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