Kyverna Therapeutics is taking a historic first step in approving a CAR-T therapy for an autoimmune disease. And now we’re getting closer to the finish line and trying to make even more commercial impact.
The California-based biotech company has hired Omeros and AbbVie alumnus Nadia Duck as its new chief commercial officer, who will “lead commercial strategy and execution for miv-cel (mivocabtagene autoreucel),” according to a May 4 statement.
The therapy recently produced positive results in a registration trial for stiff person syndrome (SPS), putting it on track to become the first CAR-T therapy approved for an autoimmune disease, after years of success in blood cancers.
The drug produced positive results across all primary, secondary and exploratory endpoints, according to a detailed analysis presented last month at the American Academy of Neurology’s annual meeting.
This could be a boon for patient populations without FDA-approved treatment options. SPS is a rare, progressive neurological autoimmune disease characterized by muscle stiffness and painful spasms that impair mobility and walking.
An estimated 6,000 people in the United States have been diagnosed with SPS, and the disease recently received widespread attention after singer Celine Dion announced that she had been diagnosed with SPS.
At AAN, Kaibana said his treatment was the first in clinical trials of any treatment to improve symptoms and reverse the course of SPS through what was described as a deep immune reset.
Perhaps the biggest uncertainty remaining with miv-cel lies with the FDA. Specifically, whether the FDA will accept the results of an open-label trial without a control group as sufficient evidence.
Kyvana CEO Warner Biddle said in an interview with Fierce Biotech last month: “This is a rare disease for which there is no approved treatment, and I think the FDA is very aware of that (and) very aware of how transformative this data is.”
“And on behalf of everyone, there is a sense of urgency to get this to patients as quickly as possible.”
Kyvana said it plans to submit a biologics license application to the FDA, initially for SPS, in the first half of 2026. Dac brings a wealth of experience as the company prepares for potential commercialization.
She most recently served as CCO at Omeros, where she built and led the commercial organization of rare disease programs in hematologic and immune-mediated diseases, including the launch of Yartemlea for thrombotic microangiopathy associated with hematopoietic stem cell transplantation.
She also held sales positions at Alder, Novartis, AbbVie, and Auxilium Pharmaceuticals.
“I’m excited to welcome Nadia to the Kyvana team at this pivotal time in our transition to a commercial stage organization,” Biddle said in a release.
“We are laying the foundation for a leading multi-indication neuroimmunology franchise as we advance miv-cel towards potential first approval in stiff person syndrome.”
The effort also includes “building and expanding our commercial organization and driving long-term growth,” Biddle said.
Kyverna is also promoting miv-cel in other autoimmune diseases. AAN confirmed a 100% response rate in generalized myasthenia gravis based on a preliminary interim analysis of six patients.
This number comes from a follow-up analysis of the Phase 2 portion of the Phase 2/3 KYSA-6 trial, which enrolled one additional patient.
The company is also evaluating miv-cel in multiple sclerosis, lupus nephritis, and systemic sclerosis.
