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USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 14, 2025 /PRNewswire/ -- USA News Group News Commentary – Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Fate Therapeutics, Inc. (NASDAQ: FATE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), and Nektar Therapeutics (NASDAQ: NKTR). Global Market Insights estimates the global oncology market at US$345.1 billion in 2025 and forecasts it will climb to US$866.1 billion by 2034, growing at a robust 10.8% CAGR. The U.S. alone is expected to contribute $377.1 billion to that total. Vision Research Reports projects an even larger figure for the global cancer drug sector, predicting it will surpass US$900 billion in sales by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its development journey—pursuing a potential registration-enabling trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) for its flagship asset, pelareorep. In its latest Q2 2025 report, the company confirmed it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin as early as Q4 2025. For investors and potential partners, this represents a clear transition from promising clinical data to potential regulatory approval in one of medicine's most challenging cancer types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The strategic focus on mPDAC reflects both compelling clinical results and a significant market opportunity. Pelareorep is a systemically delivered oncolytic virus designed to convert immunologically "cold" tumors—those typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. In first-line pancreatic cancer studies, pelareorep-based regimens have demonstrated a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark for standard chemotherapy alone. Even more compelling, when pelareorep was combined with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—particularly significant given that checkpoint inhibitors are not currently approved for use in this indication. These results stem from pelareorep's dual mechanism: it both replicates within cancer cells and activates the body's immune response against tumors. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME—all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Translational data from the GOBLET and AWARE-1 studies demonstrate how pelareorep transforms the tumor microenvironment, increasing PD-L1 expression, heightening interferon signaling, and mobilizing tumor-infiltrating lymphocytes in the blood—changes that correlate with tumor size reduction. This mechanistic validation, combined with survival data from over 1,100 patients across multiple studies, has solidified the company's decision to prioritize this indication. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. In line with their focus on capital efficiency, the company has terminated its At-the-Market and Equity Line of Credit facilities, citing sufficient resources to advance key milestones without near-term shareholder dilution. Regulatory advantages are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses streamline review processes and enhance the program's attractiveness to potential pharmaceutical partners. The context underscores the opportunity: pancreatic cancer remains one of the deadliest common cancers, with a five-year survival rate of less than 14%. Unlike other cancers where immunotherapies have transformed treatment, mPDAC has largely resisted immunotherapeutic approaches—making pelareorep's immune-activating mechanism particularly promising for this underserved patient population. Back in July, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes for patients and biomarker validation. The expert panel reinforced the view that pelareorep's mechanism of activating innate and adaptive immune responses is both biologically sound and commercially relevant for first-line mPDAC treatment. With this latest milestone, Oncolytics is entering a phase where FDA feedback will shape both clinical plans and potential commercial partnerships. If the agency accepts the company's proposed trial framework centered on an overall survival endpoint, the resulting study could provide definitive proof of pelareorep's market potential in mPDAC. The company expects to provide an updated clinical timeline in Q3 2025, with trial start-up activities potentially beginning as early as Q4 2025. With compelling survival data, regulatory designations in place, and an experienced leadership team driving execution, Oncolytics is positioning pelareorep for a pivotal test in one of oncology's most challenging and underserved markets. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported strong Q2 2025 results with $60 million in total product revenue, driven primarily by its breakthrough melanoma therapy Amtagvi, which treated over 100 patients in the second quarter. "Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs." The company's tumor-infiltrating lymphocyte (TIL) therapy—which uses a patient's own immune cells to fight cancer—generated $54.1 million in revenue and represents the first FDA-approved T-cell therapy for solid tumors, offering new hope for advanced melanoma patients who have tried other treatments without success. With expanded clinical trials planned for lung cancer and endometrial cancer, plus international approvals expected in Canada and other markets, Iovance is positioned to bring its innovative cancer treatment to patients worldwide. Fate Therapeutics, Inc. (NASDAQ: FATE) recently announced promising