Novel Topical Treatment to Induce Hair Growth via Immune Modulation

Mallia Therapeutics Secures Seed Funding

19-Jul-2023 - Germany

Mallia Therapeutics GmbH, a biopharmaceutical company developing soluble CD83 (sCD83) for the treatment of hair loss, announced that the newly founded company secured its seed financing. The Company plans to develop the sCD83 candidate based on preclinical and ex vivo human data, presented at the 20th meeting of the European hair Research Society (EHRS) in Sheffield, UK, in June for the first time.

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Worldwide, over 50% of men as well as 50% of postmenopausal women  are affected by hormone-induced androgenetic alopecia (pattern baldness) and another 147 million suffer from autoimmune-mediated alopecia areata. Despite the high need for effective therapies, current treatments often do not induce new hair growth but only extend the life cycle of existing hair or work to systemically suppress the immune system with associated adverse effects including severe infections. Mallia expects to address both these shortcomings with sCD83 with a superior safety profile and a dual mechanism of action to preserve hair and induce new hair follicles.

sCD83, which was discovered as an immune modulator by Mallia co-founder Prof. Dr. Alexander Steinkasserer in 2001, is a naturally occurring soluble form of the human CD83 protein CD83. sCD83 has an immune-modulatory function and induces hair growth via a dual mode of action: Firstly, it induces an anti-inflammatory environment at the hair follicle via regulatory T cells (Tregs), which interact with follicular stem cells and thereby activate hair growth. Secondly, sCD83 directly binds to follicular stem cells where it induces the formation of new hair follicles. This way, sCD83 not only prevents hair loss and accelerates growth like current marketed topical treatments but induces the growth of new hair.

Prof. Dr. Steinkasserer, co-founder and Managing Director of Mallia Therapeutics, and Head of the Department of Immune Modulation, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, said: “Since our first identification of sCD83, we have been investigating its regulatory function within the immune system. Our findings on its positive impact on hair growth and its striking ability to even activate the formation of new hair follicles have encouraged us to develop sCD83 as a treatment for people suffering from hair loss. Our preclinical results with sCD83 are very promising and show that its dual mode of action can lead to substantial new hair growth while our topical formulation penetrates to the hair root and the follicular stem cells but does not act systemically. This way, adverse effects that could result from systemic immune modulation could be avoided and have not been observed in our testing. While mostly regarded a cosmetical problem, hair loss can significantly affect a person’s mental well-being and even lead to anxiety or severe depression. We are therefore very motivated to bring a safe and effective treatment to people suffering from hair loss and are happy, that our scientific approach has yielded such promising preclinical results.”

In an oral presentation at the EHRS Conference, the co-founder and CSO of Mallia Therapeutics Dr. Dmytro Royzman presented data from a preclinical androgenetic hair loss model showing that sCD83 accelerated the hair growing phase (anagen phase) and induced new hair growth. In addition, using a human ex vivo system, sCD83 treatment prolonged the growing phase of human hair, and hair growth-associated pathways are induced. Further, sCD83 application led to the expansion of a stem cell population within the human hair follicles.

Dr. Manfred Groeppel, co-founder and Managing Director of Mallia Therapeutics, added: “After receiving a number of earlier project grants, Mallia Therapeutics recently successfully launched its seed funding to continue preclinical research. Based on our promising early data and the financial requirements to conduct a clinical trial, we plan to raise Series A funding promptly after the completion of the seed round. Therefore, we are pleased to have been selected to present at the Munich Life Science Pitch Day, a cooperation of the IZB Innovations- und Gründerzentrum Biotechnologie and the High-Tech Gründerfonds. Given the promising results of our ongoing preclinical studies including results using tissue samples from patients, we hope to move into the clinic and start treating patients within the next two years.”

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