NKGen Biotech’s SNK01 NK Cell Therapy Cleared to Start Phase 2

NKGen Biotech ( NKGN ), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer (NK) cell therapeutics, has announced that its Safety Review Committee has cleared the company's cryopreserved autologous, expanded, and enhanced SNK01 to progress into Phase 2 clinical development. The Phase 2 study will assess the 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 initial "proof of concept" Phase 1 study demonstrated that even after only four doses (1, 2, or 4 billion cells) given simple IV, SNK01 was very safe and able to cross the blood brain barrier to reduce amyloid, tau, alpha-synuclein proteins as well as neuroinflammation in a dose responsive manner. Despite only receiving four doses, 90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer's disease composite score (“ADCOMS”). Based on this initial pilot experience, NKGen received US 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 compared to only four total doses in the initial proof-of-concept study.

After careful review of the Phase 1 data by a majority independent Safety Review Committee, SNK01 has been cleared by an Internal Review Board (“IRB”) to enter into the Phase 2 portion of the clinical trial. This pivotal stage will assess the efficacy and further safety of SNK01 in a larger group of 30 patients with moderate Alzheimer's disease using a randomized, double-blind design (20 to receive SNK01, 10 to receive placebo). The Phase 2 trial will 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.

NKGen ( NKGN ) also announced yet another important clinical milestone in their mission to advance SNK01 as the first potential disease-modifying treatment of its kind for patients with more advanced Alzheimer's disease. The Phase 2 trial will utilize the company's cryopreserved SNK01 product given at the highest dose they have ever delivered and for a full year duration. To date, SNK01 is well-tolerated with no reported drug-related adverse events.

NKGen shares were up 22.32% at $1.37 at the time of writing with its Relative Strength Index (RSI) of 50.23. Since reaching a 5-month high of $4.05 (the highest since the start of 2024), the stock has plummeted, reaching new lows before resurging to $1.38 today.