NKGen Biotech Inc (NASDAQ:NKGN) shares are trading higher Monday after the company's SNK01 NK Cell Therapy was cleared to begin a Phase 2 trial in Alzheimer's disease.
What To Know: NKGen announced that its Safety Review Committee cleared the company's cryopreserved autologous, expanded and enhanced SNK01 to progress into Phase 2 clinical development.
The Phase 1 study demonstrated that even after only four doses, SNK01 was very safe and able to cross the blood brain barrier to reduce amyloid, tau, and alpha-synuclein proteins as well as neuroinflammation in a dose responsive manner. 90% of patients demonstrated improvement or maintained stable cognitive function.
Based on the initial pilot experience, the clinical-stage biotechnology company received U.S. FDA clearance for a new Phase 1/2a study in moderate Alzheimer's disease using its new cryopreserved autologous product at an increased dose of 6 billion cells given every three weeks for a full year.
"We are excited to announce another important clinical milestone in our mission to advance SNK01 as the first potential disease modifying treatment of its kind for patients with more advanced Alzheimer's disease," said Paul Song, chairman and CEO of NKGen.
"The Phase 2 trial will utilize our cryopreserved SNK01 product given at the highest dose we have ever delivered, and for a full year duration. To date, SNK01 has been found to be well-tolerated with no reported drug-related adverse events."
The Phase 2 study will assess efficacy and further safety of SNK01 in a larger group of 30 patients with moderate Alzheimer's disease using a randomized, double-blind design. The trial is expected to provide deep insights into the potential benefits and risks of SNK01 in moderate Alzheimer's Disease, helping clinical researchers to provide validation of the potential therapeutic value of SNK01.
NKGN Price Action: NKGen shares were up 25.1% at $1.40 at the time of publication, according to Benzinga Pro.
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