Company Product Description Indication Status
Abeona Therapeutics Inc., of New York EB-101 Autologous, gene-corrected cell therapy Recessive dystrophic epidermolysis bullosa FDA removed clinical hold after company submitted additional data points on transport stability of the therapy; study expected to begin in the first quarter of 2020
Aptevo Therapeutics Inc., of Seattle APVO-436 Bispecific antibody targeting CD123 and CD3 Acute myelogenous leukemia FDA granted orphan drug designation
Galderma SA, of Lausanne, Switzerland Nemolizumab Monoclonal antibody targeting IL-31 receptor alpha Prurigo nodularis FDA granted breakthrough therapy designation
Gensight Biologics SA, of Paris Lumevoq (GS-010) Gene therapy Leber hereditary optic neuropathy French Competent Authority, the National Drug Safety Agency, granted a named patient temporary authorization for use to the National Eye Hospital of the Quinze-Vingts
Iontas Ltd., of Cambridge, U.K., and International Biotechnology Center Generium, of Moscow Undisclosed CD3/CD19 bispecific antibody Acute lymphoblastic leukemia Received approval from the Russian Health Authorities to initiate clinical trials
Janssen Pharmaceutical Co., of Raritan, N.J., a unit of Johnson & Johnson JNJ-68284528 (JNJ-4528) CAR T targeting B-cell maturation antigen Previously treated patients with multiple myeloma FDA granted breakthrough therapy designation
Sesen Bio Inc., of Cambridge, Mass. Vicinium  Fusion protein that targets epithelial cell adhesion molecule and delivers Pseudomonas exotoxin A BCG-unresponsive non-muscle invasive bladder cancer Started rolling submission of BLA to the FDA

Notes

For more information about individual companies and/or products, see Cortellis.

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