NKMAX said on Thursday that it has received FDA approval for its natural killer (NK) cell therapy SNK01 to treat Parkinson's disease under the Expanded Access Program (EAP).

This makes NKMAX the first Korean biotech company to administer NK cell therapy to Parkinson's patients with compassionate use from the U.S. Food and Drug Administration (FDA).

The EAP is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical treatment outside of clinical trials when there are no satisfactory alternative therapy options.

Accordingly, the patient will be treated for Parkinson's disease with SNK01, by Dr. Rus Shimizu of the Sarcoma Oncology Center in California, the U.S.

Parkinson's disease is known to be caused by the accumulation of alpha-synuclein, an abnormal protein in the brain, and chronic nerve inflammation. Existing Parkinson's disease treatments only relieve symptoms, but there are no drugs that address the fundamental cause.

SNK01 can cross the blood-brain barrier (BBB) thanks to its high CX3CR1 receptor expression after culture and can recognize and eliminate autoreactive T cells that cause neuroinflammation through DNAM-1 receptor. 

In addition, a large amount of interferon-gamma is secreted to activate microglia to sterilize alpha-synuclein and remove damaged nerve cells.

Unlike conventional antibody therapies that focus only on protein elimination, SNK01 improves the overall environment in the brain, including protein accumulation, nerve inflammation, and removal of damaged neurons, the company explains.

"The patient who will be treated for Parkinson's disease this time was desperately hoping to administer SNK01 because various treatments were carried out but were ineffective," said an official from NKMAX. "The American patient will travel to the hospital on a private plane every three weeks to receive SNK01 which is expected to address the underlying cause of Parkinson's disease."

The company said it would supply the EAP NK cell therapy for the patient for free, in exchange for getting the patient's data.