MaxCyte Regulatory News (MXCT)

MaxCyte Presents at 22nd Annual ASGCT Meeting on Manufacturing Process for First CARMA™ Drug Candidate, Including One-Day Cell Processing

- CARMA drug candidates can be manufactured via streamlined, single-day process, providing a much needed faster turnaround of autologous cell therapy to patients

- CARMA cell therapies are engineered with the intention of reducing potential adverse events that have been evident with other CAR technologies and to allow for multiple dosing, an important feature for potential treatment of solid tumors

Gaithersburg, Maryland - May 1, 2019: MaxCyte (LSE: MXCT, MXCS), the global clinical-stage cell-based therapies and life sciences company, announced that Robert Keefe, Director of Technical Operations, provided an oral presentation on April 29, titled "Novel mRNA-based Autologous CAR Therapies in Oncology,"  at the annual meeting of the American Society of Gene and Cell Therapy (ASGCT) in Washington, DC. 

Dr. Keefe highlighted the CARMA platform's key differentiating features, including manufacture and delivery to a patient in a fraction of the time compared to traditional chimeric antigen receptor (CAR) therapies and without a viral component. He also described the manufacturing feasibility data for MaxCyte's first CARMA drug candidate, MCY-M11, a mesothelin-targeting chimeric antigen receptor (CAR), which is currently being evaluated in a Phase I clinical trial in mesothelin-expressing solid tumors at the National Cancer Institute (NCI) and Washington University in St Louis.  

"The advancement of our first CARMA clinical trial, which is consistently showing the feasibility of our rapid manufacturing process, is significant for MaxCyte and the application of our technology," said Claudio Dansky Ullmann, MD, MaxCyte's Chief Medical Officer. "Development of a cell therapy with application in solid tumors is impactful for patients with unmet needs in a variety of cancers and we look forward to further advancing this program."

The CARMA platform offers an innovative approach to cell-based therapies that can be applied in a broad range of diseases, including solid tumors. The manufacturing process for MCY-M11 utilizes MaxCyte's proprietary Flow Electroporation® technology to transfect mRNA into fresh (i.e., unexpanded) peripheral blood mononuclear cells (PBMCs). The entire CARMA manufacturing process allows for streamlined manufacturing providing a much needed faster turnaround of autologous cell therapy to patients. CARMA cell therapy was engineered with the intention of reducing potential adverse events that have been evident with other CAR technologies, and allowing for multiple dosing, a feature that may be key in the treatment of solid tumors with cellular therapies.

Last month, this trial was featured as a "trial in progress" at the American Association for Cancer Research (AACR) Annual Meeting , via a poster highlighting key aspects of the study design.

Dr. Keefe's ASGCT abstract (#74) can be found at the meeting's website, on page 40 of the PDF, at:

 https://www.asgct.org/global/documents/asgct19_abstracts_-final

About MaxCyte 

MaxCyte is a clinical-stage global cell-based medicines and life sciences company applying its proprietary cell engineering platform to deliver the advances of cell-based medicine to patients with high unmet medical needs. MaxCyte is developing novel CARMA therapies for its own pipeline, with its first drug candidate in a Phase I clinical trial. CARMA is MaxCyte's mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. In addition, through its life sciences business, MaxCyte leverages its Flow Electroporation Technology to enable its biopharmaceutical partners to advance the development of innovative medicines, particularly in cell therapy. MaxCyte has placed its flow electroporation instruments worldwide, with all of the top ten global biopharmaceutical companies. The Company now has more than 70 partnered program licenses in cell therapy with more than 35 licensed for clinical use, including four announced commercial licenses covering potentially more than 30 products with aggregate potential milestones of more than $250m. With its robust delivery technology platform, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit www.maxcyte.com.

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