Oncolytics Biotech is a clinical-stage biotechnology company developing pelareorep, an investigational first-in-class double-stranded RNA immunotherapeutic agent, to establish a platform immunotherapy for the treatment of gastrointestinal tumors. Pulse 2.0 interviewed Oncolytics Biotech CEO and Director Jared Kelly to learn more.
Jared Kelly’s Background
Tell me about your background. Kelly said:
“I started out wanting to make movies and write stories. College was not immediately in the cards for me coming from a one-stoplight town in rural Michigan. But after trying to build a media company for a few years when I was a teenager, I decided it was time to be a college kid. But I was impatient and graduated in 18 months. I met my wife in college, took a year off to work for the Florida legislature, which turned out to be a great decision personally and professionally. It prepared me for the realities of the professional world and made me realize there was more to achieve than career milestones. By the time I graduated from Georgetown Law School, I was a more balanced person.”
“Initially my legal career was trending toward being a regulatory lawyer but I was too frenetic to analyze rules for 10-12 hours a day. I changed practice areas and lateraled to Kirkland & Ellis early in my career. There I received exceptional formal training and began to understand how the financial, legal and transactional worlds really work together. Initially, my practice was industry agnostic but after 5-6 years I was drawn to the electric pace of the biotech and pharma transactional space.”
“After building a corporate practice and being on both sides of billion-dollar financings and M&A deals, Dan O’Connor asked me to join Ambrx and lead the legal and corporate strategy functions. I was inside of the $2 billion J&J deal with Dan and Andrew Aromando from the early discussions. Ambrx was a great story because we had the right team and leadership to “pass the baton” of great technology to an innovative, patient-focused, American institution like J&J. But for every Ambrx story, there are 100 others with great science that miss the window or let hubris get in the way of doing a transaction that is ultimately best for patients.”
Vision For The Company
What drew you to Oncolytics as CEO, and what’s your vision for the company? Kelly shared:
“The compelling clinical data pelareorep has generated in gastrointestinal (GI) tumors and the potential I saw for the drug candidate as an immunotherapy platform is why I am here. I believe GI cancer is the highest unmet medical need in oncology and we happen to have strong efficacy signals in three historically difficult to treat gastrointestinal tumors. GI cancer is the fastest growing cancer in people under 50 and one that lacks attention and treatment options. It’s a tragedy that pancreatic cancer patients’ only options are chemo followed by more chemo and a less than 10% chance to live past two years after being diagnosed with metastatic disease.”
“Oncolytics also reminds me of Ambrx. It is an older and overlooked company with strong clinical data in an exciting space with increasing visibility and momentum. Like Ambrx, Oncolytics has well-established science but had scattered focus and an inconsistent narrative that was not appealing to investors or partners. I am working to change that.”
“My vision for the company is to build a ‘platform-in-a-product’ immunotherapy to treat gastrointestinal cancers. I want to focus all our efforts on creating a clear registration path based on strong clinical data in pancreatic, colorectal and anal cancers. Our clinical data supports this approach and shows that we beat the current standard of care. We just need to execute.”
Favorite Memory
You joined Oncolytics in June 2025. What has been your favorite part of working for the company so far? Kelly reflected:
“It sounds superficial but every day has been my favorite part. That’s because my personality is best suited to thinking strategically about 100 different items all at once and how they can all come together to result in something meaningful. Getting an oncology drug approved or sold to a partner is the hardest thing I can imagine doing. There are countless things that need to go right to ultimately reach a positive outcome. Most stakeholders (investors, partners, patients, etc.) either do not have the patience or do not have the luxury of time to wait for a strategy to unfold. But drug development in America is overburdened by regulatory requirements and the related need to raise capital from investors. We need people to believe in an idea—there is no revenue or earnings per share or other metrics to make an investment decision. Then after the money is raised, the science has to work, and the clinical data needs to be strong, and so on. And sometimes great data is still not good enough. This is why most biotech companies fail.”
“But to answer the question more directly, my favorite part of taking over the CEO role here has been the continuous problem solving on hundreds of fronts on a daily basis. Because every day presents a new issue that could derail our strategy. From the need to convince investors and partners to believe in pelareorep’s potential like I do to creating a regulatory strategy and enacting it over months of interactions with regulators, every day is a fascinating and dynamic experience that is incredibly challenging. I feel fortunate to have the opportunity to solve these problems and move this company toward a transformative moment.”
Differentiation From The Competition
What differentiates the company from its competition? How does pelareorep work, and why is it unique among immunotherapies? Kelly affirmed:
“The unique genetic structure and delivery of pelareorep, especially as a potential immunotherapy treatment in gastrointestinal tumors with RAS mutations, is what sets us apart from our competition and other immunotherapies. Pelareorep is the only double-stranded RNA immunotherapy being developed to treat cancer. This is important because of the immune response that double-stranded RNA creates within the human body. Pelareorep also evades neutralization in the blood by binding to immune cells and being carried to tumors through the RAS pathway. While other immunotherapies aim to stimulate the immune system from the outside, pelareorep works from within the tumor itself. It selectively targets and kills cancer cells while simultaneously turning ‘cold’ tumors ‘hot’ by creating an inflammatory environment that attracts and activates immune cells.”
“This dual mechanism – direct oncolysis plus immune activation – sets us apart from checkpoint inhibitors, CAR-T therapies, and other immunotherapy approaches. We’re not just releasing the brakes on the immune system; we’re actively recruiting it to the fight.”
