Issued on behalf of Oncolytics Biotech Inc. 

USANewsGroup.com News Commentary

VANCOUVER, BC, Jan. 7, 2026 /PRNewswire/ -- The global cancer drugs market is surging toward $594.3 billion by 2035 as high-tech immunotherapies begin to replace traditional chemotherapy^[1]. With response rates now exceeding 90% in some previously untreatable blood cancers, these platforms are demonstrating a unique ability to reactivate a patient's own immune system to fight back^[2]. This fundamental shift toward "reprogramming" the body's defenses drives the investment case for Oncolytics Biotech Inc. (NASDAQ:ONCY), BriaCell Therapeutics Corp. (NASDAQ:BCTX) (TSX:BCT), Greenwich LifeSciences, Inc. (NASDAQ:GLSI), Citius Oncology (NASDAQ:CTOR), and Kazia Therapeutics Limited (NASDAQ:KZIA). 

 

 

With the metastatic cancer treatment market already valued at $84.66 billion, precision-guided therapies now command a dominant 54.51% market share as they displace toxic legacy regimens^[3]. As capital flows into these novel modalities, the industry is entering a new era where metastatic spread is no longer an insurmountable barrier, but a prime target for smart, targeted activation. 

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: 

BriaCell Therapeutics Corp. (NASDAQ:BCTX) (TSX:BCT) presented positive data from its Phase 3 Bria-ABC study at the 2025 San Antonio Breast Cancer Symposium, demonstrating that biomarkers may predict clinical responses in metastatic breast cancer patients treated with the Bria-IMT regimen plus checkpoint inhibitors. The interim analysis of 116 patients with a median of 6 prior therapies showed favorable progression-free survival in HR+/HER2- disease (3.7 months) and HER2-Low disease (3.9 months), with patients exhibiting a favorable Neutrophil-to-Lymphocyte Ratio achieving median PFS of 4.4 months versus 2.6 months in those with unfavorable NLR. 

"We are very excited to see the robust and positive biomarker data, which may enable us to more confidently predict clinical responses in patients treated with the Bria-IMT regimen early in their treatment course," said Kelly E. McCann, MD, PhD, breast medical oncologist at UCLA Health Jonsson Comprehensive Cancer Center and lead investigator at UCLA for the Bria-ABC pivotal Phase 3 study. "These biomarkers could serve as highly valuable tools for clinicians, helping them inform treatment decisions for metastatic breast cancer, a complex disease in which many patients have limited or no remaining treatment options." 

BriaCell's Phase 2 data demonstrated a median overall survival of 11.3 months in DTH-positive patients versus 4.7 months in DTH-negative patients, with 100% clinical benefit rate in evaluable CNS metastasis patients. The Bria-IMT regimen was well tolerated with no treatment-related discontinuations due to adverse events across all studies. 

Greenwich LifeSciences, Inc. (NASDAQ:GLSI) provided updates on its Phase III FLAMINGO-01 trial evaluating GLSI-100 to prevent breast cancer recurrences, announcing that preliminary analysis of the fully enrolled 250-patient non-HLA-A*02 arm shows approximately 80% reduction in recurrence rates after the Primary Immunization Series, trending similarly to Phase IIb results where treated patients achieved up to 80% recurrence reduction. The trial has approximately 140 sites actively enrolling, with plans to activate 10 additional sites in 2026, while the company entered discussions with leading sites in the United Kingdom and Canada regarding joining the study pending separate regulatory approvals. 

"We are looking forward to continuing our financing strategy and implementing the planned Phase III trial derisking modifications, pending regulatory approvals," said Snehal Patel, CEO. "The discussions with clinicians at SABCS 2025 were encouraging, as the study has become more widely recognized by the breast cancer community, leading to patient and investigator driven interest to expand FLAMINGO-01 into the United Kingdom and Canada." 

Greenwich is managing its $7 million annual burn rate through its ATM facility while pursuing non-dilutive strategic partnerships, with planned trial modifications including increased study size, accelerated enrollment, and use of a commercial drug product designed to derisk the registration pathway. Patent filings for non-HLA-A*02 patients will strengthen intellectual property beyond biologics data exclusivity, potentially doubling the addressable market for GLSI-100. 

Citius Oncology (NASDAQ:CTOR) recently launched LYMPHIR in the U.S. in December 2025 following FDA approval for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy, marking the first new systemic treatment option for CTCL patients since 2018. Management estimates the initial market for LYMPHIR exceeds $400 million, with the company having secured distribution agreements with three leading U.S. pharmaceutical wholesalers, NCCN guideline inclusion with Category 2A recommendation, and a permanent HCPCS J-code to support coverage and reimbursement. 

"2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma patients since 2018," said Leonard Mazur, Chairman and CEO of Citius Pharma. "With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026."

Citius Pharma owns approximately 78% of Citius Oncology and reported fiscal 2025 net loss of $39.7 million with no revenues as expected pre-launch, while raising approximately $61 million in gross proceeds through strategic financings. The companies deployed an AI-powered sales and marketing platform and secured international access to LYMPHIR in 19 markets through regional distribution partners via named patient programs.

Kazia Therapeutics Limited (NASDAQ:KZIA) presented new data at the 2025 San Antonio Breast Cancer Symposium demonstrating that paxalisib, its brain-penetrant dual PI3K/mTOR inhibitor, disrupted highly aggressive circulating tumor cell clusters and reinvigorated exhausted immune populations across both HER2-positive and triple-negative metastatic breast cancer. In HER2-positive patients, paxalisib reduced single CTCs by 42% and CTC clusters by 78% ex vivo, while the first triple-negative breast cancer patient in the Phase 1b PaxPlus-ABC trial experienced 76% primary tumor volume shrinkage with corresponding reductions in CTCs after just one treatment cycle.

"These findings reveal an important biological gap left by existing HER2+ directed therapies," said Prof. Sudha Rao, QIMR Berghofer. "CTC clusters persist even in responding patients, and paxalisib is the first agent we have observed that can directly dismantle this highly aggressive and clinically relevant compartment."

The data revealed that when paxalisib was temporarily interrupted in the TNBC patient, CTC clusters rapidly resurged, but resumption of treatment restored suppression, indicating that pembrolizumab alone cannot control these metastatic drivers. Paxalisib's ability to simultaneously disrupt mesenchymal CTC clusters while reversing T-cell exhaustion and epigenetically reprogramming tumors toward less aggressive phenotypes positions the drug as a potentially transformative immunotherapy-enhancing agent across multiple breast cancer subtypes.

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.pharmiweb.com/press-release/2026-01-06/cancer-drugs-market-advances-with-breakthrough-targeted-and-immuno-oncology-therapies
2. https://www.prnewswire.com/news-releases/immunotherapies-replacing-chemotherapy-as-blood-cancer-market-to-hit-13b-by-2030-302646893.html
3. https://www.mordorintelligence.com/industry-reports/metastatic-cancer-treatment-market

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