FDA grants clearance lupus nephritis therapy trial
The US Food and Drug Administration (FDA) has granted clearance for Kyverna Therapeutics’ Investigational New Drug (IND) application to commence a Phase I clinical trial of KYV-101 to treat lupus nephritis (LN).
The latest development comes after the company submitted the application in October this year.
Anticipated to begin early next year, the trial will assess KYV-101’s safety and its initial effect on disease activity.
A new clinical-stage therapy, KYV-101 is an autologous form of a new fully human anti-CD19 chimeric antigen receptor T-cell (CAR T) construct.
It has properties suitable for usage in B cell-driven autoimmune ailments such as LN, inflammatory myopathies, and systemic sclerosis.
The company acquired exclusive, global licences from the US National Institutes of Health (NIH) for using the CD19 construct in autologous as well as allogeneic CAR T-cell therapies.
Kyverna Therapeutics CEO Peter Maag said: “We are pleased with the FDA’s clearance of our IND application for our lead candidate KY-101 in lupus nephritis.
“We look forward to working with investigators to initiate our Phase I clinical trial in early 2023 and to continue our commitment to bringing novel treatment options to this vulnerable patient population living with this devastating disease.”
LN is a serious systemic lupus erythematosus complication.
Up to 10% and 40% of individuals with LN and diffuse LN (class IV), respectively, experience kidney failure that needs dialysis or a kidney transplant.