[이데일리 김지완 기자] “I have participated in numerous clinical trials so far, but there has never been as much attention as NK Max’s (182400) NK cell therapy ‘Super NK’”.
Dr. DeOrchis of St. Francis Hospital in New York, USA, said that Super NK is a new treatment for Alzheimer’s, and the US medical industry is very interested.
He said, “The medical industry responded 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.” compared
Dr. Deorkis administered Super NK to an Alzheimer’s patient on the 28th of last month. Previously, in November of last year, Dr. Deorkis received “approval for compassionate use” from the U.S. Food and Drug Administration (FDA) for NK Max’s NK cell therapy, Super NK (SNK01), for the treatment of Alzheimer’s patients.
The compassionate use approval system is a system in which medical authorities supply new drugs before marketing approval to give them a chance to treat patients in a situation where treatment is given up because there are no more available treatments. Compassionate use of therapies is entirely at the discretion of the physician. 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 stopping disease progression in 5 patients in 5 efficacy evaluation indexes. 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 New York hospitals, including St. Francis Hospital, as well as Mount Sinai Hospital and North Shore University Hospital. The following is a Q&A with Dr. Deorkis.
△The background of the decision to administer Super NK to Alzheimer’s patients.
First of all, the efficacy of amyloid-based therapeutics is too insignificant. Isn’t the actual Alzheimer’s treatment development market also changing toward targeting tau? I, too, stopped therapies targeting 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 NK Max’s Super NK is a pure NK cell therapy product that has not been genetically modified. It was determined that Super NK can effectively eliminate chronic neuroinflammation with the unique characteristics of NK cells.
To be honest, the mechanisms of treatments for neurodegenerative diseases currently under development are too complex. Some remedies are far beyond my level of knowledge. 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 in that it uses natural NK cells. Super NK seeks a solution by taking a simple approach rather than complicating the complex disease of Alzheimer’s. I was fascinated by this.
△ Does targeting neuroinflammation mean an effective treatment?
Yes. My careful judgment is that targeting neuroinflammation is more effective in treating tauopathy than targeting amyloid/tau.
Tauopathy refers to diseases associated with toxic tau protein, which are pointed out 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 is separated from the cytoskeleton and causes protein aggregation. During this process, tau aggregates, which change from liquid to solid, kill nerve cells and inflict ‘damage’ to the brain.
△ What type of patient is Super NK the most effective treatment for?
I am sure it will be 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 administered to early Alzheimer’s patients in the United States, 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 annual costs.
Currently, the annual treatment cost of aducadumab, which is being used as an Alzheimer’s treatment, amounts to $23,000 (28.77 million won). Recanemab is also expected to be at a similar level. All of these are difficult to cover with the CMS budget. On the other hand, Super NK is only 1/4 the price of adukadumab. If inexpensive Super NK is administered to patients with early dementia, the occurrence of severe Alzheimer’s patients can be reduced. I suspect CMS will make a similar judgment.
△ 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.