IRVINE, Calif. /PRNewswire/ -- NKMax America, a biotechnology company harnessing the power of the body's immune system through the development of Natural Killer (NK) cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for SNK01, an autologous NK cell adoptive immunotherapy candidate for the treatment of patients with pathologically confirmed cancer refractory to conventional therapy.
"We are very pleased to receive our first US IND approval to begin clinical trials in refractory cancer patients," said Paul Song, MD, CMO and CCO of NKMax America. "While we collect our initial toxicity data, we are also preparing to submit additional IND applications for combination therapy in cancer as well as for several other non-cancerous diseases."
"Our innovative autologous NK cell technology allows us to expand NK cells from cancer patients," said Amber Kaplan, PhD, CSO of NKMax America. "We are looking forward to advancing the program further into clinical trials."
SNK01 is an autologous therapy that is manufactured by harvesting a small number of a patient's immune cells. After harvesting, the NK cells are separated from the blood, purified, activated, and expanded in our cGMP facility. The activated NK cells are then injected back into the patient to fight against the cancer.
The IND approval allows NKMax America to initiate Phase I clinical trials to assess the safety and tolerability of SNK01 in adults with pathologically confirmed cancer refractory to conventional therapy.