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bluebird bio to Present New Data from LentiGlobinTM Clinical Studies at European Hematology Association (EHA) Annual Meeting

– Presentations include early data from Northstar-2 (HGB-207) study of LentiGlobin in patients with transfusion-dependent β-thalassemia (TDT) and non-β00 genotypes and updated data from HGB-205 study in TDT and severe sickle cell disease (SCD) –

– Encore presentation of data from CRB-401 study of bb2121 in relapsed/refractory multiple myeloma to be presented –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 18, 2017-- bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, announced that data from ongoing clinical studies of LentiGlobin drug product in transfusion-dependent β-thalassemia (TDT) and severe sickle cell disease (SCD) will be highlighted in oral and poster presentations at the 22nd Congress of the European Hematology Association (EHA). An encore presentation of data from the ongoing Phase 1 study of bb2121 in relapsed/refractory multiple myeloma, to be debuted at ASCO 2017, will also be presented. These abstracts became available on the EHA conference website at 12:00 pm CEST (6:00 am ET) today.

“This year at EHA, we will share the first clinical data from our HGB-207 study of LentiGlobin in patients with TDT and non-β00 genotypes, using our refined drug product manufacturing process,” said David Davidson, M.D., chief medical officer, bluebird bio. “We also look forward to seeing data from additional patients in the single-center HGB-205 study in TDT and SCD, and presenting data from our study of bb2121 in relapsed/refractory multiple myeloma to the European hematology community.”

Oral Presentations
A Phase 3 Study to Evaluate Safety and Efficacy of LentiGlobin Gene Therapy for Transfusion-Dependent β-thalassemia in Patients with non-β00 Genotypes: The Northstar-2 (HGB-207) Trial (Abstract S814)

Presenter: Mark C. Walters, M.D., UCSF Benioff Children’s Hospital, Oakland, Calif
Date & Time: Sunday, June 25, 8:00 a.m. CEST (2:00 a.m. EST)
Location: Room N111

First-in-Human Multicenter Study of bb2121 anti-BCMA CAR T Cell Therapy for Relapsed/Refractory Multiple Myeloma: Updated Results. (Abstract S142)

Presenter: Yi Lin, M.D., Mayo Clinic Division of Hematology, Rochester, MN
Date & Time: Friday, June 23, 2017, 11:45 a.m. CEST (5:45 a.m. EST)
Location: Room N109

Note: This will be an encore of data presented at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting

Poster Presentation
Update on the First Patients with Severe Hemoglobinopathies Treated with LentiGlobin Gene Therapy (HGB-205) (Abstract P631)

Presenter: TBD
Poster Session Date & Time: Saturday, June 24, 5:30 – 9:00 p.m. CEST
Location: Poster area (Hall 7)

About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D™ product candidate, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its LentiGlobin™ product candidate, currently in four clinical studies for the treatment of transfusion-dependent β-thalassemia, and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program partnered with Celgene. bb2121 is currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma. bluebird bio also has discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.

bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington and Europe.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s research, development, manufacturing and regulatory approval plans for its LentiGlobin product candidate to treat transfusion-dependent ß-thalassemia and severe sickle cell disease and its bb2121 product candidate to treat relapsed/refractory multiple myeloma, including statements whether the manufacturing process changes for LentiGlobin will improve outcomes of patients with transfusion-dependent ß-thalassemia and severe sickle cell disease, whether the planned changes to the HGB-206 clinical trial protocol will improve outcomes in patients with severe sickle cell disease. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the preliminary positive efficacy and safety results from our prior and ongoing clinical trials of LentiGlobin will not continue or be repeated in our ongoing, planned or expanded clinical trials of LentiGlobin, the risks that the changes we have made in the LentiGlobin manufacturing process or the HGB-206 clinical trial protocol will not result in improved patient outcomes, risks that the current or planned clinical trials of LentiGlobin will be insufficient to support regulatory submissions or marketing approval in the US and EU, the risk of a delay in the enrollment of patients in our clinical studies, and the risk that any one or more of our product candidates, including our bb2121 product candidate, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

Source: bluebird bio, Inc.

bluebird bio, Inc.
Investors:
Manisha Pai, 617-245-2107
mpai@bluebirdbio.com
or
Media:
Elizabeth Pingpank, 617-914-8736
epingpank@bluebirdbio.com