Business
Nkarta Receives U.S. FDA Orphan Drug Designation for NKX101 for Treatment of Patients with AML
SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered
About this update from Nkarta, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to NKX101 for treatment of acute myeloid leukemia (AML). NKX101 is a novel investigational NK cell therapy, engineered to augment the innate anti-tumor biology of NKG2D. NKG2D is an activating receptor found on naturally occurring NK cells that triggers the targeted killing of stressed and cancerous cells. AML is a blood cancer that disrupts the production of normal blood cells in the bone marrow. In patients with AML, the five-year survival rate is 26%. While frontline therapy induces remission, most patients will relapse within 3 years. No standard of care is currently available for patients with relapsed/refractory (r/r) AML. These patients may be treated with various chemotherapeutic approaches, all of which have poor results. Clinical trials have resulted in complete response rates of 12% to 18% and a 3 to 9 month median overall survival in this challenging population. “This orphan drug designation acknowledges the urgent need for new treatment options for patients with AML,” said Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. “At Nkarta, we are committed to advancing our NK cell therapy platform to develop ground-breaking treatment options for cancer, and we look forward to working with the leukemia community and the FDA to deliver the unique benefits of off-the-shelf cell therapy to AML patients.” NKX101 is currently being studied in a first-in-human Phase 1 clinical trial in adults with r/r AML or myelodysplastic syndrome (MDS). As previously announced, Nkarta expects to announce initial data from the NKX101 clinical trial in the first half of 2022. The FDA grants ODD to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. ODD may qualify the company developing the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. About NKX101 NKX101 is an investigational, off-the-sh...