Passage of the Amendment to the Advanced Regenerative Biotech Act a Positive Catalyst for Korean and Japanese Cell Therapy Companies Legislation Puts Renewed Focus on Next-Generation NK Cell Therapies
New York
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February 07, 2024 08:57 AM Eastern Standard Time
New York, Feb 7, 2024 - (Plato Data) - On Thursday February 2, 2024, the bio industry welcomed the parliament’s passage of a bill that adds regenerative medicine organizations to the list of those considered for human cell management business licenses. The National Assembly passed the “Amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals” in a plenary session paving the way for certain next generation NK Cell Therapy companies to recognized as a licensed management business.
According to a spokesperson at NKMAX, the passage of this amendment will enable the company to utilize its NK cell therapy SNK, as a customized treatment for severe, rare, and incurable diseases, such as cancer and Alzheimer's, in Korea and Japan. NKMAX, which has been developing its NK cell therapy SNK through its U.S. subsidiary, NKGen Biotech (NASDAQ: NKGN). NKMAX has existing GMP facilities enabling it to immediately generate tangible sales of SNK.
Another company which stands to benefit is CHA Biotech Co., Ltd. CHA Biotech engages in the research of cell therapy and storage of cord blood. CHA Biotech has previously entered into a collaboration with U.S. immunotherapy biotech company CanCure to develop a natural killer (NK) cell therapy. The anti-MIC antibody targets the MIC (MHC class I polypeptide-related sequence) antigen expressed by cancer cells. MIC refers to a protein that plays an important role in regulating and controlling NK cell killing of cancer cells.
GI Cell, located in South Korea and an affiliate of GI Innovation, is also currently working on a next-generation NK cell therapy that maximizes tumor-targeting function and cancer cell-killing efficiency. Recently, GI Cell submitted an application to the Ministry of Food and Drug Safety for phase 1/2a clinical trials to evaluate the safety and efficacy of a combination therapy between GI Cell's allogeneic NK cell therapy, T.O.P. NK and GI-101A, in patients with recurrent and refractory solid tumors.
Natural Killer (NK) cell therapies hold significant potential in the field of immunotherapy for treating various diseases, particularly cancer. NK cells are a type of immune cell that plays a crucial role in the innate immune system, recognizing and eliminating infected or abnormal cells without prior sensitization. Some aspects more important aspects of the potential of NK cell therapies include minimal side effects, versatility in targets and Allogeneic Therapies.
Source: Plato / Amplifi
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