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news.MaxCyte has dosed the first patient in its US phase I dose-escalation clinical trial of chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11.
Image: MaxCyte has started first clinical trial in solid tumors. Photo: courtesy of cuteimage / FreeDigitalPhotos.net.
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The study is designed to evaluate MCY-M11, a mesothelin targeting CAR, in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.
MaxCyte CEO Doug Doerfler said: “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.
“We are extremely pleased to have very experienced investigators at two leading clinical centers conducting this study in solid tumours. 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.”
CARMA utilises 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.
MaxCyte chief medical officer Dr Claudio Dansky Ullmann said: “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.
“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.”
The multi-center, non-randomized, open label, dose-escalation Phase I clinical trial will evaluate the safety and effectiveness 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.
MaxCyte anticipates approximately 15 study participants will be enrolled across the two clinical sites participating in the study (the National Cancer Institute at the National Institutes of Health (NIH) and Washington University at St. Louis).
CARMA is MaxCyte’s unique and proprietary CAR therapy platform in immuno-oncology. The platform is used to develop CAR therapies for a broad range of cancer indications.
It offers the potential to deliver autologous cell therapies across a wide range of targets with a much quicker turnaround to the patient than traditional autologous cell therapies, and with repeat dosing that may reshape the endogenous immune system of these patients towards a more effective antitumor response.
Source: Company Press Release
