NKGen Biotech Reports 3-Month Alzheimer’s Symptom Improvement with Troculeucel Cell Therapy; GSK Announces Positive Phase 2 Results for mRNA Influenza Vaccine

Sep 13, 2024 07:57 CST Updated 07:57

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Three-Month Relief of Alzheimer's Symptoms: Early Clinical Results of NK Cell Therapy Positive

NKGen Biotech Announces Interim Data from Phase 1 Cohort and Dosing of First Patient in Phase 2a Trial of Autologous Enhanced Natural Killer (NK) Cell Therapy Troculeucel for Moderate Alzheimer’s Disease (AD)

The Phase 1 patient cohort has shown positive interim results. Three patients, three months after receiving the 6 billion cell treatment, have not experienced any drug-related adverse reactions. Additionally, exploratory efficacy analysis indicates,Two of the three patients improved from moderate AD to mild AD on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale.. These findings further support the results of the company's Phase 1 study, MX04, in which a patient with moderate AD who received the highest dose (4 billion cells) also improved from moderate to mild AD.

Based on the positive results of the Phase 1 trial of troculeucel in patients with moderate Alzheimer's disease, NKGen announced the initiation of a Phase 2 clinical trial and the completion of the first patient dosing. The Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of troculeucel compared to placebo in patients with moderate Alzheimer's disease. The Phase 2 trial will provide a comprehensive understanding of the potential benefits and limitations of troculeucel in treating Alzheimer's disease, thereby validating its therapeutic potential. NKGen has currently activated four clinical trial sites in North America and expects to increase patient enrollment in the coming months.

Troculeucel (formerly known as SNK01) is an autologous, non-genetically engineered NK cell product with enhanced cytotoxicity and an activation receptor expression rate exceeding 90%, which can be stably produced from any donor. This candidate therapy effectively reduces α-synuclein (α-syn) levels in the cerebrospinal fluid (CSF) of AD patients, the elevation of which is believed to be associated with cognitive decline.

GSK's Flu mRNA Vaccine Shows Positive Phase 2 Results

GSK Announces Positive Results from Phase 2 Clinical Trial of mRNA Seasonal Influenza Vaccine Program

In young and elderly populations, the trial met the predefined success criteria. Interim data indicate that all tested mRNA formulations have acceptable safety and reactogenicity.

These results, combined with the previous Phase 2 clinical trial results, confirm that the mRNA platform can induce strong antibody titers with an acceptable safety profile. Based on these results,GSK's mRNA Seasonal Influenza Vaccine Program to Enter Late-Stage Clinical Development.

In addition, GSK recently signed a new licensing agreement with CureVac to gain full rights to develop and produce candidate vaccines for influenza and COVID-19. GSK is also continuously developing and optimizing its mRNA capabilities through investments and collaborations, including efforts in AI/ML-based sequence optimization, nanoparticle design, and manufacturing.

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References:

[1] GSK announces positive headline data from phase II seasonal influenza mRNA vaccine programme. Retrieved September 12, 2024, from https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-headline-data-from-phase-ii-seasonal-influenza-mrna-vaccine-programme/

[2] NKGen Biotech’s Positive Phase 1 Clinical Data in Moderate Alzheimer’s Disease Advances Troculeucel into Phase 2 with First Patient Dosed in Phase 1/2a Trial. Retrieved September 12, 2024, from https://www.globenewswire.com/news-release/2024/09/12/2945163/0/en/NKGen-Biotech-s-Positive-Phase-1-Clinical-Data-in-Moderate-Alzheimer-s-Disease-Advances-Troculeucel-into-Phase-2-with-First-Patient-Dosed-in-Phase-1-2a-Trial.html

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