“And perhaps most importantly, pelareorep targets primary and metastatic tumors. As clinical data has shown, pelareorep replicates within genetically disparate tumors, from breast cancer to melanoma to glioma to gastrointestinal tumors. This is critical in treating pancreatic or colorectal cancers because it is not the primary tumor that kills patients quickly in these indications, it’s the metastatic tumors in the liver and other vital organs. While other therapies target surface receptors or different components of primary tumors, such as ADCs that target a specific protein, pelareorep does not discriminate against tumors—it selectively infects all tumors that contain certain mutations, including the RAS mutation, and invites the immune system to do what it does best.”
Pelareorep
Can you briefly explain Oncolytics’ focus and your lead candidate, pelareorep’s, role in cancer therapy? Kelly noted:
“We are focused on leveraging our data in pancreatic, colorectal and anal cancers to build an immunotherapy platform in gastrointestinal tumors. We have data that exceeds current standards of care in each of these indications. That is incredibly rare.”
“Pelareorep has the unique ability to be combined with chemotherapy, checkpoint inhibitors and other approved therapies without adding additional toxicity while resulting in a survival benefit. What pelareorep can do is combine with the standard of care in many indications and add an immune response that results in cancer patients living longer lives. I believe combination therapy is the future of oncology and pelareorep combines with everything—and it does so safely and effectively.”
Upcoming Pivotal Trial
Why is the upcoming pivotal trial in first-line pancreatic cancer such an important milestone? Kelly pointed out:
“This upcoming pivotal trial represents a potential paradigm shift for first-line pancreatic cancer treatment. We would be the first immunotherapy approved in the $3 billion annual pancreatic cancer market and we might even be the only immunotherapy in a registration-enabled study in this indication. Each year, tens of thousands of patients are faced with a less than 10% chance of surviving two years after being diagnosed with metastatic pancreatic cancer. Pelareorep has consistently shown in over 100 patients across multiple studies that it more than doubles the odds to live two years after such diagnosis. Initiating a registration study in pancreatic cancer will give hope to patients suffering from this disease and will represent the culmination of nearly twenty years of research and millions of dollars toward the development of pelareorep.”
Challenges Faced
Have you faced any challenges in your work recently, and how did you overcome those challenges? Kelly acknowledged:
“Drug development is the single most difficult endeavor I have been involved with in my career. You have to maintain positive momentum and tell a consistent story to thousands of investors, analysts and other stakeholders on an individual basis. But at the same time you have to strategically plan clinical trials, maintain patent protection, ensure manufacturing and supply chain issues are addressed, and interact consistently with regulatory agencies in a smart and calculated manner. It is like running two businesses at the same time. One grounded in science and clinical data and the other centered around raising money and messaging a clear path to monetizing the product candidate. There is not one challenge I have faced—there are thousands. I overcome them by staying focused on the broader strategic goals and by finding satisfaction in solving the daily challenges.”
Changes Being Made
What changes are you making to speed up late-stage development and execution? Kelly emphasized:
“The most important change I am implementing is focusing the company’s resources on completing clinical studies that lead to approvals in our three gastrointestinal indications, pancreatic, colorectal and anal cancers. We no longer want to spend dollars and efforts on proof of concept studies. We have already proved pelareorep has a well understood safety profile in more than 1,200 patients and strong efficacy signals in three indications. Now we either need to get pelareorep approved on our own by raising the funds to complete registration-enabled studies or partner pelareorep out to a larger institution that can run these studies with its own resources. Obviously one of those options is more efficient and results in a better outcome for our shareholders and ultimately for patients.”
Strategic Partnerships
Do you see strategic partnerships playing a role in your growth plans? Kelly described:
“The top priority for small biotech companies developing oncology drugs is to either partner a product candidate out or sell the entire company to a large pharmaceutical company like Roche, Merck or J&J. If someone says otherwise, they are lying. Now there are historical examples like Celgene or Seagen or even current examples like RevMed who have decided to do it all themselves. And I salute them for that conviction and dedication. But almost every other company like Oncolytics with one or two product candidates and very interesting technology depends on investors who are willing to take huge risks to advance science and create medicines that will help humanity.”
“These investors need to see returns and liquidity events in order to continue to deploy capital. The entire system depends on it. And the best way to get liquidity is to sell or partner out product candidates to pharmaceutical companies with enough assets and resources to take those product candidates and monetize them. Small biotech companies are just not built to launch products and sell drugs and collect revenue over a 10-year horizon. They are built to develop and innovate. Our role in the system is to get new technology to the next stage of the development cycle—so a partnership or transaction with large pharma is key to ultimate success for us.”
Milestones
What milestones should investors and the biotech community watch for in this year? Kelly concluded:
“We are completely refocusing the company on achieving our mission to be the only gastrointestinal immunotherapy platform. This takes time because it requires us to organize our data, speak to regulators about our registrational path, and raise capital to execute the strategy. Over the next year, we will look to accomplish the following:
- Extend our patent protection to 2044;
- Obtain regulatory clarity on a single-arm registration enabled study in 2L and later squamous cell anal carcinoma where there is currently no approved therapy;
- Launch a controlled study in colorectal cancer to prove out the strong efficacy signal we saw in 2L RAS mutant CRC where we achieved 2-3X the efficacy endpoints; and
- Provide clinical updates from our ongoing GOBLET trial and interim readouts from the above trials.
To create value for its shareholders and attract attention from pharma partners, Oncolytics needs to show continuous progress in protecting its intellectual property, defining its regulatory pathway, and strategically developing its clinical programs. The company may have missed some opportunities in the past to achieve these milestones but we will not miss them again. I know our role in the system and what it takes to get to the next link of the development chain. I am here to execute.”
