MaxCyte has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to begin a clinical study in the United States with its first wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11.
"The IND clearance marks an important milestone for MaxCyte. We are excited to advance MCY-M11, our first therapeutic candidate in solid tumors into the clinic and we hope that the upcoming study will serve as validation of our proprietary CARMA (CAR therapeutic) drug platform as a whole," said MaxCyte CEO Doug Doerfler. "This initial study will help determine the safety and potential effectiveness of the CARMA platform, and if successful, will mark its place as a new autologous cell-therapy platform for developing improved targeted cell-based immune therapies."
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The IND allows for a Phase I clinical study to evaluate the safety of MCY-M11 in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma. The clearance is for the Company's first clinical study with MCY-M11, which is a drug candidate for next-generation CAR-engineered cell therapy. MCY-M11 is differentiated from traditional CAR therapies by its use of messenger RNA (mRNA) to engineer fresh peripheral blood mononuclear cells, allowing rapid manufacture and delivery back to the patient, without the need for a viral component or cell expansion. This cell therapy provides for transient expression, engineered with the potential to minimize the adverse side-effects seen in viral-based CAR therapies. MaxCyte anticipates commencing dosing of patients in H2 2018.