Kangstem Biotech: Cloned Hair Follicles in 2024

Update: January 6, 2025

Kangstem Biotech: Potential Organoid Technology Transfer

Kangstem Biotech will participate in the 2025 JP Morgan Healthcare Conference in San Francisco (US) from January 13th-16th 2025. More information here, where they discuss further details about potential partnerships. Key quote from the first link:

“A large American pharmaceutical company has continuously received information on the research and development results of hair follicle organoids for the past six months since the last Bio Europe, and has requested a face-to-face meeting at this conference. The company is currently investing in building an organoid portfolio. In line with the recent trend of global pharmaceutical companies actively commercializing organoids, (including the acquisition of organoid development companies by large pharmaceutical companies), specific discussions on commercialization, such as ways to utilize hair follicle organoids, are expected to take place at this meeting .”

Note that in November 2024, Kangstem signed a licensing and technology transfer agreement with Yuyoung Pharmaceutical (South Korea) for the stem cell-based fusion drug “OSCA”. This drug is under development for the treatment of osteoarthritis and showed very good results during Phase I clinical trials.

Update: May 24, 2024

Kangstem Biotech just announced that it has signed an agreement with HLB Biostep and HLB Biocode to establish an organoid-based drug safety and efficacy evaluation platform to develop cell therapy products. Among these will include a hair loss treatment based on skin organoids. Also of interest, a new study regarding skin organoid technology development that is co-authored by a Kangstem affiliated scientist.

December 28, 2023

Perhaps the best hair loss cure related news of 2023 just came out last week (h/t “Theo”). South Korea based Kangstem Biotech plans to test a hair cloning type of hair loss treatment in 2024.

The company will commercialize a cloned hair follicle-based drug screening and efficacy evaluation method; and begin nonclinical efficacy evaluation of hair transplants based on the cloned hairs.

Kangstem Biotech Hair Cloning
Kangstem Biotech hair cloning via hair follicle organoid culturing.

Kangstem Biotech Hair Cloning Test in 2024

Kangstem Biotech (South Korea) was founded in 2010 by Kyung-Sun Kang and is publicly traded. Its shareholders include a range of major Korean and Western companies. Without checking this company’s reputation, I might have delayed this post to next year.

The company specializes in cord-blood derived stem cell and other anti-aging related treatments. They are also a contract development and manufacturing organization (CDMO). I never heard about them till this week.

During the past two weeks, Kangstem Biotech had two press releases that are quite remarkable:

  1. On December 6th, the company announced plans to speed up the commercialization and launch of skin organoids to 2024. Interestingly, in 2021 they had an update about their artificial skin technology and partnership with Seoul National University.
  2. On December 22nd, the company announced plans to begin commercialization of the world’s first human hair follicle organoid-based hair loss treatment in 2024.

Per the second press release, Kangstem Biotech signed a contract with the Seoul National University Industrial Cooperation Foundation for:

“Human hair drug screening and human hair follicle production and culture technology for hair transplant materials to develop and commercialize hair loss treatment based on hair follicle organoids.”

Also check out the summary in Newsprime. And on Linkedin.

The company also states the following per the Korean to English translation:

“This technology is the world’s first artificial production of human hair follicle organoids in a test tube, and is a technology that reproduces human hair follicles.”

Kangstem has a two pronged approach when it comes to usage of its technology:

  • Provide a drug screening platform for the development of hair loss or hair growth pharmaceutical treatments. They plan to launch their business for hair follicle-based efficacy evaluation methods in 2024.
  • Begin non-clinical efficacy evaluation of using the hair follicles they culture for use in actual hair transplants. Also in 2024.

The government regulations for regenerative medicine in rapidly aging developed Asian countries have become very flexible. South Korea cannot afford to wait too long, considering that average birth rates in the country hit just 0.72 children per woman in 2023.

Also of significance, South Korea and Japan are both trying to become world leaders in cosmetic procedure related tourism.

South Korea’s Leadership in New Hair Loss Treatments

This adds yet another new South Korean entrant in the hair cloning or hair multiplication sector. Others that I have covered recently include Epibiotech and Han Bio. For a list of all major South Korean entities that are working on any kind of important hair loss treatment, check out my page on hair loss cure research around the world.

Update: Below is an e-mail update to me on 12/29/23 from “Theo”:

“From the press release I understand that they will commercialize hair follicle/skin organoids for drug testing by the first half of 2024. In parallel they will test the hair cloning technology in non-clinical trials to confirm efficiency (if I understand correctly). This technology is similar to Stemson, because both companies works with iPSCs and in vitro, and Stemson is at least 10 years away from commercialization.

Non-clinical testing in South Korea is the first step required by the state, and then comes clinical trials.

