Obexelimab

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 12, 2025 /PRNewswire/ -- USANewsGroup.com News Commentary – Scientists developed an antibody treatment that reawakens the immune system to attack pancreatic tumors by blocking sugar-coated disguises cancer cells use to evade detection[1]. Researchers also engineered an off-the-shelf immunotherapy that consistently slowed tumor growth across multiple preclinical pancreatic cancer models while maintaining potency in harsh tumor environments[2]. These advances position Oncolytics Biotech Inc. (NASDAQ: ONCY), Immuneering Corporation (NASDAQ: IMRX), Tango Therapeutics, Inc. (NASDAQ: TNGX), Moderna, Inc. (NASDAQ: MRNA), and Royalty Pharma plc (NASDAQ: RPRX) as companies advancing breakthrough approaches in one of oncology's most challenging indications. A 63% objective response rate was achieved in mismatch repair-deficient cancers when combining two checkpoint inhibitors[3]. Multiple institutions initiated therapeutic vaccine trials targeting pancreatic and lung cancers, with early pancreatic vaccine data showing immune responses associated with reduced recurrence risk[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) has secured FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial currently planned for this disease. Following a Type C meeting, the FDA and Oncolytics agreed on key trial parameters, establishing a clear path toward potential approval in a cancer with no existing immunotherapy treatments. "We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape," said Jared Kelly, CEO of Oncolytics Biotech. "The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options." The trial will test three arms: standard chemotherapy (gemcitabine plus nab-paclitaxel) alone, the same chemotherapy with pelareorep, and chemotherapy with both pelareorep and a checkpoint inhibitor. Overall survival serves as the primary goal, with either experimental arm able to independently demonstrate success. "The FDA's feedback confirms that our design is appropriate to support registration if successful," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We are now completing the administrative activities necessary to initiate the program, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete." The protocol allows checkpoint inhibitor flexibility based on ongoing partnership discussions. Pelareorep has successfully combined with multiple checkpoint inhibitors across gastrointestinal and other cancers. Oncolytics recently reported anal cancer data showing response rates more than double the current standard, reinforcing pelareorep's platform potential across gastrointestinal tumors. Previous pancreatic cancer data demonstrated a 62% response rate and two-year survival rates more than double the historical benchmark. The company recently established a Gastrointestinal Scientific Advisory Board to advance pelareorep beyond pancreatic cancer alone. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, enabling expedited review and potential market exclusivity. CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, demonstrating proven ability to advance assets through value-creating transactions. With site selection underway and protocol finalization in progress, Oncolytics stands positioned at the transition from clinical promise to regulatory reality as the only immunotherapy registration trial in first-line pancreatic cancer. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Immuneering Corporation (NASDAQ: IMRX) has reported an extraordinary 86% overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP), along with raising $225 million in cumulative financing, including a $25 million private placement with Sanofi. The company's cash position of $227.6 million as of September 30, 2025, extends its runway into 2029, including through the topline readout of its planned Phase 3 trial. "The third quarter was truly transformational for Immuneering. We announced extraordinary overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and raised $225 million of cumulative financing on the strength of the data," said Ben Zeskind, Ph.D., CEO of Immuneering Corporation. "I'm excited to say that the company is now funded into 2029 and, importantly, through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer." The company expects to report updated survival data from its atebimetinib + mGnP study in the first half of 2026 and plans to dose the first patient in its pivotal Phase 3 trial by mid-2026. Immuneering also reported two new case studies, including a patient with a complete response and another who responded sufficiently to pursue radiation and surgery with curative intent. Tango Therapeutics, Inc. (NASDAQ: TNGX) announced vopimetostat clinical data showing a median progression-free survival of 7.2 months in second-line MTAP-del pancreatic cancer patients, along with a 49% overall response rate and 9.1 months median PFS in a histology-selective cohort of 13 late-line difficult-to-treat cancer types. The company secured $225 million in gross proceeds from an October 2025 financing that extends its cash runway into 2028, while reporting third quarter collaboration revenue of $53.8 million compared to $11.6 million in the prior year period. "We are wrapping up 2025 with significant momentum, supported by our recent disclosure of vopimetostat clinical data, supporting the potential of this compound to be a turning point for treatment of multiple difficult-to-treat MTAP-del cancers, beginning with pancreatic cancer," said Barbara Weber, M.D., president and CEO of Tango Therapeutics. "The data we presented support our planned pivotal trial in 2L MTAP-del pancreatic cancer with an anticipated study start in 2026." Tango reported that vopimetostat demonstrated a potentially best-in-class safety and tolerability profile at 250 mg once daily with no drug-related dose discontinuations and an 8% dose reduction rate, while combination studies with Revolution Medicines' RAS(ON) inhibitors remain ongoing with data anticipated in 2026. The company's TNG456, a brain-penetrant PRMT5 inhibitor for glioblastoma, received FDA Orphan Drug Designation for malignant glioma, while TNG260 showed a median PFS of 27 weeks in checkpoint inhibitor-resistant STK11 mutant/KRAS wild type lung cancer patients, more than double the standard of care. Moderna, Inc. (NASDAQ: MRNA) announced its three-year business strategy targeting up to 10% revenue growth in 2026 while advancing nine ongoing Phase 2 and Phase 3 clinical studies in its