Cell therapy weekly: Reversing alopecia by reawakening dormant stem cells
This week: the Europe-wide project JOIN4ATMP has been set up to overcome the low clinical approvals of cell and gene therapies in Europe, CellProthera (Mulhouse, France) has collaborated with Shonan Kamakura General Hospital (Kamakura City, Japan) researchers to manufacture therapeutic autologous endothelial progenitor cells and Pelage Pharmaceuticals (CA, USA) has raised US$16.75 million with the intention of curing several forms of alopecia.
The news highlights:
- JOIN4ATMP: Europe-wide initiative to overcome regulatory hurdles for advanced therapies
- CellProthera collaborates with Shonan Kamakura General Hospital to advance cell therapy for ischemic and renal diseases
- Pelage Pharmaceuticalss raises $16.75 million in pursuit of an alopecia cure
JOIN4ATMP: Europe-wide initiative to overcome regulatory hurdles for advanced therapies
Despite sufficient development of cell and gene therapies in Europe, strict regulatory requirements hinder their clinical approval.
Consequently, a Europe-wide project called JOIN4ATMP has been established and will be coordinated by Charité Universitätsmedizin Berlin (Germany). The project will identify the obstacles that are preventing patient access to these therapies to improve their progression to the clinic.
“Our goal is to devise concrete recommendations for how patients in Europe can gain access to innovative gene and cell therapies faster,” remarked Annette Künkele-Langer of Charité Universitätsmedizin Berlin. “To that end, we are bringing knowledge and experience in preclinical development, production, clinical testing, market approval and reimbursement of [advanced therapy medicinal products] together Europe-wide and analyzing the obstacles and how they can be overcome at the medical, regulatory and economic levels.”
CellProthera collaborates with Shonan Kamakura General Hospital to advance cell therapy
CellProthera, a clinical-stage regenerative cell therapy developer, will partner with researchers from Shonan Kamakura General Hospital to manufacture autologous endothelial progenitor cells to treat ischemic and renal diseases.
Leveraging the expertise of Shonan Kamakura General Hospital scientists and CellProthera’s cell culturing technology and advanced automated manufacturing platform called StemXpand, endothelial progenitor cells will be produced for forthcoming clinical trials.
“Ischemic diseases remain one of the leading causes of death in Japan, with limited treatment options,” commented Takayuki Asahara, Deputy Director of the Shonan Research Institute of Innovative Medicine at Shonan Kamakura General Hospital. “We hand-picked CellProthera for collaboration based in part on how StemXpand, a tried and trusted technology, will help us meet the needs of patients with ischemic diseases through our development of targeted stem cell therapies.”
Pelage Pharmaceuticals raises $16.75 million in pursuit of an alopecia cure
A recent Series A funding round has raised US$16.75 million for Pelage Pharmaceuticals to advance a cure for several forms of alopecia, including pattern baldness and chemotherapy-induced hair loss.
This occurs following the successful Phase I trial for PP405, a small molecule that reactivates dormant hair follicle stem cells to restart hair growth through inhibition of the mitochondrial pyruvate carrier. A Phase II clinical trial is forecast to begin in mid-2024.
“What we’ve observed is that in people who experience hair loss, the actual hair follicle stem cells are still present but have reverted to a dormant state. We have uncovered a small molecule able to stimulate cellular metabolism to re-awaken hair follicle stem cells and spur new hair growth,” said William Lowry, scientific co-founder of Pelage Pharmaceuticals.
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