Scientific advisory board tasked with setting path for fragile skin treatment
Stem cell therapy tracking for late-stage trial, regulatory submission
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Inmune Bio has assembled a scientific advisory board to help guide its development of Ebstrocel, a stem cell therapy designed to promote wound healing in people with the fragile skin disease RDEB, fully recessive dystrophic epidermolysis bullosa.
The newly formed advisory board will provide Inmune with advice ranging from clinical development strategies and trial design for Ebstrocel to biomarker analyses and product release criteria, according to a company press release announcing its creation. Its members are “global experts in [stem cell] clinical translation,” per the company.
Chaired by Mark Lowdell, PhD, Inmune’s cofounder and chief scientific officer, the board will also weigh in on the development of additional treatments using Inmune’s cell therapy platform, known as CORDStrom.
“Importantly, this will be a working advisory board with defined development priorities,” Lowdell said. “The [advisory board] will help us strengthen the scientific, clinical and regulatory package supporting Ebstrocel, advance its late-stage development, and prioritize additional indications that are best suited to the differentiated biological and manufacturing capabilities of the CORDStrom platform.”
Joining Lowdell on the advisory board will be four expert scientists: Katarina Le Blanc, MD, PhD, a professor at the Karolinska Institute in Sweden; Anna Martinez, a pediatric dermatologist at Great Ormond Street Hospital and clinical lead of the U.K.’s National Epidermolysis Bullosa Service; Sowmya Viswanathan, PhD, a professor at the University of Toronto in Canada; and Daniel J. Weiss, MD, PhD, a professor at the University of Vermont Larner College of Medicine and president of the International Society for Cell and Gene Therapy.
“We have assembled four internationally recognized leaders whose experience spans the entire development continuum, from MSC biology and manufacturing to clinical-trial design, regulatory strategy and the treatment of patients with RDEB,” Lowdell said.
Stem cell therapy eased pain, itching in children
RDEB is a genetic disorder that causes skin to be abnormally thin and fragile, leading to blistering and wounds that don’t heal well. Ebstrocel uses a specific type of stem cell, called mesenchymal stem cells or MSCs, to aid in wound healing. The MSCs used in the infusion therapy are derived from donated umbilical cord tissue.
Inmune recently announced it has readied commercial-grade manufacturing for the cell therapy platform. The company is aiming to seek regulatory approval based on data from a Phase 1 clinical trial dubbed MissionEB (ISRCTN14409785). Its results showed that Ebstrocel eased pain and itching in children with RDEB.
The developer is also gearing up for a Phase 3 clinical trial to further test Ebstrocel in RDEB.
“CORDStrom is entering an important phase in its development, with Ebstrocel advancing toward regulatory submissions and the broader platform offering the potential to generate additional disease-specific cell medicines,” Lowdell said.
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