The fast track status follows the recent Investigational New Drug (IND) clearance for the candidate for use in the company’s KYSA-7 Phase 2 open-label, multicentre study
A micrograph of a demyelinated lesion caused by multiple sclerosis. (Credit: Marvin 101 from Wikimedia Commons)
Kyverna Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for KYV-101 to treat patients with refractory progressive multiple sclerosis (MS).
KYV-101 is an autologous, fully human chimeric antigen receptor (CAR) T-cell product candidate. It is designed for use in B cell-driven autoimmune diseases.
In CAR T-cell therapy, a patient’s T cells are altered to identify and eliminate B cells from their body.
KYV-101 focuses on the protein CD19, which is expressed on the surface of B cells and linked to several autoimmune disorders.
Kyverna intends to build a strong pipeline of viable product candidates and pursue further exploration of indications for KYV-101 to meet unmet medical needs in autoimmune illnesses.
The fast-track status follows the recent Investigational New Drug (IND) clearance for the candidate for use in the company’s KYSA-7 Phase 2 open-label, multicentre study.
Kyverna CEO Peter Maag said: “We appreciate the FDA’s support to accelerate the development of potentially life-changing CAR T-cell therapies that could greatly benefit patients living with severe and debilitating neurological autoimmune diseases.
“This marks another important milestone in our endeavour to change the treatment paradigm with KYV-101.”
The National Institutes of Health (NIH) created the CAR in KYV-101 to increase tolerability, and it was evaluated in a Phase 1 oncology trial including 20 patients.
Kyverna Therapeutics is presently conducting two multi-centre, open-label Phase 1 trial of KYV-101 in patients with lupus nephritis. Both studies are currently ongoing in the US and Germany.
The biopharmaceutical company also has plans to conduct more KYV-101 clinical trials for multiple sclerosis, myasthenia gravis, and systemic sclerosis.
Kyverna offers next-generation autologous and allogeneic chimeric antigen receptor (CAR) T-cell therapies to treat autoimmune disorders caused by B cells.