FDA Accepts Application from Juno for CAR T-Cell Treatment

Juno Therapeutics, a biopharmaceutical company focused on stimulating the body's immune system as a means to treat cancer, has announced that the U.S. Food and Drug Administration (FDA) accepted the Company's investigational new drug (IND) application for JCAR017, intended for patients with relapsed or refractory B cell non-Hodgkin's lymphoma.

JCAR017 is a chimeric antigen receptor (CAR) T cell product candidate targeting CD19, a protein expressed on the surface of most B cell leukemias and lymphomas.

This IND allows Juno to begin a multi-center Phase I trial exploring JCAR017 for relapsed or refractory non-Hodgkin's lymphoma beginning sometime in 2015, with the potential to advance to a registration trial in 2016.

"Based on the encouraging results of JCAR017 in pediatric acute lymphoblastic leukemia, we are excited to begin investigating this product candidate in non-Hodgkin lymphoma," said Mark Frohlich, M.D., Juno EVP of development and portfolio strategy. "FDA acceptance of the JCAR017 IND for this multi-institutional study is an important milestone for Juno. Together with our planned fully-human CD19 CAR-T cell trial, combination study with AstraZeneca's anti-PDL-1 antibody, and ongoing translational clinical trial with JCAR014, it will provide important biologic insights that will inform our future strategies."

Juno will collaborate with Seattle Children's Research Institute investigating JCAR017 in pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Results of a Phase I study to date demonstrated 91 percent of patients achieved a complete remission. These results were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2015 in Philadelphia.

Source: MarketWatch