Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – The global oncology therapeutics market reached $164.2 billion in 2025 and is projected to hit $285.4 billion by 2030[1]; it signaled a massive capital rotation. Smart money is pivoting toward targeted therapies after the FDA granted Fast Track designations to multiple treatments in January alone[2]. This regulatory confidence creates a pivotal opportunity for Oncolytics Biotech Inc. (NASDAQ: ONCY), Merck & Co. (NYSE: MRK), C4 Therapeutics (NASDAQ: CCCC), Immatics (NASDAQ: IMTX), and Personalis, Inc. (NASDAQ: PSNL). These are the critical players addressing billions in unmet medical need within gastrointestinal cancers and hard-to-treat subtypes.
Institutions are now positioning for therapeutic convergence. They are tracking cancer immunotherapy technologies that advance through combination strategies[3] to reshape resistant tumor microenvironments. The urgency is financial: pharmaceutical acquirers face a $170 billion patent cliff through 2030. This pressure is driving strategic investment[4] into novel modalities like oncolytic viruses and protein degraders; it creates scalable valuation premiums for clinical-stage assets delivering registration-ready data.
Oncolytics Biotech Inc. (NASDAQ: ONCY) just received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.
The designation is based on clinical data showing pelareorep combined with standard chemotherapy achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy alone. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.
This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually.
"Adding pelareorep to the standard of care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.
The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.
Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.
Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.
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:
Merck & Co. (NYSE: MRK) reported fourth-quarter worldwide sales of $16.4 billion with full-year 2025 sales of $65.0 billion, demonstrating strength in oncology and Animal Health. KEYTRUDA/KEYTRUDA QLEX sales reached $31.7 billion for the year, representing 7% growth, while WINREVAIR contributed $1.4 billion and CAPVAXIVE generated $759 million.
"In 2025, we continued to advance leading-edge science to deliver transformative medicines and vaccines that are improving health outcomes for patients around the world," said Robert Davis, CEO of Merck & Co. "The transformation of our portfolio, bolstered by the acquisitions of Verona Pharma and Cidara Therapeutics, is well underway, and momentum is building as we continue to execute on our strategy."
The company announced positive late-stage trial results from 18 Phase 3 trials in 2025 and received FDA Commissioner's National Priority Vouchers for Enlicitide and Sacituzumab Tirumotecan. Merck & Co. anticipates full-year 2026 worldwide sales between $65.5 billion and $67.0 billion, with non-GAAP earnings per share expected between $5.00 and $5.15.
C4 Therapeutics (NASDAQ: CCCC) has outlined strategic milestones to advance cemsidomide as a potential best-in-class IKZF1/3 degrader with Phase 2 MOMENTUM trial initiation in Q1 2026 using the recommended 100 µg dose. The company plans Phase 1b trial combining cemsidomide with elranatamab in Q2 2026 and targets potential accelerated approval in fourth line or later by year-end 2028 with new drug application submission.
"We begin 2026 with compelling opportunities ahead, anchored by cemsidomide's path to become a foundational medicine for multiple myeloma by reaching patients across multiple lines of therapy," said Andrew Hirsch, CEO of C4 Therapeutics. "As we prepare to initiate two cemsidomide trials in the coming months, we believe the emerging data exploring the class in combination with BiTE therapies derisks our strategy."
The company's new discovery strategy focuses on inflammation, neuro-inflammation and neuro-degenerative diseases with novel targets in clinically validated pathways. C4 Therapeutics maintains a cash runway through the end of 2028 and targets up to three investigational new drug applications by year-end 2028.
Immatics (NASDAQ: IMTX) presented updated Phase 1a dose escalation data for IMA203CD8, a second-generation PRAME cell therapy, showing promising anti-tumor activity in heavily pre-treated patients with solid tumors. The therapy achieved 36% confirmed objective response rate and 46% overall response rate across various PRAME-expressing indications at a low median dose.
"IMA203CD8, our second-generation PRAME cell therapy, marks another wave of innovation in our PRAME franchise," said Cedrik Britten, Chief Medical Officer of Immatics. "The data from the ongoing dose escalation, including the initial proof-of-concept in patients with ovarian carcinoma, reinforce the promise of IMA203CD8 as a monotherapy for difficult-to-treat indications."
The Company showed particularly promising dose-dependent clinical signals in ovarian carcinoma, with deep confirmed objective responses at higher dose levels. Immatics is on track to complete Phase 1a dose escalation and determine the recommended Phase 2 dose in 2026, positioning IMA203CD8 for tumor-agnostic treatment of advanced PRAME cancers beyond melanoma.
Personalis (Nasdaq: PSNL) announced publication of a study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease assay, NeXT Personal, in monitoring immunotherapy response across advanced cancers. The study included 39 patients with advanced solid tumors across nine different cancer types treated with immune checkpoint inhibitors, demonstrating molecular response detectable a median of 23 days after starting therapy and identifying molecular progression 161 days before imaging.
"We continue to expand the clinical evidence that NeXT Personal can be used to monitor therapy response in advanced cancer patients on immunotherapy," said Richard Chen, Chief Medical Officer and Executive Vice President of R&D at Personalis. "This pan-cancer study builds on our recent publication in Clinical Cancer Research, similarly showing the impact of ultrasensitive ctDNA testing in late-stage cancers."
The study found that 33% of positive ctDNA detections occurred in the ultrasensitive range below 100 PPM, which could be missed with less sensitive tests. Patients who achieved molecular complete response had seven times higher overall survival than patients who did not achieve ctDNA clearance. Personalis tracks up to approximately 1,800 tumor-specific variants unique to each patient's tumor using a personalized approach.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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SOURCES:
1. https://www.globenewswire.com/news-release/2026/01/30/3229367/28124/en/Oncology-Companion-Diagnostic-Research-Report-2026-Global-5-Bn-Market-Trends-Opportunities-and-Forecasts-to-2031.html
2. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-january-2026
3. https://www.globenewswire.com/news-release/2026/02/03/3230954/28124/en/Cancer-Immunotherapy-Research-Report-2026-Market-Forecasts-2025-2029-for-Immuno-Oncology-Therapeutics-by-Therapy-Cancer-and-Customer-with-Executive-and-Consultant-Guides.html
4. https://www.morningstar.com/news/pr-newswire/20260114ln63385/precision-killers-why-big-pharma-is-betting-billions-to-beat-a-170b-patent-cliff
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