FDA clears third IND for Kyverna’s CAR T-cell drug to treat systemic sclerosis
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The FDA has approved an investigational new drug application for Kyverna Therapeutics’ KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for diffuse cutaneous systemic sclerosis, according to a company press release.
The FDA decision marks the third IND clearance for KYV-101, following earlier authorizations for lupus nephritis and B cell-driven autoimmune diseases. Kyverna is now clear to pursue the therapy in its KYSA-5 trial, a phase 1/2, open-label multicenter trial of patients with scleroderma. Data from this trial will supplement the ongoing phase 1 KYSA-1 trial in the United States and the phase 1/2 KYSA-3 trial in Germany where KYV-101 is currently being investigated for patients with active lupus nephritis.
“We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” Kyverna Therapeutics CEO Peter Maag, PhD, said in the press release. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B-cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their overactive immune system.”
Kyverna’s announcement comes only days after the FDA cleared an IND for Cabaletta Bio’s CABA-201, another CD19-CAR T-cell investigational therapy, in patients SSc; both therapies are designed to deplete B cells to reduce the burden of disease activity in patients. In June, the FDA granted fast-track designation to KYV-101 for the treatment of refractory lupus nephritis.
“We welcome Kyverna’s enthusiasm and interest to push forward with their CAR-T approach in scleroderma patients with the KYSA-5 trial,” Luke Evnin, chairman of the Scleroderma Research Foundation, said in the release. “We await the results with optimism that CAR-T driven B-cell ablation may ultimately deliver efficacy with adequate safety for a broader range of our patients than immune-ablative chemotherapy alone.”
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