Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities

Cision Canada

16-07-2025

Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER. BC, July 16, 2025 /CNW/ -- As lawmakers weigh potential cuts to scientific research funding, the outlook for developing cancer cures faces growing uncertainty. The situation is further complicated by renewed regulatory scrutiny of mRNA vaccines at both federal and state levels, casting a shadow over ongoing cancer research efforts. Meanwhile, the incidence of cancers—especially gastrointestinal and colorectal cancers among younger populations—is on the rise, heightening the need for new therapeutic approaches. In response, a new generation of biotech companies is stepping forward with promising clinical milestones on the horizon, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), GeoVax Labs, Inc. (NASDAQ: GOVX), OS Therapies (NYSE-American: OSTX), and SELLAS Life Sciences Group, Inc. (NASDAQ: SLS).
Industry forecasts suggest the global oncology drug market could climb past US$900 billion by 2034. Within that, next-generation cancer treatments —powered by advances in personalized and precision medicine—are expected to reach US$175.2 billion, according to Precedence Research, growing at a compound annual rate of 7.35%.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just rolled out an expanded translational data review package that tightens the scientific case for pelareorep, its intravenously delivered oncolytic virus.
Fresh analyses from the GOBLET gastrointestinal‑cancer study and the AWARE‑1 breast‑cancer study shows pelareorep actively replicating inside tumors, switching on interferon signaling in the immune system, and drawing tumor‑infiltrating lymphocytes into the cancer microenvironment.
"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."
Investigators also recorded a clear increase in PD‑L1 expression, a checkpoint marker that helps immune cells recognize tumors, and tracked newly expanded T‑cell clones in the blood that matched those inside shrinking lesions. Together, these findings suggest pelareorep can convert "cold" tumors into "hot" ones that respond better to modern immunotherapies.
"The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs."
Two GOBLET cohorts—metastatic pancreatic ductal adenocarcinoma (mPDAC) and anal cancer—remain open. Management plans to outline the next clinical milestones before the end of the third quarter.
Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a two‑year overall‑survival rate of 21.9%, compared with the historical benchmark of 9.2%. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective response rate. No immune checkpoint therapy is approved in this cancer today, which makes the signal especially noteworthy.
Progress extends to hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC). Across two randomized trials, pelareorep added more than ten months of median overall survival. In BRACELET‑1, the drug nearly doubled median progression‑free survival to 12.1 months versus 6.4 months in the control arm, suggesting durable disease control.
Next week, Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes.
To steer these data toward value‑creating deals and late‑stage trials, Oncolytics Biotech strengthened its leadership earlier this year. The board tapped industry veteran Jared Kelly for the CEO seat and named Andrew Aromando Chief Business Officer. Both executives helped guide Ambrx Biopharma into a $2‑billion sale to Johnson & Johnson, giving them a playbook for capital‑efficient development and strategic partnering.
"Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy."
As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile.
"I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term."
Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe.
In other recent industry developments and happenings in the market include:
Zai Lab Limited (NASDAQ: ZLAB) recently reported that its Phase 3 FORTITUDE‑101 study found bemarituzumab plus mFOLFOX6 significantly improved overall survival over chemotherapy alone in first‑line fibroblast growth factor receptor 2b (FGFR2b)‑positive gastric and gastroesophageal junction cancers. The antibody becomes the first FGFR2b inhibitor to post a statistically and clinically meaningful survival benefit, and the company plans a rapid regulatory filing in China under its Breakthrough Therapy designation.
"Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible."
GeoVax Labs, Inc. (NASDAQ: GOVX) recently stated that the FDA's curative‑intent approval of Keytruda for head and neck cancer strengthens the rationale for its planned Phase 2 trial combining Gedeptin and pembrolizumab.
"We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed," added Dr. Kelly McKee, GeoVax's Chief Medical Officer. "We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease."
The study, expected to launch in 2026, will give Gedeptin intratumorally before surgery to trigger local cytotoxicity, then add checkpoint inhibition to boost systemic immunity. Endpoints include pathologic response, recurrence rates, and immune biomarkers, aligning with guidance in a recent New England Journal of Medicine editorial.
OS Therapies (NYSE-American: OSTX) has locked in an End‑of‑Phase 2 FDA meeting for 27 August 2025 to discuss a rolling Biologics License Application for OST‑HER2 in recurrent, lung‑metastatic osteosarcoma, while parallel regulatory consultations are set with the EMA and the UK MHRA.
"We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher ("PRV") program," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale."
The company is also advancing a Phase 1 prostate‑cancer immunotherapy, OST‑504, with full data expected later in 2025. OST‑HER2 already carries Rare Pediatric Disease, Fast Track, and Orphan Drug designations, positioning the program for a potential Priority Review Voucher and accelerated approvals in multiple markets.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) met every primary endpoint in its Phase 2 trial of SLS009 in relapsed/refractory acute myeloid leukemia-myelodysplasia-related changes (AML MR), delivering a 44% overall response rate at the optimal 30 mg twice‑weekly dose and a median overall survival of 8.9 months—far above the 2.4 month historical benchmark. The CDK9 inhibitor also showed a 50% response rate in high‑risk ASXL1‑mutated and M4/M5 subgroups, with no dose‑limiting toxicities reported.
"We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks," said Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS. "AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes."
Following FDA guidance, the company will launch an 80‑patient randomized study in newly diagnosed first‑line AML by Q1 2026 to support a potential New Drug Application.
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