Gaithersburg, Maryland – May 18, 2020: – MaxCyte, the global clinical-stage cell-based therapies and life sciences company, announces that clinical data from the first three cohorts of the ongoing Phase I dose-escalation trial demonstrating safety of MCY-M11 and feasibility of one-day manufacturing will be shared at the American Society of Clinical Oncology’s (ASCO) upcoming annual meeting. The ASCO20 Virtual Scientific Program will be held May 29-31, 2020.
The Poster Discussion presentation, entitled Feasibility and preliminary safety and efficacy of first-in-human intraperitoneal delivery of MCY-M11, anti-human-mesothelin CAR mRNA transfected into peripheral blood mononuclear cells, for ovarian cancer and malignant peritoneal mesothelioma, will be available in the Developmental Therapeutics: Immunotherapy session, which can be accessed on demand beginning at 8 a.m. ET on Friday, May 29, 2020.
MCY-M11 is a wholly-owned, non-viral, mRNA-based cell therapy candidate manufactured using un-manipulated peripheral blood mononuclear cells. It is under development for the treatment of ovarian cancer and peritoneal mesothelioma. The ongoing study so far demonstrates both the safety and of MCY-M11 as well as the feasibility of one-day manufacturing and intraperitoneal delivery of our cell product.
“This is a presentation of the preliminary results of our ongoing first-in-human study with the novel mRNA-based CARMA platform designed to treat malignancies expressing mesothelin,” said Christina M. Annunziata, MD, PhD, Investigator at the Women’s Malignancies Branch and Head of the Translational Genomics Section at the National Cancer Institute Center for Cancer Research. “We have so far demonstrated the feasibility to deliver MCY-M11 CARMA cells intraperitoneally to treat patients, the acceptable overall safety of using a transient CAR expression approach and early evidence that supports moving forward with and further building on this strategy.”
As previously announced, dosing began in October 2019 in the third cohort in MaxCyte’s Phase I dose-escalation trial with MCY-M11 and there have been no dose-limiting toxicities or related serious adverse events observed in the three completed cohorts. A fourth dosing cohort commenced in March 2020 as expected. Preliminary clinical results for the trial are expected to be announced in H2 2020. Clinical development of MCY-M11 continues now under the auspices of MaxCyte’s subsidiary CARMA Cell Therapies™.
For more information about the ASCO20 Virtual Scientific Program and a link to the abstract, please visit: //meetinglibrary.asco.org/record/185279/abstract.
About CARMA Cell Therapies
Through its wholly owned subsidiary, CARMA Cell Therapies, MaxCyte is facilitating advancement of novel mRNA-based cell therapies for cancer and other diseases with serious unmet needs. MaxCyte has developed CARMA, a novel and proprietary platform for the development of non-viral, human messenger RNA (mRNA)-based, chimeric antigen receptor (CAR) or T-cell receptor (TCR) redirected immune cell therapies. CARMA [derived from CAR mRNA] utilizes MaxCyte’s Flow Electroporation® technology for highly efficient, non-viral, delivery of one or more mRNA(s) into un-manipulated peripheral blood mononuclear cells (PBMCs) or isolated immune cells such as T- or NK-cells. CARMA offers the potential for a safer cell therapy, as a result of transient expression of receptor(s) and a non-viral delivery approach. Together, CARMA and MaxCyte’s EXPERT® family of instruments also offer the potential for a significantly streamlined, scalable, and cost-effective GMP manufacturing process without the complexity of virus-based products. At the start of 2020, MaxCyte established CARMA Cell Therapies as a wholly owned subsidiary to facilitate independent investment and new partnerships to advance the CARMA platform. MaxCyte has retained Locust Walk, a global life science strategic advisory and transaction firm. The Company expects CARMA to be self-funded by end of 2020. For more information, visit /carma-cell-therapies/.
MaxCyte is a clinical-stage global cell-based therapies and life sciences company. As the inventors of the premier cell-engineering enabling technology, the Company helps bring the promise of next-generation cell and gene-editing therapies to life. The Company’s technology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licenses have been granted for more than 100 cell therapy programmes, with more than 70 licensed for clinical use, and the Company has now entered into ten clinical/commercial license agreements with leading cell therapy and gene editing developers. MaxCyte was founded in 1998 and is headquartered in Gaithersburg, Maryland, US. For more information, visit www.maxcyte.com
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