Immunotherapy Breakthroughs Turn Cold GI Tumors Hot as Market Tops $443B
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Dec. 16, 2025 /CNW/ -- USANewsGroup.com News Commentary – Gastrointestinal cancers that once resisted checkpoint inhibitors are finally responding to novel combination strategies[1], with the FDA fast-tracking multiple targeted therapies designed to transform immunologically cold tumors into treatment-responsive hot targets[2]. This pivotal shift positions Oncolytics Biotech Inc. (NASDAQ: ONCY), AIM ImmunoTech (NYSE-American: AIM), ArriVent BioPharma, Inc. (NASDAQ: AVBP), Merus N.V. (NASDAQ: MRUS), and Halozyme Therapeutics, Inc. (NASDAQ: HALO) as potential leaders in the battle against stolid tumors, including gastrointestinal cancers.
The global cancer immunotherapy market is projected to reach $443.17 billion by 2030, growing at 11.90% annually as regulators accelerate approvals for therapies that activate immune responses in historically resistant gastrointestinal malignancies[3]. Institutional capital flows reflect surging confidence in immunotherapy platforms and bispecific antibody combinations, with oncology capturing 53 deals from 115 investors in Q2 2025 alone as the sector races to overcome the immunosuppressive tumor microenvironments that have made first-line GI cancer immunotherapy one of oncology's most challenging frontiers[4].
Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced promising efficacy and translational data supporting pelareorep in KRAS-mutant metastatic colorectal cancer, achieving a 33% objective response rate in second-line patients with microsatellite-stable disease who received pelareorep, Avastin, and FOLFIRI. This represents triple the historical response rate of 6-11% for Avastin plus FOLFIRI in this setting.
The data strengthen pelareorep's potential across gastrointestinal tumors, building on recent anal cancer results showing a 30% response rate in second-line squamous cell anal carcinoma, more than double the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for current standard care, with two durable complete responses among responders.
Translational analysis revealed that pelareorep treatment led to notable increases in KRAS-mutant-specific T-cell populations, providing mechanistic support for the clinical activity observed in this genetically defined patient population. These findings position pelareorep as a precision immunotherapy capable of providing a meaningful clinical benefit over the current standard of care.
"Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033," said Jared Kelly, CEO of Oncolytics Biotech. "Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting. With translational data supporting its unique activation of KRAS-specific T cells, pelareorep has delivered a 33 percent response rate in KRAS-mutant, MSS colorectal cancer."
The company plans to sponsor a controlled study in second-line KRAS-mutant MSS colorectal cancer following consultation with key opinion leaders and regulatory authorities, providing analytical rigor to support potential regulatory submissions. This will enable Oncolytics to have control over the data generated from this study and update relevant stakeholders at their discretion, including investors and potential partners.
"These results are extremely encouraging," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. "Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study."
The company recently established a Gastrointestinal Tumor Scientific Advisory Board to guide registration strategy across pancreatic, colorectal, and anal cancers. Inaugural members include Dr. Goel, Dr. Deva Mahalingam from Northwestern University, and Dr. Dirk Arnold, principal investigator of the GOBLET study.
Oncolytics has also 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. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer.
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.
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:
AIM ImmunoTech (NYSE-American: AIM) has reported positive clinical progress in its ongoing DURIPANC clinical trial combining Ampligen and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi for metastatic pancreatic cancer. The company reported Q3 2025 research and development expenses of approximately $607,000, compared to $1.4 million in the prior year period, while maintaining a focused monthly burn rate of approximately $550,000.
"The third quarter was marked by solid and positive clinical and operational execution," said Thomas K. Equels, CEO of AIM ImmunoTech. "Our clinical, manufacturing and regulatory teams are heavily focused on moving Ampligen down a pathway toward eventual FDA approval as part of a combination therapy for pancreatic cancer."
The company expects to release a year-end update from the DURIPANC trial by the end of the current quarter. AIM ImmunoTech reported cash, cash equivalents and marketable investments of $2.4 million as of September 30, 2025, with a net loss of $3.3 million or $1.57 per share for Q3 2025.
ArriVent BioPharma, Inc. (NASDAQ: AVBP) presented final Phase 1b data at the 2025 World Conference on Lung Cancer, demonstrating clinically meaningful outcomes for firmonertinib in EGFR PACC mutant non-small cell lung cancer, advancing two global Phase 3 pivotal studies across uncommon EGFR mutations. The company maintained $305.4 million in cash and investments as of September 30, 2025, supporting operations into mid-2027, while receiving FDA IND clearance for ARR-217, a CDH17-targeted antibody-drug conjugate for gastrointestinal cancers.
"Our late-stage firmonertinib program continues to make strong progress across EGFR-mutant NSCLC populations, with two global Phase 3 pivotal studies being conducted in uncommon EGFR mutant non-small cell lung cancer," said Bing Yao, CEO of ArriVent. "Following our strong Phase 1b findings, we are advancing to pivotal development with enrollment of the first patient in our global pivotal Phase 3 trial for PACC mutant NSCLC expected in the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation."
The ALPACCA Phase 3 study expects to enroll its first patient in Q4 2025 for first-line PACC mutant NSCLC, while the FURVENT Phase 3 trial targeting exon 20 insertion mutations projects topline data in early 2026. ArriVent also appointed Brent S. Rice as Chief Commercial Officer to establish commercial leadership ahead of potential regulatory milestones.
Merus N.V. (NASDAQ: MRUS) and Halozyme Therapeutics, Inc. (NASDAQ: HALO) entered a global collaboration to develop a subcutaneous formulation of petosemtamab using Halozyme's ENHANZE® drug delivery technology. Petosemtamab, an EGFR x LGR5 bispecific antibody, continues to show encouraging results across numerous solid tumor cancers with the potential to become a first-in-class treatment for head and neck cancer.
"We are excited to collaborate with Merus to advance treatment options for patients with r/m HNSCC and other potential indications," said Dr. Helen Torley, CEO of Halozyme. "This collaboration represents a new opportunity for our ENHANZE® technology to improve treatment efficiency and enhance the patient treatment experience."
Under the agreement terms, Merus will make an upfront payment to Halozyme plus potential future milestone payments related to commercial and sales attainment. Halozyme will be entitled to up to low-mid single digit royalties on net sales of petosemtamab formulated with the ENHANZE® technology during the royalty term.
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SOURCES CITED:
1. https://www.targetedonc.com/view/fda-fast-tracks-novel-adc-in-pancreatic-cancer
2. https://www.globenewswire.com/news-release/2025/11/25/3194494/28124/en/PD-1-Resistant-Head-and-Neck-Cancer-Market-Research-Report-2025-2030-Cracking-the-Code-of-Immunotherapy-Resistance-How-Sox9-and-Anxa1-Shape-the-Tumor-Immune-Standoff.html
3. https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market
4. https://www.globenewswire.com/news-release/2025/08/21/3136906/28124/en/Venture-Capital-Investment-Trends-in-Pharma-Q2-2025-115-Investors-Back-53-Oncology-Deals-in-Q2-2025-s-Pharma-Sector.html
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