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bluebird bio to Present Updated Clinical Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti- BCMA CAR T Cell Therapy in Patients with Late Stage Relapsed/Refractory Multiple Myeloma at ASCO Annual Meeting

– Presentation will include safety and efficacy data from 21 patients treated in dose-escalation phase and early data from patients treated in dose-expansion phase –

– Additional poster exploring the significance of MRD negativity in patients in this study to be presented –

– Company to host conference call and live webcast, Friday, June 1, 6:30 p.m. CT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 16, 2018-- bluebird bio, Inc. (Nasdaq: BLUE) announced that updated interim data from CRB-401, its Phase 1 study of bb2121, an anti-BCMA CAR T cell therapy being developed by the company and Celgene, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

“Since we first presented data for bb2121 in heavily pretreated patients with multiple myeloma, we have been hopeful about its potential to markedly improve the outcomes and expectations for this incurable disease,” said David Davidson, M.D., chief medical officer, bluebird bio. “One of the most striking changes has been to see patients testing negative for minimal residual disease (MRD), which was previously unexpected in this population with advanced disease. As the data from the Phase 1 study continue to advance our understanding of the bb2121 dose response and safety profiles, we and Celgene are applying these lessons to optimize outcomes in KarMMA, the ongoing registration-enabling study of bb2121 in patients with relapsed/refractory multiple myeloma.”

Oral Presentation
bb2121 anti-BCMA CAR T-cell therapy in patients with relapsed/refractory multiple myeloma: Updated results from a multicenter phase I study. (Abstract 8007)

Presenter: Noopur S. Raje, M.D., Massachusetts General Hospital, Boston, Massachusetts
Date & Time:Friday, June 1, 2018, 2:45-5:45 p.m. CT (3:45-6:45 p.m. ET)
Location: E450
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Poster Presentation
Early MRD negativity to predict deepening myeloma response in relapsed/refractory multiple myeloma (RRMM) patients treated with bb2121 anti-BCMA CAR T cells. (Abstract 8024)

Presenter: Nikhil C. Munshi, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts
Poster Session Date & Time:Monday, June 4, 2018, 8:00 – 11:30 a.m. CT (9:00 a.m.12:30 p.m. ET)
Location: Poster Area Hall A
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Conference Call & Webcast Information

bluebird bio will host a conference call and live webcast at 6:30 p.m. CT (7:30 p.m. ET) on Friday, June 1, 2018. To access the live webcast, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at http://investor.bluebirdbio.com. Alternatively, investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 1489304. A replay of the webcast will be available on the bluebird bio website for 90 days following the call.

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 Lenti-D for the treatment of cerebral adrenoleukodystrophy, and LentiGlobin for the treatment of transfusion-dependent β-thalassemia, also known as β-thalassemia major, 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 programs, bb2121 and bb21217, are anti-BCMA CAR T programs partnered with Celgene. 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, Durham, North Carolina and Zug, Switzerland.

LentiGlobin and Lenti-D are trademarks of bluebird bio, Inc.

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 and development plans and potential for the bb2121 product candidate to treat relapsed/refractory multiple myeloma. 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 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 to Present Updated Clinical Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti- BCMA CAR T Cell Therapy in Patients with Late Stage Relapsed/Refractory Multiple Myeloma at ASCO Annual Meeting

bluebird bio, Inc.
Investors:
Elizabeth Pingpank, 617-914-8736
epingpank@bluebirdbio.com
or
Media:
Stephanie Fagan, 201-572-9581
sfagan@bluebirdbio.com

Media Contacts

Jenn Snyder

VP, Corporate Communications

(617) 448-0281

JSnyder@bluebirdbio.com

 

Catherine Falcetti

Senior Director, Corporate Communications

(339) 499-9436

CFalcetti@bluebirdbio.com

 

Investor Contact

Elizabeth Pingpank

Director, Corporate Communications

(617) 914-8736

EPingpank@bluebirdbio.com