Precision BioSciences Receives FDA Acceptance of IND for PBCAR269A, a CAR T Therapy for Multiple Myeloma

Jan 16, 2020 | Hematology, Leading Pharma, News, Oncology, Pharma Watch

Precision BioSciences Receives FDA Acceptance of IND for PBCAR269A, a CAR T Therapy for Multiple Myeloma

Precision BioSciences announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PBCAR269A, the Company’s third allogeneic chimeric antigen receptor (CAR) T cell therapy candidate. The FDA has also granted Orphan Drug Designation to PBCAR269A for the treatment of multiple myeloma. 

Precision plans to initiate dosing in a Phase 1 clinical trial in 2020. The multicenter, open-label dose-escalation and dose-expansion clinical trial will enroll adult relapsed/refractory multiple myeloma patients. The trial will be conducted at multiple U.S. sites.

“In preclinical disease models, PBCAR269A has demonstrated no evidence of graft-versus-host disease at doses that resulted in potent anti-tumor activity,” commented Chris Heery, Chief Medical Officer of Precision BioSciences. “There remains significant unmet need in the treatment of relapsed/refractory multiple myeloma, and we are excited to begin clinical trials with an off-the-shelf CAR T therapy candidate in this setting.”

About PBCAR269A

PBCAR269A is an allogeneic CAR T therapy candidate which targets the B-cell maturation antigen (BCMA).

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