Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, Baystreet.ca News Commentary, The global oncology and cancer drugs market, valued at $167 billion in 2023, is projected to reach $335.2 billion by 2033 at a compound annual growth rate of 7.2%[1]. Forecasts for the broader oncology sector paint an even more aggressive picture, with the market expected to swell to $748.17 billion by 2035 as targeted therapies and immunotherapies gain clinical traction[2]. Five companies executing on this thesis include Oncolytics Biotech (NASDAQ: ONCY), Pfizer (NYSE: PFE), Celcuity (NASDAQ: CELC), AstraZeneca (NYSE: AZN), and AbbVie (NYSE: ABBV).
The immuno-oncology segment alone is expected to expand from $65.22 billion to $170.19 billion by 2032, reflecting a 14.9% CAGR as the shift toward precision medicine intensifies[3]. Rising cancer prevalence and the growing pipeline of innovative immunotherapeutic drugs continue to draw capital into the sector[4].
Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval.
The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication.
With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs.
"GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution."
The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment.
KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026.
Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy.
The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.
CONTINUED… Read this and more news for Oncolytics Biotech at:
https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other industry developments:
Pfizer (NYSE: PFE) recently reported positive results from its Phase 3 BREAKWATER trial, demonstrating that the BRAFTOVI regimen achieved a statistically significant improvement in progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
"These results build on the positive objective response rate data we recently shared, providing further evidence of the meaningful benefit this BRAFTOVI-based targeted approach may offer patients with BRAF V600E-mutant metastatic colorectal cancer," said Jeff Legos, Chief Oncology Officer, Pfizer.
The company received accelerated FDA approval for BRAFTOVI in combination with cetuximab and mFOLFOX6 in December 2024, and plans to share the latest Cohort 3 data of BRAFTOVI plus cetuximab and FOLFIRI with regulators to support potential full approval.
Celcuity (NASDAQ: CELC) recently announced FDA acceptance of its New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, with Priority Review and a PDUFA goal date of July 17, 2026. The submission is based on data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial.
"The FDA's acceptance of our New Drug Application for gedatolisib and the assignment of a PDUFA goal date is a pivotal milestone in our efforts to bring a much-needed new treatment option to patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity.
Gedatolisib previously received both Breakthrough Therapy and Fast Track designations, underscoring the urgency of addressing unmet need in this patient population.
AstraZeneca (NYSE: AZN) secured FDA approval for CALQUENCE in combination with venetoclax as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia. The Phase 3 AMPLIFY trial demonstrated a 35% reduction in the risk of disease progression or death versus chemoimmunotherapy.
"Today's approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukemia," said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.
AbbVie (NYSE: ABBV) secured FDA approval for the combination of VENCLEXTA and acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated patients with chronic lymphocytic leukemia (CLL). The Phase 3 AMPLIFY trial showed the regimen reduced the risk of disease progression or death by 35%.
"This FDA approval marks a significant milestone for AbbVie and, more importantly, for people living with CLL," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.
The company is expanding its antibody-drug conjugate pipeline with a stated vision to replace chemotherapy across multiple oncology settings.
Article Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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SOURCES:
1. https://www.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-335-2-billion-by-2033-globally-at-7-2-cagr-allied-market-research-302683974.html
2. https://www.pharmiweb.com/press-release/2026-02-19/oncology-market-value-to-more-than-double-reaching-usd-74817-billion-by-2035
3. https://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-as
4. https://www.globenewswire.com/news-release/2026/02/17/3239494/28124/en/Immunotherapy-Drugs-Market-Research-and-Forecast-Report-2020-2025-2025-2026-with-Analyst-Recommendations-Adoption-of-AI-in-Drug-Discovery-Combination-Therapies.html
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