Shanghai, China (Press Release) – CARsgen Thera­peutics Co., Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, to­day an­nounced the Euro­pean Medicines Agency (EMA) Com­mit­tee for Orphan Medicinal Products (COMP) adopted a pos­i­tive opinion on CARsgen's appli­ca­tion for orphan desig­na­tion of its inves­ti­ga­tional CT053 CAR T-cell ther­apy, fully human anti-BCMA (B cell maturation an­ti­gen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T cells for the treat­ment of mul­ti­ple myeloma. CT053 was pre­vi­ously granted orphan drug desig­na­tion by the US Food and Drug Admin­istra­tion in August 2019.

"The COMP's adoption of a pos­i­tive opinion for CT053 orphan drug desig­na­tion is another im­por­tant recognition of CARsgen's com­mitment to the de­vel­op­ment of its poten­tial best-in-class CAR T cell ther­apy for the treat­ment of mul­ti­ple myeloma," said Zonghai Li, M.D., Ph.D., Chief Executive Officer of CARsgen. "We look for­ward to work­ing closely with the EMA under the recently granted PRIME eligibility and continuing the clin­i­cal de­vel­op­ment of CT053 in Europe."

The pos­i­tive opinion issued by COMP will be sent to the Euro­pean Com­mis­sion, which is ex­pec­ted to grant the orphan desig­na­tion within 30 days. EMA orphan drug desig­na­tion helps sup­port the de­vel­op­ment of new treat­ments for rare con­di­tions, those affecting not more than five in 10,000 people in the EU, that are life-threatening or chronically debilitating. Medicines that meet the EMA's orphan desig­na­tion criteria qualify for incentives to en­cour­age ad­vancement of drug de­vel­op­ment.

About CARsgen Thera­peutics, Co., Ltd.

CARsgen Thera­peutics is a clin­i­cal-stage immune-oncology com­pany com­mit­ted to the de­vel­op­ment and com­mer­cial­iza­tion of CAR T-cell thera­peutics for unmet med­i­cal needs. The com­pany has col­lab­o­rated with top hos­pi­tals in China to launch several other first-in-human stud­ies such as anti-GPC3 CAR T cells for hepato­cellular carcinoma and squamous lung cancer, anti-EGFR/EGFRvIII CAR T cells for glio­blas­toma multiforme and anti-claudin18.2 CAR T cells for gastric and pancreatic cancer.

For more in­for­ma­tion, please visit: www.carsgen.com

Source: CARsgen Thera­peutics.