Presenter: Jonathan A. Nowak, MD, PhD, Brigham and Women's Hospital Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702 P osters Jan. 23, 11:30 AM PT | Abstract # TPS512 | Gastroesophageal adenocarcinoma (Poster) Presenter: Elizabeth Catherine Smyth, MD, Oxford University Hospitals NHS Foundation Trust A single arm phase II trial of trastuzumab deruxtecan in patients with gastroesophageal adenocarcinoma cancer who are ctDNA and HER2 posiative: DECIPHER Jan. 23, 11:30 AM PT | Abstract # 836 | Gastrointestinal cancers (Poster) Presenter: Sakti Chakrabarti, MD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Short interval circulating tumor DNA (ctDNA) kinetics as a predictor of tumor response in patients with gastrointestinal (GI) cancer receiving immune checkpoint inhibitor (ICI)-based treatment Jan. 25, 7:00 AM PT | Abstract # 266 | Tissue-free MRD testing (Poster) Presenter: John Paul Y.C. Shen, MD, University of Texas MD Anderson Cancer Center Development of a methylation-based, tissue-agnostic test for the detection of molecular residual disease by circulating tumor DNA Jan. 25, 7:00 AM PT | Abstract # 232 | Early cancer detection: colorectal cancer (Poster) Presenter: Yoshiaki Nakamura, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East Performance of a blood-based screening test for the early detection of colorectal cancer Jan. 25, 7:00 AM PT | Abstract # TPS306 | Early cancer detection: Trial in Progress (Poster) Presenter: Sarah Sawyer, PhD, Clinical Trial Operations, Natera, Inc. Austin, TX, USA Trial in progress for a colorectal cancer detection blood test Jan. 25, 7:00 AM PT | Abstract # LBA 22 | Colorectal cancer (Poster) Presenter: Hideaki Bando, MD, National Cancer Center Hospital Japan A Randomized, Double-Blind, Phase III Study Comparing Trifluridine/Tipiracil (FTD/TPI) Versus Placebo in Patients with Molecular Residual Disease Following Curative Resection of Colorectal Cancer (CRC): The ALTAIR Study Jan. 25, 7:00 AM PT | Abstract # 220 | Metastatic colorectal cancer (Poster) Presenter: D.E. van Steijn, MSc, Netherlands Cancer Institute Longitudinal ctDNA measurements for treatment response monitoring in patients with metastatic colorectal cancer undergoing systemic therapy: The ORCA trial Jan. 25, 7:00 AM PT | Abstract # 284 | Locally advanced rectal cancer (Poster) Presenter: Jun Watanabe, MD, PhD, Department of Colorectal Surgery, Kansai Medical University Circulating tumor DNA for predicting complete response to total neoadjuvant therapy in locally advanced rectal cancer: ENSEMBLE-2 Jan 25, 7:00 AM PT | Abstract # 263 | Rectal adenocarcinoma (Poster) Presenter: Seth Felder, MD, H. Lee Moffitt Cancer Center Correlation of mid-chemoradiation ctDNA results and clinical complete response to total neoadjuvant therapy (TNT) for locally advanced rectal adenocarcinoma Jan 25, 7:00 AM PT | Abstract # 48 | Colorectal cancer (Poster) Presenter: Elisabeth Arrondo, BSc, Translational Research Support Office, National Cancer Center Hospital East Molecular characteristics and prognostic impact of GNAS mutation in colorectal cancer: An international collaborative study between United States and Japan About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .