Mallia selects Northway to produce alopecia therapy

Backed by new financing, German Mallia Therapeutics (Erlangen) and Vilnius-based CDMO Northway Biotech have started to co-develop a scalable production process of Mallia’s soluble CD83 protein (sCD83), a treatment aimed at promoting hair follicle formation and growth.

Under the agreement, Northway Biotech will leverage its expertise in biologics manufacturing to develop the production process for the recombinant sCD83 protein for large scale production, utilising a Pichia pastoris expression system. This collaboration includes the development of analytical methods, technology scale-up, and the manufacturing of a cGMP drug substance.

“Preclinically, sCD83’s mode of action induced both the formation of new hair follicles, and thus hair growth, and has the potential to redefine treatment approaches for hormone-induced androgenetic alopecia as well as immune-mediated alopecia areata,” said Alexander Steinkasserer, co-founder and Managing Director of Mallia.

sCD83 shows a dual mechanism of action to preserve hair and induce new hair follicles: 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