Precision BioSciences Receives FDA Authorization to Initiate Clinical Study of Gene Edited Cancer Immunotherapy
DURHAM, N.C.–(BUSINESS WIRE)–Nov 27, 2018–Precision BioSciences and Servier today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PBCAR0191, an allogeneic anti-CD19 CAR T therapy for B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL). Upon trial initiation, PBCAR0191 will be Precision’s first clinical-stage product candidate.
“Our allogeneic CAR T program has exceeded all expectations, moving from concept to IND acceptance in under three years,” said Matt Kane, Chief Executive Officer of Precision. “We are thrilled to have received authorization to initiate clinical studies for a therapy that we believe could be transformative for patients suffering with NHL and B-ALL.”
Precision’s PBCAR0191 is positioned to be the first gene-edited allogeneic CAR T product candidate in human clinical trials for NHL. Data provided to the FDA in connection with the IND submission included the results of in depth off target cutting analyses and evidence to support the elimination of graft versus host interactions. Manufacturing data were provided to the FDA in support of the scalability and reproducibility of the T cell genome editing production process. Precision is currently producing clinical trial material at full scale with its manufacturing partner.