NKGen Biotech Inc Stock Price, News & Analysis

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.

NKGen Biotech (Nasdaq: NKGN) has been selected as the preferred stalking horse bidder for NKMax in its court-managed rehabilitation process in South Korea. The proposal includes up to $18 million in committed funding from a third-party investor. Upon closing, expected in 1Q 2025, NKGen would secure global IP rights for troculeucel and other proprietary technologies. This acquisition would allow NKGen and partners to commercialize troculeucel in markets where NK cell therapy is already legal, including Korea and Japan. NKMax currently holds a 25% equity stake in NKGen, and post-acquisition, NKGen and its financing partners expect to hold a majority stake in NKMax.

NKGen Biotech (Nasdaq: NKGN) received a notice from Nasdaq on November 20, 2024, stating non-compliance with listing rules due to delayed filing of Q3 2024 Form 10-Q. The delay stems from additional time needed for internal derivative securities valuation. Nasdaq granted a temporary exception until January 7, 2025, pending the Seoul Bankruptcy Court's decision on NKMax's rehabilitation and NKGen's proposal to acquire majority interest. The company must submit an updated compliance plan following the court's decision. The notice doesn't immediately affect NKGN's Nasdaq Global Market listing, and the company aims to file the Form 10-Q promptly.

NKGen Biotech presented Phase 1/2a trial data for troculeucel in Alzheimer's Disease at the CTAD Conference. The Phase 1 trial showed that troculeucel reduces several biomarkers detectable up to 10 years before dementia symptoms. In the Phase 1/2a trial, using the highest dose of 6 billion cells, all three treated subjects showed stable or improved cognitive function, with two subjects improving from moderate to mild disease after three months. The treatment demonstrated strong safety with no adverse reactions. The Phase 1 pilot trial showed 90% of evaluable subjects experienced stable or improved cognitive function, with reductions in neuroinflammation biomarkers.

NKGen Biotech Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company, has announced its upcoming presentation at the 16th World Stroke Congress (WSC 2024) in Abu Dhabi, UAE from October 23–26, 2024. The company will showcase results of troculeucel, their innovative natural killer cell therapeutic, in a poster format.

The e-poster, titled "Therapeutic potential of expanded SNK01 (activated autologous natural killer cells) post-stroke to reduce neuroinflammation, inflammation-mediated cell death, and damage," will be presented in two sessions:

• Free Communications 09: Health Services & Implementation of Stroke Care on October 25, 2024, 8:00 am – 9:30 am GST in Hall F
• Plenary 03: Plenary, Awards & Late Breaking on October 25, 2024, 10:00 am – 11:30 am GST in Hall A/Plenary

The poster will be available on NKGen's website after the presentation.