Biotechnology Company Receives Clearance For Alzheimer's Treatment Development
NKGen Biotech's SNK01 NK Cell Therapy Cleared to Start Phase 2 Clinical Trial in Alzheimer's Disease.
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NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on developing and commercializing innovative autologous, allogeneic, and CAR-NK natural killer (“NK”) cell therapeutics, has announced a significant milestone. The company's cryopreserved autologous enhanced SNK01 NK cell therapy has received clearance from its Safety Review Committee to progress into Phase 2 clinical development for treating Alzheimer's disease.
The Journey Through Phase 1 Trials
The journey of SNK01 began with an initial "proof of concept" Phase 1 study, which was an open-label, 3+3 dose escalation study. This initial study aimed to test the safety and preliminary efficacy of SNK01 in patients with moderate Alzheimer’s Disease. The study involved administering four doses of SNK01 (1, 2, or 4 billion cells) intravenously to patients. The results were promising. Even after only four doses, SNK01 was found to be very safe and capable of crossing the blood-brain barrier. It demonstrated a reduction in amyloid, tau, and alpha-synuclein proteins, as well as neuroinflammation, in a dose-responsive manner. Remarkably, 90% of patients (with a median MMSE score of 14) showed improvement or maintained stable cognitive function according to the Alzheimer's Disease Composite Score (ADCOMS). Following these encouraging results, NKGen received US FDA clearance for a new Phase 1/2a study in moderate Alzheimer’s disease. This new study uses a cryopreserved autologous product at an increased dose of 6 billion cells given every three weeks over a full year, compared to just four total doses in the initial proof-of-concept study. The Phase 1 portion of this trial enrolled three patients to examine the safety of the higher 6 billion cell dose. In this phase, SNK01 was well-tolerated without any drug-related adverse effects.
After a meticulous review of the Phase 1 data by a predominantly independent Safety Review Committee, SNK01 has been cleared by an Internal Review Board (IRB) to advance into Phase 2. This critical stage will assess both the efficacy and further safety of SNK01 in a larger cohort of 30 patients with moderate Alzheimer’s disease. Using a randomized, double-blind design, 20 patients will receive SNK01 while 10 will receive a placebo. The Phase 2 trial is designed to provide comprehensive insights into the potential benefits and risks of SNK01 in moderate Alzheimer’s Disease, ultimately validating its therapeutic value. Dr. Paul Y. Song, Chairman and CEO of NKGen, expressed his enthusiasm for this milestone, stating, “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. 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 well-tolerated with no reported drug-related adverse events. We are also very encouraged with the clinical progress we have made to date in moderate Alzheimer’s disease research and look forward to generating additional significant clinical and biomarker data from our randomized placebo-controlled Phase 2 trial.” Dr. Jesse Carr, MD, Medical Director of Behavioral Research Specialists, LLC, who is independently overseeing the trial site, added, “I am encouraged by the continued promise of NKGen’s SNK01 NK cell therapy in a difficult-to-treat disease such as Alzheimer’s. The advancements we are making could pave the way for a significant breakthrough in the treatment of this debilitating condition.” Natural Killer (NK) cells are a type of lymphocyte that play a crucial role in the body's immune response. They have the ability to target and destroy infected or cancerous cells without the need for prior sensitization. In the context of Alzheimer’s disease, NK cells can potentially reduce neuroinflammation and clear pathological proteins like amyloid, tau, and alpha-synuclein, which are hallmarks of the disease. SNK01 is a cryopreserved, autologous enhanced NK cell therapy. Unlike traditional therapies, it uses a patient’s own NK cells, which are harvested, expanded, and activated outside the body before being reintroduced. This method ensures that the therapy is both personalized and potent. The initial Phase 1 trials have set a solid foundation for the future of SNK01. The absence of drug-related adverse events and the ability of SNK01 to cross the blood-brain barrier and reduce pathological proteins are significant achievements. These findings not only demonstrate the safety of SNK01 but also indicate its potential efficacy as a treatment for Alzheimer’s disease. With the commencement of the Phase 2 trials, NKGen aims to build on these preliminary successes.
The larger sample size and extended treatment duration will provide a more comprehensive understanding of the therapy's long-term effects and its potential to modify the course of Alzheimer’s disease.
The Road Ahead
As NKGen advances into Phase 2, the company remains committed to its mission of developing innovative NK cell therapies. The upcoming trials will be critical in determining the therapeutic value of SNK01 and its potential to become a groundbreaking treatment for Alzheimer's disease. The biotechnology community and stakeholders alike are eagerly watching the progress of these trials. A successful outcome could revolutionize the treatment landscape for Alzheimer’s disease, offering hope to millions of patients and their families.
NKGen Biotech's SNK01 NK cell therapy represents a promising frontier in the fight against Alzheimer’s disease. With the initiation of Phase 2 clinical trials, the company is on the cusp of potentially delivering a transformative treatment for this challenging condition. As research progresses, the medical community remains hopeful that SNK01 will bring a much-needed breakthrough in Alzheimer’s treatment.
Disclaimer: This article is for informational purposes only and should not be considered medical advice. The efficacy and safety of SNK01 will be determined through ongoing clinical trials. Always consult with a healthcare professional for medical advice and treatment options.