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It’s a new challenge for you stepping into the role of CEO at Kyverna, but I understand CAR T-cell therapy is something you’re already familiar with.
I’ve been with Kyverna for about a month now, and it's an exciting time to join this company as it is poised for the next phase of growth. I’ve spent over 30 years in the industry, in both pharma and biotech in the U.S., Canada — where I started my career — and also the UK and Switzerland working across small- and large-scale organizations.
Most recently, I was at Kite Pharma, where I helped navigate the company through tremendous growth, particularly in CAR T-cell therapies for hematological conditions.
When I joined Kite over four years ago, there was a lot of excitement around CAR T, but many unanswered questions — would we deliver long-term remissions? Could we scale to treat thousands of patients? Could we build a sustainable, profitable operation?
Fast forward to today, and the answers are resoundingly positive. That gives me the confidence to take on this role at Kyverna, working in the autoimmune space, which is earlier in its development, but with the potential to be just as impactful and transformative for patients and the field of medicine.
One thing we always say is that CAR T therapy is a team sport. You need cross-functional input from internal teams and external stakeholders, whether they’re clinicians, opinion leaders, or patients. I am really excited about the people I am meeting and the team we have here at Kyverna. This is truly a team of pioneers and the opportunity in CAR T for autoimmune diseases is massive. We are building something entirely new, and I’m really energized to see where we can take the company.
Could we delve into the scientific side a bit more? How does Kyverna’s pipeline work - what sets it apart?
What’s exciting is what we’ve learned from earlier CAR T constructs. Our lead candidate product, KYV-101, was specifically designed for deep B-cell depletion and an improved safety profile, with the potential to reset the immune system and provide long-lasting remissions for autoimmune patients, and easier administration. We have a robust clinical program underway with multiple ongoing clinical trials for KYV-101, and our data to date highlight these advantages.
We’ve made significant progress in neuroinflammation. We presented some very encouraging early clinical data at the ECTRIMS conference in Copenhagen recently, focusing on diseases like Stiff-Person Syndrome (SPS). SPS is rare but incredibly devastating for patients and is progressively debilitating over time.
We’re seeing transformative early results in SPS. Patients who were so debilitated by their disease, bedridden and couldn’t walk, are now walking five kilometers within six to eight months of starting therapy. These are remarkable outcomes; they remind me of the life-changing early data we saw with CAR T in hematology.
In addition to SPS, we are studying KYV-101 in other neuroinflammatory and rheumatologic conditions. We have Phase 2 clinical trials in progressive multiple sclerosis and in refractory myasthenia gravis. We are currently conducting Phase 1 clinical trials in lupus nephritis and in systemic sclerosis. There’s a massive unmet need in many autoimmune diseases. Currently approved treatments often show modest effects and require chronic administration, often in the setting of concomitant immunosuppressant use.
There are often worries around the cost of CAR T therapies. What’s the scope for reducing the cost of these treatments?
I think it’s crucial to highlight the cost-effectiveness of CAR T. Bodies like ICER in the US and NICE in the UK have evaluated CAR T-cell therapies and found them to be very cost-effective, especially when you consider the long-term benefits for patients.
CAR T is a one-time therapy. Payers are still adjusting to the idea of paying upfront for a treatment that could provide long-term remission. But when you look at the data, these therapies offer incredible value for money – not only to patients but also to public health and healthcare systems.
We are always looking at ways to bring costs down. As we continue to scale manufacturing and shift towards more automated processes, we believe costs will fall.
Particularly with JP Morgan Week nearing, there seems a lot of focus on cell and gene therapy. Why is the sector gaining so much traction?
The success of CAR T companies in the hematology space has shown that CAR T can be scalable, profitable, and truly transformative for patients. The early data coming out of the autoimmune space is incredibly promising.
We’re not just seeing incremental improvements for patients; we’re seeing transformative changes. Combine that with the scope of this opportunity in autoimmune diseases, with over 80 B cell-driven conditions that could benefit from CAR T, and you have a field that’s poised for exponential growth.
2025 is going to be a pivotal year for us. We are focused on maintaining our leadership position in this space and building on KYV-101’s differentiated profile; and as we hone our focus on initial indications, ultimately, we believe KYV-101 can be beneficial in other autoimmune diseases.
Our priorities are clear: continue enrolling patients in our clinical trials, focus on executing those trials to generate readouts, and scale our organization to support future growth.
The commercialization strategy revolves around two key areas: building a strong value proposition for KYV-101 and scaling the logistics of delivering the therapy to patients. We need to demonstrate to payers and physicians that KYV-101 is differentiated from other therapies and provides substantial value for patients. Focusing on these areas will ensure that longer-term, we are building an organization that is capable of meeting the demand for the tens of thousands of patients that are waiting. It’s a challenging process, but I’ve been through it before, and I’m confident we are heading in the right direction here at Kyverna.
Are there any broader trends or developments in the industry that you think we should be watching closely?
I’m particularly excited about the increased capacity for CAR T treatment in both academic centers and community settings. This is paving the way for the broader adoption of CAR T therapies, which will be crucial as more products come to market.
I’m also keeping a close eye on the growing number of tools available to conduct and analyze deep molecular profiling of the immune system and the potential of identifying the right patients for CAR T therapies. We have a robust biomarker program through which we are generating very large amounts of data associated with our clinical trials. Analyses of these data may provide insights that predict responders vs non-responders and reduce adverse events. Advanced data analytics has the potential to revolutionize how we design clinical trials and treat patients, and I think we’re just scratching the surface of what’s possible.
