Lifileucel

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /PRNewswire/ -- Equity Insider News Commentary – The 2025 ASCO Annual Meeting has wrapped, leaving behind a wave of cautious optimism across the oncology landscape. From advances in immunotherapy and CAR T-cell strategies to new applications in AI, diagnostics, and even exercise-based interventions, this year's gathering spotlighted a broad array of promising approaches. However, looming over the scientific excitement are concerns about proposed U.S. budget cuts, including a potential 40% reduction in funding for the National Cancer Institute (NCI). As public investment comes under pressure, many are turning to the private sector to carry the load — with recent moves by companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Anixa Biosciences, Inc. (NASDAQ: ANIX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and ImmunityBio, Inc. (NASDAQ: IBRX). Continue Reading Pelareorep Facts (PRNewsfoto/Equity Insider) The rising global burden of cancer is driving urgent demand for next-generation therapies. By 2030, annual case counts are expected to climb 20%, with projections pointing to a 75% surge by 2050, according to Statista. Market researchers anticipate oncology spending will scale to match: ResearchAndMarkets forecasts the sector hitting US$866.1 billion by 2034, growing at a 10.8% CAGR, while Vision Research Reports places the market for cancer treatments even higher — surpassing US$903.81 billion at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy. Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy. The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC)—a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers. In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls— and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit. And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators. As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding— Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Anixa Biosciences, Inc. (NASDAQ: ANIX) is advancing two novel programs at the frontlines of cancer immunotherapy. The company will present new data from its first-in-human ovarian cancer CAR-T clinical trial later this month at the ESMO Gynaecological Cancers Congress, showcasing a unique chimeric endocrine receptor T-cell (CER-T) platform targeting the follicle stimulating hormone receptor (FSHR). Separately, Anixa is also working with Cleveland Clinic to develop a preventative breast cancer vaccine designed to train the immune system to recognize "retired" proteins reactivated in early malignancies. "While cancer vaccines have traditionally faced significant hurdles, our approach is aimed at a novel target that has not been previously explored in this context," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We believe this could represent a new paradigm in immuno-oncology. The breast cancer market, particularly for triple-negative breast cancer and genetically high-risk populations, continues to face a major unmet need. Our vaccine may offer a unique, immunologic pathway for both prevention and treatment." Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has published the final five-year analysis from its Phase 2 C-144-01 trial evaluating Amtagvi® (lifileucel), the first FDA-approved T cell therapy for solid tumors in patients with advanced melanoma. "Amtagvi has demonstrated long-term benefit and meaningful overall survival in a difficult-to-treat melanoma patient population resistant to immune checkpoint inhibitor therapy," said Theresa Medina, M.D., medical oncologist at the University of Colorado Cancer Center on the Anschutz Medical Campus. "Five years following one-time Amtagvi treatment, responses persisted or deepened during an extended treatment-free interval for some patients. Amtagvi offers a new standard of care for the advanced melanoma community and sets a new bar for one-time cell therapies with curative intent in solid tumors." The results, featured in the Journal of Clinical Oncology and presented at ASCO 2025, highlight durable responses in heavily pretreated patients—with nearly one-third of responders maintaining benefit five years after a single treatment. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently reported compelling Phase 3 results for Libtayo® (cemiplimab) as an adjuvant therapy in patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery. The trial showed a 68% reduction in disease recurrence or death and strong secondary endpoint performance, including 80% and 65% reductions in locoregional and distant recurrence, respectively. "The Phase 3 C-POST trial demonstrates that cemiplimab is a highly active therapy in high-risk CSCC, with clinically meaningful outcomes across primary and secondary endpoints and exceptionally low rates of locoregional and distant recurrence," said Danny Rischin, M.D., Head of Head and Neck Cancer and Cutaneous SCC at Peter MacCallum Cancer Centre. "While surgery and radiotherapy remain the cornerstones of treatment, there is a critical unmet need for systemic therapies to help prevent relapse and metastasis." Regulatory filings have already been submitted in the U.S. and EU, and experts say these findings could reshape treatment standards. ImmunityBio, Inc. (NASDAQ: IBRX) is advancing what may be the first true therapy for lymphopenia—a condition long associated with poor outcomes in cancer but never directly treated until now. "Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. " Backed by FDA Expanded Access authorization, the company's Cancer BioShield™ platform centers on ANKTIVA®, an IL-15 superagonist approved in bladder cancer and now being deployed to help restore immune function in patients with solid tumors who've exhausted first-line therapies. "This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA," said Soon-Shiong. "The survival benefit we observed at ASCO 2025 in 3rd to 6th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease." At ASCO 2025, ImmunityBio presented landmark data showing that reversing lymphopenia with ANKTIVA and CAR-NK cells significantly extended survival in late-stage pancreatic cancer patients, especially when intervention occurred at a lower tumor burden. The results represent a potential paradigm shift: treating immune collapse itself—not just the tumor—may drive better long-term outcomes. Based on this mechanism, the platform could open doors to broader applications in oncology, infectious disease, and immune senescence. 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