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Equity Insider News Commentary
Issued on behalf of Oncolytics Biotech Inc.
Equity Insider News Commentary – Rising rates of cancer are going to come at a major cost, and it's looking more and more like the solution is going to have to come from the private sector. Recent reports suggest the U.S. government may slash National Cancer Institute (NCI) funding by nearly 40%, while Bloomberg reports growing concern over affordability and access to cancer drugs whose prices are rising sharply. From Wall Street's point of view, the focus needs to shift towards up-and-coming treatments being developed by promising candidates, including from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Indaptus Therapeutics, Inc. (NASDAQ: INDP), Perspective Therapeutics, Inc. (NYSE-American: CATX), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), and Autolus Therapeutics plc (NASDAQ: AUTL).
Analysts at Nova One Advisor are currently projecting the global oncology drug market to hit US$366.24 billion by 2034, expanding at a 7.4% CAGR. Others are even more optimistic, with ResearchAndMarkets estimating the sector will reach US$866.1 billion by 2034, growing at a 10.8% CAGR, and Vision Research Reports anticipating the market will top US$903.81 billion by the same year, driven by accelerating demand for advanced diagnostics and treatments. All this points to an optimal timing period for breakout cancer stocks.
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://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the market include:
Indaptus Therapeutics, Inc. (NASDAQ: INDP) recently initiated dosing in a Phase 1b/2 study arm testing its lead candidate Decoy20 with PD-1 inhibitor tislelizumab in advanced solid tumors.
"This is an important milestone in our clinical development," said Jeffrey Meckler, CEO of Indaptus. "We have long believed the Decoy platform has the potential to be a game-changing approach to treating solid tumors."
The combination is being evaluated in patients previously treated with checkpoint inhibitors or with tumor types typically unresponsive to immunotherapy. Early preclinical findings showed Decoy20 could synergize with PD-1 blockade to activate stronger anti-tumor immunity. The trial will monitor safety and preliminary signals of efficacy before broader enrollment.
Perspective Therapeutics, Inc. (NYSE-American: CATX) has recently opened enrollment for Cohort 3 of its Phase 1/2a trial testing [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors.
"We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs."
The newly approved dose level represents a 20% increase over the previous cohort and will be evaluated for safety and early signals of efficacy. Interim results presented at American Society of Clinical Oncology (ASCO) Annual Meeting and Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting showed evidence of anti-tumor activity and favorable tolerability at lower doses. The company expects to submit additional clinical updates in the second half of 2025 following extended patient follow-up.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently presented new preclinical data at the 2025 ASCO Annual Meeting showing that its CDK9 inhibitor SLS009 demonstrated potent activity in ASXL1-mutated colorectal cancer cell lines.
"These results provide strong rationale for continued advancement of SLS009 as a potential treatment for ASXL1-mutated cancers," said Dr. Dragan Cicic, Senior Vice President, Chief Development Officer at SELLAS. "The ability to selectively target ASXL1-driven tumors at concentrations well below the known safety threshold opens the door for tolerable and effective therapy. Based on the findings, we believe that ASXL1 mutation status could serve as a potential biomarker for response to SLS009 inhibition, which may allow us to further refine patient selection and improve outcomes. We look forward to presenting these results at ASCO."
In the study, 75% of lines with ASXL1 frameshift mutations responded at low nanomolar concentrations, while no response was observed in wild-type lines. These findings suggest that ASXL1 mutation status may serve as a potential biomarker for patient selection.
Autolus Therapeutics plc (NASDAQ: AUTL) has released updated results from its FELIX study, showing that obe-cel, a next-generation CAR T cell therapy, may provide long-term remission for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). With a median follow-up of nearly 33 months, more than 50% of patients were still in remission at 24 months, and 38% had not needed any additional therapy.
"Obe-cel's durability of response without any subsequent therapy in two out of every five responders is a key factor leading the transformation of therapy for adult r/r B-ALL patients. At a median follow up of 33 months, we are encouraged to see a continuation of the long-term plateau we observed at the last data cut," said Dr. Christian Itin, CEO of Autolus. "A well-tolerated, effective, durable treatment option for ALL patients who often have a poor prognosis and have had multiple prior treatments is of significant clinical benefit."
The data suggested obe-cel could serve as a standalone option for some patients, reducing the need for transplants or further treatment. The company also reported a strong safety profile and plans to continue advancing obe-cel as a potential cornerstone in adult B-ALL care.
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