[테크다윗을 키우자]Dementia that cannot be conquered? “Catch degenerative brain disease with multi-acting gene therapy”
- Taekyun Kim, CEO of Innoputix
Established following 20 years of service as a researcher for approval review at the Ministry of Food and Drug Safety
Non-clinical progress with adeno-associated virus (AAV) treatment
“The era of gene therapy with endless possibilities is coming soon”
| Taekyun Kim, CEO of Innoputix [회사 제공] |
In July, a big controversy broke out in the medical world around the world. This is because the international scientific journal ‘Science’ announced that a 2006 paper by a research team at the University of Minnesota in the United States had been fabricated on the ‘Amyloid beta (Aβ)’ protein, which has been pointed out as the cause of dementia.
It was a bombshell announcement that would shock the pharmaceutical companies developing dementia treatment, which had been developing amyloid beta as a target for over 10 years. While there is still no treatment for dementia, suspicions of thesis manipulation on amyloid beta, which were pointed out as the main cause of the disease, have been raised, raising concerns that the development of a treatment for dementia may become more difficult.
However, even in this situation, the development of dementia treatment does not stop. This is because dementia is the biggest challenge that we face most directly in the age of an aging population. The number of patients suffering from Alzheimer’s disease, which accounts for 70% of dementia patients, is 600,000 in Korea (2019) and 5.8 million in the United States (2020). The annual medical cost due to this is 20.42 million won in Korea and more than 60 million won in the United States. In 40 years, it is expected that the number of patients will increase by 1.4 million in Korea and 11.6 million in the United States.
Innoputix is a bioventure that is developing treatments for degenerative brain diseases such as Alzheimer’s and Parkinson’s.
Innoputix CEO Taekyun Kim (Photo) worked as a research official at the Ministry of Food and Drug Safety for 20 years (from 1996 to 2016). He was mainly responsible for the approval review for biopharmaceuticals, especially gene therapies. After that, he started Innoputix in 2019 following working as a technology general director (CTO) and R&D head of Pharma Research at NK Max.
Regarding the background of the founding, CEO Kim said, “Since childhood, my dream has been to develop a ‘good medicine that can cure sick people’. My mother passed away following struggling in the hospital for 8 years, so I felt even more so.” “After leaving the Ministry of Food and Drug Safety, I gained practical experience in developing new drugs and started the business with the confidence that I was ready to challenge the dream of developing a good treatment. ” he explained.
However, it was not an easy journey following starting the business. Innoputix, founded in May 2019, was at a time when bad news overlapped with the Invossa and Shillagen incidents in the bio industry at the time. There were many ventures into the bio industry, but it was not easy to find investors.
CEO Kim said, “The meeting itself has become difficult as the corona virus has exploded in a situation where it is not easy to find investors. It took 1 year and 6 months to receive the first investment following founding,” he said.
Innoputix is developing Adeno-Associated Virus (AAV) platform technology as a gene transfer vector. Professor Lee took over the patent in 2019 saying that he is the right person to develop this candidate material. CEO Kim said, “I knew that degenerative brain diseases such as Alzheimer’s and Parkinson’s are difficult to treat. However, following seeing the results of Professor Lee’s research, I thought that I might expect an effect with these various mechanisms of action, so I started the development with confidence.”
What makes Innoputix’s treatment different from existing treatments is that it does not target only one substance with a single mechanism of action, but rather targets various causes of degenerative brain disease.
CEO Kim said, “When therapeutic genes (Nurr1 and Foxa2) are expressed in the administration site (hippocampus and lateral ventricle), they not only eliminate the accumulation of pathological substances, amyloid beta and tau protein, but also suppress inflammation and immune activity of glial cells and neurotrophic activity. By promoting factor expression, it works to return the patient’s brain to a normal environment. Through this, the expression of neural synapses required for cognitive function increased and the long-term memory function was also increased. That is, the therapeutic agent removes the causative agent of the disease and simultaneously induces the change to the regenerative environment, thereby enabling fundamental improvement.”
Innoputix is conducting non-clinical trials such as pharmacokinetic and toxicology tests for both diseases from 2022. It has been selected for the government’s regenerative medical technology development project and dementia overcoming R&D project and is conducting research.
This background was possible thanks to CEO Kim’s know-how in the approval review accumulated at the Ministry of Food and Drug Safety.
CEO Kim said, “Science and technology are required for new drug development, but knowledge of ‘regulatory affairs’ that will allow new drugs to pass clinical approval and product approval is also important.” Regulatory knowledge gained through his career has reduced trial and error for cutting-edge biopharmaceutical R&D. In particular, they are well aware of the types of data to be submitted to regulatory agencies, the time required for preparation, the importance/difficulty level, and bottlenecks, so that they can efficiently and quickly prepare for clinical trials.”
The company is planning to apply for a phase 1 clinical trial approval (IND) to the Ministry of Food and Drug Safety early next year. After that, following evaluating clinical results in patients in 2024, if it shows efficacy, it will proceed with an IND application in the United States and then discuss joint development, partnering, and licensing with Global Big Pharma.
CEO Kim sees the future of AAV gene therapy very positively. AAV treatment is one of the most difficult products to develop production technology and quality technology among advanced biopharmaceuticals. So far, only a few US pharmaceutical companies have this production capacity.
CEO Kim said, “As AAV gene therapy products, such as ‘Zolgensma’ for intravenous injection to newborns and ‘Luxtana’ for direct administration to the eyes were approved and used by thousands of people so far, there have been no major side effects. Patients’ expectations are high as it is a great advantage that a complete treatment is possible with single administration. In the next 10 years or so, we expect that gene therapy such as AAV will become as popular as the current antibody.”
By Son In-gyu, staff reporter