NKMAX Completes Development of Allogeneic NK Cell Therapy Overcoming Previous Technical Limitations

[Asia Economy Reporter Oh Ju-yeon] NKMAX announced on the 24th that it has completed the development of an allogenic NK cell therapy with enhanced cancer cell-killing ability and has entered preclinical trials.

An allogenic immune cell therapy is an off-the-shelf drug form in which immune cells extracted from donors are mass-cultured and then administered directly to patients visiting hospitals. This formulation is preferred in the industry because it allows for mass production and increased patient convenience.

However, the cancer cell-killing ability of immune cells significantly decreases during the process of freezing and thawing mass-cultured NK cells in the off-the-shelf form just before administration. This has been recognized as a common technical limitation among leading NK cell therapy developers in the U.S. and other countries. Recently, CAR-NK allogenic formulation technology published in the NEJM (New England Journal of Medicine) also fails to overcome the technical limitations of the freeze-thaw process, using live cell formulations rather than frozen formulations for each patient administration, making it difficult to consider it a true allogenic immune cell therapy.

Recently, NKMAX completed the development of an allogenic formulation that maintains the cancer cell-killing ability of NK cells even after freezing and thawing processes and has filed a patent. Additionally, to enter clinical trials for the allogenic cell therapy, the company has signed a contract with a nonclinical toxicity testing institution and started research focusing on evaluating the drug’s toxicity and side effects.

Yongman Kim, Director of NKMAX Research Institute, said, "With NKMAX’s unique technology, we overcame the industry’s technical challenges by maintaining not only the number of cells (cell viability) but also the cancer cell-killing ability (cell cytotoxicity) during the freezing and thawing process." He added, "The expansion fold of Super NK cell culture is on average 19 billion times, which is 1,000 times higher than other companies in the market, enabling an outstanding mass production capacity." He continued, "This means that from 80ml of blood, NK cells can be mass-cultured to produce 400,000 doses based on a 2 billion cell dosage," and said, "NKMAX has laid the foundation for the commercialization of allogenic therapies."

Paul Song, Vice President of NKMAX America, stated, "The U.S. and European markets, centered on pharmaceutical companies, are conducting allogenic clinical trials and promoting license-out to large pharmaceutical companies, while in the Asian market, we have a two-track strategy to commercialize autologous therapies, which allow patient-customized treatment, on average more than five years faster."

This content was produced with the assistance of AI translation services.