Cell therapy weekly: bluebird bio scales back plans in Europe following US FDA clinical hold on gene therapy studies
This week: bluebird bio has announced that they are scaling back their plans in Europe following the US FDA’s decision to place a clinical hold on their gene therapy studies; Imugene and Celularity have entered a research collaboration to develop novel oncolytic virus–allogeneic CAR-T immunotherapy combinations for solid tumors; and IN8bio has announced completion of dosing of the first patient cohort in a Phase I clinical trial of INB-100.
The news highlights:
- bluebird bio scales back plans in Europe following US FDA clinical hold on gene therapy studies
- Partnership to develop novel oncolytic virus–allogeneic CAR-T immunotherapy combination for solid tumors
- First cohort dosing completed in Phase I trial with allogeneic T-cell therapy in leukemia patients
bluebird bio scales back plans in Europe following US FDA clinical hold on gene therapy studies
bluebird bio (MA, USA) has reported financial results and business highlights for the second quarter and provided operational updates, including the announcement that the US FDA has placed a clinical hold on studies of elivaldogene autotemcel (eli-cel, Lenti-D™) gene therapy for cerebral adrenoleukodystrophy (CALD).
“I’m tremendously proud of what bluebird has accomplished this quarter both operationally and strategically to read yourselves to launch both bluebird bio and 2seventy bio. Seven months after announcing our intent to split, and thanks to the incredibly hard work by our teams, we have created a solid foundation for both organizations,” stated Nick Leschly, Chief Bluebird.
Partnership to develop novel oncolytic virus–allogeneic CAR-T immunotherapy combination for solid tumors
Imugene Ltd (Sydney, Australia) and Celularity Inc. (NJ, USA) have entered into a research collaboration to explore the therapeutic potential of a combination of Imugene’s CF33-CD19 oncolytic virus (onCARlytics) and Celularity’s CD19 targeting chimeric antigen receptor (CAR) placental-derived investigational T-cell therapy (CyCART-19) for the treatment of solid tumors.
“In preclinical studies Celularity’s cellular therapies have shown the ability to overcome limitations that have hindered other approaches, including increased proliferation and persistence in vivo, resistance to T-cell exhaustion and low immunogenicity, which allows for repeated dosing. These unique characteristics perfectly align with our vision for a combination treatment strategy, and we look forward to closely working together to bring this treatment strategy to the clinic and patients in need,” commented Leslie Chong, Chief Executive Officer of Imugene.
First cohort dosing completed in Phase I trial with allogeneic T-cell therapy in leukemia patients
IN8bio (NY, USA) announced completion of dosing of the first patient cohort in a Phase I clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutics in development for patients with leukemia undergoing haploidentical stem cell transplant (HSCT). The three patients comprising the first cohort did not experience any severe adverse infusion reactions or dose-limiting toxicities to date.
“Our goal with INB-100 is to generate an anti-leukemic effect by supplementing patients’ immune systems with allogeneic gamma-delta T cells to reduce relapse and improve overall survival in patients who have undergone an allogeneic HSCT. Although early, we are encouraged by data obtained to date indicating the potential for well-tolerated allogeneic gamma delta T-cell therapies. We look forward to announcing additional data on this program in 2022,” said William Ho, Chief Executive Officer of IN8bio.
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