Better late than never for Maxcyte’s one-day CAR-T approach

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It is just as well that Maxcyte has an electroporation service business as well as an R&D operation, otherwise its past two years would have been pretty quiet. It has taken that long for Carma, its flagship CAR-T technology, to get off the ground. The group’s 2016 listing in London was a bet on a mesothelin-directed CAR-T project using Carma, a trial of which was to begin last year. The US IND for this asset, now coded MCY-M11, was filed last November, and has only just been approved, a delay Trinity Delta analysts put down to the FDA’s cautious stance regarding novel cell and gene therapies. There might also have been questions over mesothelin – a notoriously dirty target expressed in several healthy tissues. Unlike conventional CAR-T, Carma uses mRNA electroporation rather than viral transfection, and takes fresh apheresis product, with no cell expansion; the aim is to cut manufacturing time from several weeks to a day, and generate transient CAR-T cells that need to be redosed. More details about the trial, in ovarian cancer and peritoneal mesothelioma, will presumably emerge before it begins in the second half.

Selected anti-mesothelin CAR-T studies
Project Sponsor Cancer type Status Trial ID
CART-meso University of Pennsylvania, Novartis Pancreatic, epithelial ovarian, epithelial pleural mesothelioma Completed (data at AACR 2015) NCT02159716
CART-meso + Kymriah University of Pennsylvania, Novartis Pancreatic Completed NCT02465983
RNA Meso CAR-T* University of Pennsylvania, Novartis Pancreatic Completed NCT01897415
RNA Meso CAR-T* University of Pennsylvania, Novartis Mesothelioma Completed NCT01355965
Mesothelin-specific CAR-T cells Memorial Sloan Kettering Cancer Center Breast Ending Jun 2019 NCT02792114
Hu-CART-meso University of Pennsylvania, Novartis Lung, ovarian, peritoneal, fallopian tube, mesothelioma Ending Mar 2021 NCT03054298
Hu-CART-meso University of Pennsylvania, Novartis Pancreatic Ending Sep 2021 NCT03323944
MCY-M11** Johns Hopkins University , Maxcyte Ovarian, mesothelioma Starting H2 2018 None
Source: Clinicaltrials.gov; *uses Maxcyte electroporation technology; **uses Maxcyte Carma technology.

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