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bluebird Stock Up on Positive Interim Multiple Myeloma Data
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bluebird bio, Inc. (BLUE - Free Report) announced interim results from the ongoing open-label phase I study (CRB-401) on bb2121 for the treatment of relapsed/refractory multiple myeloma. Data were presented at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium. Shares of the company soared 13.8% on the news.
bluebird’s year-to-date (YTD) share price movement shows that though the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry for the most part, in the past couple of months, it has outshone the industry. The stock has gained 6.9% YTD in comparison to a drop of approximately 27% for the industry.
Patients enrolled in the study were heavily pre-treated with a median of six prior therapies. As of the Nov 18, 2016 data cut-off, 11 patients were enrolled and dosed across four dosing cohorts. All the dosed patients were evaluable for safety, and the first nine patients who underwent the first multiple myeloma tumor restaging, were evaluable for efficacy.
Interim data showed that patients achieved an overall response rate (ORR) of 78%, while those in the higher dosing cohorts achieved an ORR of 100%. The latter group of patients includes those with stringent complete responses and elimination of minimal residual disease. On the safety front, no dose-limiting toxicity, Grade 3 or higher neurotoxicity or higher cytokine release syndrome was observed in the dosed patients.
We note that bb2121 is a chimeric antigen receptor T cell (CAR T) therapy targeting B cell maturation antigen. bluebird is developing bb2121 in collaboration with Celgene Corporation . The companies expect to complete the dose-escalation stage of the study, followed by the initiation of an expansion cohort.
We are encouraged by the latest interim data, which so far shows high response rates and no safety concerns. Although the candidate still has a long way to go before hitting the market, it could turn out to be a promising treatment option for the eligible patient population.
CAR-T based therapies have bright prospects ahead as they represent a new approach to the treatment of cancer by engaging the body’s immune system. However, their development is becoming increasingly challenging due to constant scrutiny for adverse side effects.
Last week, Juno Therapeutics, Inc.’s shares tumbled after the company announced that it has voluntarily placed a phase II ROCKET study on JCAR015 on clinical hold after two patients suffered cerebral edema and died eventually. The study was evaluating JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.
Earlier in July, the FDA had placed the same study on clinical hold after two patients died following the addition of fludarabine to the pre-conditioning regimen. However, the hold was lifted within a week and the study continued under a revised protocol.
bluebird currently carries a Zacks Rank #3 (Hold).
Vanda’s loss estimates narrowed from 68 cents to 52 cents for 2016, while its earnings estimates increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 67% year to date.
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bluebird Stock Up on Positive Interim Multiple Myeloma Data
bluebird bio, Inc. (BLUE - Free Report) announced interim results from the ongoing open-label phase I study (CRB-401) on bb2121 for the treatment of relapsed/refractory multiple myeloma. Data were presented at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium. Shares of the company soared 13.8% on the news.
bluebird’s year-to-date (YTD) share price movement shows that though the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry for the most part, in the past couple of months, it has outshone the industry. The stock has gained 6.9% YTD in comparison to a drop of approximately 27% for the industry.
Patients enrolled in the study were heavily pre-treated with a median of six prior therapies. As of the Nov 18, 2016 data cut-off, 11 patients were enrolled and dosed across four dosing cohorts. All the dosed patients were evaluable for safety, and the first nine patients who underwent the first multiple myeloma tumor restaging, were evaluable for efficacy.
Interim data showed that patients achieved an overall response rate (ORR) of 78%, while those in the higher dosing cohorts achieved an ORR of 100%. The latter group of patients includes those with stringent complete responses and elimination of minimal residual disease. On the safety front, no dose-limiting toxicity, Grade 3 or higher neurotoxicity or higher cytokine release syndrome was observed in the dosed patients.
We note that bb2121 is a chimeric antigen receptor T cell (CAR T) therapy targeting B cell maturation antigen. bluebird is developing bb2121 in collaboration with Celgene Corporation . The companies expect to complete the dose-escalation stage of the study, followed by the initiation of an expansion cohort.
We are encouraged by the latest interim data, which so far shows high response rates and no safety concerns. Although the candidate still has a long way to go before hitting the market, it could turn out to be a promising treatment option for the eligible patient population.
CAR-T based therapies have bright prospects ahead as they represent a new approach to the treatment of cancer by engaging the body’s immune system. However, their development is becoming increasingly challenging due to constant scrutiny for adverse side effects.
Last week, Juno Therapeutics, Inc.’s shares tumbled after the company announced that it has voluntarily placed a phase II ROCKET study on JCAR015 on clinical hold after two patients suffered cerebral edema and died eventually. The study was evaluating JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.
Earlier in July, the FDA had placed the same study on clinical hold after two patients died following the addition of fludarabine to the pre-conditioning regimen. However, the hold was lifted within a week and the study continued under a revised protocol.
bluebird currently carries a Zacks Rank #3 (Hold).
BLUEBIRD BIO Price
BLUEBIRD BIO Price | BLUEBIRD BIO Quote
A Stock to Consider
Vanda Pharmaceuticals, Inc. (VNDA - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates narrowed from 68 cents to 52 cents for 2016, while its earnings estimates increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 67% year to date.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>