Oncolytics Biotech® Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies
Consistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indication
Data from over 1,100 patients across tumor types reveals a favorable, well-understood safety profile
SAN DIEGO and CALGARY, AB , July 8, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company's intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies.
"We are no longer in the business of funding proof-of-concept studies," said Jared Kelly , Chief Executive Officer of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology."
Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC.
Pelareorep's clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm.
"Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman , Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies."
Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile. The most common treatment-related adverse events (TRAEs) are "flu-like" symptoms, such as fever, chills, headache, fatigue, myalgia, cough, anorexia, nausea, diarrhea, or vomiting, and rarely resulted in clinically significant grade ≥3 TRAEs. Adverse events are typically transient and manageable with over-the-counter medications.
Pelareorep received Fast Track designations from the U.S. Food and Drug Administration (FDA) in 2017 for metastatic breast cancer and in 2022 for mPDAC in combination with chemotherapy and atezolizumab. In 2015, pelareorep also received Orphan Drug Designations from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer.
The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data.
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 more about Oncolytics, please visit: www.oncolyticsbiotech.com 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 plans, objectives and strategies; our focus on advancing pelareorep directly into registration-enabling trials; our plans to use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology; 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
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Toronto Star
27 minutes ago
- Toronto Star
Our financial future is getting murkier. Here's how to Trump-proof your investments
It's been a roller-coaster of a summer for Canadian investors whose stocks are affected by U.S. President Donald Trump's tariff announcements. On July 31, Trump hiked tariffs on goods that fall outside of the Canada-U.S.-Mexico Agreement (CUSMA) to 35 per cent from 25 per cent. The tariff and market uncertainty is affecting how Canadians manage their money: a May survey from Nanos found that 59 per cent have made changes to their financial situation as a result of U.S. tariffs, with 39 per cent cutting back on spending.
CBC
28 minutes ago
- CBC
Heat warning in Waterloo region, surrounding area extended into this week
Heat and humidity never seem to go out of style in Waterloo region and the surrounding area — and this week is no exception. Hot weather could persist as late as Wednesday in the region, according to Environment and Climate Change Canada. The national weather agency says the region can expect daytime highs ranging from 30 to 35 C with the humidex between 35 and 40. Overnight lows will only get down to between 19 and 22 C, which Environment Canada meteorologist Kristina Kretchman says isn't much consolation. "When you have overnight lows with the hot, humid conditions near 20 C, there's not much relief from the heat," she told CBC News. Kretchman says a cold front will end the heat wave for parts of southern Ontario on Monday, but it won't reach Waterloo region and the surrounding area until late Tuesday, "however there's a slight chance that the heat could continue into Wednesday." Environment Canada's heat warning says the deteriorating air quality that comes with hot and humid air could result in the Air Quality Health Index reaching the high-risk category. Kretchman says people should watch for the early signs of heat exhaustion in themselves and others. "Just remember that heat can affect everyone's health," she said. Kretchman recommends people check on older adults, those living alone and other at-risk people in-person or on the phone multiple times a day. Signs of heat exhaustion may include headache, nausea, dizziness, thirst, dark urine and intense fatigue. Region of Waterloo Public Health recommends people drink plenty of liquids, especially water, and go in the shade to get out of the sun. If someone is experiencing heat stroke, that's a medical emergency and 911 should be called. The person should be moved to a cool place, fan them and apply cold water to large areas of skin or clothing. Where to cool down Cooling spaces are available in Waterloo region and include city hall locations, township offices, library branches as well as shopping malls. Also listed as cooling centres are: Cambridge: City hall, all Cambridge Public Library locations, WG Johnson Centre, Region of Waterloo Public Health and Social Services building at 150 Main St. Kitchener: Activia Sportsplex, Breithaupt Centre, Bridgeport Community Centre, Centreville Chicopee Community Centre, Chandler Mowat Community Centre, Country Hills Community Centre, Doon Pioneer Park Community Centre, Country Hills Library at 1500 Block Line Rd. and Community Healthcaring K-W at 44 Francis St. S., Region of Waterloo administration building at 150 Frederick St., Region of Waterloo Public Health and Social Services building on Weber Street E. Waterloo: RIM Park, Albert McCormick Community Centre, Moses Springer Community Centre, Waterloo Memorial Recreation Centre, Region of Waterloo's Public Health and Social Services at 99 Regina St. S., and Waterloo Public Library branches. North Dumfries: Ayr branch of the Region of Waterloo Public Library, North Dumfries Community Complex. Wellesley: Linwood, St. Clements and Wellesley branches of the Region of Waterloo Public Library. Wilmot: Baden, New Dundee and New Hamburg branches of the Region of Waterloo Public Library and the Wilmot Recreation Complex. Woolwich: Bloomingdale, Breslau, Elmira, and St. Jacobs branches of the Region of Waterloo Public Library, the Breslau Community Centre and the Woolwich Memorial Centre in Elmira. Guelph: City hall, West End Community Centre, Victoria Road Recreation Centre, Evergreen Seniors Community Centre, all branches of the Guelph Public Library. These spaces are open as cooling centres during regular business hours. Burn ban in Waterloo region The dry conditions in Waterloo region are also expected to continue and that has prompted a fire ban in Kitchener, Cambridge and the four townships. Backyard fires are not permitted in Waterloo or Guelph. The burn ban in the townships of North Dumfries, Wellesley, Wilmot and Woolwich went into effect on Thursday and it means any current fire permits are suspended until further notice and no new fire permits will be issued. This will also impact fires at campgrounds. "The ban prohibits all fires except those set for the sole purpose of cooking food in a contained fire pit. Cooking fires should be attended constantly and extinguished completely after use," the townships said in a joint statement. On Friday, Kitchener and Cambridge issued fire bans, meaning no backyard fires are permitted. Cambridge noted the ban is expected to remain in place "until such time as there is significant rainfall in the region." Cambridge also noted that while the bylaw usually allows for cooking fires, that will not be the case during the fire ban. Alexandra Cournoyer, a weather spokesperson for Environment and Climate Change Canada, says Waterloo region has seen about 25 to 50 mm less rain in the past month than what it should be normally for this time of year. The past three weeks there has been very little rain locally, she said. This weekend, "mainly what we're going to get is a mix of sun and clouds. So there's no huge amount of precipitation that is forecasted, which is a little unfortunate because it's not going to help with this rainfall deficit," she said. She said there could be pop-up showers or thunderstorms because of the heat, but "it's not going to be a huge amount of precipitation and it's really localized."
CBC
28 minutes ago
- CBC
How important is Alberta to Canada's economy?
Resource-rich Alberta has long been hailed as the economic engine of Canada. But is it? Plus, the U.S. Supreme Court takes up one of President Donald Trump's most controversial executive orders: ending birthright citizenship.
