Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – Recent cuts to public cancer research funding are reshaping the oncology landscape as private-sector innovation surges to fill critical gaps left by government retrenchment. According to CB Insights, the shift has created unprecedented momentum for biotech companies, with oncology tech already raising $1.3 billion year-to-date[1], exceeding full-year totals for both 2023 and 2024. Meanwhile, August 2025 marked a transformative month[2] as the FDA accelerated approvals for innovative cancer therapies, granting multiple breakthrough therapy designations, including breakthrough status for ifinatamab deruxtecan in small cell lung cancer[3] and izalontamab brengitecan in EGFR-mutated NSCLC[4]. These regulatory accelerations position Oncolytics Biotech Inc. (NASDAQ: ONCY), C4 Therapeutics, Inc. (NASDAQ: CCCC), Nuvation Bio, Inc. (NYSE: NUVB), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), and Pfizer Inc. (NYSE: PFE).
Market analysts at Precedence Research project the global cancer immunotherapy market will reach $338.40 billion by 2034, growing at a 10.65% CAGR[5]. This expansion reflects a fundamental shift in how cancer treatment is approached, with institutional capital flowing toward companies capable of addressing the most resistant tumor types through novel mechanisms rather than traditional approaches.
Oncolytics Biotech Inc. (NASDAQ: ONCY) just marked a key milestone with the expansion of its GOBLET study into U.S. clinical sites, setting the stage for faster enrollment and upcoming data readouts across multiple gastrointestinal cancers. The company's immunotherapy, pelareorep, is now planned to open at Northwestern University and other academic institutions, bringing this breakthrough treatment to American patients with pancreatic cancer and other hard-to-treat tumors.
"We expect to build on this clinical momentum to lay the foundation for our regulatory strategy," said Jared Kelly, CEO of Oncolytics. "It's imperative that we leverage our clinical data to obtain regulatory clarity and position pelareorep as a platform immunotherapy in these gastrointestinal tumors where patients desperately need treatment options."
The timing is significant, with multiple cohorts from GOBLET already showing strong efficacy signals, including a 33% overall response rate in second-line squamous cell carcinoma of the anal canal patients. This nearly triples the response rate achieved by existing treatments in this rare but deadly cancer. With 20 evaluable patients enrolled and completion expected by the end of 2025, an efficacy update is anticipated in Q4 2025.
The most closely watched program is Cohort 5, which evaluates pelareorep in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This randomized cohort tests pelareorep with modified FOLFIRINOX chemotherapy with or without a checkpoint inhibitors, building on earlier data where pelareorep combinations achieved a stunning 62% objective response rate in 13 evaluable patients. Enrollment is 40% complete, with full enrollment expected by the end of 2026, and interim overall survival data anticipated in Q1 2026.
The expansion strategy validates pelareorep's potential as a platform immunotherapy. This systemically delivered oncolytic virus transforms immunologically "cold" tumors into "hot" targets responsive to immune-based treatments. Unlike traditional chemotherapy that attacks cells indiscriminately, pelareorep selectively replicates within cancer cells while simultaneously activating the body's natural immune defenses.
Previous colorectal cancer studies reinforced pelareorep’s potential, showing survival nearly tripled compared to standard of care and extended disease control in KRAS-mutant patients.
Pancreatic cancer data has been equally compelling. Patients achieved a two-year survival rate of 21.9 percent, more than double the historical benchmark of 9.2% with standard chemotherapy. Crucially, pelareorep combinations showed objective responses in a majority of patients (62%), suggesting it may unlock checkpoint inhibitor effectiveness in tumors long considered resistant to immunotherapy.
The company is in active discussions with the FDA to finalize pivotal study parameters, aiming to begin trial activities by Q4 2025. This signals a move from proof-of-concept toward regulatory-stage development.
Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones.
With U.S. site expansion accelerating enrollment, multiple efficacy readouts scheduled through 2026, and ongoing FDA discussions for registration-enabling trials, Oncolytics appears positioned at a critical inflection point. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes.
