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USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns around drug affordability and access. These headwinds are forcing a shift in expectations — placing the burden of innovation on the private sector, where companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Citius Oncology, Inc. (NASDAQ: CTOR), ADC Therapeutics SA (NYSE: ADCT), and OS Therapies Incorporated (NYSE-American: OSTX).
The shift reflects more than a funding gap — it signals a structural realignment in how cancer breakthroughs may be brought to market. As public systems face pressure and timelines extend, nimble biotech firms are advancing targeted treatments, combination trials, and regulatory conversations once dominated by legacy institutions. Against this backdrop, market watchers see a pivotal window opening for investors willing to back the next wave of oncology innovation.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new chapter with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. With a background in high-value biotech transactions and late-stage development strategy, Kelly brings experience that may help position the company for its next phase of clinical and corporate progress.
Prior to joining Oncolytics, Kelly was General Counsel at Ambrx Biopharma, where he played a key role in the company's $2 billion acquisition by Johnson & Johnson. He also advised a range of life sciences firms on partnerships, licensing, and M&A during his tenure at Kirkland & Ellis LLP and Lowenstein Sandler LLP. His arrival comes as Oncolytics continues advancing pelareorep, a viral-based immunotherapy being evaluated in combination with checkpoint inhibitors and other agents across multiple cancer indications.
"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 appears aligned with a focused strategy: advancing pelareorep through late-stage development while maintaining capital efficiency and openness to potential partnerships. The company's lead program continues to generate data that support further investigation across several difficult-to-treat cancers.
Pelareorep already holds FDA Fast Track designation in two separate indications — metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) — a distinction that highlights regulatory interest in its potential.
Across clinical studies, the viral-based immunotherapy has consistently shown signs of immune activation, combinability with checkpoint inhibitors and chemotherapy, and efficacy in heavily pretreated populations.
In mPDAC, a Phase 2 cohort from the trial has reported objective response rates (ORR) above 60% in tumor-evaluable patients, exceeding historical benchmarks for this indication. Additional analyses have noted extended two-year survival rates compared to previous benchmarks. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) observed overall survival trends that support continued clinical evaluation.
Elsewhere, a Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor demonstrated partial or complete response rates that exceeded historical control trials for checkpoint inhibitor monotherapy, suggesting potential utility beyond the company's lead programs.
"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."
Kelly's compensation framework includes equity-based awards and performance-linked incentives tied to future financings and strategic outcomes. The structure is designed to align leadership priorities with long-term shareholder value while reinforcing a disciplined approach to capital and partnership development.
As multiple cohorts advance within the GOBLET study — including those in pancreatic and anal cancers backed by external funding and regulatory support — Oncolytics appears positioned to continue its progress with a blend of clinical momentum, financial flexibility, and sharpened strategic direction.
Prior to Kelly's appointment, Oncolytics presented new data from its GOBLET trial at the 2025 ASCO Annual Meeting, highlighting pelareorep's ability to stimulate both innate and adaptive immune responses in metastatic pancreatic cancer. With fresh clinical insights and new leadership in place, the company appears positioned to advance both its scientific and strategic priorities in tandem.
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:
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has entered into a strategic partnership with Fosun Pharma to accelerate development of TEV-56278, a novel anti-PD1-IL2 immunotherapy designed using its proprietary ATTENUKINE™ technology.
"This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva's innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients."
This investigational fusion protein is aimed at selectively delivering IL-2 to PD-1+ T cells, potentially enhancing anti-tumor response while limiting toxic side effects. Under the agreement, Fosun will lead clinical, manufacturing, and commercial activity in China and parts of Southeast Asia, while Teva retains global rights elsewhere.
Citius Oncology, Inc. (NASDAQ: CTOR) recently announced that it expects to commercially launch LYMPHIR™ in 2025 for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), pending FDA approval.
"We've made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community."
ADC Therapeutics SA (NYSE: ADCT) recently reported updated Phase 2 data from an investigator-initiated trial of ZYNLONTA® in relapsed/refractory marginal zone lymphoma (r/r MZL), showing an 84.6% overall response rate and a 69.2% complete response rate.
"Based on the updated Phase 2 IIT data to be shared at ICML, we are encouraged by the potential opportunity in r/r MZL and look forward to seeing additional data, as the trial expands to other sites." said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "As this trial progresses, assuming the results continue to be positive, we plan to potentially pursue a regulatory pathway and compendia in parallel as soon as sufficient data are available."
The trial also showed encouraging durability, with complete responses maintained in 17 of the 18 patients who achieved a complete response and progression-free survival of 92.9% at 12 months. ZYNLONTA was generally well tolerated, with safety findings consistent with its existing clinical profile.
OS Therapies Incorporated (NYSE-American: OSTX) received positive written feedback from the FDA following a Type D meeting regarding its lead candidate, OST-HER2, for pediatric lung metastatic osteosarcoma.
"We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting."
The agency supported the company's proposed use of external comparators in its Phase 2b trial, potentially laying groundwork for accelerated approval. OS Therapies has submitted requests for an End of Phase 2 Meeting and Breakthrough Therapy Designation, with regulatory filings expected to advance in late 2025.
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