The $185B Cancer Surge: Why the FDA's Fast-Track Pivot is Scaling a New Immunotherapy Era
VANCOUVER, British Columbia, Jan. 14, 2026 (GLOBE NEWSWIRE) -- USANewsGroup.com News Commentary – The global immuno-oncology market is set to explode from its current $35 billion level to a massive $185.69 billion by 2035 as the industry moves toward the coordinated activation of the immune system[1]. This surge is being accelerated by the $69.16 billion genomics revolution, which is now integrating advanced profiling into every oncology workflow to pick winning treatments[2]. This strategic push for registration-ready precision assets fuels the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ:ONCY), ImmunityBio (NASDAQ:IBRX), OS Therapies (NYSE-A: OSTX), BioNTech SE (NASDAQ:BNTX), and Compass Therapeutics (NASDAQ:CMPX).
Capital is flooding the sector, with the precision medicine market projected to hit $537.17 billion by 2035 as investors chase targeted therapeutic platforms[3]. Current FDA accelerated approval frameworks are proving to be a massive catalyst, delivering survival gains across 65% of solid tumor studies and fast-tracking response-heavy drugs for commercialization[4]. For retail investors, the narrative is clear: the race to cure rare and resistant cancers is being redefined by clinical speed and regulatory alignment.
Oncolytics Biotech Inc. (NASDAQ:ONCY) is strengthening its operational and statistical 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 Therapeutics, 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 strategic focus is 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, with a median duration of response of 15.5 months compared to 9.5 months for standard care.
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.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
Other recent industry developments and happenings in the market include:
ImmunityBio (NASDAQ:IBRX) announced positive results demonstrating ANKTIVA as a lymphocyte-stimulating agent in combination with checkpoint inhibitors across two clinical trials in 151 patients with non-small cell lung cancer (NSCLC). In second- and later-line NSCLC, 77% of patients achieved restoration or maintenance of immune competence, with responders experiencing significantly longer overall survival of 16.2 months versus 11.8 months for non-responders.
"Today, the default standard of care for these patients remains cytotoxic chemotherapy such as docetaxel, which is associated with substantial toxicity and limited survival benefit," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "Large, randomized trials have demonstrated median overall survival of approximately nine months with docetaxel. The results from these studies support a potential paradigm shift toward what we define as Immunotherapy 2.0, which is the coordinated activation of the innate immune system through natural killer cells and the adaptive immune system through T cells to restore immune competence and extend survival."
Patients achieving higher immune competence demonstrated a median overall survival of 21.1 months, independent of PD-L1 status, substantially exceeding historical benchmarks. A randomized Phase 3 confirmatory trial comparing ANKTIVA plus checkpoint inhibitor versus docetaxel in second-line NSCLC is ongoing.
OS Therapies (NYSE-A: OSTX) is finalizing preparations for an end of January 2026 FDA Biologics License Application submission for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma under the Accelerated Approval Program. The company expects to release biomarker data from its Phase 2b Metastatic Osteosarcoma Program during the week of the J.P. Morgan Healthcare Conference 2026, with UK and EU Marketing Authorisation Application submissions expected by the end of February 2026 and March 2026, respectively.
"OS Therapies is potentially at the cusp of improving the standard of care for patients with metastatic osteosarcoma," said Paul Romness, Chairman and CEO of OS Therapies. "2025 was a transformational year in which we announced promising OST-HER2 clinical trial results and had significant interactions with regulatory agencies in the U.S., U.K. and Europe regarding the path toward conditional marketing authorizations in 2026."
OST-HER2 has received Orphan Disease Designation, Fast Track Designation and Rare Pediatric Disease Designation from the FDA, which could make the company eligible for a Priority Review Voucher if approved prior to September 30, 2026.
BioNTech SE (NASDAQ:BNTX) and OncoC4 recently received FDA Orphan Drug Designation for gotistobart in squamous NSCLC, an aggressive subtype with limited therapeutic options in the advanced stage. Gotistobart is a novel tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, designed to selectively deplete tumor-infiltrating regulatory T cells within the tumor microenvironment while preserving immune checkpoint function at peripheral organs.
The pivotal Phase 3 clinical trial PRESERVE-003 is ongoing, evaluating gotistobart in patients with metastatic squamous NSCLC at 160 sites globally. In a data readout from the non-pivotal dose-confirmation stage of the trial, gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard-of-care chemotherapy and a manageable safety profile in squamous NSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. Squamous NSCLC accounts for around 25% of all lung cancer cases, with a 5-year relative survival rate of 15% and a median survival time of 11 months in the United States, representing a devastating disease with limited treatment options in the advanced stage.
Compass Therapeutics (NASDAQ:CMPX) provided a corporate update highlighting that progression-free survival and overall survival analyses remain on track for late Q1 2026 in the ongoing Phase 2/3 COMPANION-002 study of tovecimig in patients with advanced biliary tract cancer. The company's CTX-8371 PD-1 x PD-L1 bispecific antibody has demonstrated responses in patients with both solid tumor and hematologic malignancies, with a confirmed third response in a patient with Hodgkin Lymphoma, and cohort expansions now open for enrollment in triple-negative breast cancer and NSCLC.
"Compass enters 2026 with significant momentum across our organization," said Thomas Schuetz, M.D., Ph.D., CEO and Vice Chairman of the Board of Directors of Compass Therapeutics. "We are advancing multiple first-in-class, bispecific antibodies and expect to achieve major data-driven milestones this year."
The company expanded its senior leadership team with the appointment of Arjun Prasad as Chief Commercial Officer and Cynthia Sirard, M.D., as Chief Medical Officer. Compass estimated $209 million in cash and marketable securities as of December 31, 2025, which is expected to provide cash runway into 2028.
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SOURCES CITED:
- https://www.globenewswire.com/news-release/2026/01/07/3214447/0/en/Immuno-Oncology-Drugs-Market-Projected-to-Reach-US-185-69-Billion-by-2035-Astute-Analytica.html
- 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
- https://www.globenewswire.com/news-release/2025/12/22/3209349/0/en/Global-Precision-Medicine-Market-Growth-Accelerates-at-16-26-CAGR-Through-2035-Expands-Rapidly-as-AI-Genomic-Testing-and-Targeted-Therapies-Gain-Momentum.html
- https://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/
