After Major Oncology Conference, All Eyes Turn to Industry Innovation

USA News Group News Commentary

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, June 12, 2025 /PRNewswire/ -- After the close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers are optimistic, especially in the fields of immunotherapy, Car T-cell therapy, liquid biopsies, breast cancer, AI, and even exercise. However, with reports coming out that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors, there have been several oncology innovators and healthcare providers with recent developments to pay attention to, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Tempest Therapeutics, Inc. (NASDAQ: TPST), Citius Oncology, Inc. (NASDAQ: CTOR), Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), and Cardinal Health (NYSE: CAH).

As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to analysts at ResearchAndMarkets, the global oncology market is projected to reach US$866.1 billion by 2034, rising at a 10.8% CAGR, while Vision Research Reports projects the global oncology market to surpass US$903.81 billion by 2034, at a 10.9% CAGR.

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy.

Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors.

"Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "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. I am excited to get to work accelerating development and unlocking significant value for stakeholders."

Kelly's appointment signals a clear priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy.

The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC)—a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers.

In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls— and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit.

And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy.

"Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors."

To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators.

As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding—Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership.

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:

Tempest Therapeutics, Inc. (NASDAQ: TPST), has secured Orphan Drug Designation from the European Medicines Agency (EMA)  for amezalpat, its lead small molecule immunotherapy for hepatocellular carcinoma (HCC). The news builds on prior FDA Fast Track and Orphan Drug status granted earlier this year.

"We're incredibly pleased to receive Orphan Drug Designation from the EMA, building on the momentum of regulatory support we've already received from the FDA," said Stephen Brady, president and chief executive officer of Tempest Therapeutics. "These designations reflect the significant unmet need in liver cancer and reinforce our belief in the potential of amezalpat to make a meaningful difference for patients and families affected by this devastating disease."

In a randomized Phase 1b/2 study, amezalpat added to standard-of-care therapy extended median overall survival by six months and showed preserved benefit across key subpopulations. The compound is designed to inhibit PPAR⍺ activity and enhance immune response in the HCC tumor microenvironment.

Citius Oncology, Inc. (NASDAQ: CTOR), the oncology division of  Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), has signed a U.S. distribution agreement with Cardinal Health (NYSE: CAH) as it prepares to launch LYMPHIR, its recently FDA-approved treatment for relapsed or refractory cutaneous T-cell lymphoma (CTCL).

"This agreement marks a key step forward in our launch readiness efforts," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "Cardinal Health's proven distribution capabilities will help ensure LYMPHIR reaches healthcare providers and patients efficiently and reliably, as we work to build a robust commercial distribution network."

LYMPHIR is a targeted recombinant fusion protein that binds IL-2 receptors and delivers diphtheria toxin fragments to malignant cells. The drug is indicated for adult patients with Stage I–III CTCL after at least one prior systemic therapy and was approved by the FDA in August 2024.

Under the agreement, Cardinal Health will serve as an authorized distributor of record and provide specialty pharmaceutical distribution services across the U.S. market. This collaboration is designed to ensure patients and providers have reliable access to LYMPHIR as demand grows. Citius estimates the addressable market for this indication exceeds $400 million and remains underserved by current treatment options.

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

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