Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has appointed Jared Kelly as Chief Executive Officer and Board member, bringing proven expertise in transformative biotech transactions to advance the company's immunotherapy programs. Kelly most recently played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion and previously advised leading biotech companies on M&A and licensing transactions at Lowenstein Sandler LLP and Kirkland & Ellis LLP.
Strategic Leadership for Clinical Development
Wayne Pisano, Chair of Oncolytics' Board of Directors and outgoing Interim CEO, emphasized Kelly's alignment with the company's clinical achievements: "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date. 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 outlined his strategic vision for the company's lead asset: "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."
Compelling Clinical Results Across Multiple Indications
Pelareorep, an intravenously-administered immunotherapeutic agent, has received FDA Fast Track designation for metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). The drug has demonstrated particularly strong efficacy in mPDAC, a high-value indication with significant unmet medical need.
In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep delivered a >60% objective response rate in tumor evaluable patients in the most recent study, representing more than double the benefit observed in historical control trials. Additionally, the treatment achieved two-year survival rates 4-6 times those observed in control patients or against benchmarks in prior studies.
The immunotherapy has also shown meaningful survival benefits in metastatic breast cancer across two randomized Phase 2 studies involving over 100 combined mBC patients in the IND-213 and BRACELET-1 trials. In second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients, Phase 2 objective response rate data continue to exceed historical data for treatment with checkpoint inhibitors alone.
Mechanism of Action and Safety Profile
Pelareorep functions by inducing anti-cancer immune responses and promoting an inflamed tumor phenotype, effectively turning "cold" tumors "hot" through innate and adaptive immune responses. The drug has demonstrated synergies with multiple approved oncology treatments and maintains a well-defined and favorable safety profile based on data from more than 1,100 patients across multiple tumor types.
These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, position pelareorep as a high-potential asset for further development in-house and through strategic partnerships, according to the company.
Executive Compensation and Strategic Alignment
As part of his appointment, Kelly received an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares at the same exercise price, which will vest upon achieving certain financing objectives. Additionally, Kelly was granted restricted stock units entitling him to receive shares equal to 2% of the company's outstanding common shares upon entering a definitive agreement for acquisition of the company or exclusive license of pelareorep.
Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances toward registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received FDA Fast Track designation.
