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EpiBiotech One pill every day to prevent hair loss A powerful new drug for fundamental hair loss is coming | Korea's No.1 Hair Loss Community, DAEDAMO

세종대왕 · 2023-02-23T09:51:44+09:00

The era of antihair loss agents which help to lose even a little less hair is now time to say goodbye An innovative cell therapy that grows hair by directly cultivating and proliferating breast milk cells of hair follicles which are deeply involved in hair growth is just around the corner Epi Biotech will take the lead in finding a healthy and confident life for people with hair loss Hair loss is a common symptom for modern people as there is a saying that it is the 10 million era of hair loss Even the joke that if the development of a hair loss treatment is successful it will become richer than Microsofts Bill Gates is so sympathetic that many people are waiting for the emergence of a fundamental hair loss treatment According to the Health Insurance Review and Assessment Service the number of hair loss patients in Korea was estimated to be 233000 as of 2020 In addition Grandview Research a global market research firm predicted that the global hair loss treatment market was worth 10 trillion won in 2021 and that it will reach 20 trillion won in 2028 Currently hair loss treatment is partially resolved by delaying and alleviating hair loss by taking medicine every day or by transplanting hair However several abnormal cases of drugs have been reported and hair transplants have a high burden of surgery and scarring so hair loss treatment is still in high demand for unmet medical care Epi Biotech is developing a completely new treatment for hair loss Based on the recently developed biotechnology technology fundamental hair loss cell therapy is developed by utilizing breastpox cells directly involved in hair growth The hair growth effect has been proven in the actual mouse model and the pig model similar to the human scalp raising expectations for future clinical trials Pharmacy Dotcom Pharmaceutical Newspaper met with CEO Sung Jonghyuk at the headquarters of Epi Biotech in Songdo Incheon and heard about the current status and possibility of Epi Biotech hair loss treatment Please introduce EpiBiotech Epi Biotech is a biotech specializing in the development of hair loss treatments It has established a unique evaluation system for hair loss treatment and hair growth efficacy and is developing various modality pipelines based on this In particular it is developing firstinclass innovative cell therapy rather than temporary treatments such as hair loss relief and delay In addition to the most advanced breastpox cellbased hair loss drug new hair loss treatment targets such as CXCL12 neutralizing antibodies and RIPK1 inhibitors are being discovered and developed It is known to have several platform technologies specialized in hair loss Introducing the platform and its competitiveness First Epi Biotech has developed and built a mother papilla cell separation and culture technology Breasthead cells are key to hair growth and are highly likely to be the optimal cell therapy applicable to the treatment of hair loss Breasthead cells are present in small amounts in hair follicles and take more than six weeks to cultivate an appropriate amount of cells making it difficult to secure the number of cells for cell therapy development and the hair growth ability has significantly decreased after the 7th stage so there was a limit to developing them as treatments To overcome this limitation EpiBiotech has established a technology to masscultivate breastpox cells while maintaining excellent quality after years of research and development EpiBiotechs patented separation and culture technology greatly shortened the time it takes to attach dermal papilla separated from dermal papilla to the culture plate by culturing it under hypoxic conditions In addition a dedicated cell culture solution was developed to have excellent production economy and prevent cell aging The key to EpiBiotechs separation and culture technology is to cultivate a sufficient number of autologous dermal papilla cells in a short period of time with a small amount of hair follicles In the future the ultimate goal is to develop allogeneic treatments by culturing large quantities of dermal papilla cells Currently the development of the process has been completed and in the future we will open an era in which patients with difficulties in existing hair transplantation can treat hair loss without collecting hair follicles The second technology is HairI Epi Biotech is exploring new target genes with artificial intelligence systems HairI in addition to the known hair loss target genes 5Alpha reductase androgen receptor Jak inhibitor When a gene is entered into the HairI program the hair growth association of the gene is formed by networking the hair growth association through individual name recognition and the hair growth association is scored Currently HairI has accumulated data from years of research and only genes with a specific score or higher are selected first Through this it is possible to discover firstinclass candidates with a high probability of success Epi Biotech is also planning to develop a circular hair loss treatment based on the CytAb antibody platform Jakinhibitors have recently been approved by the FDA and will be marketed but there is still a limit to being used as a popular treatment due to systemic side effects and high costs As a result of prior research by the EpiBiotech Research Institute suppressing cytokines that cause inflammation and immune responses in the scalp is very effective in treating circular hair loss and a paper is being published Lowmolecular substances or siRNAs that inhibit cytokines are also effective but antibodies have the advantage of reducing systemic side effects and acting on the scalp for a long time Based on this various antibody treatments for cytokines are being made and the drugs effectiveness is evaluated Soon humanized antibody cell lines will be made and nonclinical trials will begin Please introduce the main pipeline