Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – Genomics-driven cancer diagnostics are accelerating market growth, with the genomics in cancer care market projected to reach $69.16 billion by 2032 as genomic profiling becomes standard practice for treatment selection[1]. The orphan drug market is expanding even faster, calculated at $216.66 billion in 2025 and projected to reach $687.47 billion by 2035, driven by supportive regulations and advancements in personalized medicine targeting rare genetic mutations[2]. This strategic focus on high-value, genetically defined targets drives the investment thesis for Oncolytics Biotech Inc. (NASDAQ: ONCY), Halozyme Therapeutics, Inc. (NASDAQ: HALO), Zai Lab Limited (NASDAQ: ZLAB), IDEAYA Biosciences, Inc. (NASDAQ: IDYA), and Coherus Oncology, Inc. (NASDAQ: CHRS).
December 2025 marked transformative regulatory milestones, with FDA approvals and fast track designations for precision therapies targeting specific genetic mutations across multiple cancer types[3]. The 2025 oncology regulatory landscape emphasized genotype-directed therapies, with highly specific tyrosine kinase inhibitors and targeted biologics addressing previously difficult-to-treat mutations like HER2 and EGFR emerging as primary value drivers heading into 2026[4].
Clinical-stage biotech company Oncolytics Biotech Inc. (NASDAQ: ONCY) is well on its way in developing pelareorep, an investigational immunotherapy designed to activate the immune system against cancer.
Closing out the company’s 2025, Oncolytics announced exciting efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat population, addressing a colorectal cancer market projected to reach $20 billion by 2033.
Equally compelling anal cancer results put out in late October showed a 30% response rate in second-line squamous cell anal carcinoma, more than doubling 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 standard care, with two durable complete responses. These results across colorectal and anal cancers reinforce pelareorep's potential as a platform immunotherapy for gastrointestinal tumors.
Along the way, this clinical momentum has attracted elite academic validation. Now Oncolytics has expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts: Dr. Eileen O'Reilly, Winthrop Rockefeller Endowed Chair of Medical Oncology at Memorial Sloan Kettering Cancer Center (“MSK”); Dr. Neil Segal, Research Director of the Division of Gastrointestinal Oncology at MSK; and Dr. Van Morris, Section Chief for Colorectal Cancer at MD Anderson Cancer Center.
"I have a strong belief in the potential of immunotherapies like pelareorep to help patients in the gastrointestinal cancer setting," said Dr. Morris. "This drug candidate has shown very promising findings in early trials for patients with colorectal and anal cancers, which should be further studied as soon as possible."
The SAB now comprises six leading oncologists spanning Rutgers Cancer Institute, Northwestern University, Asklepios Tumorzentrum Hamburg, MSK, and MD Anderson. The inaugural three members have served as lead investigators in clinical trials involving pelareorep. When researchers of this caliber attach their names to a development program, they stake their professional reputation on the underlying science. Big pharma business development teams take notice when elite academic oncologists congregate around a platform asset.
Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer. This positions 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. This track record demonstrates their proven ability to advance clinical 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:
Halozyme Therapeutics, Inc. (NASDAQ: HALO) received FDA approval for RYBREVANT FASPRO, co-formulated with ENHANZE, for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (“mNSCLC”). The subcutaneous formulation represents the first and only SC-administered targeted therapy for EGFR+ mNSCLC, reducing administration time from several hours to approximately five minutes with a fivefold reduction in administration-related reactions compared to intravenous delivery.
"Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPRO has the potential to make administration faster and more convenient for patients and their families compared to intravenous administration," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "By reducing administration times and simplifying the treatment experience, ENHANZE-formulated products could also support efficiencies for healthcare providers and lower costs for the healthcare system."
Based on Phase 3 PALOMA-3 study results, RYBREVANT FASPRO delivered consistent pharmacokinetic endpoints superior to intravenous RYBREVANT. Halozyme's ENHANZE technology has touched more than one million patient lives through ten commercialized products across over 100 global markets.
Zai Lab Limited (NASDAQ: ZLAB) announced NMPA approval of the supplemental New Drug Application for AUGTYRO for the treatment of adult patients with solid tumors harboring neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion, marking the second indication approval in China following the May 2024 ROS1-positive NSCLC approval. The approval covers locally advanced or metastatic disease where surgical resection would cause significant morbidity, spanning both TKI-naïve and TKI-pretreated patients across solid tumors.
"We are pleased with the NMPA's approval of AUGTYRO for patients with NTRK-positive solid tumors," said Dr. Rafael Amado, President and Head of Global Research and Development at Zai Lab. "This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population."
The NMPA decision was based on results from the pivotal Phase 1/2 TRIDENT-1 study demonstrating robust efficacy and a manageable safety profile in patients with NTRK fusion-positive solid tumors. Zai Lab contributed to the global pivotal study and dosed the first patient in Greater China in May 2021, under an exclusive license agreement with Bristol Myers Squibb covering mainland China, Hong Kong, Taiwan and Macau.
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) completed targeted full enrollment of 435 patients in the Phase 2/3 OptimUM-02 trial evaluating darovasertib in combination with crizotinib in first-line HLA*A2-negative metastatic uveal melanoma. The registration-enabling study will report median progression-free survival data in the first quarter of 2026 to support a potential accelerated approval filing, with median overall survival data supporting potential full approval once available.
"We are very pleased to announce that we have achieved the target enrollment to enable potential full approval filing in our Phase 2/3 registration-enabling trial of darovasertib in combination with crizotinib in first-line HLA*A2-negative metastatic uveal melanoma," said Yujiro Hata, President and Chief Executive Officer of IDEAYA Biosciences. "With target full enrollment now complete, we look forward to the availability of median PFS data we project from OptimUM-02 in the first quarter of next year, and, if approved, making darovasertib in combination with crizotinib available to patients with HLAA2-negative metastatic uveal melanoma as a first-line treatment as expeditiously as possible."
Darovasertib has received FDA Breakthrough Therapy Designation as a neoadjuvant therapy and Fast Track designation for combination therapy. IDEAYA also operates a pivotal Phase 3 trial of darovasertib as a neoadjuvant therapy.
Coherus Oncology, Inc. (NASDAQ: CHRS) published research in Molecular Cancer Therapeutics describing the preclinical and clinical biomarker data for tagmokitug, its investigational anti-CCR8 monoclonal antibody. The publication demonstrates picomolar binding affinity, selective targeting of CCR8-positive regulatory T cells, and high abundance of CCR8 expression across a broad range of solid tumors, supporting tagmokitug's potential differentiated profile.
"This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells," said Theresa LaVallee, Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program."
The publication provides critical evidence supporting tagmokitug's advancement in Phase 1b/2a clinical studies evaluating combinations with toripalimab across multiple solid tumor settings, including head and neck, colorectal, gastric, and esophageal cancers. Tagmokitug demonstrated selective elimination of CCR8-positive cells with no off-target binding in translational studies.
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/2026/01/05/3212639/0/en/Genomics-in-Cancer-Care-Market-Size-to-Hit-USD-69-16-Billion-by-2032-Growing-at-a-CAGR-of-16-04-SNS-Insider.html
2. https://www.towardshealthcare.com/insights/orphan-drug-market-sizing
3. https://www.targetedonc.com/view/december-2025-year-end-fda-oncology-actions-at-a-glance
4. https://www.targetedonc.com/view/key-fda-oncology-approvals-in-2025-precision-therapies-and-new-targets
