NK Max, a local pharmaceutical company, said Tuesday that it has applied for a phase 1 clinical trial of its “Super Natural Killer (NK)” immunotherapy to the U.S. Food and Drug Administration.
NK Max's Super NK is a 99-percent pure immune cell treatment that overcomes the limitations of existing treatments by growing 10,000 to up to 1 billion times faster.
The company plans to confirm the safety of Super NK as a monotherapy to patients with solid cancer. “Super NK showed no problems in Japan where it is currently being administered directly to patients,” a company official said. “Therefore, we expect that there will also be no problem in the U.S. clinical trials.”
To accelerate its test in the U.S., the company recruited Dr. Pearl Fang as the head of clinical development in September. Feng was the head of clinical development at ARMO Bioscience, a Silicon Valley-based immunotherapy company.
The company also hired Dr. Kenneth L. Berger, an FDA expert with 40 years’ experience in the clinical practice of many biotech companies and good manufacturing practice (GMP) tasks, to prepare for the FDA approval.
“To advance to the U.S., the company has completed the purchase of a GMP factory and land for a headquarter in the States,” Fang said. “With the help of various experts, the company plans to complete the trial on solid cancers.”