EPI001 mother papilla cell therapy EPI001 is being developed with the aim of treating fundamental hair loss based on dermal papilla cells Mass cultivation of breastpox cells collected from the patients occipital region and administering these healthy cells to the patients scalp to grow new hair When breastpox cells shrink and aging progresses hair falls out or the thickness of the hair becomes thinner It is a mechanism by which various growth factors secreted from the cells stimulate weakened hair follicles and hair turning the hair back into a healthy state when administered healthy breast milk cells cultured from the outside I heard that remarkable results were achieved in the EPI001 nonclinical trial Please explain based on the data As a result of evaluating efficacy in mice better growthinducing effects were demonstrated compared to cell therapy products from other companies Figure 1 In addition the excellent hair growth effect of dermal papillae was confirmed in the male hair loss model In particular there was no toxicity in singledose toxicity tests and oncogenicity tests and no significant abnormal cases were observed How likely is it that it will be successful in humans It has submitted its IND to the Ministry of Food and Drug Safety as it has secured its effectiveness and safety in animal testing Phase 1 clinical trials are expected to begin in earnest in the second half of this year Recently very positive results have been obtained for hair loss treatment in a pig model similar to the human scalp Figure 2 In particular only one dose of human cells increased the number and thickness of pigs hair and the hair growth effect was maintained for more than 3 months In addition the hair growth effect continued even when repeatedly administered two or three times and the administered cells survived for more than three months Given the excellent results obtained from animal models similar to those of the human body I am sure that the same effect will be seen in the actual human body EPI001 plans to complete phase 2 clinical trials in Korea It plans to confirm the effectiveness of the hair loss treatment in the human body through the results of phase 2 clinical trials and license out LO to Big Pharma at home and abroad In addition we are currently developing an offtheshelf allogeneic treatment for dermal papilla cells For an offtheshelf allogeneic treatment 20 to 30 hair follicles of healthy donors were collected and a process was established to cultivate cells that can be used by tens of thousands of people and a source patent was also applied for a method of reducing the immunogenicity of breast papillae which was the largest hurdle Patients are diagnosed with hair loss at a hospital and they plan to establish a system that can treat hair loss by receiving banked organism homeopathic cells from donors EpiBiotech currently plans to maximize the companys revenue through EPI001 technology exports and allogeneic cell therapy In addition please introduce promising pipeline EPI005 antibody therapy Epi Biotech is also developing monoclonal antibodies that neutralize CXCL12 We are developing antibody treatments that are administered every two weeks or a month Antibody treatments have the advantage of being able to minimize systemic side effects when administered to the scalp for a long period of time Antibody treatments for hair loss treatment are slow to develop There are no FDAapproved drugs yet and two to three drugs are undergoing phase 2 clinical trials in the world including China and the United States but there are no unique candidates Epi Biotechs hair loss antibody treatment has been selected as a national new drug development project in 2022 and research is underway Currently it has completed the production of humanized antibodies and has applied for a patent The treatment of hair loss with antibodies is somewhat unfamiliar The scientific basis for this is EpiBiotech researchers found that among the representative types of hair loss CXCL12 secreted by fibroblasts in the dermis induces hair degeneration and has a significant impact on hair loss Accordingly the researchers demonstrated that hair grows smoothly again by inhibiting CXCL12 or inhibiting its receptor CXCR4 In addition similar to male hair loss circular hair loss increases cytokines due to various causes and immune cells are activated leading to hair loss In particular CXCL12 expression increases in the circular hair loss site and administration of EPI005 a CXCL12 neutralizing antibody can treat hair loss Two doses of EPI005 in the circular hair loss animal model confirmed an excellent hair loss effect Figure 3 In addition after administration of EPI005 CD8 T cells causing circular hair loss decreased and the expression of MHCI and II causing autoimmunity decreased This is the result of proving its potential as a new mechanism of action to treat circular hair loss The recently developed Jakinhibitorbased hair loss treatment has a high possibility of systemic side effects from oral administration but antibodybased EPI005 is more free from these side effects and is highly anticipated Series C investments and future IPO plans Epi Biotech plans an IPO as early as 2024 Recently however investment in the bio industry has shrunk too much Additional funding is urgently needed for the fast progress and achievement of promising pipelines It plans to provide additional funding for the Phase 1 clinical trial of cell therapy EPI001 and nonclinical trials of antibody therapy EPI005 this year and antibody therapy in particular is working to produce technology transfer results Please tell me the EpiBiotech future vision and the last thing you want to say There are many companies worldwide that do research on hair loss but I am confident that Epi Biotech is the only company that is developing various modality treatments based on cells antibodies and lowmolecular compounds chemicals Epi Biotech will join us in finding new hair loss targets developing firstinclass innovative new drugs and finding a healthy and confident life for hair loss patients

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