BioNTech SE

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, Feb. 25, 2026 /CNW/ -- Equity Insider News Commentary, The immuno-oncology market is forecast to grow from $65.22 billion in 2025 to $170.19 billion by 2032, fueled by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines^[1]. Five companies positioned at the forefront of this expansion include Oncolytics Biotech (NASDAQ: ONCY), ImmunityBio (NASDAQ: IBRX), CRISPR Therapeutics (NASDAQ: CRSP), BioNTech (NASDAQ: BNTX), and Novocure (NASDAQ: NVCR).

The broader oncology market is projected to nearly triple from $279.98 billion to $748.17 billion by 2035, with North America commanding a 43% market share^[2]. Targeted therapy remains the fastest-growing segment within the $335.2 billion cancer drugs market projected for 2033, as personalized medicine reshapes treatment paradigms^[3].

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://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

In other industry developments:

ImmunityBio (NASDAQ: IBRX) recently announced a partnership with Accord Healthcare to expand European access to ANKTIVA for bladder cancer patients across 33 countries. ANKTIVA achieved a 71% complete response rate in BCG-unresponsive non-muscle invasive bladder cancer, with approvals spanning the U.S., EU, UK, and Saudi Arabia.

"Our partnership with Accord marks a significant step in our European growth strategy and our mission to redefine cancer care," said Richard Adcock, President and CEO of ImmunityBio.

The company continues to advance its IL-15 receptor agonist platform.

CRISPR Therapeutics (NASDAQ: CRSP) provided a business update reporting encouraging clinical data from its allogeneic CAR-T candidate, zugocabtagene geleucel (zugo-cel), in both autoimmune disease and oncology indications. CASGEVY generated $116 million in full-year 2025 revenue, with patient initiations increasing nearly three-fold year-over-year.

"We made meaningful advances across multiple clinical and preclinical programs, including encouraging data from zugo-cel in autoimmune disease and oncology, continued global uptake of CASGEVY, and important developments across our in vivo liver editing portfolio," said Samarth Kulkarni, Ph.D., Chairman and CEO of CRISPR Therapeutics.

The company is building a differentiated oncology platform with its allogeneic CAR-T approach, which could enable off-the-shelf cancer therapies without patient-specific manufacturing.

BioNTech (NASDAQ: BNTX) outlined its 2026 strategy at the J.P. Morgan Healthcare Conference, detailing plans to initiate six additional Phase 3 clinical trials this year. The company now has more than 25 ongoing Phase 2 or 3 oncology trials spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies.

"We see 2026 as a year when science translates into tangible results," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.

The company held approximately 17.2 billion euros in cash as of December 2025, positioning it to fund at least 17 late-stage data readouts expected by 2030.

Novocure (NASDAQ: NVCR) received FDA approval for its Optune Pax system in locally advanced pancreatic cancer, the first new treatment approved for this indication in approximately 30 years. The Phase 3 PANOVA-3 trial demonstrated a statistically significant improvement in overall survival.

"Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells," said Frank Leonard, CEO, Novocure.

The Tumor Treating Fields platform is also approved in certain countries for glioblastoma and malignant pleural mesothelioma, with additional pipeline candidates in development.

Article Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

CONTACT:

EQUITY INSIDER

info@equity-insider.com

(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

SOURCES:

1. https://www.openpr.com/news/4395526/immuno-oncology-market-set-for-remarkable-expansion-as
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.prnewswire.com/news-releases/oncologycancer-drugs-market-to-reach-335-2-billion-by-2033-globally-at-7-2-cagr-allied-market-research-302683974.html

Logo - https://mma.prnewswire.com/media/2840019/5821165/Equity_Insider_Logo.jpg

View original content to download multimedia:https://www.prnewswire.com/news-releases/immuno-oncology-investments-accelerate-as-pipeline-catalysts-multiply-in-2026-302695977.html

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC., Jan. 28, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – As the global oncology clinical trials market surges toward a projected $25.61 billion valuation by 2035^[1], a structural rotation is favoring 'registration-ready' platforms that demonstrate exceptional efficacy and pivotal-trial alignment with 2026's evolving FDA regulatory frameworks^[2]. Investors are increasingly prioritizing late-stage and newly commercial companies poised for rapid maturation as sector fundamentals strengthen. This structural shift creates a window for Oncolytics Biotech Inc. (NASDAQ: ONCY), BioNTech (NASDAQ: BNTX), MAIA Biotechnology (NYSE-A: MAIA), Acrivon Therapeutics (NASDAQ: ACRV), and ImmunityBio (NASDAQ: IBRX).

