Juno IND application given FDA nod for leukemia drug candidate JCAR015

Having secured the IND designation, the company now intends to start a multi-center, pivotal Phase II trial soon to evaluate JCAR015 in patients with r/r ALL.

Registration of the drug is likely to be filed by late 2016 or early 2017.

JCAR015 is an autologous chimeric antigen receptor (CAR) T cell immunotherapy targeting CD19, a protein expressed on the surface of most B cell leukemias and lymphomas.

Juno development and portfolio strategy executive vice-president Mark Frohlich said: "Based on the encouraging results of JCAR015 in its Phase I adult ALL trial conducted by Memorial Sloan Kettering Cancer Center, we are excited to begin Juno’s first pivotal trial investigating this product candidate in a multi-center study.

"FDA clearance of the JCAR015 IND for this pivotal Phase II trial is a significant milestone for the company, highlighting the early returns on the investments we have made in process development and manufacturing as well as providing clarity on a potential path toward our first product approval."

The initial trial to be conducted under this IND is a single-arm, multicenter Phase II trial to determine the efficacy and safety of JCAR015 in adults with relapsed or refractory b-cell acute lymphoblastic leukemia (The ROCKET Study).

The trial’s primary objective is to evaluate the efficacy of JCAR015 as measured by overall remission rate in subjects with morphologic evidence of disease.

Around 90 subjects, including 50 with morphologic disease following salvage chemotherapy, will be enrolled in the trial at 14 clinical sites in the US.