It seems like MalliaBioTech will now be known as Mallia Therapeutics (Germany). The company was officially founded in June 2023.
Update: June 18, 2024
Mallia Therapeutics expects to start 150-person clinical trials at the beginning of 2025.
Update: July 11, 2023
Mallia Therapeutics Secures Seed Funding
Mallia Therapeutics (previously MalliaBioTech) finally has a website. Moreover, the company just announced that it has raised seed funding. They now plan to raise Series A funding prior to beginning clinical trials.
The company is developing a soluble CD83 (sCD83) based topical treatment of hair loss.
This sCD83 has an immune-modulatory function and induces hair growth via a dual mode of action:
- It induces an anti-inflammatory environment around the hair follicles via regulatory T cells (Tregs). These interact with follicular stem cells and activate hair growth.
- It directly binds to follicular stem cells and induces the formation of new hair follicles. So sCD83 not only prevents hair loss and accelerates growth, but also induces the growth of new hair.
Moreover, this treatment will supposedly work for both androgenetic alopecia (AGA) and the less common alopecia areata (AA).
Key quote (slightly reworded):
“The company is led by world leading experts in the field of CD83, with more than 60 CD83-related publications and 20 years of relevant experience.”
November 4, 2021
A new biotech company in Germany named MalliaBioTech is working on a topical hair loss treatment based on the CD83 molecule. Thanks to “Marcus” and “James” for sending me several of the below links.
CD83 and Hair Loss
On October 27, the Friedrich-Alexander University (FAU) in Germany published an important page on their site titled:
“FAU project wins funding for remedies against hormone-related hair loss.”
An soluble CD83 based active ingredient newly developed at FAU leads to new hair growth. The FAU researchers from the Department of Immunomodulation and the Department of Dermatology at the University Hospital Erlangen received the m4 Award for this project on October 21, 2021.
So far, this CD83 (see gene card) based active ingredient has not shown any side effects in pre-clinical studies. The video of this work can be found in this article.
MalliaBioTech
The research team is led by Dr. Alexander Steinkasserer, who I e-mailed for more information. His co-researchers include Dr. Dmytro Royzman and Prof. Dr. Carola Berking. Their new company is called MalliaBioTech, and it received EUR 500,000 via the m4 Award. It is officially called the m4 Award from the state of Bavaria.
“The new product has the potential to conquer the large unfulfilled market of hair loss.”
In contrast to existing hair loss treatments Finasteride and Minoxidil, this topical treatment based on a soluble form of the CD83 molecule:
“Stimulated the formation of new hair follicles and thus induces new hair growth.”
While the current pre-clinical work is in mice and yet to enter human clinical trials, this research represents yet one more new method to tackle androgenetic alopecia. We read about at least five such major new hair loss cure related discoveries every year, so reader skepticism is warranted.
When I first heard about CD83 for hair growth, I assumed it would be for alopecia areata. This is due to the frequent use of the word “immune” in tandem with CD83. However, the new German research clearly indicates that this treatment will work for hormonal hair loss (aka male pattern baldness).
If someone speaks German, please translate the scientific portions of the video at the bottom. Thanks.
I will try it.
Translation from the video:
Prof. Steinkasserer was actually researching for proteins to treat MS. They were surprised when they found out that the protein induced hair growth in mice. The animals got a higher hair density. Further research showed that they even created brand new hair follicles. 3 times more new hair follicles than the untreated mice. Right now they are testing the CD83 in humans. If they get the same positive effect of it, clinical trails might start in 4 to 5 years. Its gonna be topical.
That is everything important I guess. On the screen they show the hair follicles which are growing at the moment, induced by the protein.
I hope my English is good enough.
Thanks Georg! The 4-5 years start date estimate seems odd, but the 3x hair growth is good to hear.
Yeah but serioiusly everything does grow hair on mice. Its actually difficult to find something which doesn’t haha.
Its already strange that they still get money to research for growing hair on mice.
I hope so much that riken will be fast… But since they don’t even have found a partner for clinical trials…
This is great news because hair follicle neogenesis is a conserved process between mouse and humans. Traditional hair growth in mice is usually hair elongation and shaft thickness. Those are indicators researchers look for because Mice do not have androgenic alopecia . so it’s very very exciting that this molecule was able to induce hair follicle neogensis which is something we rarely if ever see .
Who knows… maybe just like finasteride… the best hair loss treatment twill once again come as an unexpected result while being tested for other morbidities.
Hi Georg – I don‘t think that Dr. Steinkasserer said they are testing in humans (that’s completely unrealistic right now and would be almost equal to a clinical trial) but something like „Humansystem“ (it‘s hard to understand). So in my opinion he means a traditional „in vitro“-testing, which is the logical next step.
I would add one thing: they said that completely new follicles emerged, and that in pretty big numbers – so I think we are talking about neogenesis.
The 4 – 5 years seem to be a very conservative timeline for a topical. I would expect something like 2 years maximum. See Samumed or Follicum. That’s why I find it very alluring, but completely uninteresting from a standpoint of availability.
Hey.
He is talking about testing it in human systems yes.
They figured out that the molecule triggers new hair follicles to grow IN MICE. They think first trials might be possible in 4-5 years.
Yeah even if it works won’t be available before what..15 years from now…i.can go hang myself.
Promising. I wish it wouldn’t take a decade or more like I’m sure it will to find out if it works on humans and, if it does, get it into our hands. These things take forever. Still, it’s good news. Something to add to the list of maybes.
Unrelated to hairloss at the moment but maybe of big interest in the future: Demis Hassabis founded a new company together with Google. Based on Deepmind‘s research regarding protein folding, Alphafold.
https://www.isomorphiclabs.com/
Fascinating!
