Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – Artificial intelligence and platform-based approaches reshaped cancer treatment development in November 2025, as healthcare providers deployed intelligent technologies across imaging, pathology, and genomic platforms to identify subtle patterns that enable faster, more precise clinical decisions[1]. Meanwhile, bispecific T-cell engagers achieved full FDA approval for challenging cancer indications, demonstrating how platform technologies can unlock new treatment approaches through unified mechanistic strategies[2]. This convergence positions companies advancing AI-enabled and novel platform strategies to capture expanding opportunities across oncology development, including Oncolytics Biotech Inc. (NASDAQ: ONCY), Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), Tempus AI, Inc. (NASDAQ: TEM), Sana Biotechnology, Inc. (NASDAQ: SANA), and Absci Corporation (NASDAQ: ABSI).
Analysts project the global immuno-oncology market will climb at a CAGR of 15.7% toward a value of US$416.28 billion by 2034[3].
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: 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:
Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX) achieved a $30 million milestone from Roche and Genentech for delivering a whole-genome phenotypic map of microglial immune cells, bringing total upfront and milestone payments across all partnerships to over $500 million. The clinical-stage TechBio company reported approximately $785 million in cash and cash equivalents as of October 9, 2025, providing runway through the end of 2027 without additional financing.
"Recursion continues to deliver on our internal pipeline, our strategic partnerships and the continued building and refinement of the Recursion OS. On the partnership front, we are proud to announce that with the option of our second neuro map in the Roche and Genentech collaboration, we've achieved over $500 million in upfront and milestone payments from our partners to date as we continue to deliver novel insights and advance programs for some of the toughest disease areas," said Chris Gibson, Co-Founder and CEO of Recursion. "This is only the beginning of the returns we expect to see on the investment in our platform."
The company's oncology pipeline continues advancing with REC-617 establishing a maximum tolerated dose of 10 mg once-daily in its ELUCIDATE Phase 1/2 trial for advanced solid tumors, while REC-7735, a precision-designed PI3Kα H1047R inhibitor for breast cancer, was nominated as a Development Candidate with IND-enabling studies now underway. Additional data from REC-4881 in the Phase 2 TUPELO study for familial adenomatous polyposis is expected in December 2025.
Tempus AI, Inc. (NASDAQ: TEM) has launched its first nonprofit foundation collaboration with the Institute for Follicular Lymphoma Innovation to create a comprehensive dataset for follicular lymphoma research using next-generation sequencing, proteomics, and methylation analysis. The multi-year study targets follicular lymphoma, the second most common non-Hodgkin lymphoma affecting approximately 10-20% of U.S. cases, where about 20% of patients experience progressive disease within two years of initial treatment with five-year survival rates of just 50%.
"This collaboration with IFLI signifies our shared commitment to generating rich, multimodal datasets that can help transform research for this specific patient population," said Kate Sasser, PhD, Chief Scientific Officer of Tempus. "This comprehensive approach will provide researchers with a uniquely deep and actionable understanding of follicular lymphoma, paving the way for new discoveries and personalized treatment strategies."
The study will integrate real-world clinical data with advanced molecular profiling to accelerate biomarker discovery and support the development of precision medicine approaches for follicular lymphoma patients. The collaboration also aims to contribute critical insights for developing and validating comprehensive whole genome sequencing methodologies.
Sana Biotechnology, Inc. (NASDAQ: SANA) published positive 12-week results from its investigator-sponsored type 1 diabetes study in The New England Journal of Medicine, demonstrating that UP421 hypoimmune-modified pancreatic islet cells survive, evade immune detection, and produce insulin in patients without immunosuppression. The company announced it will prioritize development of SC451, a HIP-modified stem cell-derived pancreatic islet cell therapy for type 1 diabetes, and SG293, a next-generation in vivo CAR T candidate showing deep B-cell depletion in non-human primates with a single treatment and no conditioning chemotherapy.
"Given our recent progress and the potentially transformative impact with SC451 in type 1 diabetes, as well as with our in vivo CAR T platform across a range of diseases, now is the time to concentrate our efforts in these programs," said Steve Harr, President and CEO of Sana. "Our goal for SC451 in type 1 diabetes is a single treatment leading to normal blood glucose with no need for further insulin treatment or immunosuppression, and the past several quarters of clinical results, manufacturing progress, and regulatory developments have solidified our confidence that this is possible. Based upon our momentum and given the resources required to fully exploit these opportunities, we have made the difficult decision to suspend our allogeneic CAR T programs, including SC291 and SC262."
Sana expects to file an IND and begin Phase 1 clinical trials for SC451 as early as 2026, with an IND filing for SG293 in B-cell cancers and B-cell mediated autoimmune diseases anticipated as early as 2027. The company raised aggregate gross proceeds of $133.2 million in the third and fourth quarters of 2025, maintaining a pro forma cash balance of $170.5 million with an expected runway into late 2026.
Absci Corporation (NASDAQ: ABSI) has reported interim Phase 1 results for ABS-101 demonstrating extended half-life compared to first-generation anti-TL1A competitor programs with no serious adverse events, while strategically pivoting resources toward accelerated development of ABS-201 for two high-value indications. The company is on track to initiate a Phase 1/2a trial for ABS-201 in androgenetic alopecia in December 2025, targeting approximately 80 million individuals in the United States, with potential interim efficacy data in the second half of 2026, and will host a key opinion leader seminar on December 11 to discuss the program's differentiated profile and market potential.
"This quarter marks a pivotal inflection point for Absci as we sharpen our focus on ABS-201, advancing this program in two high-value indications with strong biological rationale and significant unmet need," said Sean McClain, Founder and CEO of Absci. "By reallocating our resources toward the PRLR mechanism in androgenetic alopecia and endometriosis, we're positioned to create meaningful impact for patients while driving the greatest return for shareholders."
The company has expanded its ABS-201 strategy to include endometriosis as an additional indication affecting an estimated 9 million women in the United States with no current medical or surgical cure, anticipating Phase 2 trial initiation in the fourth quarter of 2026 with potential proof-of-concept data in the second half of 2027.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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SOURCES CITED:
1. https://www.globenewswire.com/news-release/2025/11/21/3192702/0/en/AI-Powered-Oncology-Market-Poised-to-Transform-Cancer-Care-with-a-29-36-CAGR-by-2034.html
2. https://www.mskcc.org/news/fda-grants-full-approval-to-lung-cancer-drug-tarlatamab-based-on-trial-led-by-msk-researcher
3. https://media.market.us/global-immuno-oncology-market-news/
