MaxCyte announced the first patient has been dosed in its Phase I dose-escalation clinical trial in the United States with the company's lead wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11. The study is designed to evaluate MCY-M11, a mesothelin targeting CAR, in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.
"The initiation of patient dosing in our first clinical trial with our lead CAR therapeutic candidate is a significant milestone for MaxCyte, validating our streamlined manufacturing process for clinical use," said MaxCyte CEO Doug Doerfler. "We are extremely pleased to have very experienced investigators at two leading clinical centers conducting this study in solid tumors. We believe this clinical trial will further demonstrate the potential of our proprietary CARMA (CAR therapeutic) autologous cell-therapy platform to develop meaningful, targeted cell-based immune therapies."
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CARMA utilizes messenger RNA (mRNA) as the delivery vehicle for a CAR transfected into freshly isolated peripheral blood mononuclear cells, allowing for rapid manufacture and delivery back to the patient, without the need for a viral component or cell expansion. The CARMA platform provides a cell therapy with transient expression, enabling repeat dosing and with the potential to reduce the cost and minimize adverse side-effects seen in viral-based CAR therapies.
"In recent years we have seen tremendous progress in the treatment of some types of cancer, but there remains a significant need to explore novel treatments that may benefit patients," said Claudio Dansky Ullmann, MD, MaxCyte Chief Medical Officer. "Individuals with advanced and relapsed ovarian cancer or peritoneal mesothelioma have limited effective therapeutic options today. MCY-M11 is an exciting new approach with the potential to improve outcomes for these patients. We look forward to the continued progress of this first clinical study."