Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – The global oncology market is projected to reach US$668.26 billion by 2034[1], as investors increasingly reward companies deploying specialized therapeutic platforms over conventional chemotherapy approaches. Cancer treatment drugs are expected to reach US$320.92 billion by 2033[2], driven by rapid adoption of targeted therapies, radiopharmaceuticals, and immunotherapy combinations that address specific tumor mutations and rare disease indications. This pivot toward specialized mechanisms drives the investment thesis for Oncolytics Biotech Inc. (NASDAQ: ONCY), Celcuity Inc. (NASDAQ: CELC), Immunome, Inc. (NASDAQ: IMNM), Bicycle Therapeutics plc (NASDAQ: BCYC), and CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (NASDAQ: PSTV).
Market analysts project the radiopharmaceuticals sector to expand from US$7.51 billion in 2025 to US$14.44 billion by 2034[3], reflecting investor confidence in novel delivery platforms that target cancer cells with unprecedented precision. Next-generation cancer therapeutics are forecasted to reach US$175.20 billion by 2034 as artificial intelligence[4], personalized medicine, and molecular profiling technologies enable treatments tailored to individual patient genetics rather than broad tumor classifications.
Oncolytics Biotech Inc. (NASDAQ: ONCY) is a clinical-stage biotech developing pelareorep, an investigational immunotherapy designed to activate the immune system against cancer. The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant 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 patient population.
"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 data establishes pelareorep as a precision immunotherapy that delivers meaningful clinical benefit over current treatment standards. Translational analysis revealed that pelareorep increases KRAS-mutant-specific T-cell populations, providing mechanistic proof that it targets this genetic mutation, driving many colorectal and gastrointestinal cancers.
Equally compelling anal cancer results 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 demonstrating pelareorep's ability to achieve deep, lasting tumor control.
"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."
The company plans to sponsor a controlled study in second-line KRAS-mutant colorectal cancer following consultation with key opinion leaders and regulatory authorities. This represents a critical advancement, as Oncolytics will control the data generated and update investors and potential partners at its discretion.
Oncolytics recently established a Gastrointestinal Tumor Scientific Advisory Board to guide registration strategy across pancreatic, colorectal, and anal cancers. The board includes leading oncologists from Rutgers Cancer Institute, Northwestern University, and the principal investigator of the company's pivotal GOBLET study.
Oncolytics has also secured FDA alignment on its 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://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Celcuity Inc. (NASDAQ: CELC) presented updated results from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer at the San Antonio Breast Cancer Symposium. Among patients whose time to progression on prior therapy exceeded 18 months, median progression-free survival was 12.4 months with gedatolisib plus palbociclib and fulvestrant versus 1.9 months for fulvestrant alone. For patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS reached 16.6 months with the triplet regimen.
"The updated results provide further evidence of the potential for gedatolisib combined with fulvestrant with or without palbociclib to offer paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "This safety-profile, combined with the 16.6 months of median PFS reported for patients from the U.S., Canada, Western Europe, and Asia Pacific who received the gedatolisib triplet, further highlights the differentiated profile of the gedatolisib regimens."
The therapy demonstrated favorable tolerability with most patients experiencing resolution of stomatitis within two weeks, and patients reported 23.7 months delay in definitive deterioration of well-being versus 4.0 months with fulvestrant.
Immunome (NASDAQ: IMNM) announced positive topline results from the Phase 3 RINGSIDE trial of varegacestat, an oral once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors. The registrational trial met its primary endpoint with an 84% reduction in the risk of disease progression or death compared to placebo and achieved a 56% objective response rate versus 9% with placebo. The 156-patient trial met all key secondary endpoints, including tumor volume reduction and pain intensity improvement.
"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, CEO of Immunome. "These findings demonstrate the potential of varegacestat to offer best-in-class results in a convenient, once-daily, oral medicine."
Varegacestat demonstrated a median best change in tumor volume of negative 83% versus positive 11% with placebo and was generally well tolerated. Immunome plans to submit a New Drug Application to the FDA in Q2 2026.
Bicycle Therapeutics (NASDAQ: BCYC) has established strategic partnerships creating an end-to-end supply chain for its radiopharmaceutical pipeline, including a 15-year contract with the UK Nuclear Decommissioning Authority for access to up to 400 tonnes of reprocessed uranium. The company partnered with the United Kingdom National Nuclear Laboratory to extract 228Th from reprocessed uranium and with SpectronRx to develop a bespoke 212Pb generator, with initial quantities of 212Pb successfully produced. This infrastructure positions Bicycle to potentially deliver tens of thousands of doses annually of 212Pb-based Targeted Alpha Therapy.
"These new collaborations are testaments to the potential of Bicycle to advance a differentiated and exciting isotope agnostic radiopharmaceuticals portfolio," said Mike Hannay, D.Sc., FRPharmS, chief product and supply chain officer of Bicycle Therapeutics. "We believe we now have the resources and infrastructure we need to create the world's first end-to-end 212Pb radiopharmaceutical ecosystem from discovery through development to commercial supply."
The company continues advancing its Bicycle Radioconjugate pipeline targeting novel antigens EphA2 and MT1-MMP, with initial EphA2 human imaging data expected in the first half of 2026. Bicycle also maintains partnerships with Eckert & Ziegler for radioisotope supply and has formed a Research and Innovation Advisory Board of leading radiopharmaceutical experts.
CNSide Diagnostics, a wholly-owned subsidiary of Plus Therapeutics (NASDAQ: PSTV), expanded licensure to California, Rhode Island, and Maryland, bringing its CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test to 48 US states, covering over 90% of the US population. The CNSide CSF Assay Platform supports rapid diagnoses, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases, demonstrating superior clinical utility over standard of care in nine peer-reviewed publications and the FORESEE clinical trial. More than 11,000 CNSide tests have been performed at over 120 US cancer institutions since 2020, delivering 92% sensitivity and 95% specificity while influencing treatment decisions in 90% of cases.
"CNSide Diagnostics is now licensed to provide our proprietary testing service in 48 of 50 U.S. states and obtaining state licensure is a key enabler of our plan to bring the benefits of CNSide CSF testing to the broadest possible set of patients with CNS cancers," said Russ Bradley, president and general manager of CNSide Diagnostics. "We remain focused on executing on U.S. market access and launch strategy and look forward to continued expansion of coverage across payors and states."
Plus Therapeutics is advancing a pipeline of targeted radiotherapeutic product candidates for central nervous system cancers with lead programs in leptomeningeal metastases and recurrent glioblastoma. The company has built a supply chain through strategic partnerships, enabling development, manufacturing, and future commercialization of its products.
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/2025/12/02/3198196/0/en/Oncology-Market-Size-Worth-USD-668-26-Billion-by-2034.html
2. https://www.openpr.com/news/4309725/cancer-treatment-drugs-market-to-reach-usd-320-92-billion
3. https://www.precedenceresearch.com/radiopharmaceuticals-market
4. https://www.precedenceresearch.com/next-generation-cancer-therapeutics-market
