FDA Clears IND for Kyverna Therapeutics’ Scleroderma Treatment
October 13, 2023
Source: drugdu
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KYV-101 designed as a CD19 CAR T-cell therapy.
Image Credit: Adobe Stock Images/Trsakaoe
Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma).
"We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma," said Peter Maag, PhD, CEO, Kyverna Therapeutics. "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."
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