Manfred Gröppel (Mallia Therapeutics GmbH)

Gröppel, Manfred (Mallia Therapeutics 202307 CEO + Co-Founer before Immunic + 4SC)

	Organisation	Mallia Therapeutics GmbH
	Former/major organisation	Immunic Inc. (Nasdaq: IMUX)
	Group	Immunic (Group)
	Product	sCD83 (Mallia Therapeutics, soluble form of human CD83 protein)
	Product 2	immunotherapy

Mallia Therapeutics GmbH. (7/11/23). "Press Release: Mallia Therapeutics Secures Seed Funding for its Novel Topical Treatment to Induce Hair Growth via Immune Modulation". Erlangen.

> Topical treatment with the human immune-modulating soluble CD83 protein (sCD83)

> sCD83 induces hair growth and new hair follicles via dual mode of action

> Non-systemic treatment represents a promising strategy for both, hormone-induced androgenetic alopecia as well as autoimmune-mediated alopecia areata

> Company co-founded in June 2023 by Prof. Dr. Alexander Steinkasserer, a leading expert in CD83 biology who discovered sCD83 as an important immune modulator, and biotech expert Dr. Manfred Groeppel

> Promising preclinical and ex vivo human data presented at European Hair Research Society (EHRS) meeting

> Selected by High-Tech Gründerfonds as participant at upcoming Munich Life Science Pitch Day on July 13

Mallia Therapeutics GmbH, a biopharmaceutical company developing soluble CD83 (sCD83) for the treatment of hair loss, today 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.

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.”

About sCD83

sCD83 is an immune-modulatory protein that is in development for the topical treatment of hair loss. First identified in 2001 by Mallia co-founder Prof. Dr. Steinkasserer, the soluble protein induces resolution of inflammation, propagates wound healing and induces new hair growth. Several preclinical in vivo models have shown that sCD83 activates regulatory T cells (Tregs), which can directly interact and activate hair follicles. In addition, sCD83 directly binds to hair follicles thereby activating hair follicle stem cells and thus inducing new hair growth.

sCD83 can be applied topically to reach the hair follicle, which is a big advantage compared to systemic treatment options. Mallia Therapeutics develops the dual mode of action of sCD83 for the treatment of hormone-induced male or female pattern baldness (= androgenetic alopecia) and autoimmune mediated male or female patchy hair loss (= alopecia areata), the two most prevalent forms of hair loss.

Androgenetic alopecia is the most common type of alopecia. It typically occurs gradually and is related to genetic and hormonal factors. In men, it often results in a receding hairline and baldness on the top of the head, while in women, it leads to thinning hair on the crown of the head. Alopecia areata causes patchy hair loss on the scalp, face, or other parts of the body. It occurs when the immune system “mistakenly” attacks hair follicles, resulting in an autoimmune mediated hair loss.

About Mallia Therapeutics GmbH

Mallia Therapeutics GmbH is a biopharmaceutical company focused on developing novel treatments for patients suffering from hair loss. The Company was founded in 2023 in Erlangen, Germany, and is led by an experienced management team and worldwide leading experts in the field of CD83, with more than 60 CD83-related publications and 20 years of experience in the field.

With sCD83, a potential treatment for hair loss in preclinical development, Mallia aims to enter the multi-billion-dollar alopecia market and provide patients with a safe and effective topical treatment.

Connect with us on LinkedIn or find out more here: https://mallia-therapeutics.com/

Contact Information

Dr. Manfred Groeppel
Founder & Managing Director
E-Mail: IR@mallia-therapeutics.com

Media contact:

MC Services AG
Dr. Regina Lutz / Katja Arnold
Tel.: +49 (0)89 210 228 0
E-Mail: mallia-therapeutics@mc-services.eu