NKGen Biotech Inc - NKGN STOCK NEWS

NKGen Biotech (OTC: NKGN) presented updated Phase 1 clinical data for troculeucel, their NK cell therapy for moderate Alzheimer's disease (AD), at AD/PD™ 2025. The trial administered the highest dose of 6 billion cells every three weeks to three patients with moderate AD.

Key findings after 12 months: Two patients completed all 17 doses, showing improvement from moderate to mild AD within 3 months. One patient achieved a CDR-SB score of 4.5, near the mild cognitive impairment threshold. No drug-related adverse reactions were reported. All patients showed decreased GFAP levels in CSF and plasma at 6 months, while the two completing patients demonstrated improved Amyloid Beta 42/40 ratios at 12 months.

The company is now proceeding with the randomized, placebo-controlled Phase 2a portion of the study, expecting significant cognitive and biomarker differences between treatment and placebo groups within 6 months.

NKGen Biotech (OTC: NKGN) has announced its upcoming presentation at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™ 2025), scheduled for April 1-5, 2025, in Vienna, Austria. The event will also be available online.

Dr. Paul Y. Song, Chairman and CEO of NKGen, will present updated data from their Phase 1/2a clinical trial of troculeucel NK cell therapy for moderate Alzheimer's disease. The presentation will cover three-month cognitive and biomarker results from the Phase 1 cohort, along with new six-month analysis data.

AD/PD™ 2025 is a leading international conference that gathered over 4,700 participants from 70+ countries and featured 2,250 abstracts in 2024. The conference serves as a platform for experts to share the latest developments in Alzheimer's and Parkinson's research, clinical trials, and treatments.

NKGen Biotech (OTC: NKGN) announced its participation in the 13th Annual Alzheimer's & Parkinson's Drug Development Summit in Boston from March 18-20, 2025. Chairman and CEO Paul Y. Song will present on troculeucel, the company's autologous, non-genetically modified NK cell therapy for neurodegenerative diseases.

The presentation will focus on troculeucel's mechanism and promising Phase 1 clinical trial results, which led to FDA Fast Track designation for moderate Alzheimer's Disease and a new Investigational New Drug designation for Parkinson's Disease. The company also plans to explore troculeucel's potential in Frontotemporal Dementia and post-stroke/traumatic brain injury treatment.

The Summit, featuring over 150 experts, is the only industry-focused event covering the complete drug development process from discovery to commercialization, highlighting advancements in neurodegenerative therapeutics, presymptomatic diagnosis, and new treatment modalities.

NKGen Biotech (NKGN) announced its delisting from Nasdaq Global Market effective March 4, 2025, due to non-compliance with market value requirements. The company will transition to OTC Markets starting March 5, 2025, trading under symbols 'NKGN' for common stock and 'NKGNW' for warrants.

The company has cancelled its previously planned 1-for-6 reverse stock split and intends to apply for the OTCQX platform, maintaining SEC reporting compliance. NKGen's Phase 2a Alzheimer's trial enrollment is expected to complete by Q2 end, with initial readout planned for late 2025.

Despite challenges related to their former parent company NKMAX's financial restructuring, NKGen highlighted progress in their Alzheimer's program, including FDA Fast Track designation, Phase 1 results publication, and presentations at major conferences in 2024. The company aims to eventually re-list on Nasdaq once meeting listing requirements.

NKGen Biotech (NKGN) has administered its first dose of troculeucel, an expanded autologous NK cell therapy, to a stroke patient under an FDA-cleared compassionate use program. The treatment, administered at George Washington University Medical Center, marks the company's initial exploration into stroke treatment applications.

The initiative, led in collaboration with Dr. Dimitri Sigounas and Dr. Amarendra K. Neppalli, aims to investigate troculeucel's potential in reducing chronic neuroinflammation in post-stroke patients. This is particularly significant as stroke remains the second leading cause of death and long-term disability, with 20% of survivors developing dementia.

The company's previous Alzheimer's trials demonstrated troculeucel's ability to cross the blood-brain barrier and reduce cerebrospinal fluid levels of brain injury markers GFAP and NfL. This compassionate use program represents a stepping stone toward a possible full IND application for stroke treatment.

NKGen Biotech (NKGN) has administered its first dose of troculeucel, an expanded autologous NK cell therapy, to a frontotemporal dementia (FTD) patient under FDA-cleared compassionate use program. The patient carries the C9orf72 gene mutation, representing one of the estimated 60,000 people living with FTD in the U.S.

This administration marks a significant step in exploring troculeucel's potential for treating neurodegenerative diseases, particularly in cases where existing therapies have proven ineffective. The company's previous experience with Alzheimer's and Parkinson's patients has shown that troculeucel can cross the blood brain barrier and improve various protein levels in CSF, including reducing neuroinflammation markers like GFAP.

The treatment will be conducted at the Sarcoma Oncology Center under Dr. Sant Chawla and Dr. Erlinda Gordon's guidance, with patient assessment by UCLA's Dr. Mario Mendez. This compassionate use program serves as an initial step towards a future full IND application.

NKGen Biotech (NKGN) has appointed Dr. Anita Fletcher as National Principal Investigator for its Phase 2a clinical trial of troculeucel, an enhanced autologous NK cell therapy for moderate Alzheimer's disease. AdventHealth Research Institute in Orlando will be the first East Coast clinical site enrolling moderate-stage Alzheimer's patients.

The trial follows promising Phase 1 results where 90% of evaluable subjects showed stable or improved ADCOMS scores at Week 11. Improvements in CSF biomarkers were observed in multiple markers: 70% p-Tau181, 60% AB42/40 ratio, 60% GFAP, 40% GDF-15, 30% LTBP2, and 30% NF-L. No treatment-related adverse events were reported.

The Phase 2a trial will use cryopreserved product at the highest dose of 6 x 109 cells every three weeks for one year, targeting moderate Alzheimer's disease, for which there is currently no approved disease-modifying therapy.

NKGen Biotech (NKGN) has published results from its Phase 1 clinical trial of troculeucel, an expanded autologous NK cell therapy for Alzheimer's disease (AD) treatment. The trial, involving 11 subjects with a median age of 79 years, demonstrated stable or improved outcomes in 90% of evaluable subjects.

The study utilized three dose cohorts (1×10⁹, 2×10⁹, and 4×10⁹ cells), with subjects receiving four doses at three-week intervals. Key findings showed that troculeucel was well-tolerated with no drug-related adverse events. The therapy reduced neuroinflammation and positively affected brain protein aggregates, as indicated by CSF biomarker levels.

The treatment showed dose-dependent decreases in pTau181 and GFAP biomarkers. Following these promising results, a larger trial with higher dosing/duration has been initiated in the U.S. The research has been published in the peer-reviewed journal Alzheimer's Research & Therapy.

NKGen Biotech (NKGN) has received Fast Track designation from the U.S. FDA for troculeucel, its autologous NK cell therapy for treating moderate Alzheimer's disease (AD). This designation accelerates the development and review process, offering enhanced FDA interactions and potential eligibility for Accelerated Approval, Priority Review, and Rolling Review.

The company specifically targets moderate AD patients, who represent approximately 30% of all Alzheimer's cases. The Fast Track designation follows promising safety and efficacy results from their Phase 1 trial. NKGen is currently enrolling patients in its Phase 2a trial and expects to share updated clinical data by the end of 2025.