clinical progress for its off-the-shelf CAR T-cell therapy FT819, which showed lasting responses in lupus patients and received FDA clearance to begin trials for a solid tumor program targeting MICA/B proteins. While primarily focused on autoimmune diseases, the company's next-generation FT836 CAR T-cell therapy represents a significant advancement in cancer treatment as it's designed to target solid tumors without requiring harsh conditioning chemotherapy, potentially making the treatment safer and more accessible. "Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA, President and CEO of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and Shield™ technology toward the clinic." The company's stem cell-based platform continues to advance multiple programs, including partnerships for HER2-positive solid tumors, positioning Fate as a leader in developing ready-made cancer cell therapies. Inovio Pharmaceuticals, Inc. (NASDAQ: INO) remains on track to submit its application for INO-3107 in the second half of 2025, targeting Recurrent Respiratory Papillomatosis (RRP), a rare cancer-related condition caused by HPV that affects the airways. The company's DNA medicine platform represents a novel approach to treating HPV-related diseases and cancers, with INO-3107 showing significant clinical benefit by reducing the need for repeated surgeries in RRP patients from an average of 4.1 procedures annually to just 0.9 procedures. "We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease," said Dr. Jacqueline Shea, President and CEO of INOVIO. "I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026." Beyond RRP, Inovio's technology platform is designed to treat various HPV-related cancers and other tumors by teaching the body's immune system to recognize and fight cancer cells. With breakthrough therapy designation from the FDA and plans for a trial involving 100 patients, INO-3107 could become the first DNA-based therapy approved for treating this serious cancer-related condition. Nektar Therapeutics (NASDAQ: NKTR) reported impressive Phase 2b data for rezpegaldesleukin in treating moderate to severe atopic dermatitis, with the company positioning this immune system regulator as a first-in-class treatment for autoimmune diseases. While primarily focused on autoimmune conditions, Nektar's pipeline includes NKTR-255, a treatment designed to boost the immune system's ability to fight cancer, which is being tested in multiple ongoing clinical trials with various partners. "As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders," said Howard W. Robin, President and CEO of Nektar. "Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target." The company's technology platform creates novel treatments that could potentially address both autoimmune diseases and cancer by enhancing the immune system's cancer-fighting abilities. With additional data expected from hair loss trials in December 2025 and continued development of next-generation programs, Nektar is advancing a unique approach to immune system therapy that could benefit millions of patients with serious diseases. 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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– GL-IL2-138 is a small molecule RNA agent that modulates natural IL-2, allowing for downregulating or upregulating the immune system to fight devastating diseases – Potential to unite Humira-grade inflammation control and Keytruda-class anti-cancer power in a single pill, without the drawbacks NEW YORK, NY, USA I July 16, 2025 I Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GL-IL2-138, the company’s small-molecule modulator of natural interleukin-2 (IL-2). IL-2 is a pleiotropic cytokine that regulates the careful homeostatic balance between immune tolerance and activation. The tremendous potential of IL-2 to address multiple major diseases is universally recognized. Recombinant IL-2 protein (rIL-2) was the first FDA-approved immunotherapy proven effective against cancer at high dose, though toxicity has historically limited its use. And low dose rIL-2 is clinically effective in autoimmune and neurodegeneration diseases. But numerous attempts by pharma companies to remove toxicity from rIL-2 muteins have flopped, earning IL-2 its reputation as an impossible target. Genetic Leap addressed this herculean challenge by developing a small molecule drug that binds endogenous IL-2 mRNA to drive controlled, systemic production of natural IL-2 protein by immune cells, which has many advantages over rIL-2 including: “We created the Genetic Leap AI platform to deliver breakthroughs like GL-IL2-138,” said Dr. Bertrand Adanve, Founder and CEO of Genetic Leap. “Innovative medicine that defies known scientific limitations, like a sci-fi drug made real. GL-IL2-138 is like combining Humira (leading autoimmune biologic) and Keytruda (leading cancer biologic) into one oral pill without the downsides and applicable to even more diseases. GL-IL2-138 is poised to be a giant leap for human health, and Genetic Leap is the company making it happen.” The drug will now be tested in a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate its tolerability, pharmacokinetics and pharmacodynamics in humans. About Genetic Leap Genetic Leap is innovating at the cutting edge of AI and RNA genetic therapeutics to redefine drug development and more quickly address the health needs of millions of people. For more information, please visit www.genetic-leap.com or our LinkedIn . SOURCE: Genetic Leap