The US Food and Drug Administration (FDA) has accepted Juno Therapeutics' Investigational New Drug (IND) application for JCAR017 for treatment of patients with relapsed/refractory (r/r) B cell non-Hodgkin lymphoma, or NHL.
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.
The IND enables Juno to initiate a multi-center phase I trial exploring JCAR017 for r/r NHL, scheduled to begin in 2015, with the potential to advance to a registration trial in 2016.
"Based on the encouraging results of JCAR017 in paediatric 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."
In collaboration with Seattle Children's Research Institute, Juno continues to investigate JCAR017 in paediatric patients with r/r acute lymphoblastic leukemia (ALL). Results of a phase I study to date demonstrated 91 per cent of patients achieved a complete remission, all of which were documented by flow cytometry. Adverse events were consistent with what has been previously reported. The results were presented in an oral presentation at the American Association for Cancer Research (AACR) annual meeting 2015 in Philadelphia.
Juno's chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognise and kill cancer cells. Juno's CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognise cancer cells based on the expression of a specific protein located on the cell surface. Juno's TCR technology provides the T cells with a specific T cell receptor to recognise protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.