This week: Kite announces collaborative clinical trial, cell therapy manufacturing accelerated, acquisition of Juno by Celgene and Nohla granted orphan drug designation.
Kite (CA, USA) and Pfizer Inc. (NY, USA) have entered into a collaborative clinical trial to evaluate the safety and efficacy of the combination of Yescartaâ„¢ (axicabtagene ciloleucel) and utomilumab to treat refractory large B-cell lymphoma. Yescarta, the first CAR-T cell therapy indicated for the treatment of relapsed or refractory large B-cell lymphoma, is hoped to be enhanced by Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody
“Kite is committed to realizing the full potential of Yescarta and other cell therapy technologies across a range of cancers,” commented David Chang, Worldwide Head of Research and Development and Chief Medical Officer at Kite.
“We are pleased to collaborate with Pfizer on this study with utomilumab, which adds to the growing number of combination approaches we are exploring with Yescarta for patients living with lymphoma.”
Read the full press release here.
Cellular Biomedicine Group Inc. (CBMG; CA, USA) has announced plans to configure its facility with GE Healthcare’s FlexFactoryâ„¢, a start-to-finish platform designed to speed up manufacturing timelines. FlexFactory aims to reduce the time taken to optimize a lab for industrial-scale manufacturing from 18 months to 9 months, ultimately delivering therapies to patients sooner.
“This is a productivity revolution in the CAR-T space — this new generation of semi-automated and standardized CAR-T manufacturing capabilities created by GE Healthcare and CBMG may allow cell therapy to provide an optimal platform and opportunity for general oncology patients. This long-term collaboration with GE could help us utilize digital technology, semi-automation and analytics, in an effort to reduce overall costs, and deliver treatments to patients more efficiently,” concluded Tony (Bizuo) Liu, Chief Executive Officer of CBMG.
Read the press release here.
Celgene (Uxbridge, UK) is buying Juno Therapeutics (WA, USA), a company known for CAR-T cell therapy, in a USD $9 billion deal. This is the second deal of 2018 for the biotech Celgene, who acquired Impact Biosciences at the beginning of the month.
“The acquisition of Juno builds on our shared vision to discover and develop transformative medicines for patients with incurable blood cancers,” commented Celgene CEO Mark Alles.
Read the article here.
Nohla Therapeutics Inc. (WA, USA) has announced that the European Commission has granted Orphan Drug Designation to NLA101 for treatment in hematopoietic stem cell transplantation. NLA101 is currently being evaluated in a Phase IIb multi-center, open-label randomized study of myeloablative cord blood transplantation with or without infusion of NLA101 in patients with hematologic malignancies. NLA101 is a stem and progenitor cell therapy, shown to provide a short-term bridge to immune repair and essential blood cell production, and increase patient survival.
“NLA101 has shown encouraging results when used in combination with a cord blood transplant,” remarked Katie Fanning, President and CEO of Nohla. “We believe NLA101 has the potential to make a meaningful difference for patients with hematologic malignancies who are candidates for an allogeneic transplant and we look forward to reporting results from the Phase IIb randomized trial later this year.”
Read the press release here.