Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – The global oncology market is surging toward $668.26 billion by 2034 with an 11.50% CAGR as innovative modalities overcome treatment resistance[1]. This structural shift drives the CAR T cell therapy market to expand at 31% annually through 2030 by delivering outcomes traditional chemotherapy cannot match[2]. Institutions are now prioritizing Oncolytics Biotech Inc. (NASDAQ:ONCY), Amgen (NASDAQ:AMGN), Immunome (NASDAQ:IMNM), Allogene Therapeutics (NASDAQ:ALLO), and Kura Oncology (NASDAQ:KURA) as this technical frontier redefines standard-of-care benchmarks.
Biotech share sales raised $2.5 billion in January's first week, marking the strongest start since 2021 as regulatory tailwinds and acquisition momentum restore sector confidence[3]. Healthcare's Q4 2025 outperformance across S&P 500 sectors signals that science-anchored, modality-disruptive platforms command asymmetric upside as buyers facing $170 billion patent cliffs compete for registration-ready assets delivering breakthrough response rates[4].
Oncolytics Biotech Inc. (NASDAQ:ONCY) is building out its leadership team as it moves its cancer treatment pelareorep through late-stage clinical trials targeting several gastrointestinal cancers.
The company recently announced two key hires: John McAdory as Executive Vice President of Strategy and Operations, and Yujun Wu as Vice President, Head of Biostatistics. McAdory comes from CG Oncology, where he ran late-stage clinical trials for oncolytic virus therapies (cancer-fighting viruses, similar to pelareorep). Wu joins from Morphic Therapeutic, where he led the statistics department through the company's sale to Eli Lilly, and previously designed multiple Phase 3 oncology trials at Takeda. Both bring the specific expertise needed to execute the complex, multi-country registration trials that determine whether a drug gets FDA approval.
"John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."
These hires complete a significant management upgrade. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. The company also added three leading cancer specialists from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center to its gastrointestinal tumor scientific advisory board.
The clinical data driving this expansion looks compelling. In colorectal cancer, pelareorep combined with chemotherapy and a vascular endothelial growth factor (VEGF) inhibitor achieved a 33% response rate in patients with KRAS mutations (a genetic marker found in about 40% of colorectal cancers). That's three times better than the 6-11% response rate chemotherapy and a VEGF inhibitor typically achieves in these patients. Response rate measures the percentage of patients whose tumors shrink significantly or disappear entirely.
In anal cancer, where treatment options are extremely limited after first-line therapy fails, pelareorep is showing even stronger results. Third-line patients (those who've already failed two prior treatments) saw a 29% response rate with responses lasting around 17 months. That nearly triples the historical benchmarks in a setting where no FDA-approved treatments currently exist.
In second-line patients, the 30% response rate more than doubled the 13.8% benchmark for the only FDA-approved immunotherapy available, with responses lasting 15.5 months versus 9.5 months for standard treatment.
Oncolytics has also secured FDA agreement on its Phase 3 trial design for pancreatic cancer, clearing the way to launch what would be the only immunotherapy registration trial currently planned for this notoriously difficult-to-treat disease.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Amgen (NASDAQ:AMGN) announced its acquisition of Dark Blue Therapeutics Ltd., a UK-based biotechnology company advancing first-in-class targeted protein degraders for oncology, in a transaction valued at up to $840 million. The acquisition adds an investigational small molecule targeting MLLT1/3 proteins that drive specific types of acute myeloid leukemia.
"Acute myeloid leukemia remains one of the most difficult cancers to treat, and we see an urgent need for new mechanisms capable of changing the trajectory of this disease," said Jay Bradner, M.D., Executive Vice President of Research and Development at Amgen. "This acquisition complements and extends our research in targeted protein degradation and leukemia therapeutics, advancing our strategy to invest early in rising medicines for novel therapeutic targets."
Preclinical data demonstrate promising anti-cancer activity and mechanistic differentiation from currently available therapies, establishing a rationale for single-agent and combination use to overcome treatment resistance. Amgen expects to integrate Dark Blue Therapeutics into its existing research organization to strengthen early oncology discovery efforts.
Immunome (NASDAQ:IMNM) announced positive topline results from its Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors, meeting the primary endpoint with an 84% reduction in risk of disease progression or death versus placebo. The trial achieved a confirmed objective response rate of 56% with varegacestat compared to 9% with placebo.
"RINGSIDE is the largest and most comprehensive clinical trial conducted to date in patients with desmoid tumors, and the topline results represent the highest objective response rate observed in a randomized clinical trial in this patient population," said Clay Siegall, Ph.D., CEO of Immunome. "These findings demonstrate the potential of varegacestat to offer best-in-class results in a convenient, once-daily, oral medicine that may help patients reclaim their lives."
Varegacestat demonstrated a median best change in tumor volume of -83% versus +11% with placebo, with a generally well-tolerated safety profile. Immunome plans to submit a New Drug Application to the FDA in Q2 2026.
Allogene Therapeutics (NASDAQ:ALLO) outlined 2026 as a program-defining year for its off-the-shelf allogeneic CAR T platform, with multiple first-half clinical readouts expected across oncology and autoimmune disease applications. The company's lead program cemacabtagene ansegedleucel is being evaluated in the pivotal Phase 2 ALPHA3 trial for first-line consolidation in large B-cell lymphoma, with an interim futility analysis planned for early Q2 2026.
"We believe 2026 is a program-defining year for allogeneic CAR T and Allogene with value-defining readouts and clinical maturity unmatched in the allogeneic field," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene Therapeutics. "With multiple first-half clinical milestones, we aim to demonstrate that CAR T can be delivered at biologic-like scale in real-world settings."
Initial proof-of-concept data for ALLO-329, the dual CD19/CD70 AlloCAR T designed to reduce or eliminate lymphodepletion in autoimmune diseases, is expected by the end of the first half of 2026. Allogene Therapeutics maintains a cash runway extending into the second half of 2027.
Kura Oncology (NASDAQ:KURA) reported $2.1 million in preliminary KOMZIFTI net product revenue during the five-week period of initial commercial availability following FDA approval on November 13, 2025. The company also received $195 million in milestone payments under its Kyowa Kirin collaboration agreement in the fourth quarter.
"Following the landmark FDA approval of KOMZIFTI on November 13, 2025, we are executing a robust commercial launch to drive rapid adoption and market share growth," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "With KOMZIFTI's compelling efficacy, favorable safety profile and ease of use, we believe that we are strongly positioned for success and encouraged by the first few weeks of our commercial launch."
KOMZIFTI was added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a Category 2A recommended treatment option for adults with relapsed/refractory NPM1-mutated acute myeloid leukemia. Kura Oncology ended 2025 with $667.3 million in cash, cash equivalents, and short-term investments.
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