Nkarta Receives IND Approval for Lupus Therapeutic; Shares Soar 112%
Biopharmaceutical company, Nkarta (Nasdaq: NKTX) has received FDA clearance for its Investigational New Drug (IND) application to evaluate NKX019 for the treatment of lupus nephritis (LN). Nkarta’s study is designed to evaluate up to 12 patients, with the first patient expected to be enrolled in the first half of 2024. The company’s share price surged 112% following the news.
David R. Shook, M.D., Chief Medical Officer of Nkarta, said, “Patients with severe autoimmune diseases such as lupus nephritis need safe and novel therapies. We will continue to work closely with leading investigators to bring the promise of cell therapy to patients in need to explore this potentially transformative therapeutic approach.”
Nkarta’s multi-center, open label, dose escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory LN.
LN is a serious autoimmune disease characterized by abnormal B cell function and autoantibody production and results in a range of clinical manifestations including organ damage and an increased risk of death.
Patients with LN have limited treatment options and up to 30 percent of patients progress to end stage kidney disease, which can be fatal unless dialysis or a kidney transplant is received.
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.