Vitiligo is caused by autoreactive CD8+ T cells that react against skin melanocytes, where IL-15 has been shown to activate these T cells. Innovent Biologics (Suzhou) Co. Ltd. recently presented data on their monoclonal antibody (mAb) – IBI-3013 – that targets IL-15. IBI-3013 was evaluated in vitro in immune cell expansion and CD8 T-cell activation assays, as well as in vivo in a skin inflammation model and in a graft-vs.-host disease (GVHD) model.
Regenerative medicine company Avita Medical Inc. raised AU$23 million (US$15 million) through a private placement on the Australian Securities Exchange (ASX:AVH) to support growth of its Recell therapeutic acute wound portfolio. Funds raised will support continued growth of the company’s therapeutic acute wound portfolio and will cover operations through 2026.
European biotech investor Medicxi announced the closure of its fourth fund at $400 million, a sum it said is “deliberately sized” for its asset-focused investment model.
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.
Incyte Corp. has agreed to acquire Villaris Therapeutics Inc., the developer of a monoclonal antibody for vitiligo that aims to treat a larger proportion of the skin than an available topical cream, for $70 million up front, plus up to $310 million in potential development and regulatory milestone payments. The deal includes up to $1.05 billion in commercial milestones on net sales of auremolimab, a preclinical MAb that works against IL-15Rβ and is expected to reach the clinic in 2023.
Prospects for Zerigo Health Inc. brightened with a series B fundraising round that brought in $43 million to support expansion of the company’s at-home ultraviolet B phototherapy system for chronic skin conditions. The connected system enables a physician to ensure the prescribed dose is delivered while freeing patients from the thrice-weekly office visits often required for treatment of psoriasis, vitiligo and eczema.
