Shares of the company bluebird bio, Inc. BLUE, went up almost 17.9% after the company along with its partner Celgene Corporation CELG announced five months of follow-up data from the ongoing phase I study (n=21) of its chimeric antigen receptor T-cell (CAR-T) therapy candidate- bb2121. The open-label phase I CRB-401 study is evaluating the preliminary safety and efficacy of bb2121 in patients with relapsed and/or refractory multiple myeloma. The study also aims to identify a dose to use in phase II studies.
So far this year, bluebird’s shares have skyrocketed 227%, compared with the industry’s gain of 3%.
As of the cutoff date of Oct 2, 2017, 21 patients had been enrolled patients and dosed in the dose-escalation phase of the study in four dose cohorts. The patients in the study were heavily pre-treated and had failed on a median of seven prior lines.
Of the 18 patients in the active dose cohorts of the study, 94% achieved an objective response (OR). 56% patients achieved a complete response compared with the CR rate of 27% as shown in the data released at ASCO in June this year. The increase in CR rate from the previous update led to the increase in share price.
The study also showed that nine out of ten (90%) of patients evaluable for minimal residual disease (MRD) status were found to be MRD-negative. The study did not reach the median progression free survival (PFS) with median follow up of 40 weeks in active dose cohorts. These encouraging data and the deepening response showed by bb2121 in the study bode well for the candidate and if approved can prove to be a groundbreaking CAR-T therapy in multiple myeloma.
However bluebird’s competitor Juno Therapeutics, Inc. JUNO released additional data from the TRANSCEND phase I study on its CAR-T candidate JCAR017 (in patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL). The TRANSCEND trial demonstrated that in a high risk patient population, 74% of patients achieved an overall response rate while and 68% achieved CR rate at 3 months.
We also note that another company Gilead Sciences Inc.’s GILD CAR-T therapy, Yescarta (axicabtagene ciloleucel), was approved by the FDA in October for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Yescarta is the first CAR-T therapy approved by the FDA for this indication.
We also note that Novartis breakthrough gene transfer treatment, Kymriah (tisagenlecleucel) received FDA approval for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
bluebird bio, Inc. Price
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bluebird carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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