Guidelines for clinical trial approval (CTA) for drugs:

https://credevo.com/articles/2017/09/25/south-korea-clinical-trials-regulatory-process/

This is a very well established company, very well funded, with high quality infrastructure and connections. So it should go very fast.

The main CEOs and scientists in KangStem come from Seoul National University, which is in the top 25 universities worldwide.”

Veradermics VDPHL Tablet for Hair Loss

Veradermics VDPHL Tablet for Hair Loss
Veradermics VDPHL tablet for hair loss. Pipeline screenshot from company website.

Update: January 2, 2025

Veradermics Phase 2/3 Clinical Trial Enrollment Link

Veradermics Phase 2/3 US clinical trial enrollment link is live. Their 40 plus locations are pretty widely spread across the country. Please note that we are not certain of the active ingredient(s) in this tablet. From the company’s patent, I previously guessed that it is an extended release oral Minoxidil, plus hopefully some other surprises (see bottom of this post). But it could end up being something totally different too.

The study involves 13 visits to a clinic over the course of 12 months. Participants will either get the new treatment or be part of the placebo group (that will still also get a tablet).

Update: December 11, 2024

Veradermics Raises $75 Million for Phase 2/3 Trials

Veradermics just raised $75 million in Series B financing (h/t “meko”). They have also initiated a Phase 2/3 trial for their lead candidate VDPHL01 for the treatment of androgenetic alopecia (AGA). The trial will enroll 480 patients across 44 sites in the US.

Note that Veradermics also has an ongoing 20-patient Phase 2 trial for VDPHL. Per this latest press release, the company plans to report topline data from that Phase 2 study in the first half of 2025.

VDPHL Clinical Trial Updated Links

VDPHL01 Phase 2 Trial

  • 20 patients.
  • Start date = 2024-07-08.
  • Completion date =2025-08-01.

VDPHL01 Phase 2/3 Trial

  • 480 patients.
  • Start date = 2024-11-06.
  • Completion date =2026-07.

August 9, 2024

Veradermics VDPHL Tablet: Phase 2 Trials Begin

Veradermics is a US-based startup that is working on a new tablet to treat androgenetic alopecia (AGA). They just started Phase 2 clinical trials for VDPHL01 in male subjects with AGA. Only 20 patients are enrolled, and the completion date is listed as August 1, 2025. The trial will take place at Therapeutic Research’s center in San Diego, California. Interestingly, Therapeutic Research is also conducting a topical hair loss product study at this very moment.

However, on Veradermics’ website, the pipeline page suggests that Phase 2 trials for VDPHL are finished (screenshot above). Thanks to reader “John Doe” for e-mailing me about this difference in time frame (and acronym — VDPHL01 versus VDPHL). In any case, this product is still a few years away from reaching the market assuming successful trial results. Note that VDPHL likely stands for Veradermics Pattern Hair Loss.

The tablet does not impact hormone levels as do dihydrotestosterone (DHT) inhibitors finasteride and dutasteride. Thus avoiding potential side effects. Veradermics’ CEO is a young dermatologist named Reid Waldman.

Modified Release/Extended Release Oral Minoxidil

The mechanism of action (MOA) and key ingredient(s) in this tablet are both confidential. However, when I searched through the company’s patent, it seems like the drug candidate will be a “modified release” oral minoxidil tablet. In the patent, they use the term “extended release (ER)”.

Note that they do not use the term “sublingual minoxidil” anywhere in the patent. Also, I wonder how they will be able to differentiate from the existing oral minoxidil based “Hairy Pill” from Australian dermatologist Dr. Rodney Sinclair’s company?

Other Potential Ingredients in VDPHL

In the patent, they also have a massive list of 191 claims. Within that section, all of the following drugs are listed 11 times each:

  • Setipiprant (11 times).
  • Valproic acid (11 times).
  • Cetirizine (11 times).
  • Medrogestone (11 times).

For long time readers of this blog, setipiprant (and Kythera) will ring a bell. It caused so much excitement a decade ago. I cannot believe that the very optimistic 9-yr old audio interview with Kythera’s CEO is still online. Setipiprant is an oral antagonist to the prostaglandin D2 (PGD2) receptor.

I covered valproic acid and hair growth in detail in the past. Follica also has a patent that covers valproic acid and hair regrowth. Valproic acid activates the Wnt/β-catenin signaling pathway.

Cetirizine is a PGD2 inhibitor that has been shown to benefit hair growth even when used topically.

I have never covered medrogestone on this site before. Per Wikipedia, it is a progestin that is an agonist of the progesterone receptor and a weak anti-androgen. Progesterone is a female sex hormone that has beneficial properties towards hair growth.