This significant milestone follows the FDA’s Fast Track designation of SEL-212 in
“We are very pleased to initiate the rolling submission of the BLA for SEL-212, bringing Sobi one step closer to providing a potential new, effective treatment option for patients with chronic refractory gout,” said
SEL-212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which can lead to gout flares and joint deformity when left untreated. Sobi licensed SEL-212 from Selecta Biosciences (NASDAQ:) (now Cartesian Therapeutics) in
About SEL-212
SEL-212 is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, Selecta’s proprietary pegylated uricase, co-administered with ImmTOR™, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout.
About Chronic refractory gout
Gout is the most common form of inflammatory arthritis with more than 8.3 million people in
About Cartesian Therapeutics
Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in phase 2b clinical development for patients with generalised myasthenia gravis. Additional phase 2 studies are planned in systemic lupus erythematosus under an allowed IND, as well as basket trials in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T.
About Sobi ®
Sobi ® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi has approximately 1,800 employees across
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Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout |
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