oncology pipeline, including three Phase 3 programs for intismeran autogene. The company expects to expand its seasonal vaccine franchise from three to up to six approved products by 2028, with cash generated from marketed products being invested into oncology and rare disease programs. "Over the next three years, we expect to build a large seasonal vaccine franchise for at-risk populations and invest the cash generated into oncology and rare disease therapeutics," said Stéphane Bancel, CEO of Moderna. "We plan to deliver up to 10 percent revenue growth in 2026 while continuing to reduce our R&D investments and diversify further into oncology." Moderna's oncology pipeline includes mRNA-4157 (intismeran autogene), advancing in collaboration with Merck across eight Phase 2 and Phase 3 trials in multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. The company improved its 2026 and 2027 expected GAAP operating expenses by approximately $0.5 billion each year, remaining on the path to targeted cash breakeven in 2028 with a projected year-end 2025 cash position of $7.1 to $7.6 billion. Royalty Pharma plc (NASDAQ: RPRX) delivered strong third quarter results with Portfolio Receipts growing 11% to $814 million and net cash from operating activities of $703 million, while raising full-year 2025 guidance to $3,200-$3,250 million. The company significantly expanded its oncology portfolio with the acquisition of royalties on Amgen's Imdelltra for extensive-stage small cell lung cancer ($950 million), Zenas BioPharma's obexelimab ($300 million), and Alnylam's Amvuttra ($310 million). "We delivered strong third quarter 2025 results, raised our full year guidance and are on track to deliver another year of double-digit top-line growth," said Pablo Legorreta, founder and CEO of Royalty Pharma. "In addition, we had an especially active past few months for deals, expanding our portfolio with three innovative therapies and increasing our Capital Deployment to $2.0 billion for the year." Royalty Pharma received positive clinical updates on Revolution Medicines' daraxonrasib showing encouraging first-line metastatic pancreatic cancer data supporting Phase 3 initiation in fourth quarter 2025, with the FDA awarding a Commissioner's National Priority Voucher to accelerate development and review. The company repurchased four million Class A ordinary shares for $152 million in third quarter 2025, bringing total year-to-date share repurchases to $1.2 billion. 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. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. 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Royalty Pharma penned similar financing deals this year with Biogen, Zenas BioPharma and Revolution Medicines.\n While Denali Therapeutics awaits a delayed FDA decision on its Hunter syndrome drug, the biotech is already banking on the therapy’s commercial success.The agency had originally been due to make an approval call for the enzyme replacement therapy, called tividenofusp alfa, in early January 2026. But the FDA recently pushed back the decision date by three months.While Denali waits for the regulator’s verdict in April, the biotech is busy leveraging the potential sales tividenofusp alfa could bring in. This morning’s deal with Royalty Pharma, a buyer of biopharmaceutical royalties, will give Denali access to $200 million if the drug secures FDA approval, with an additional $75 million to follow if the therapy gets the green light in Europe.In return, Royalty will receive a 9.25% royalty on worldwide sales of tividenofusp alfa from Denali until it reaches three times the amount Royalty has handed to Denali—or, alternatively, 2.5 times the amount if the target is achieved by the first quarter of 2039.“We are delighted to partner with Denali and acquire a royalty on tividenofusp alfa, an innovative therapy that addresses a significant unmet need in the cognitive and physical manifestations of Hunter syndrome,” Royalty’s CEO and founder Pablo Legorreta said in the release.“Denali’s technology platform delivers therapeutics across the blood-brain barrier and is a promising new approach to brain diseases,” Legorreta added. “We are thrilled to establish a relationship with Denali and believe tividenofusp alfa is a potential practice-changing therapy that could transform the lives of patients with Hunter syndrome.” Royalty has penned similar financing deals so far this year, helping Biogen bankroll phase 3 development of its lupus candidate litifilimab, allowing Zenas BioPharma to complete work on its autoimmune candidate obexelimab and supporting Revolution Medicines in commercializing its lung cancer drug daraxonrasib.Denali already had almost $873 million in the bank at the end of September. CEO Ryan Watts, Ph.D., said the additional funds from Royalty would ensure the biotech was “well positioned to advance our development programs as we prepare for the launch of tividenofusp alfa, unlocking broad opportunities across serious diseases.”Tividenofusp alfa is a version of the iduronate 2-sulfatase enzyme that is engineered to penetrate the blood-brain barrier by binding to transferrin receptor 1, which normally shuttles iron into the brain.When Denali revealed the three-month delay to the FDA’s decision date back in October, the company put the move in the context of the updated clinical pharmacology information it had supplied to the FDA as part of the application review process. While Denali said this information was not related to the drug’s efficacy, safety or biomarkers, and did not involve supplying any additional clinical data, the FDA classified the submission as a major amendment to the application, which requires a three-month extension to the deadline.Hunter syndrome, also called mucopolysaccharidosis type II (MPS II), is characterized by patients\' inability to break down certain sugars, which leads to tissue and organ damage that ultimately causes stiff joints, delayed growth and enlarged spleens and livers, among other symptoms. The disease can also lead to cognitive and behavioral problems, and, in severe cases, patients may not survive beyond their teenage years.There is one approved enzyme replacement therapy for Hunter syndrome in Takeda’s Elaprase, which the Japanese drugmaker secured as part of its acquisition of Shire Pharmaceuticals in 2019.In August, the FDA pushed back the approval decision deadline for another Hunter syndrome treatment in the form of Regenxbio’s gene therapy clemidsogene lanparvovec after requesting additional data.