Adagrasib

2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced new durability data in metastatic colorectal cancer (“mCRC”), demonstrating meaningful and sustained clinical benefit in patients with RAS-mutant, microsatellite-stable (“MSS”) disease. Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line (“2L”) KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting. 1 Additional data from this study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6-11% for the standard of care. 2 , 3 “We believe these data demonstrate a compelling durability signal for pelareorep in colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “A 19.5-month median duration of response in second-line patients—representing a three- to four-fold improvement over historical expectations—highlights pelareorep’s potential to deliver sustained benefit in a population with few effective options. We believe these results support a path toward accelerated approval in second-line RAS-mutant MSS metastatic colorectal cancer, and we are actively engaging with the FDA to align on a regulatory strategy leveraging our ongoing randomized study.” Oncolytics is currently enrolling patients in its randomized Phase 2 study evaluating pelareorep in combination with FOLFIRI and bevacizumab in second-line RAS-mutant MSS mCRC ( link to study on ClinicalTrials.gov ). The Company is actively engaging with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated approval pathway based on response durability and time-to-event endpoints from this study. Colorectal cancer remains one of the largest oncology markets globally, with significant unmet need in later-line settings. RAS-mutant MSS mCRC represents a particularly difficult-to-treat population, where patients typically experience rapid disease progression and limited durability of response on standard therapies. The magnitude and consistency of durability and patient response observed with pelareorep-based combinations suggest the potential to meaningfully extend clinical benefit in this setting. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics . References FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C–mutated colorectal cancer. Published June 21, 2024. Accessed April 28, 2026. Bennouna J. Lancet Oncol (14):29-37, 2013 Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015 Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. 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 beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies, and projected outcomes of the Company’s planned clinical study of pelareorep, including the potential for accelerated regulatory approval; its belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers. 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. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics.ca

Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-break moment for Bristol Myers Squibb, and Lei Lei Wu and I had updates on Amgen’s ongoing saga over its rare disease drug Tavneos. Meanwhile, Andrew Dunn reported from one of the world’s largest AI research gatherings, I attended Supreme Court arguments in a patent case that’s being closely watched by the generics industry, and John Carroll put out his annual review of pharma’s biggest research spenders. We’ll be back next week with earnings updates from several more companies, including Pfizer and Novo Nordisk. Have a great weekend! — Nicole DeFeudis 🤔 Bristol Myers Squibb is facing a bit of an identity crisis. As it approaches two looming patent cliffs for the blood thinner Eliquis and the immunotherapy Opdivo, BMS will have to figure out where its next big source of growth will come from. The company has a slate of pipeline readouts coming this year that has drawn excitement from Wall Street. But analysts say BMS is struggling to clearly chart a path beyond these multibillion-dollar franchises. “I don’t know what you really say right now, if you say, like, ‘What is Bristol Myers?’” William Blair’s Matt Phipps told Endpoints. Max Gelman took a look at the dilemma ahead of BMS’ earnings this week in what’s expected to be the company’s most pivotal year since it acquired Celgene for $74 billion in 2019. Here are some other highlights from earnings this week: 🔍 The FDA escalated its push this week to withdraw a rare disease drug now owned by Amgen, accusing ChemoCentryx’s study personnel of manipulating the results of a pivotal clinical trial used to approve the drug. ChemoCentryx won approval for Tavneos in 2021 to treat an autoimmune disease called ANCA-associated vasculitis, and Amgen swooped in the following year with a $4 billion acquisition. The FDA asked Amgen to withdraw the drug voluntarily at the beginning of this year, but Amgen said it had no plans to do so. CDER reiterated its effort in a proposal to withdraw the drug this week, citing new information that it says suggests Tavneos “has not been shown to be effective for its approved use,” and that its marketing application held “untrue statements of material fact.” Regulators also said they were “increasingly concerned” about the drug’s safety, bringing up cases of drug-induced liver injury. Amgen said in its first-quarter earnings report that it intends to engage with the FDA, but reiterated that it continues to believe Tavneos “demonstrates effectiveness and a favorable benefit-risk profile.” The company also filed a supplement that would add more information to the warning label about post-market cases of vanishing bile duct syndrome, a serious liver complication. 🖥️ Biopharma companies may be thinking too small when it comes to implementing AI, senior correspondent Andrew Dunn reports from Rio de Janeiro . At one of the world’s largest AI research gatherings, the International Conference on Learning Representations, Andrew chatted with Roche vet Kyunghyun Cho, who said the industry is looking at things the wrong way. Pharma is looking at AI as a way to shave a few months off the drug development process. Instead, he sees potential for it to upend the labyrinthine system leading to medications that somewhat help a percentage of patients but work perfectly for relatively few. “We’ve got to lower the barrier between the pharmaceutical and the care providers, because the incentives are not aligned despite the fact that the technology is actually getting better,” Cho said. Read more from Andrew here . 🧬 An experimental treatment that uses CRISPR to edit genes directly inside the body succeeded in a Phase 3 trial this week in a first for the technology. It puts the treatment on track for a potential FDA approval in the first half of next year. The one-time infusion reduced swelling attacks in people with hereditary angioedema by 87% compared to placebo, Intellia announced. It’s one of the biggest milestones yet for CRISPR , a nearly 14-year-old technology that has promised to bring cures to thousands of diseases. But as in vivo gene editing gets closer to becoming a bona fide drug, skepticism about how big a role the technology will have in medicine and this disease has grown. Read more from Ryan Cross and Lei Lei Wu here . 💵 Endpoints founding editor John Carroll reviewed the top 15 biggest pharma research spenders. John wrote that these companies “play with big stakes for even larger pots,” as pipeline-in-a-product assets “remain the holy grail of R&D” and the field continues to shift toward drugs that address big populations. It’s no surprise that Merck is at the top of the list, as it looks to navigate Keytruda’s upcoming patent cliff. You can see the full list here . DON’T MISS: