NKGen Biotech Secures FDA IND Clearance for SNK01 NK Cell Therapy in Moderate Alzheimer’s Disease

SNK01 is a non-gene-modified autologous NK cell therapy.，Its inCollecting patients' bloodAfter liquidIsolate and screen target NK cells, then activate the NK cells and promote their expansion.Increase.SNK01HasEnhanced cytotoxicity and activated receptor expression, combined with NKGen's unique cryopreservation process, can maintain significant cell viability and cytotoxicity.

In October this year, NKGen Biotech presented a poster on the interim data from the Phase 1 clinical trial of SNK01 for the treatment of AD patients at the 26th World Congress of Neurology (WCN) annual meeting.Data show that SNK01 is well-tolerated and able to cross the blood-brain barrier, demonstrating signs of effectively reducing neuroinflammation., which is a key factor in the effective treatment of Alzheimer's disease. At the same time, positive changes in patients' cognitive function and cerebrospinal fluid biomarkers were also observed.

NKGen Biotech CEO Paul Y. Song stated, "This approval is a key milestone for NKGen's neurodegenerative disease program. Currently, most treatments still focus on individuals with mild cognitive impairment or mild dementia, but this approval allows us to target more severe cases. We believe the Phase 1/2a clinical trial may demonstrate greater benefits." Thanks to this news, NKGen’s stock opened significantly higher.

NKGen Biotech, as a first-tier company in the NK cell therapy field, has a referential value in its layout of indications.In summary, it means "both precise and broad" – precise pipeline with broad indications.NKGen Biotech currently discloses only two pipelines under research: autologous SNK01 and allogeneic SNK02.

SNK01

Among them, SNK01 is not only used for the treatment of AD, but NKGen has also laid out a variety of indications. The cause of Parkinson's disease is the misfolding and abnormal accumulation of α-synuclein in the central nervous system and peripheral nervous system. AndNK cells can help clear α-synuclein, reduce inflammation caused by autoreactive T cells, and remove damaged neurons, playing a crucial role in regulating and suppressing brain tissue inflammation and abnormal protein aggregation.。

Last November,NKGen Biotech Collaborates with the Parkinson's Foundation, to jointly advance the research of SNK01 for the treatment of advanced Parkinson's disease. NKGen has also established a dedicated Scientific Advisory Board to drive its pipeline strategy for natural killer cell therapies targeting neurodegenerative diseases. Based on long-term research into the interaction between the central nervous system (CNS) and the cellular immune system, the board experts believe:The role of NK cells has been significantly underestimated until now. The NK cell products from NKGen Biotech, Inc. appear to possess some strong Treg-like characteristics, which may influence certain autoimmune aspects of neuroinflammation and could potentially promote tissue repair.It is worth mentioning that this may mean NKGen Biotech will next expand the indications of NK cell therapy to autoimmune diseases.

In the most mainstream field of oncology, NKGen Biotech is also conducting related clinical trials. Previously,NKGen Biotech Collaborated with Affimed to Explore the Combination of Cell Engager AFM24 and SNK01 for Treating Patients with Advanced/Metastatic EGFR-Positive Solid TumorsIn August this year, Affimed announced the preliminary results of the phase 1 clinical trial of the combination therapy: As of June 2023, seven patients who had received an average of five prior treatments were treated with the combination of AFM24 and SNK01. Stable disease was observed in three patients, including a heavily pretreated microsatellite-stable colorectal cancer patient. In terms of safety, no dose-limiting toxicity was observed. This marks the first release of data on this combination therapy, providing proof of concept. However, for now, the two companies have decided to pause temporarily as Affimed moves forward with a combination of allogeneic NK and AFM24.

SNK02

SNK02 is an allogeneic, cryopreserved NK therapy., composed of NK cells isolated from peripheral blood mononuclear cells of healthy donors, is based on NKGen's proprietary allogeneic manufacturing process, capable of producing hundreds of thousands of potential doses of NK cell therapy from materials collected from a single donor, andPurity can reach 99%, with a very high receptor expression rate, and supportsNo need to clear the urinary tract before administration.. Last October, the FDA had already approved the IND application for SNK02, which was also the first product of its kind to be approved for clinical trials.

In August this year,First Patient Dosed in Phase 1 Clinical Trial of SNK02 for Solid TumorsAt the same time, Paul Y. Song stated, "If the trial goes well, future clinical trials will be conducted to test SNK02 in combination with immune checkpoint inhibitors for cancer treatment." The official website also disclosed that after being equipped with HER2 CAR, SNK02 can be used to treat HER2-positive solid tumors; however, this project is still in the preclinical exploration stage.

And in order to support the advancement of its NK pipeline,NKGen Biotech, Inc. merged with Graf Acquisition in October this yearNKGen becomes a wholly-owned subsidiary of Graf, which changes its name to NKGen Biotech and lists on Nasdaq. Entering the public market will help NKGen fund the clinical development of advanced neurodegenerative diseases and support the advancement of NKGen's allogeneic NK project in the field of oncology.

Although NKGen Biotech is currently focusing on only two NK therapy products, their progress is considered to be among the leading in the industry. Moreover, based on the disclosed data, both efficacy and safety appear to be promising. This strategic focus allows NKGen Biotech to effectively prevent internal competition in the early stages, while its exploration in the field of neurodegenerative diseases provides more validated information for those who follow in the industry.

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