With 2026 set to be a banner year for M&A as buyers facing patent cliffs compete for a limited pool of late-stage assets^[3], companies demonstrating disciplined pivotal execution and FDA alignment command asymmetric upside in an environment where executive infrastructure determines valuation floors.

Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.

The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions.

"John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."

These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.

The company recently announced breakthrough 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 patient population.

The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.

Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.

Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.

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:

BioNTech (NASDAQ: BNTX) received FDA Fast Track designation for BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. The designation was granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1, a cancer type with limited treatment options where patients experience median overall survival of 20.7 months under current standard of care.

Head and neck squamous cell carcinoma is the seventh most common cancer type worldwide with increasing global incidence, with about one third of cases being HPV-positive and approximately 90% of oropharyngeal cancers driven by HPV16. BNT113 is designed to induce HPV16-specific anti-tumor immune responses by encoding the E6 and E7 proteins of HPV16 that are frequently found in HPV16+ solid tumors, with the FDA Fast Track designation enabling more frequent engagement with the FDA to support development and expedite regulatory review of this novel HPV-targeted chemotherapy-free treatment option.

MAIA Biotechnology (NYSE-A: MAIA) advanced ateganosine into pivotal development with high probability of technical success based on exceptional efficacy data in third-line non-small cell lung cancer. The telomere-targeting agent secured FDA Fast Track designation and represents the first and only direct telomere-targeting anticancer therapy in clinical development, targeting an estimated $50+ billion global immunotherapy market.

"MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, M.D., founder and CEO of MAIA. "The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA's Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways."

The company advanced concurrent Phase 3 and Phase 2 expansion trials targeting potential early commercial approval within 18 to 24 months. MAIA Biotechnology received a $2.3 million NIH grant supporting U.S. patient enrollment and is advancing second-generation molecules into Phase 1 development with enhanced expected efficacy.

Acrivon Therapeutics (NASDAQ: ACRV) announced positive data from its ACR-368 Phase 2b registrational-intent trial showing 39% overall response rate in endometrial cancer with 52% confirmed response rate in serous subtype patients with up to two prior lines of therapy. The company submitted EU Clinical Trial Application for Arm 3 enrollment across more than 20 European sites in four major countries, with enrollment completion expected in Q4 2026.

"We are pleased with tangible progress accelerating across multiple high-value opportunities," said Peter Blume-Jensen, M.D., Ph.D., CEO of Acrivon. "We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate. This provides an attractive opportunity for rapid Arm 3 enrollment without the need for a pretreatment biopsy, both in the US and more than 20 newly selected sites in major EU countries."

Acrivon Therapeutics has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 combined with anti-PD-1 therapy in frontline endometrial cancer based on strong preclinical synergy data. The company also reported initial ACR-2316 Phase 1 data showing tumor shrinkage in endometrial cancer, SCLC and squamous NSCLC, with ACR-6840 nominated as its next CDK11 inhibitor development candidate.

ImmunityBio (NASDAQ: IBRX) announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company's supplemental Biologics License Application for ANKTIVA plus Bacillus Calmette-Guérin in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. The Company presented more than five years of follow-up data demonstrating durable disease-specific survival of approximately 96% at 36 months with median survival not yet reached even with five years of follow-up, high rates of cystectomy avoidance of 92% and 82% at one and three years respectively, and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors.

"We appreciate the FDA's collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency's review."

Based on discussions with the FDA, the Agency recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication, with this additional information not contemplating the initiation or design of a new clinical trial. ImmunityBio commercially launched ANKTIVA for NMIBC CIS with or without papillary tumors in the United States and has since expanded approvals to the United Kingdom and Saudi Arabia, with conditional approval in the European Union.

Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ 

CONTACT:

USA NEWS GROUP

info@usanewsgroup.com

(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.

While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

SOURCES CITED:

1. https://www.globenewswire.com/news-release/2026/01/20/3222140/0/en/Global-Oncology-Clinical-Trials-Market-Projected-to-Reach-US-25-61-Billion-by-2035-Supported-by-Advances-in-Precision-and-Targeted-Therapies-Says-Astute-Analytica.html 
2. https://lumanity.com/perspectives/the-8-fda-regulatory-trends-shaping-2026-and-beyond/ 
3. https://www.biospace.com/business/with-biotech-back-analysts-make-their-picks-for-2026

Logo: https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/late-stage-breakthroughs-how-2026s-top-clinical-platforms-are-redefining-cancer-treatment-302671490.html