Juno Therapeutics Inc (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, announced the U.S. Food and Drug Administration (FDA) accepted the Company’s investigational new drug (IND) application for JCAR017 for 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 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.”
In collaboration with Seattle Children’s Research Institute, Juno continues to investigate JCAR017 in pediatric patients with r/r acute lymphoblastic leukemia (ALL). Results of a Phase I study to date demonstrated 91 percent 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. (Original Source)
Shares of Juno Therapeutics closed last Friday at $46.61 . 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 $52.43 and its 200-day moving average is $50.22.
On the ratings front, Juno Therapeutics has been the subject of a number of recent research reports. In a report issued on June 17, Maxim Group analyst Jason McCarthy initiated coverage with a Buy rating on JUNO and a price target of $78, which represents a potential upside of 67.3% from where the stock is currently trading. Separately, on June 1, J.P. Morgan’s Cory Kasimov reiterated a Buy rating on the stock and has a price target of $66.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Cory Kasimov have a total average return of 6.5% and 13.4% respectively. McCarthy has a success rate of 33.3% and is ranked #1869 out of 3681 analysts, while Kasimov has a success rate of 60.2% and is ranked #248.
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.