Can they use the AI drug development system right away or does that have to go through FDA approval…?
BIG NEWS GUYS!
After more than a decade, Replicel has finally…
…named their dermal injector: DermaPrecise!
https://twitter.com/DermaPrecise
I’m optimistic that within the next 5-20 years we can expect an official name for RCH-01.
Holy they are on fire now!
“Clinical trails might start in 4 to 5 years”. Meanwhile, no hair transplant surgeons are willing to test FDA approved veterporfin on a patient.
Verteporfin has very limited potential use. Basically it’s only use would be to improve donor areas by stimulating follicle neogenesis post extraction. It doesn’t have a topical application. Right now there are a number of well known modalities for this such as ACell, PRP, PRF, etc. There are very few patients that would be willing to undertake the use of verteporfin for this, especially if they will also be paying for the surgery themselves. Most Hair transplant surgeons are interested in doing Hair Transplants for profit, not research.
If this company said their treatment was contagious like covid they could fast track it and come out with a billion doses sent globally in less than a year lol. I don’t have hope for this company especially when they said 4 years till trials. Why even bother put a press release out of trials are half a decade away lol. Stupid. History repeats itself with mpb industry. The only hope I have is a company out of nowhere that we know nothing about comes out with a drug side effect of massive hair growth and they commercialize it. Just like min and fin. All the drugs that were created for mpb have failed miserably. Happy Friday all:)
Agreed. Have a great weekend mjones.
Well this situations seems similar. The researchers were testing a molecule to treat MS and stumbled across hair neogenesis albeit on mice.
I understand how the process works, but really, there are thousands (perhaps hundreds of thousands) that would sign up for testing right now – and sign whatever was needed. Heck, they’d do a video staring whatever these folks wanted to ensure they couldn’t sue etc. Do the testing on humans already! I’ll never understand why it takes six to ten years to get to human trials. The red tape and approval process must be insane in some countries. It’s sure there is good reason for it but come on.
True! We would be faster if we buy it our selfs and try it like RU.
Any1 seen this min/fin spray topical we have in the Uk? Un-Thin it’s called:
https://unthin.co.uk/
Got this in my alerts:
https://mallia-therapeutics.com/
New website online. Haven’t had the time to read it all yet, but looks good so far. A clear, informative and official communication tool (in form of a website) builds a lot of trust imho.
Admin, maybe you can break it down for us.
Thanks Ben! They are yet to begin Phase 1 trials, but I still republished the post with the update. Interesting based on the team’s relevant and long-term CD83 experience.
Me likey. Also of course hoping for more than 3x new hair follicle growth (3 x 0 is still 0…exaggerating a bit but you know what I mean).
https://www.laborjournal.de/editorials/3043.php
Newish interview, nothing new though. They seem incredibly slow to me, as if they‘ve done nothing since 2021? If you can’t even set up phase 1 with 30 participants in 3 years, than all
hope is lost. Very unfortunate.
It’s a pity as Mallia’s tech sounds like a really good approach.
I‘ve been a little too pessimistic in my last post. A few updates and keypoints from Germany:
• new funding of 2 million € in two tranches
• will be used for production of sCD83
• sCD83 clearly induces new hair, not just reactivation of dormant hair
• sCD83 is well known with an excellent safety profile
• CD83 is a endogenous protein which guarantees a faster development and route to market. The release as a cosmetic is also possible. It‘s considered to be available within a reasonable time frame.
• Next step is human application in 2025
Hi Ben, where did you find this info? Do you have a link?
Yes sure!
https://www.goingpublic.de/wp-content/uploads/epaper/epaper-Life-Sciences-2-2024/#94
Page 94, it’s in German though.
Great, thanks Ben! … Thats OK I am German :-)
I think thats the most positive news I have read since a long time. Sounds all very encouraging. They clearly say it can come as Cosmetics and Trial starts in 2025. So my guess would be they plan to do a Phase 1 and try to marked a Cosmetics after the Phase 1. Other companies do it the same way like Olix for instance.
Yes, I’m cautiously optimistic too.
This could be a really effective treatment, especially if it is neogenesis (which would be completely novel; except Verteporfin or Scube3 possibly).
In this case you might accumulate gains with every treatment cycle. A combination with microneedling might enhance effects too, but that’s purely speculative from my side.
Minor news:
https://mallia-therapeutics.com/mallia-therapeutics-and-northway-biotech-announce-partnership-for-the-manufacturing-of-soluble-cd83-protein-for-hair-loss-treatment/
I‘ve just reread the article admin posted above – Dr. Steinkasserer said in that interview that 3 people tested the substance twice a week (topical application) for four months – he then showed pictures to the journalist stating „more hair, no question“. That sounds absolutely great, though how can they test it in humans in such a uncontrolled way and without any permission? I think that’s against every code of ethics in the scientific community…I am sure this happens all the time behind closed doors, but to mention that to a journalist in such a nonchalant way is rather unusual. They at least must be certain that it’s very safe…
Anyhow, a great contender, and I still believe that sCD83 combined with microneedling can be an absolute gamechanger as I also went through their research regarding wound healing – which was the initial target for Mallia‘s molecule.
Top 5 hairloss company imho.
Thanks Ben.
Thanks Ben. Hopefully they are able to release it as a cosmeceutical in a few years.
I have no clue about timelines, they announced it could be marketed as a cosmeceutical, yes.
Sometime I think that is only to please potential investors, as it is a much quicker and cheaper route. If they have to finance 3 phases then I doubt they’ll survive.
CD83 is endogenous and probably not patentable – but its soluble version might be though. It’s supposed to be very safe…twice weekly topical application over 4 months had visible results. So daily over a longer period could be even better. Plus the from me suspected superior effect with microwounding/needling.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9564224/