With additional catalysts lined up through 2026, an experienced leadership team, and survival outcomes far ahead of standard care, pelareorep may be approaching the point where clinical promise becomes commercial reality.
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:
C4 Therapeutics, Inc. (NASDAQ: CCCC) has completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in multiple myeloma, demonstrating a well-tolerated safety profile and compelling response rates. The clinical-stage biopharmaceutical company will present updated results from all safety and efficacy evaluable patients at the International Myeloma Society Annual Meeting on September 20, 2025. C4T's cemsidomide is an investigational, orally bioavailable small-molecule degrader designed as a more potent and selective degrader of IKZF1/3 transcription factors that drive multiple myeloma and non-Hodgkin's lymphomas.
"C4T has completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in MM, which continues to demonstrate a well-tolerated safety profile and compelling response rates," said the company in its announcement. "The presentation at the IMS Annual Meeting will include data from all safety and efficacy evaluable MM patients from all dose levels studied in the cemsidomide with dexamethasone cohort in the Phase 1 trial."
C4T's investor webcast will highlight the data from the oral presentation and provide additional detail on the company's planned next steps of clinical development. The company's degrader medicines are designed to harness the body's natural protein recycling system to rapidly degrade disease-causing proteins, offering potential to overcome drug resistance and improve patient outcomes.
Nuvation Bio, Inc. (NYSE: NUVB) has announced new and updated results from pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib), with TKI-naïve patients in TRUST-I achieving a median progression-free survival of 44.6 months. The global oncology company's findings from one of the largest clinical trial programs in ROS1-positive NSCLC to date, with over 300 patients enrolled, were highlighted at the 2025 World Conference on Lung Cancer. Nuvation Bio's IBTROZI received FDA approval in June 2025 for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
"With additional follow-up time, these updated findings from the TRUST studies show notable progression-free survival results and demonstrate that responses with IBTROZI remain durable, with a well-characterized, manageable safety profile," said Geoffrey Liu, M.D., Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto. "The results further support the recent approval of IBTROZI in the U.S., which has added an important new option for a range of patients with this form of lung cancer, regardless of prior exposure to tyrosine kinase inhibitor therapy."
Nuvation Bio's diverse pipeline includes taletrectinib as a next-generation ROS1 inhibitor, safusidenib as a brain-penetrant IDH1 inhibitor, and NUV-1511 as an innovative drug-drug conjugate designed for targeted cancer treatment. The company continues to focus on tackling some of the toughest challenges in cancer treatment with therapies designed to create profound positive impact on patients' lives.
Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has entered into a new clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) to evaluate palazestrant plus atirmociclib in a Phase 1b/2 study for patients with ER+/HER2- metastatic breast cancer.
"We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and CEO of Olema Oncology. "Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting."
The clinical-stage biopharmaceutical company will lead the conduct of the study exploring the combination in approximately 35 patients, with initiation anticipated in H2 2025. Olema's palazestrant is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and selective ER degrader (SERD) that has been granted FDA Fast Track designation.
Olema will maintain full global commercial and marketing rights to palazestrant while Pfizer supplies atirmociclib for the study, with all clinical data and inventions jointly owned. The company's OPERA-01 pivotal study of palazestrant is currently underway, with the OPERA-02 ribociclib combination trial in frontline metastatic breast cancer anticipated to initiate this quarter.
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SOURCES CITED:
1. https://www.cbinsights.com/research/oncology-tech-trends-q3-2025/
2. https://www.targetedonc.com/view/a-month-of-breakthroughs-the-fda-s-oncology-decisions-in-august-2025
3. https://www.merck.com/news/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer/
4. https://news.bms.com/news/corporate-financial/2025/Izalontamab-Brengitecan-EGFRxHER3-ADC-Granted-Breakthrough-Therapy-Designation-by-U-S--FDA-for-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer/default.aspx
5. https://www.precedenceresearch.com/cancer-immunotherapy-market
