NKMAX Receives US FDA Compassionate Use Approval for Alzheimer's Cell Therapy

[Asia Economy Reporter Kim Young-won] NKMAX's subsidiary NKGEN Biotech announced on the 2nd that its NK cell therapy 'SNK01' has received 'compassionate use approval' from the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's patients.

The compassionate use approval system allows medical authorities to provide investigational new drugs before market approval to patients who have no other available treatment options and are at the point of giving up treatment.

Following this approval, NKGEN Biotech plans to administer SNK01 to a patient at St. Francis Hospital in New York, USA.

Unlike existing therapies designed to remove target proteins such as amyloid beta, SNK01 fundamentally improves the brain environment through immune modulation functions, the company explained. Currently, a Phase 1 clinical trial for Alzheimer's patients is underway in Mexico.

According to interim results released by NKMAX, administration of SNK01 to six Alzheimer's patients showed no side effects or toxic reactions, proving safety as the primary evaluation indicator, and in five efficacy evaluation indicators, five patients showed halted disease progression.

Park Sang-woo, CEO of NKMAX, said, "In a situation where no domestic company has ever received compassionate use approval for Alzheimer's in the U.S. and administered cell therapy, the potential of SNK has been verified. We will strive to become a company that can offer hope to brain disease patients worldwide by actively advancing treatments for Alzheimer's, Parkinson's, and autism patients with SNK, as well as cancer."

This content was produced with the assistance of AI translation services.