NKGen’s FDA Fast Track & Positive Alzheimer’s Results: A Win For NK Cells

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NKGen Biotech had a good week. On Wednesday, the company announced that the FDA had granted Fast Track designation to their autologous NK cell therapy, troculeucel, for the treatment of moderate Alzheimer’s disease (AD). Then, on Thursday they announced the publication of their phase 1 results that showed a whopping 90% of patients displayed stable/improved disease outcomes.

These updates bode well for the entire NK cell field as a whole. Here’s what you need to know.

NKGen and Their Super-Activated NK Cells

NKGen Biotech is a clinical-stage biotechnology company headquartered in Santa Ana, California, specializing in the development of innovative autologous and allogeneic natural killer (NK) cell therapies. Originally focused on oncology, NKGen pivoted to neurodegenerative diseases after early compassionate use cases suggested that NK cells could play a role in treating Alzheimer’s disease. Their SNK (super-activated NK) platform utilizes a proprietary expansion method that enhances NK cell cytotoxicity and activating receptor expression on their surface, making them more effective at identifying and eliminating diseased cells.

Troculeucel (also known as SNK01) is an ex vivo expanded autologous NK cell therapy that the company is investigating for the treatment of moderate AD patients – a group representing about 30% of all Alzheimer’s cases. Unlike traditional AD treatments that primarily target amyloid plaques, troculeucel has a dual mechanism of action: i) reducing neuroinflammation and ii) working to degrade protein aggregates.

Their recently published phase 1 results showed that 90% of patients experienced stable or improved disease outcomes with no drug-related adverse events. On top of improving disease symptoms, troculeucel was able to influence various biomarkers associated with AD pathology, such as pTau181 and GFAP, which both showed dose-dependent reductions.

These promising findings have paved the way for ongoing Phase 2a trials.

A Growing List of Fast Track Designations for NK Cell Therapies

As for the Fast Track designation for troculeucel, this is part of a broader trend of regulatory support for NK cell therapies with Affimed’s AFM-13 + Artiva’s Allo-NK receiving Fast Track designation in September 2023 for relapsed/refractory Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma and Indapta Therapeutics’ IDP-023 in February 2024 for multiple sclerosis and hematologic malignancies.

A Positive Sign for NK Cell Therapies

While NKGen is primarily focusing neurodegenerative disorders, the positive clinical results bode well for the use of NK cells in other indications such as cancer and autoimmunity. Also, the FDA’s willingness to grant Fast Track and other special designations to NK cell therapies may hint at its general support for NK cells as a treatment modality. For troculeucel, this means faster development timelines and closer collaboration with regulators, but for the NK cell field as a whole, this designation represents one more small victory in the battle towards the first FDA approval.