NKMax America Receives FDA Clearance to Amend its Current Phase I Monotherapy Trial to Include an Additional New Cohort of SNK01 + Checkpoint Inhibitor in Refractory Solid Tumors
SANTA ANA, Calif., Aug. 31, 2020 (GLOBE NEWSWIRE) -- NKMax America, a biotechnology company harnessing the power of the body's innate immune system through the development of Natural Killer (NK) cell therapies, today announced that the FDA has granted permission to amend its existing Phase I trial (NCT03941262) to add a new cohort of up to 18 patients to be treated with SNK01 in combination with either Pembrolizumab or Avelumab, two established checkpoint inhibitors.
Based on several compassionate use IND cases in individual patients that demonstrated safety and promising activity with a combination of SNK + Pembrolizumab, the U.S. FDA encouraged the Company to submit a protocol amendment to its ongoing monotherapy trial in refractory solid tumors rather than to file an entirely new IND.
This fourth cohort in the trial will include all tumor types refractory to conventional therapies regardless of their PD-L1 expression as well as those who have failed prior checkpoint inhibitor therapies. The primary outcome will be safety, with objective response rate as a secondary endpoint.
“We are extremely grateful to the U.S. FDA for its proactive guidance, vision, and support that has expedited patient enrollment to study this promising regimen,” said Paul Song, MD – Vice Chairman and Chief Medical Officer of NKMax America.
Patient enrollment will commence in September 2020.
About NKMax America
NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous and allogenic products which are all derived from peripheral blood. Our first in class autologous product, SNK-01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkmaxamerica.com.
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing