CRISPR Therapeutics says the conditioning agent busulfan is unlikely to be the cause of adverse events that prompted Bluebird Bio to halt LentiGlobin trials. As a medicine busulfan is used to treat chronic myelogenous leukemia. It works by slowing or stopping the growth of cancerous cells. It is also used in cell and gene therapy as a conditioning agent to destroy bone marrow to prepare patients for transplant. Busulfan hit the headlines this month after Bluebird Bio started investigating it as…

Cell and gene therapy developers will have a close eye on cancer cases linked to Bluebird Bio’s LentiGlobin, say analysts. Earlier this month Bluebird halted two trials of LentiGlobin in sickle cell disease – specifically HGB 206 NCT02140554 and HGB 210 NCT04293185. It said the decision was prompted by a case of acute myeloid leukemia (AML) in a patient in group A of the Phase I/II HGB-206 study and a case of myelodysplastic syndrome (MDS) in a patient in Group C of the…

Monoclonal antibody (mAb) manufacturers aiming for an EUA should prepare for their SARS-CoV-2 therapies to be combined with others, according to the US FDA. The US regulator issued the advice in guidance this week in which it also urged developers to collaborate and share data. The FDA said, “Strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the…

Bluebird Bio’s suspension of trials of its sickle cell gene therapy LentiGlobin has put the vector used to make it in the spotlight. The US biotech announced the temporary suspension of two LentiGlobin trials – specifically HGB 206 NCT02140554 and HGB 210 NCT04293185 – this week. It said the measure was prompted by reports a patient in group A of the Phase I/II HGB-206 study treated with the therapy five years ago had developed acute myeloid leukemia (AML). Bluebird also…

Bristol Myers-Squibb (BMS) has set a 24-day production target for Breyanzi and set up a digital platform to let physicians and patients track manufacture of the lymphoma cell therapy in real-time. The US Food and Drug Administration (FDA) cleared Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma this month. A BMS spokeswoman told us “BMS plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facilities, initially…