Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation from FDA and Prime Eligibility from EMA for Relapsed and Refractory Multiple Myeloma
Celgene Corporation (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) today announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).
BTD designation and PRIME eligibility for bb2121 were based on preliminary clinical data from the ongoing phase 1 study CRB-401. Updated data from CRB-401 is scheduled to be presented at the 59th annual meeting of the American Society of Hematology in Atlanta during an oral presentation on Dec. 11.
“Receiving Breakthrough Therapy Designation and PRIME eligibility for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment,” said Jay Backstrom, M.D., Chief Medical Officer and Head of Global Regulatory Affairs for Celgene. “We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma.”
“Despite recent advances, multiple myeloma remains an incurable disease, and heavily pretreated patients have limited therapeutic options,” said David Davidson, M.D., Chief Medical Officer for bluebird bio. “Early data suggest that treatment with bb2121 has the potential to induce durable responses in this patient population. It is encouraging for both the FDA and EMA to identify bb2121 as a candidate for accelerated development as we continue our work with Celgene to bring this therapy to patients in need of new options.”
Breakthrough Therapy Designation is intended to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
PRIME is a program launched by the EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier. The program focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA. To be accepted for PRIME, a medicine must show its potential to benefit patients with unmet medical needs based on early clinical data.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
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 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 has operations in Cambridge, Massachusetts, Seattle, Washington and Europe.
About the bluebird bio-Celgene Collaboration
In March 2013, bluebird bio and Celgene entered into a collaboration to develop chimeric antigen receptor (CAR) T cell therapies to target and destroy cancer cells. In June 2015, the collaboration was amended and restated to focus on developing product candidates targeting B-cell maturation antigen (BCMA). bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma. bluebird bio and Celgene are also working together on a second anti-BCMA CAR T program, bb21217.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of, and plans relating to the collaboration between bluebird bio and Celgene; the potential of bb2121 as a therapeutic drug; and the benefit of each company’s strategic plans and focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs. For example, there can be no guarantee that any product candidate will be successfully developed or complete necessary preclinical and clinical phases, or that development of any of product candidates will successfully continue. There can be no guarantee that any positive developments will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; the ability to obtain and maintain requisite regulatory approvals and to enroll patients in planned clinical trials; unplanned cash requirements and expenditures; competitive factors; the ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates; the ability to maintain key collaborations; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in each company’s public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and neither company has any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Hyperlinks are provided as a convenience and for informational purposes only. Neither Celgene nor bluebird bio bears responsibility for the security or content of external websites or websites outside of their respective control.
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
itslearning and Google for Education Strike New Education Partnership, Deliver Major New Integrations to Improve Learning Outcomes15.8.2018 09:00 | Tiedote
itslearning today announced its collaboration with Google for Education, delivering the first phase of a comprehensive technology roadmap. This initial milestone aligns with the itslearning mission to improve the efficacy of technology in education. The collaboration will involve significant work across R&D, Sales, and Marketing functions. With phase one complete, these capabilities are now available: Use of Google assignment templates to quickly ‘make a copy’ of a single Google file for each student with one click Easy administration of assignments within the itslearning environment by uploading from or linking to documents on Google Drive Ability to collaborate and give real-time feedback in Google Docs directly from an itslearning assignment screen Automatic management of file permissions to prevent learners from making post-deadline changes to a submitted file View, annotate, and grade submitted files with a grade or against a rubric, all from within one itslearning screen “We are
Pacific Drilling Announces Second-Quarter 2018 Results15.8.2018 00:38 | Tiedote
Pacific Drilling S.A. (OTC: PACDQ) today reported results for the second quarter of 2018. Net loss for the second-quarter 2018 was $103.7 million or $4.86 per diluted share, compared to net loss of $96.1 million or $4.50 per diluted share for the first-quarter 2018, and net loss of $138.1 million or $6.48 per diluted share for second-quarter 2017. Pacific Drilling CEO Paul Reese commented, “This quarter we continued to provide outstanding operational services to our clients, delivering revenue efficiency of 98.7 percent. Our strong operating results have been recognized by clients as we successfully secure new work for our high-specification, deepwater drillship fleet. Petronas recently exercised its option to contract Pacific Santa Ana for an additional year of work commencing in mid-2019. In addition, we have a letter of intent from Eni for Pacific Bora to work in Nigeria, as well as two letters of award for drilling services in the U.S. Gulf of Mexico for Pacific Khamsin and Pacific
Gilead Sciences Announces Executive Promotions15.8.2018 00:00 | Tiedote
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that Gregg Alton has been appointed Chief Patient Officer, a newly created role that will facilitate access to the company’s medicines and increase focus on reaching patients. The company also announced that Diana Brainard, MD, has been promoted to Senior Vice President, HIV and Emerging Viral Infections, and that Andrew Cheng, MD, PhD, Chief Medical Officer, has decided to leave Gilead to pursue another opportunity. Mr. Alton joined the company nearly 20 years ago and was the architect of its access program, which has enabled Gilead’s HIV medicines to reach more than 11 million people in the developing world. He has helped shape the organization in a number of executive positions, including as general counsel, and more recently, leading the company’s international commercial operations and corporate affairs groups. Prior to joining Gilead, he was an attorney at the law firm of Cooley Godward, LLP, where he specialized in mergers and
Thales and Gemalto Announce Regulatory Clearance from the Minister of Innovation in Canada14.8.2018 19:00 | Tiedote
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received foreign investment Regulatory Clearance in Canada. Together with the anti-trust clearance obtained in China and Israel, and clearance relating to foreign investments in Australia, Thales and Gemalto have obtained 4 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with the competent antitrust authorities to obtain the remaining
BCW Acquires Creative Powerhouse HZ, Significantly Expanding Expertise in Integrated Communications14.8.2018 17:26 | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency and a WPP company, today announced it has acquired HZ, one of the largest independent, digitally driven, integrated creative agencies in the U.S. Headquartered in Rockville, Maryland with offices in Baltimore, Los Angeles, New York and Washington, D.C., the acquisition will add the capability of HZ’s nearly 200 creative and digital professionals to BCW’s deep expertise in integrated communications across all industry sectors. HZ’s wide-ranging offerings include a full spectrum of multichannel digital design and development, mobile activation, social media, brand and identity creation, content, film and video production, search marketing (SEO/SEM), data and analytics as well as integrated media solutions. HZ’s broad client base spans the consumer, hospitality, food & beverage, education, B2B, real estate, sports & entertainment, healthcare and technology industries and counts Hilton Worldwide, Salesforce.org and Tishman S
Andersen Global Initiates Expansion in Mozambique14.8.2018 16:30 | Tiedote
Andersen Global continues expansion in Africa with Isalcio Mahanjane e Associados, a law firm headquartered in Maputo, Mozambique. The collaboration with Isalcio Mahanjane e Associados signifies Andersen’s growth in the African region, as Mozambique provides strategic coverage in Southeast Africa and is the sixth country to collaborate or join in Africa in the past 14 months. Led by Managing Partner Isalcio Mahanjane, the firm includes 10 professionals and specializes in providing quality services in all branches of law for corporations and individuals. These services include commercial and corporate law, banking and financial law, labor law, real estate management, oil and gas, mines, and law and administrative litigation. “Mozambique will be a key point of connectivity with our practice in Portugal as we continue to focus on best-in-class solutions in Africa,” commented Global Chairman and Andersen Tax LLC CEO, Mark Vorsatz. “Isalcio and his team are passionate about their practice a
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme