[이데일리 김지완 기자] “I have participated in a number of clinical trials so far, but there has never been as much attention as NK Max (182400) ‘Super NK’ cell therapy”.
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Dr. DeOrchis of St. John’s Hospital said. Francis in New York, USA, that Super NK is a new treatment for Alzheimer’s, and the US medical industry is very interested.
He said, “The medical industry reacted explosively to the recently posted Alzheimer’s treatment using Super NK. He continued, “There is a flood of text messages from acquaintances asking how to participate in the ‘Super NK’ (SNK01) Alzheimer’s clinical trial.”
Dr. Deorkis Super NK for an Alzheimer’s patient on the 28th of last month. Previously, in November of last year, Dr. Deorkis received “compassionate use approval” from the US Food and Drug Administration (FDA) for the NK Max cell therapy, Super NK (SNK01), for the treatment of Alzheimer’s patients.
The compassionate use approval system is a system where medical authorities supply new drugs before marketing approval to give them the opportunity to treat patients in a situation where treatment is stopped because there are no more treatments available. Compassionate use of therapies is entirely at the physician’s discretion. For this reason, compassionate use applications must be submitted by a physician directly to the FDA on a patient-by-patient basis.
NKMAX is currently conducting phase 1 clinical trials for Alzheimer’s patients in Mexico. According to the interim results disclosed by NKMAX, the administration of SNK01 to 6 Alzheimer’s patients showed no side effects and toxic reactions, proving the primary evaluation index, safety, and the effect of preventing disease progression in 5 patients in 5 efficacy evaluation indices appeared.
Edaily had a written interview with Dr. Deorkis on the 3rd through NKMax’s US subsidiary, NKgen Biotech. Dr. Deorkis is a neurologist and is affiliated with several hospitals in New York, including St. Francis, as well as Mount Sinai Hospital and North Shore University Hospital. The following is a question-and-answer session with Dr. Deorkis.
△ The background to the decision to give Super NK to Alzheimer’s patients.
First of all, the efficacy of amyloid-based therapeutics is too negligible. Isn’t the Alzheimer’s treatment development market itself also shifting towards targeting tau? I, too, stopped therapies that target beta amyloid. After that, he found a new alternative called Super NK.
△ How is SuperNK different from existing Alzheimer’s treatments?
First of all, we paid attention to the fact that Super NK NK Max is a pure non-genetically modified NK cell therapy product. It was determined that Super NK can effectively eliminate chronic neuroinflammation with the unique characteristics of NK cells.
In truth, the mechanisms of treatments for neurodegenerative diseases currently being developed are too complex. Some answers are way beyond my knowledge level. Some treatments target as many as 24 biomarkers. Therapies work in ways that even I, an Alzheimer’s expert, cannot understand. On the other hand, Super NK was simple and clear as it used natural NK cells. Super NK tries to answer by taking a simple approach rather than complicating the complex Alzheimer’s disease. I was fascinated by this.
△ Does targeting neuroinflammation mean effective treatment?
Yes. My cautious opinion is that targeting neuroinflammation is more effective in treating tauopathy than targeting amyloid/tau.
Tauopathy refers to diseases associated with toxic tau protein, which is identified as a major cause of various neurological diseases, including Alzheimer’s. Normally, tau protein is dissolved in nerve cells and exists in a liquid state. Tau protein attaches to the cytoskeleton and stabilizes the cell structure or induces differentiation. However, it becomes a problem when tau protein becomes detached from the cytoskeleton and causes protein aggregation. During this process, ‘aggregates’, which change from liquid to solid, kill nerve cells and cause ‘damage’ to the brain.
△ For what type of patient is Super NK the most effective treatment?
I am sure this is the most useful treatment for Dementia with Lewy bodies. There is currently no cure for Lewy body dementia. Lewy body dementia is the second most common degenerative brain disease after Alzheimer’s disease. Lewy body dementia has been reported to account for up to 31% of all dementia patients.
△ What is the outlook for the Super NK market?
There are 6 million people with dementia in the United States. Among them, 2 to 3 million people have severe Alzheimer’s disease. The number of early Alzheimer’s patients is between 500,000 and 750,000. If Super NK is given to early Alzheimer’s patients in the US, Medicare (health insurance) of the Center for Health Insurance Service (CMS) under the US Department of Health and Welfare will be able to save $11.5 billion (14 trillion won) in costs annual.
Currently, the annual treatment cost of aducadumab, which is used as an Alzheimer’s treatment, comes to $23,000 (28.77 million won). Recanemab is also expected to be at a similar level. All of these are difficult to accommodate with the CMS budget. On the other hand, Super NK is only 1/4 the price of adukadumab. If cheap Super NK is given to patients with early dementia, the incidence of severe Alzheimer’s patients can be reduced. I suspect CMS will make a similar ruling.
△ The last thing I want to say.
If possible, I would like to participate in all clinical trials of Super NK, including phase 2 and 3 clinical trials.
