Kyverna Therapeutics is on the cusp of a historic first: getting a CAR-T therapy approved for an autoimmune disease—and now it’s looking to boost its commercial chops as it nears the finish line.
The California-based biotech has hired Omeros and AbbVie alum Nadia Dac as its new chief commercial officer, where she will “lead commercial strategy and execution for miv-cel [mivocabtagene autoleucel],” according to a May 4 statement.
The therapy recently posted positive results in a registrational trial in 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.
According to detailed analyses presented last month at the American Academy of Neurology annual meeting, the drug delivered positive results across all primary, secondary and exploratory endpoints.
That could be a boon for a patient population with no FDA-approved treatment options. SPS is a rare, progressive neurologic autoimmune disease characterized by muscle stiffness and painful spasms that impair mobility and gait.
An estimated 6,000 patients are diagnosed with SPS in the U.S., and the disease recently gained wider attention after singer Celine Dion said she had been diagnosed with the condition.
At AAN, Kyverna said its therapy, for the first time in a clinical trial of any treatment, improved symptoms and reversed the course of SPS, enabled by what it described as a deep immune reset.
Perhaps the biggest remaining uncertainty for miv-cel lies with the FDA—specifically, whether the agency will accept results from an open-label study without a control arm as sufficient evidence.
Speaking to Fierce Biotech last month, Kyverna CEO Warner Biddle said: “This is a rare disease with no approved therapies, and I think the FDA is very well aware of that, [and] very well aware of how transformative this data is as well.
“And there’s a sense of urgency, I think, on behalf of everybody, to get this to patients as quickly as possible.”
Kyverna said it plans to submit a biologics license application to the FDA in the first half of 2026, initially for SPS. Dac brings deep experience as the company prepares for a potential commercial launch.
She most recently served as CCO at Omeros, where she built and led the commercial organization for rare disease programs in hematologic and immune-mediated conditions, including the launch of Yartemlea for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
She has also held commercial roles at Alder, Novartis, AbbVie and Auxilium Pharmaceuticals.
“We are thrilled to welcome Nadia to the Kyverna team at this pivotal time of transitioning to a commercial-stage organization,” Biddle said in the release.
“As we advance miv-cel toward a potential first approval in stiff person syndrome, we are laying the foundation for a leading, multi-indication neuroimmunology franchise.”
That effort will also include “building and scaling our commercial organization and driving long-term growth,” Biddle said.
Kyverna is also advancing miv-cel in other autoimmune conditions. Building on a prior interim analysis of six patients, the company at AAN confirmed a 100% response rate in generalized myasthenia gravis.
The figure comes from a follow-up analysis of the phase 2 portion of the phase 2/3 KYSA-6 trial, with one additional patient enrolled.
The biotech is also evaluating miv-cel in multiple sclerosis, lupus nephritis and systemic sclerosis.