MaxCyte receives FDA approval to start Phase I study of MCY-M11

17th July 2018 (Last Updated July 17th, 2018 00:00)

MaxCyte has received investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase l clinical study of MCY-M11 to treat patients with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

MaxCyte receives FDA approval to start Phase I study of MCY-M11
Micrograph of malignant mesothelioma. Credit: Nephron.

MaxCyte has received investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase l clinical study of MCY-M11 to treat patients with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

The company expects to start dosing patients in the trial this year.

Peritoneal mesothelioma is a type of cancer that attacks the lining that protects the contents of the abdomen, which also provides a lubricating fluid to enable the organs to move and work properly.

Symptoms of peritoneal mesothelioma are weight loss and abdominal pain and swelling, as well as pain, trouble swallowing, or swelling of the neck or face.

MaxCyte CEO Doug Doerfler said: “We are excited to advance MCY-M11, our first therapeutic candidate in solid tumours 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.

"This initial study will help determine the safety and potential effectiveness of the CARMA platform."

“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.”

MCY-M11 is a drug candidate developed by MaxCyte for next-generation chimeric antigen receptor (CAR) engineered cell therapy.

It is designed to use messenger RNA (mRNA) to develop new peripheral blood mononuclear cells, thereby allowing rapid manufacture and delivery back to the patient, eliminating the need for a viral component or cell expansion.

MCY-M11 is also developed to offer transient expression, created with the potential to reduce the adverse side-effects seen in viral-based CAR therapies.