The company closed a follow-on public offering and private placement of approximately 8 million shares in September 2017 at .00 per share, raising about 8 million in cash.
FDA brought RMAT Designation to life in March 2017 for products of cell therapies, tissue engineering products, human cell and tissue products, and other combination products that intend to treat serious or life-threatening diseases or conditions if evidence exists that the product can provide benefit in an area of unmet need.
Most common adverse events other than cytokine release syndrome and neurotoxicity that showed higher than 25% occurrence for JCAR017 included neutropenia (41%), fatigue (30%), thrombocytopenia (30%), and anemia (26%).
Revenue for the three months ended September 30, 2017 was $44.8 million, in connection with a sublicense agreement with Novartis (NVS) .
Non-GAAP research and development expenses for Q3 2017 were $98.4 million.
JUNO also recently teamed up with CELG to initiate a phase 1b study evaluating JCAR017 in combination with durvalumab (CELG) in adult r/r aggressive NHL patients.
The market for leukemias is expected to reach .3 billion by 2020.
GILD's therapy, (purchased from Kite Pharma) Yescarta, was approved recently for DLCBL patients who have already received multiple lines of chemotherapy.
Yescarta clinical trials reported 13% of patients with serious cytokine release syndrome and 28% of patients demonstrating severe neurological events (potentially higher than JUNO in a clinically significant manner).
Lead candidate JCAR017, in collaboration and license deal with Celgene, is demonstrating impressive efficacy and safety in early DLCBL trials.
JCAR017 received FDA Breakthrough Therapy Designation, RMAT, and EMA Priority Medicines Eligibility over the past twelve months.
Court ruled in favor of JUNO in patent dispute with KITE.