While Kyverna awaits an FDA decision on whether to grant the first-ever approval for an autoimmune CAR-T therapy, the biotech has halted work on a next-gen follow-up.
The autologous CD19 CAR-T, dubbed KYV-102, had been in development for autoimmune diseases. KYV-102 was produced using Kyverna’s whole-blood, rapid manufacturing process and incorporated the same construct as the company's lead autologous CAR-T, mivocabtagene autoleucel (miv-cel).
The biotech had previously touted KYV-102 as an opportunity to expand the patient reach of its pipeline by removing the need for apheresis, a process in which a patient's blood is collected and T cells are separated for engineering before being returned to the patient's body.
The original plan had been for Kyverna to seek permission from the FDA in the fourth quarter of 2025 to take KYV-102 into the clinic. The FDA subsequently cleared the program to enter clinical testing in January 2026, but the company has since gone quiet on the asset.
In its third-quarter earnings results Thursday, Kyverna explained that it had now “elected to deprioritize its KYV-102 program as the company continues to focus on accelerating its late-stage neurologic indications with miv-cel.”
Fierce Biotech has reached out to Kyverna for clarification on the status of the KYV-102 program.
“The company will continue to advance lifecycle management activities for miv-cel to broaden access for patients and lower costs,” Kyverna added in the release.
Kyverna recently completed its FDA approval application for miv-cel in stiff person syndrome, requesting priority review as it prepares for a potential commercial launch in 2027.
These preparations have included “targeted site activation engagements with CAR-T experts, neurologists and payers, and building an integrated patient support and reimbursement network to streamline the treatment journey,” Kyverna explained in Thursday morning’s release.
If approved, CD19-targeted miv-cel would become the first CAR-T therapy approved for an autoimmune disease.
The company is also exploring miv-cel in generalized myasthenia gravis, with long-term phase 2 data released in September and enrollment in an ongoing phase 3 trial expected to wrap up in mid-2027. Updated data from a phase 1 study in progressive multiple sclerosis were also presented in October.
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