Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

CAR-T Win: Bluebird Bio Announces Positive Phase I Clinical Trial Results

XTALKS VITALS NEWS

CAR-T

So far, bluebird hasn’t reported any serious adverse events related to bb2121, which is being developed alongside pharmaceutical company, Celgene.

Share this!

December 2, 2016 | by Sarah Hand, M.Sc.

Earlier this week, biotech company bluebird bio released positive interim results from their Phase I clinical trial of CAR-T immunotherapy, in patients with relapsed or refractory multiple myeloma. The dose escalation study showed a 78 percent overall response rate for its investigational anti-B-cell maturation antigen (BCMA), known as bb2121.

“We are pleased that these early data from our ongoing Phase 1 study of bb2121 demonstrate objective anti-tumor responses in heavily pre-treated patients with multiple myeloma,” said Dr. David Davidson, chief medical officer, bluebird bio. “We are also encouraged by the safety profile to date, particularly the lack of severe cytokine release syndrome or neurotoxicity.”



Last week, bluebird’s competitor in the immunotherapy space, Juno Therapeutics, announced that two patients in its CAR-T clinical trial died as a result of a potentially treatment-related adverse event. The deaths prompted Juno to put a hold on the trial for the second time since its launch, and increased the number of CAR-T associated fatalities to six patients.

Earlier this year, the US Food and Drug Administration (FDA) mandated a clinical hold on Juno’s Phase II clinical trial – ROCKET – after two patients died of cerebral edema. Less than one week after the study was put on hold, the FDA allowed the trial to continue after changes were made to the treatment protocol.

So far, bluebird hasn’t reported any serious adverse events related to bb2121, which is being developed alongside pharmaceutical company, Celgene. While bluebird’s CAR-T cell product has shown promising efficacy in interim trial results, the study is still ongoing.

“In light of these positive data,” continued Davidson, “and thanks to the multiple participating clinical sites and centralized manufacturing infrastructure we and our partner Celgene have built for this program, we anticipate efficiently completing the dose escalation stage of the trial and initiating the expansion cohort.”


Keywords: CAR-T, Clinical Trial, Immunotherapy


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Small Molecule May Disrupt Biofilm Formation on Implantable Medical Devices

March 28, 2017 - Researchers at Trinity College Dublin in Ireland have identified a small molecule capable of preventing bacterial biofilms from growing on medical implants.

Featured In: Medical Device News


FDA Approves PD-L1 Immunotherapy Developed by Pfizer and Merck KGaA

March 27, 2017 - Pfizer and Merck KGaA’s PD-L1 inhibitor, Bavencio (avelumab), has become the first immunotherapy to be approved by the US Food and Drug Administration (FDA) to treat a rare form of skin cancer, known as metastatic Merkel cell carcinoma (MCC).

Featured In: Biotech News


New Approach Could Allow Red Blood Cells to be Manufactured

March 27, 2017 - UK researchers at the University of Bristol have developed an immortal line of early adult erythroblasts capable of continuously producing mature red blood cells.

Featured In: Biotech News

LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?

REGISTER FOR THESE WEBINARS

Strategies for Deploying Innovative Solutions for Perimeter Security


High Performance Computing for High Content Screening - A Case Study


The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review


Treatment of Psoriasis: Improvements Through Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.