ElevateBio will be the primary source of Kyverna’s autologous CAR-T cell therapy for anticipated U.S. and global launches in autoimmune indications.
Kyverna Therapeutics has formed a manufacturing agreement with ElevateBio to support launches of its CAR-T cell therapy in autoimmune diseases.
In May, Kyverna began a rolling submission for approval of an autologous, CD19-targeting CAR-T cell therapy with CD28 co-stimulation in a rare autoimmune neurological disorder called stiff person syndrome (SPS). The biotech expects to complete the filing in the fourth quarter. Kyverna is also running a Phase 3 trial of the drug candidate, mivocabtagene autoleucel (miv-cel), in generalized myasthenia gravis (gMG).
With launches in two indications planned, the biotech has struck a clinical and commercial supply deal with ElevateBio, a Massachusetts-based contract development and manufacturing organization (CDMO). Under the five-year agreement, Kyverna has agreed to “order at least certain minimum quantities” of the cell therapy “in certain calendar years” or following regulatory approval.
In a note to investors, William Blair analysts said they are “encouraged” by Kyverna’s deal with ElevateBio and “believe management is already enacting key elements to ensure a successful commercial launch in SPS in 2027.” The agreement will “provide the company with flexible and scalable supply” to support U.S. and global launches in SPS and gMG, as well as ongoing clinical studies, the analysts wrote Monday.
The deal replaces the development and manufacturing services agreement that Kyverna entered into with ElevateBio in July 2023. Kyverna’s work with ElevateBio for the past three years “has increased management’s confidence in their partnership and capabilities to support a successful FDA inspection,” the analysts said.
Problems discovered during preapproval inspections have led the FDA to reject multiple filings in recent years, including a series of complete response letters tied to Novo Nordisk’s ex-Catalent plant in Indiana. Kyverna is working closely with ElevateBio to prepare for an FDA visit, the analysts said, and recently completed a successful mock facility inspection with its manufacturing partner.
The deal is a win for ElevateBio, which began working with Kyverna one year after the biotech struck a cell manufacturing, release and testing services agreement with Minaris Advanced Therapies. Kyverna is currently working with two CDMOs to produce miv-cel, but ElevateBio will be the primary source for the commercial launch, the analysts said.
ElevateBio has achieved a clinical manufacturing success rate of more than 98% for miv-cel and has shown its ability to scale production, Kyverna said. The CDMO’s clinical and commercial manufacturing facilities are certified under the Initiative for Certification of Manufacturing Capabilities, a Dark Horse Consulting program that assesses plants ahead of preapproval inspections.
