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SANTA ANA, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced promising early interim data from the Phase 1 cohort and the dosing of the first Phase 2 patient in the Phase 1/2a clinical trial of troculeucel, NKGen’s cryopreserved autologous enhanced NK cell therapy for the treatment of moderate Alzheimer’s disease (“AD”).
The Phase 1 cohort is already demonstrating positive interim results. Early independent review of the data shows that after only three months treatment with a dose of 6 billion cells per treatment, the three patients in the Phase 1 cohort had no drug-related adverse reactions, and exploratory efficacy analyses showed that two of the three patients went from a moderate to a mild AD rating on the Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale. These findings further support the company’s MX04 Phase 1 AD study, where the one moderate AD patient who received the highest dose in that study (4 billion cells) also went from a moderate to a mild rating on the CDR-SB. Additionally, six-month interim cognitive data from Phase 1 cohort patients receiving troculeucel is expected to be disclosed at an upcoming national Alzheimer’s conference in Q4 2024.
Building upon positive interim Phase 1 results of troculeucel in moderate Alzheimer’s patients, the Company is pleased to have dosed its first patient in the Phase 2 randomized, double-blind, placebo-controlled trial evaluating the efficacy of troculeucel compared to placebo in patients with moderate Alzheimer’s disease. Troculeucel will be evaluated for effectiveness and additional safety in a broader cohort of 30 patients with moderate Alzheimer’s disease, employing a randomized, double-blind setup (n=20 randomly assigned to the treatment arm and n=10 to placebo). The Phase 2 trial aims to provide a thorough understanding of both the potential benefits and limitations of troculeucel in treating Alzheimer’s disease, thereby validating its potential therapeutic efficacy. NKGen has now activated four clinical sites across North America and expects to increase enrollment in the coming months.
“We continue to make great progress with our troculeucel clinical program in AD,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “In the Phase 1 cohort of the Phase 1/2a study, we can proudly announce two of our first three patients have been clinically upgraded from moderate to mild AD following only three months of treatment with troculeucel. Additionally, we have recently dosed the first patient in the Phase 2 cohort, which is a significant milestone, particularly since the dose used is cryopreserved and continuing at our highest dosing of 6 billion cells per treatment. With encouraging cognitive improvements and a favorable safety profile from the trial’s Phase 1 interim analysis, dosing our first patient in Phase 2 is a crucial step towards creating a much-needed treatment option for patients facing this challenging condition. We are particularly eager to explore the enhanced cognitive benefits that ongoing usage of the higher dosing may bring in our Phase 2 trial.”
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SANTA ANA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in solid tumors without lymphodepletion at the 6th Annual Allogeneic Cell Therapies Summit to be held in Boston, MA, from June 10-12, 2024.
Presentation Details:
Title: Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function
Conference Track: Clinical Track
Date and Time: Wednesday, June 12, 2024, 12:00 pm ET
Dr. Song’s presentation will detail the Company’s novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation process, as well provide an update on their initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors. Furthermore, Dr. Song will explore the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function, and potentially enhancing treatment efficacy. The presentation will also include a discussion on an unexpected discovery from the SNK02 Phase 1 trial, hinting at its possible applicability as a treatment for patients beyond cancer.