Juno Therapeutics Inc (JUNO) Announces FDA Clearance of IND Application for JCAR015 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

Juno Therapeutics Inc (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) application for JCAR015 for treatment of adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The IND enables Juno to initiate a multi-center, pivotal Phase 2 trial evaluating JCAR015 in patients with r/r ALL. The trial is scheduled to begin in the near term, with the potential to file for registration by late 2016 or early 2017. JCAR015, Juno’s most advanced product candidate, 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.

“Based on the encouraging results of JCAR015 in its Phase 1 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,” said Mark Frohlich, M.D., Juno EVP of development and portfolio strategy. “FDA clearance of the JCAR015 IND for this pivotal Phase 2 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 titled “Protocol 015001: A Phase 2, single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (The ROCKET Study).” The primary objective of this trial is to evaluate the efficacy of JCAR015 as measured by overall remission rate in subjects with morphologic evidence of disease (5% or more leukemic blasts in the bone marrow). The trial will also evaluate the safety and tolerability of the therapy. The study will open at 14 clinical sites in the U.S. and enroll approximately 90 subjects in order to achieve 50 subjects with morphologic disease following salvage chemotherapy. (Original Source)

Following the FDA Clearance news, shares of Juno Therapeutics are up 1.48% in after-hours trading. JUNO has a 1-year high of $62.50 and a 1-year low of $34.71. The stock’s 50-day moving average is $52.37 and its 200-day moving average is $50.89.

On the ratings front, Juno has been the subject of a number of recent research reports. In a report issued on June 30, J.P. Morgan analyst Cory Kasimov reiterated a Buy rating on JUNO, with a price target of $83, which implies an upside of 73.7% from current levels. Separately, on June 29, Maxim Group’s Jason McCarthy maintained a Buy rating on the stock and has a price target of $78.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Jason McCarthy have a total average return of 11.7% and 3.4% respectively. Kasimov has a success rate of 57.9% and is ranked #311 out of 3721 analysts, while McCarthy has a success rate of 46.2% and is ranked #1943.

Juno Therapeutics Inc is a biopharmaceutical company. The Company is engaged in revolutionizing medicine by re-engaging the body’s immune system to treat cancer.

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