News

Abeona poised to seek FDA approval of EB-101

Abeona Therapeutics is preparing to request U.S. approval of EB-101, a cell therapy candidate for treating recessive dystrophic epidermolysis bullosa (RDEB). The announcement follows a successful pre-biologics license application (BLA) meeting with the U.S. Food and Drug Administration (FDA). “With the constructive feedback from the FDA now in-hand,…

Paradigm Therapeutics acquires rights to SD-101 cream

Paradigm Therapeutics has acquired worldwide rights to SD-101, an investigational cream that’s being developed as a whole-body therapy to promote wound healing and ease pain and itching in all forms of epidermolysis bullosa (EB). The company now plans to meet with the U.S. Food and Drug Administration (FDA)…

Biological therapies may help manage hard-to-treat EBA

The use of biological anti-inflammatory therapies effectively controlled epidermolysis bullosa acquisita (EBA) in four people with the disease, a recent study reports. “According to our clinical experience and literature data in severe EBA cases with rapid progress, biologicals should be considered promptly,” the researchers wrote. They added that the…

2 cases highlight immunotherapy challenges in RDEB-linked cancer

Researchers have highlighted the challenges of treating two cases of aggressive squamous cell carcinoma (SCC), a form of skin cancer associated with recessive dystrophic epidermolysis bullosa (RDEB), with immunotherapy when surgery was no longer an option. One patient, who had many genetic mutations within cancer cells, responded well to…

Abeona provides new data to FDA on EB-101 ahead of meeting

Abeona Therapeutics has submitted a data briefing package on its cell therapy candidate EB-101 to the U.S. Food and Drug Administration (FDA) ahead of a meeting with the agency planned for this month. The meeting’s purpose is to discuss Abeona’s planned application seeking approval of EB-101 to treat recessive …

EBA skin lesions recurred after COVID-19 vaccination: Case report

Lesions in the skin and mucosa in a 20-year-old woman with epidermolysis bullosa acquisita (EBA) came back years later, after a COVID-19 vaccination, according to a case report. While rapid development of skin disease after receiving vaccinations had been reported, this is the first case of possible EBA with autoantibodies…

Funding call launched for projects seeking to repurpose therapies

LifeArc and DEBRA Austria have launched a £2.5 million (around $3.3 million) funding call for projects that seek to repurpose therapies for epidermolysis bullosa (EB). Treatment repurposing consists of identifying new therapeutic use for approved medicines. It is an alternative approach to the traditional process of developing…

Skin stem cell therapy helped prevent new wounds in RDEB

People with recessive dystrophic epidermolysis bullosa (RDEB) developed fewer new wounds after getting treatment with skin-derived mesenchymal stem cells, a new clinical trial analysis shows. The treatment also led to newly developed wounds healing more quickly, and healed wounds more frequently remained closed. The study, “Kinetics of…

C5aR2 protein in neutrophils may drive inflammation in EBA

New study findings show how the complement system C5aR2 protein at the surface of neutrophils, a type of immune cell, may contribute to the progression of the rare autoimmune disease epidermolysis bullosa acquisita (EBA). Mice lacking C5aR2 specifically at the surface of neutrophils had lessened inflammation. “Signaling through C5a receptors induces…