Juno Therapeutics Inc (NASDAQ:JUNO) shares gained 9% after the company said it will present updated clinical and preclinical results from the company and its collaborators. The biotechnology company will make the presentation at the 59th American Society of Hematology (ASH) Annual Meeting. Senior executives will also review results and provide an update on Juno’s clinical development program at an analyst and investor event, which will also be available via webcast.
Juno shares reacted to the news, soaring nearly 9% to $48.99 in early trading Wednesday.
“The presentations at ASH will showcase promising data coming from our pipeline of CD19- and BMCA-directed CAR T cell product candidates,” said Sunil Agarwal, M.D., Juno’s President of Research and Development. “Results from the ongoing TRANSCEND study of JCAR017 in adults with aggressive lymphoma help advance understanding of cell therapy, providing new insights into the differentiation between CAR T products now reaching the market and Juno’s next-generation JCAR017, which we believe could offer a best-in-class clinical profile.”
Updated data from the TRANSCEND study of JCAR017 in patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) will be presented by Principal Investigator Jeremy Abramson, M.D., of the Massachusetts General Hospital, on December 11. The presentation will include new information on enrollment, safety, response rates, duration of response, and overall survival.
The primary TRANSCEND abstract released today includes data from the core analysis group (N=49), which includes patients that represent the population that Juno is studying in the ongoing pivotal cohort. The core group includes patients with DLBCL (NOS and transformed from follicular lymphoma) who are ECOG Performance Status 0-1. These patients represent a highly refractory population based on some key factors that are associated with a poor prognosis including an older age, having a double or triple hit, and being chemorefractory.
Topline data from the abstract for both dose levels for the core group as of a data cutoff date of July 7, 2017included:
- Dose level 2 (DL2 = 100 million cells), the dose in the pivotal cohort for the TRANSCEND study, showed a 3 month overall response rate (ORR) of 80% (12/15) and a 3 month complete response (CR) rate of 73% (11/15) in the core group. Data support a dose response relationship. Dose level 1 (DL1 = 50 million cells) showed 3 month ORR of 52% (11/21) and a 3 month CR rate of 33% (7/21).
- Across both doses in the core group, the best overall response was 84% (41/49) and the best overall CR rate was 61% (30/49).
- There was no increase in cytokine release syndrome (CRS) and neurotoxicity (NT) rates associated with the higher dose or between the full and core groups. Across doses in the full group, 1% (1/69) experienced severe CRS and 14% (10/69) experienced severe NT. 30% (21/69) had any grade CRS and 20% (14/69) had any grade NT. 64% (44/69) had no CRS or NT.
- The most common treatment-emergent adverse events other than CRS and NT that occurred at ≥25% in the full group included neutropenia (41%), fatigue (30%), thrombocytopenia (30%), and anemia (26%).
JCAR017 is a defined composition CD19-directed CAR T cell product candidate using a 4-1BB costimulatory domain. Juno believes JCAR017’s clinical profile could enable outpatient administration.
On the ratings front, Juno stock has been the subject of a number of recent research reports. In a report released yesterday, Citigroup analyst Robyn Karnauskas maintained a Buy rating on JUNO, with a price target of $59, which implies an upside of 31% from current levels. On October 26, Cowen’s Chris Shibutani reiterated a Buy rating on the stock and has a price target of $49.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Robyn Karnauskas and Chris Shibutani have a yearly average return of 7.0% and 19.8% respectively. Karnauskas has a success rate of 54% and is ranked #766 out of 4699 analysts, while Shibutani has a success rate of 52% and is ranked #472.
Overall, 4 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $45.57 which is 1.5% above where the stock closed yesterday.
Juno Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of innovative cellular immunotherapy for the treatment of cancer. It offers platforms which includes chimeric antigen receptors and T-cell receptors.