Shots
- Pelareorep is gaining regulatory momentum through multiple FDA interactions and Fast Track designations, providing greater clarity around potential registration pathways and shaping Oncolytics’ clinical development and partnership strategy.
- REO-033 could mark a pivotal step toward registration as the randomized study in RAS-mutant MSS metastatic colorectal cancer builds on encouraging clinical data and has the potential to become Oncolytics’ first randomized registrational program.
- PharmaShots welcomes Jared Kelly, CEO and Director at Oncolytics Biotech, in an Exclusive Interview discussing pelareorep’s clinical development, regulatory strategy, strategic partnerships, IP expansion, and long-term commercial vision.
Saurabh: The FDA recently granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for SCAC. How does this milestone validate the therapy’s potential, and what impact will it have on your clinical development and regulatory strategy moving forward?
Jared: The most important point isn’t simply that we received another Fast Track designation. It’s that over the past twelve months we’ve systematically reduced regulatory risk across our lead programs. We’ve held multiple productive interactions with the FDA, received multiple Fast Track designations, and today have significantly greater clarity around potential registration pathways than we did a year ago.
Those milestones are changing how we prioritize capital, how we design clinical trials, and how potential partners evaluate pelareorep. Our focus is no longer simply generating encouraging clinical data. It’s executing programs that have the potential to support product approvals. Fast Track provides more frequent engagement with the FDA and helps ensure our development strategy remains aligned with regulatory expectations as we advance toward registrational opportunities.
Saurabh: Oncolytics recently initiated the randomized REO-033 study in RAS-mutant MSS metastatic colorectal cancer. What makes this program so important?
Jared: REO-033 represents much more than another clinical study. It has the potential to become our first randomized registrational program. The study was intentionally designed based on prior clinical data and ongoing regulatory dialogue with the FDA, allowing us to efficiently build upon the encouraging efficacy we’ve already observed.
If those results are reproduced in the randomized setting, we believe REO-033 has the opportunity to become one of the most compelling immunotherapy programs in MSS colorectal cancer. Importantly, we’re designing our development strategy with potential registration in mind while remaining disciplined in our capital allocation.
Saurabh: What were the biggest takeaways from AACR and ASCO?
Jared: The biggest takeaway wasn’t a single presentation—it was the consistency of the biology. Every new translational dataset continues to reinforce the same conclusion: pelareorep functions as an immune primer across multiple gastrointestinal tumors.
That consistency gives us confidence to focus resources on indications where we believe we have the greatest opportunity to create registrational pathways and meaningful value for patients and shareholders.
Saurabh: Emerging data support pelareorep in combination with checkpoint inhibitors and targeted therapies. How do you view these opportunities?
Jared: Checkpoint inhibitors remain a foundational component of our strategy. We’ve spent considerable time evaluating potential partners whose portfolios align with ours, and those discussions continue to advance. Increasingly, the conversations are centered around long-term development, regulatory strategy and commercialization rather than simply evaluating the science.
We believe the right checkpoint inhibitor relationship can create value across multiple programs rather than a single indication, and that’s the type of strategic partnership we’re focused on building.
Saurabh: Oncolytics recently expanded its intellectual property portfolio. How important is IP to your commercialization strategy?
Jared: Intellectual property is one of the pillars supporting long-term enterprise value. Our recently issued manufacturing patent protects commercial-scale production of pelareorep and represents an important milestone as we prepare for later-stage development.
Equally important, we expect two additional patents over the next twelve months that could further strengthen our exclusivity position. Our objective is to build an IP estate that protects pelareorep throughout its commercial lifecycle while increasing its strategic value to future partners.
Saurabh: How is Oncolytics positioning itself for its next phase of growth?
Jared: We’ve deliberately built the organization required to execute registrational development. Over the past year we’ve strengthened our regulatory, clinical operations, manufacturing, biostatistics and commercial planning capabilities because companies don’t become commercial organizations overnight. Those capabilities need to be built well before approval.
Saurabh: What role do strategic partnerships play going forward?
Jared: As our programs mature, the nature of partnership discussions changes. Early conversations tend to focus on scientific rationale. Today, discussions increasingly center on regulatory strategy, development timelines, manufacturing readiness and commercial opportunity.
We believe pelareorep has the potential to become a foundational immunotherapy backbone across multiple solid tumors. Our objective is to identify partners that maximize the long-term value of the platform rather than simply support an individual study.
Saurabh: What is your long-term vision for Oncolytics?
Jared: When I joined Oncolytics, our objective was to transform a company with compelling science into a company capable of delivering approved medicines. Over the past year we’ve established greater regulatory clarity, strengthened our intellectual property portfolio, advanced multiple registrational opportunities and continued building an organization capable of commercial execution.
The next chapter is straightforward: execute our clinical strategy, expand our strategic partnerships, continue strengthening our intellectual property estate and deliver the data required to bring pelareorep to patients. If we execute against those priorities, I believe we’ll create significant long-term value for patients, partners and shareholders.
About Jared Kelly
Jared Kelly is an accomplished biotechnology executive and legal strategist with extensive experience across corporate law, capital markets, mergers & acquisitions, and business development within the life sciences industry. Prior to joining Oncolytics Biotech, he served as Head of Legal and Corporate Strategy at Ambrx, where he played a key role in the company’s $2 billion acquisition by Johnson & Johnson. Throughout his career, he has advised and led numerous strategic transactions for both public and private biotechnology companies.Pharmaceuticals & Biotech
At Oncolytics Biotech, Jared is focused on advancing the company’s clinical and corporate vision as it continues to develop pelareorep across multiple oncology indications. Under his leadership, the company is strengthening its position in immuno-oncology through strategic collaborations, clinical innovation, and a focused approach toward addressing challenging solid tumors.
