NKGen Biotech (NASDAQ: NKGN) stock soared over 50% in intraday trading Monday following an update on its Phase 2 clinical trial.
NKGen Biotech (NKGN) has announced that its Safety Review Committee has given the green light for the company’s investigational treatment, SNK01, to progress into Phase 2 clinical development. This milestone follows promising results from the Phase 1 clinical trial, demonstrating the safety and potential efficacy of SNK01.
The Phase 1 study revealed that after only four doses, SNK01 was very safe and capable of crossing the blood-brain barrier. The treatment showed a dose-responsive reduction in amyloid, tau, and alpha-synuclein proteins and decreased neuroinflammation. Impressively, 90% of the patients in the trial showed improvement or maintained stable cognitive function.
Building on these encouraging findings, NKGen Biotech received U.S. FDA clearance to initiate a new Phase 1/2a study. This study will focus on moderate Alzheimer’s disease, using a new cryopreserved autologous version of SNK01 administered at an increased dose of 6 billion cells every three weeks for a year.
Management Commentary
Paul Song, chairman and CEO of NKGen Biotech, expressed enthusiasm about this progress, 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.”
He further emphasized that the Phase 2 trial will utilize the highest dose of cryopreserved SNK01 given to date, for a year-long duration. To date, SNK01 has been well-tolerated with no reported drug-related adverse events.
The Phase 2 study will evaluate the efficacy and further safety of SNK01 in a larger group of 30 patients with moderate Alzheimer’s disease through a randomized, double-blind design. This trial aims to provide substantial insights into the potential benefits and risks of SNK01, aiding in validating its therapeutic value for moderate Alzheimer’s disease.
NKGen Biotech (NASDAQ: NKGN) Stock Reaction
NKGN stock surged 52.68% on Monday, closing at $1.71. This marks a 37.90% increase over the week. Trading volume soared to 33,434,920 (33.43 million) shares, significantly higher than the average daily volume of 4.13 million.
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