Cancer Drug Developers Secure Regulatory Clarity as FDA Reshapes Approval Standards
VANCOUVER, British Columbia, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – The FDA is moving to require just one clinical trial for new drug approvals, signaling a dramatic shift toward faster regulatory pathways that could accelerate oncology breakthroughs[1]. This momentum is already materializing, with five major oncology approvals secured in November across multiple cancer indications, demonstrating regulators' willingness to green-light promising therapies when supported by compelling clinical data[2]. Against this backdrop of regulatory evolution, several clinical-stage biotechs are advancing toward definitive registration studies and commercial readiness, positioning themselves at exactly the right moment in the approval cycle. These companies include Oncolytics Biotech Inc. (NASDAQ:ONCY), Immunome, Inc. (NASDAQ:IMNM), Prelude Therapeutics Incorporated (NASDAQ:PRLD), Context Therapeutics Inc. (NASDAQ:CNTX), and Relay Therapeutics, Inc. (NASDAQ:RLAY).
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://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the market include:
Immunome, Inc. (NASDAQ:IMNM) has delivered positive topline results from its pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors, meeting its primary endpoint with an 84% reduction in the risk of disease progression or death compared to placebo (hazard ratio = 0.16, p<0.0001). The trial also met all key secondary endpoints, with varegacestat achieving a confirmed objective response rate of 56% versus 9% with placebo, and demonstrating a median best change in tumor volume of -83% versus +11% with placebo. Varegacestat was generally well tolerated with a manageable safety profile, with the most common adverse events being diarrhea, fatigue, rash, nausea and cough, most of which were grade 1 or 2.
"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."
Based on these results, Immunome plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second quarter of 2026. The company is also advancing an emerging pipeline of targeted oncology therapies, including IM-1021, a ROR1 ADC currently in clinical development, and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance.
Prelude Therapeutics Incorporated (NASDAQ:PRLD) has presented the first preclinical data on its JAK2V617F mutant selective JH2 inhibitors at the American Society of Hematology 67th Annual Meeting, with lead candidate PRT12396 demonstrating selective inhibition of JAK2V617F activity while preserving wild-type JAK2-mediated cytokine signaling. PRT12396 showed robust preclinical activity in multiple myeloproliferative neoplasm models, superior to ruxolitinib, and demonstrated selective inhibition of JAK2V617F stem and progenitor cell proliferation both in vitro and in vivo. The compound was well-tolerated in toxicological studies with minimal effects on hematologic parameters.
"Since JAK2V617F was first identified as a major driver mutation in JAK2 enzyme in myeloproliferative neoplasms two decades ago, our industry has been searching for an inhibitor that can selectively target the mutant JAK2 enzyme without disrupting normal JAK2 function," said Kris Vaddi, Ph.D., CEO of Prelude. "We are proud to have made significant advances in the discovery of such molecules and to share preclinical data demonstrating that our lead candidate meaningfully differentiates between mutant and wild-type JAK2 and potentially overcomes dose-limiting toxicities associated with current therapies."
The company has completed GLP toxicology studies and anticipates filing an IND and initiating a Phase 1 study in the first quarter of 2026. Prelude's JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025, while the company also disclosed additional preclinical data from its mutant calreticulin-targeted degrader antibody conjugate discovery program featuring a novel CDK9 degrader payload.
Context Therapeutics Inc. (NASDAQ:CNTX) has shared data on its CT-95 and CT-202 programs at the Society for Immunotherapy of Cancer's 40th Annual Meeting, with CT-95, a Mesothelin x CD3 bispecific T cell engager, demonstrating a favorable safety profile in its ongoing Phase 1 trial with no cytokine release syndrome greater than Grade 2 observed in any cohort. The company has enrolled 6 patients as of the October 30, 2025 cutoff and is currently enrolling Cohort 3 with a priming dose of 0.18 µg/kg and a full dose of 0.6 µg/kg, with no dose limiting toxicity observed and a maximum tolerated dose not yet reached. Based on preclinical data, CT-95 is projected to achieve target dose exposure starting at Cohort 4.
Context anticipates providing initial Phase 1a data for CT-95 in the middle of 2026 as the company continues dose escalation toward target dose levels. The company also presented preclinical data supporting the best-in-class potential of CT-202, a Nectin-4 x CD3 bispecific T cell engager that demonstrates potent preclinical activity with a favorable pharmacokinetic and safety profile, with Context expecting to complete necessary regulatory filings to support the initiation of a first-in-human trial for CT-202 in the second quarter of 2026.
Relay Therapeutics, Inc. (NASDAQ:RLAY) has announced an efficacy subset analysis of interim clinical data for zovegalisib (RLY-2608) + fulvestrant at the 2025 San Antonio Breast Cancer Symposium, showing median progression-free survival of 10.3 months for all patients and 11.4 months for second-line patients in the ReDiscover first-in-human study. Among 31 patients with measurable disease, the objective response rate was 39% overall and 47% for second-line patients, with efficacy remaining consistent across subsets including patients who received prior SERD therapy (median PFS 11.4 months, ORR 44%) and patients with detectable ESR1 mutations at baseline (median PFS 8.8 months, ORR 60%). The overall tolerability profile remained consistent with mutant-selective PI3Kα inhibition, with treatment-related adverse events that were mostly low-grade, manageable and reversible.
"Data presented today demonstrate the robust activity of zovegalisib + fulvestrant across subgroups of patients whose baseline characteristics are known to affect outcomes, such as prior fulvestrant or SERD and ESR1 mutation status," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "The broad range of activity highlights the importance of selectively targeting the driver of disease, mutant PI3Kα, and gives us confidence that the data observed to date should translate to our ongoing Phase 3 trial, ReDiscover-2."
Relay is continuing enrollment of its Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer, while also advancing dose escalation in its Phase 1/2 ReDiscover trial with triplet cohorts that will inform which regimen could be used in a future frontline metastatic trial.
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SOURCES CITED:
- https://www.statnews.com/2025/12/04/fda-considers-single-clinical-trial-for-new-product-approvals/
- https://www.ajmc.com/view/5-key-oncology-fda-approvals-from-november
