MaxCyte, Inc. - Expansion of CARMA’s Phase I Trial of MCY-M11
CARMA Cell Therapies™ Expands Phase I Trial of
Anti-Mesothelin mRNA CAR-PBMC Cell Therapy MCY-M11
· New parallel cohort will broaden evaluation of MCY-M11 in patients through inclusion of a preconditioning regimen and multiple dosing cycles
· Clinicians at
· To date, ongoing first-in-human study has demonstrated promising tolerability of MCY-M11 and feasibility of rapid, one-day autologous manufacturing
The new parallel Phase I cohort will evaluate intraperitoneal delivery of MCY-M11 at escalating doses in additional patients with relapsed/refractory ovarian cancer and malignant peritoneal mesothelioma, with the addition of a preconditioning regimen of cyclophosphamide prior to MCY-M11 infusion. This parallel Phase I cohort with preconditioning will progress independently from the ongoing evaluation of MCY-M11 in the existing no-preconditioning Phase I cohort. The MCY-M11 Phase I trial will also allow for multiple treatment cycles where indicated for both future preconditioning and no-preconditioning patients.
New clinical sites for the study at
In May, encouraging preliminary results for MCY-M11, which support this study expansion and the pursuit of new strategies with the therapy, such as the addition of a preconditioning regimen and delivering multiple cycles of treatment to further enhance efficacy, were presented at the virtual ASCO meeting. Results to date also support the continued validation of
For the ASCO abstract, please visit: https://meetinglibrary.asco.org/record/185279/abstract.
Following the expansion of the Phase I trial, preliminary clinical data for the existing no-preconditioning MCY-M11 trial are anticipated in H2 2020.
"We are very pleased with the progress of this first-in-human trial to date, and have great hopes that we are moving closer towards bringing a more effective immunotherapeutic option for patients with solid tumors," said Claudio Dansky Ullmann, MD, Chief Medical Officer of
MCY-M11 is a non-viral, mRNA-based anti-mesothelin CAR-PBMC cell therapy manufactured using un-manipulated peripheral blood mononuclear cells (PBMC). It is being evaluated in the clinic as treatment for high mesothelin expressing solid tumors. It is under ongoing development in a first-in human multi-center, non-randomized, open label, dose-escalation Phase I clinical trial evaluating the safety and preliminary efficacy of intraperitoneal infusions of MCY-M11 in individuals with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube, or individuals with advanced peritoneal mesothelioma, with recurrence after prior chemotherapy.
About CARMA Cell Therapies
Through its wholly owned subsidiary, CARMA Cell Therapies,
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).
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