Gemcitabine

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Jan. 22, 2025 /PRNewswire/ -- USA News Group News Commentary – Big developments are expected this week at the 2025 ASCO Gastrointestinal Cancers Symposium, running January 23-25 in San Francisco. This year's event is particularly critical as researchers highlight the alarming rise in cancer rates among people under 50, with gastrointestinal cancers leading the increase. Colorectal and pancreatic cancers, two of the top three deadliest cancer types, remain significant concerns as pancreatic cancer mortality continues to climb. Among the innovators presenting at the symposium are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Agenus Inc. (NASDAQ: AGEN), Guardant Health, Inc. (NASDAQ: GH), Xilio Therapeutics, Inc. (NASDAQ: XLO), and RenovoRx, Inc. (NASDAQ: RNXT). Continue Reading Pelareorep Factsheet (PRNewsfoto/USA News Group) The article continued: According to USD Analytics' recently introduced study, the Global Pancreatic Cancer Treatment Market is expected to soar in the upcoming years, growing at a 7.6% CAGR. Analysts at Precedence Research project that the global stomach cancer treatment market will grow at a 12.54% CAGR to US17.6 billion by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today shared details about the data it will present at the ASCO GI symposium. The presentations will highlight pelareorep, an innovative immunotherapy that trains the immune system to target cancer by turning "cold" tumors—typically resistant to treatment—into "hot" tumors that respond better to therapy. In relapsed anal cancer, 4 out of 12 evaluable patients achieved a partial response for a response rate of 33%, and one patient achieved a remarkable complete response, meaning their cancer became undetectable and remained so for over 15 months. To put this into perspective, similar treatments typically achieve response rates of only 10-24%. This underscores pelareorep's potential to deliver life-changing results in some of the toughest-to-treat cancers. "In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "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 has also demonstrated strong potential to improve outcomes for patients with this aggressive disease. The upcoming ASCO GI presentation will feature new safety data showing that pelareorep can be combined with modified FOLFIRINOX, another widely used chemotherapy regimen for patients with pancreatic cancer. "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," added Dr. Heineman. "We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available." This builds on prior results from the GOBLET study, where pelareorep, combined with atezolizumab, gemcitabine, and nab-paclitaxel, achieved a 62% objective response rate—more than double historical averages of 25%. These findings were pivotal in earning pelareorep FDA Fast Track designation in 2022, highlighting its promise to fill the critical unmet need for more effective pancreatic cancer therapies. The ability to pair pelareorep with modified FOLFIRINOX represents an important step forward in expanding treatment options for metastatic pancreatic cancer. These results not only highlight pelareorep's versatility but also its potential to enhance outcomes across multiple standard-of-care therapies. "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." As Oncolytics Biotech advances its clinical programs and prepares for pivotal studies, the growing body of evidence continues to solidify pelareorep as a transformative therapeutic option for patients in desperate need of effective treatments. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Agenus Inc. (NASADAQ: AGEN), a leader in immuno-oncology, recently announced it too will share five presentations at ASCO GI's symposium featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody), and showcasing BOT/BAL's consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer. "These presentations will highlight BOT/BAL's potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings," said Dr. Garo Armen, Chairman and CEO of Agenus. "We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide." ALX Oncology Holdings Inc. (NASDAQ: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives, also recently announced that updated results from its Phase 2 ASPEN-06 clinical trial were accepted for oral presentation at ASCO GI 2025. ASPEN-06 is a global clinical trial testing evorpacept, ALX Oncology's innovative therapy designed to block the "don't eat me" signal used by cancer cells to evade the immune system. The study is evaluating evorpacept in combination with trastuzumab, CYRAMZA® (ramucirumab), and paclitaxel (a combination known as TRP) compared to TRP alone in patients with HER2-positive gastric or gastroesophageal junction cancer who have previously received anti-HER2 treatments. This approach aims to enhance the effectiveness of existing therapies and improve outcomes for patients with this aggressive cancer type. Xilio Therapeutics, Inc. (NASDAQ: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, recently announced its plans to present initial data from its ongoing Phase 2 trial for vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the ASCO GI Symposium. In addition, the company also announced preliminary data from Phase 1 dose escalation for XTX301, an investigational tumor-activated IL-12. "We are encouraged by the early evidence of responses in patients with cold tumors, including MSS colorectal cancer, reported for the combination of vilastobart and atezolizumab in Phase 1C dose escalation earlier this year, and we look forward to sharing initial Phase 2 data for the combination in MSS CRC at ASCO GI in January," said Katarina Luptakova, M.D., Chief Medical Officer of Xilio. "In addition, the preliminary Phase 1 data we reported today for XTX301, our tumor-activated IL-12, highlight its promising clinical profile, including no dose-limiting toxicities reported to date and consistent interferon gamma signaling observed throughout treatment cycles." RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared delivery platform, also announced that three of its abstracts were accepted to be presented at several upcoming industry conferences, including ASCO GI 2025. RenovoRx is pioneering a novel therapy platform called TAMP, which delivers chemotherapy directly to the tumor through the arterial wall, potentially reducing side effects and improving treatment effectiveness compared to standard intravenous therapy. Their ongoing Phase III TIGeR-PaC trial, evaluating this approach with their FDA-cleared RenovoCath device, is expected to complete patient enrollment and a key interim analysis by mid-2025. "These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy's toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor." 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. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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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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