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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Darzalex®▼(daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible12.12.2017 16:33 | Tiedote
Janssen-Cilag International NV (“Janssen”) today announced data from the Phase 3 ALCYONE study, showing Darzalex® (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).1 These data were accepted as a late-breaking abstract (LBA) for presentation at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, today at 7:30 a.m. ET (Abstract #LBA-4).1 Study findings were simultaneously published in the New England Journal of Medicine (NEJM) . 2 Daratumumab is currently indicated for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for
MIPI Alliance Opens Access to its MIPI I3C Sensor Interface Specification12.12.2017 16:00 | Tiedote
The MIPI® Alliance, an international organization that develops interface specifications for mobile and mobile-influenced industries, today announced it is opening access to its sensor interface specification, MIPI I3C. Starting today, all companies, including those not currently members of MIPI Alliance, may access the MIPI I3C v1.0 specification so they may evaluate the incorporation of the specification into their sensor integration plans and design applications. “MIPI I3C provides a welcome update to the I2C technology that has been widely adopted over the past 35 years. Extending access provides an opportunity to spur innovation and help other industries beyond mobile," said Joel Huloux, chairman of MIPI Alliance. "It helps MIPI members as well, because it supports greater adoption and interoperability, strengthens the ecosystem and provides for a richer
CTS Engines Announces Senior Management Hire12.12.2017 16:00 | Tiedote
CTS Engines, the global leader for mature jet engine maintenance, announced today that it had hired Diane E. Cavuoto as Senior Vice President, Supply Chain, in an effort to continue to provide its customers with outstanding engine overhaul services. Ms. Cavuoto will be based in CTS’s Ft. Lauderdale headquarters and will report directly to Vesa Paukkeri, CTS’s President and Chief Operating Officer. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171212005050/en/ Diane E. Cavuoto, Senior Vice President, Supply Chain, for CTS Engines (Photo: Business Wire) Ms. Cavuoto, most recently Vice President, Strategic Sourcing at Honeywell International, brings years of supply chain management experience to CTS. In her prior role at Honeywell, Ms. Cavuoto managed a global commodity team of 150 employees managing $4
LTI to Offer Blockchain Solution Powered by Microsoft Azure12.12.2017 13:45 | Tiedote
Larsen & Toubro Infotech Ltd. (NSE: LTI, BSE: 540005), a global technology consulting and digital solutions company, announced today the availability of its blockchain-based trade finance solution on Microsoft Azure marketplace. The solution tracks the flow of goods in a value chain, improving transparency across multiple entities involved. It enables accelerated adoption of distributed ledger technologies by bringing together LTI’s deep industry knowledge and blockchain capabilities together with Microsoft’s expertise in cloud-based solutions. Aftab Ullah, Chief Operating Officer, LTI said, "Our vision is to deliver exponential operational efficiencies to the world’s leading companies through digital innovation. LTI’s Blockchain services include end-to-end consulting and implementation and are designed to help transform our clients’ business operations. The collaboration
Munich Re Automation Solutions Ltd. today announced the launch of their latest data analytics and reporting product, ALLFINANZ Insight12.12.2017 12:06 | Tiedote
Munich Re Automation Solutions Ltd., the leading provider of digital underwriting solutions to the life insurance industry, today announced the launch of their latest data analytics and reporting product, ALLFINANZ Insight. ALLFINANZ Insight is designed to help life insurance companies unlock the insights hidden in their underwriting data using a creative and intuitive interface and 30 years of underwriting expertise built in. A vast amount of data is captured during the new business and underwriting process. Accurately categorising and understanding this data can be hugely valuable as the insights generated will significantly improve the design of underwriting rules, the new business and underwriting process as well as operations and distribution management. ALLFINANZ Insight gives your whole team a clearer, deeper view into their underwriting data. The software uses cutt
New Data for Darzalex®▼(daratumumab) Presented at ASH 2017 Show Feasibility of Subcutaneous Use and Potential of Darzalex as a Treatment for Smouldering Multiple Myeloma12.12.2017 11:00 | Tiedote
Janssen-Cilag International NV (“Janssen”) today announced new data from the Phase 1b PAVO clinical study, which demonstrated that the subcutaneous delivery of Darzalex® (daratumumab) co-formulated with recombinant human hyaluronidase enzyme (daratumumab-SC), was generally well-tolerated, with a 12 percent rate of infusion-related reactions (IRRs), in patients with relapsed or refractory multiple myeloma.1 These data were featured as an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta. Daratumumab is currently approved for intravenous (IV) administration, and results from the PAVO trial serve as the basis for an actively enrolling Phase 3 study comparing subcutaneous administration of daratumumab over 3-5 minutes with the approved IV administration in relapsed and refractory multiple myeloma patients.2 Daratumumab is currently indica
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