Cell therapy weekly: Could CAR-T therapy be used to treat multiple myeloma?

This week: Aldevron announce expansion of fermentation and manufacturing facilities, Precigen opens new cell and gene therapy manufacturing facility in Maryland, and preclinical data shows promise for multiplex base editing.

May 02, 2019
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The news highlights:

Could CAR-T therapy be used to treat multiple myeloma?
Aldevron announce expansion of fermentation and manufacturing facilities
Precigen opens new cell and gene therapy manufacturing facility in Maryland
Preclinical data shows promise for multiplex base editing

Could CAR-T therapy be used to treat multiple myeloma?

A new preclinical study, published in The New England Journal of Medicine, has suggested that an anti-BCMA CAR T-cell therapy bb2121 may be used to treat of multiple melanoma. The therapy was shown to produced high response rates with managing toxicity among patients with heavily pretreated relapsed or refractory multiple myeloma – previous therapies have prolonged survival but failed to prevent relapse.  

“The adverse events noted in our study were very manageable and we saw low rates of cytokine release syndrome and neurotoxicity,” explained Noopur Raje, Director of the Center for Multiple Myeloma at Massachusetts General Hospital and Professor of medicine at Harvard Medical School. “The toxicity was manageable to the extent that we are now thinking forward to outpatient settings. Response rates were high, but we did not see a plateauing of responses in very late-stage multiple myeloma.”

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Aldevron announce expansion of fermentation and manufacturing facilities

Aldevron (ND, USA) has announced its new fermentation capacity of 1,000 liters and plans to expand the company’s manufacturing facilities in Madison, Wisconsin. The increased fermentation capacity will assist cell and gene therapy research requiring large amounts of plasmid DNA, recombinant proteins and gene editing enzymes. Design of the manufacturing space is currently in progress with the facility expected to be fully operational in the forth quarter of this year.    

“We constantly review each of Aldevron’s manufacturing capabilities in an effort to provide the highest quality biologics that our clients need, exactly when they need them,” commented Michael Chambers, Founder and CEO of Aldevron. “Increasing our fermentation capabilities is a direct result of what the market is demanding, and this expansion is a further commitment to our clients and our staff to better serve our industry.”

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Precigen opens new cell and gene therapy manufacturing facility in Maryland

Clinical stage biopharmaceutical company, Precigen (MD, USA), has declared the official opening of its new cell and gene therapy manufacturing facility in Germantown, Maryland. The new facility adds to Precigen’s existing footprint in Maryland, and was designed to provide rapid GMP manufacturing with suitable control to scale production to meet early stage clinical trial needs. 

“Precigen needs to be agile and cost-conscious in our early stage clinical manufacturing. In today's drug development environment, it's important to reduce a myriad of risks that can impact manufacturing such as technology transfer risks when outsourcing to contract manufacturing organizations as well as process and timing risks,” explained President of Precigen, Helen Sabzevari. “This facility puts Precigen in control of our gene therapy manufacturing needs.”

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Preclinical data shows promise for multiplex base editing

Biotechnology company, Beam Therapeutics (CA, USA), presented preclinical data on multiplex base editing for engineered CAR T-cells at the American Society of Gene and Cell Therapy (ASGCT) 22nd Annual Meeting. Data for the base editor BE4 demonstrated high efficiency multiplex base editing of three cell surface targets in primary human T cells (TRAC, B2M and PD-1) which was able to knock out the expression of each gene in 95%, 95% and 88% of cells, respectively. These results show promise for the application of multiplex base editing in CAR T-cell therapy design for improved therapeutic properties.

 “Beam is actively applying base editing across a wide range of serious genetic diseases using both ex vivo and in vivo delivery approaches, and we are pleased to begin sharing some of the research progress in our therapeutic programs,” commented John Evans, CEO of Beam Therapeutics. “For advanced cellular therapies requiring a large number of simultaneous edits, base editing represents an important new technology that could open up new options for patients with cancer and other immune-mediated diseases.”

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For more weekly cell therapy news, read previous editions of the cell therapy weekly.

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