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– A new parallel cohort will expand the evaluation of MCY-M11 in patients by including a preconditioning regimen and dosing cycles.
– Doctors at Massachusetts General Hospital and Hackensack University Medical Center will register for doctors at the National Cancer Institute and Washington University in St. Louis to report MCY-M11 in the ongoing Phase I clinical trial.
– To date, the first ongoing human being has demonstrated a promising tolerability of MCY-M11 and the viability of one-day rapid autologous manufacturing.
GAITHERSBURG, Maryland, August 18, 2020 / PRNewswire / – MaxCyte, Inc., a global mobile treatment and life sciences company, announced the expansion of Phase I intrapitoneal management and a higher dose of the CARMA Cell Therapies subsidiary trial of MCY-M11, its leading candidate for mobile anti-mesothelin CAR-PBTM mobile treatment. The expansion will involve a new parallel patient cohort and the opening of two more clinical sites.
The new Phase I parallel cohort will compare the intrapitoneal treatment of MCY-M11 at increasing doses in other patients with recurrent/refractory ovarian cancer and malignant peritoneal mesothelioma, with the addition of a preconditioning preconditioning regimen prior to the infusion of MCY-M11. This pre-conditioning Phase I parallel cohort will progress independently of mcY-M11’s ongoing evaluation in the Phase I cohort without existing preconditioning. The Phase I MCY-M11 assay will also allow several remedy cycles when indicated for patients with and without long-term preconditioning.
New clinical sites for the exam at Massachusetts General Hospital /Harvard Medical School and Hackensack University Medical Center enroll in existing sites at the National Cancer Institute of the National Institutes of Health and the University of Washington in St. Louis.
In May, the encouraging initial effects of MCY-M11, which help the expansion of this study and the continuation of new cure methods, such as the addition of a preconditioning regimen and the provision of several cycles of remedies to improve efficacy, were presented at the ASCO virtual meeting. The effects to date also help the ongoing validation of MaxCyte’s exclusive CARMA autologous mobile curator platform.
To view the asCO summary, visit: https://meetinglibrary.asco.org/record/185279/abstract.
Following the extension of the Phase I trial, initial clinical knowledge of the existing preconditioning of the MCY-M11 trial is expected to be available at the time of 2020.
“We are well with the progress of this first human trial to date and hope to be approaching the implementation of a more effective immunotherapeutic option for patients with counterfeit tumors,” said Claudio Dansky Ullmann, MD, MaxCyte’s chief physician.
About the MCY-M11
MCY-M11 is a non-viral CAR-PBTM mobile anti-mesothelin cure discovered in mRN made from unper manipulated peripheral mononucleated blood cell (PBMC). It is being clinically evaluated as a remedy for counterfeit tumors on top of mesothelin. It is being developed as a component of the first multicenter Phase I clinical trial in humans, non-randomized, open, with increased dose, comparing the protection and initial efficacy of intraconsistent MCY-M11 with tea infusions in others with serous-grade ovarian adenocarcinoma, number one compatible withitoneo or fallopian tubes, or other people with complex compatible with itoneal mesothelioma Matrix with recurrence after previous cheiocura. MaxCyte anticipates that 27 participants of the exam component will be enrolled in the existing parallel cohort and the new parallel cohort. The intermediate effects presented at the ASCO 2020 assembly show that intrapitoneal infusion of MCY-M11 is feasible, safe and well tolerated. There was no dose-limiting toxicity or remedy-related interruptions or deaths and the maximum of adverse remedy-related occasions reported were grades 1 to 2 consistent with NCI CTCAE in 3 full doses as a single agent in the existing cohort. Registration for the fourth dose point of the existing cohort is ongoing and will be carried out in parallel with the inscription in the new parallel cohort, which includes a preconditionalization regimen. Several remedy cycles will be allowed for the fourth dose point of the existing cohort and at all dose grades in the new parallel preconditioning cohort. Lately we expect initial clinical knowledge by the time of 2020. More information about the exam can be found in ClinicalTrials.gov (Identifier: NCT03608618).
About CARMA Cell Therapies
Through its wholly owned subsidiary, CARMA Cell Therapies, MaxCyte facilitates the advancement of new mRN-based mobile treatments for cancer and other diseases with serious unmet needs. CARMA is a new patented platform for the progression of non-viral treatments, based on human messenger RNA (MRNA), chimeric antigen receptor (CAR) or redirected T mobile receptor (TCR). CARMA [derived from CAR mRN] uses MaxCyte’s Flow Electroporation® generation for highly effective non-viral handling of one or more mRNs in un tampered peripheral blood mononucleated mobiles (PBB) or remote immune mobiles such as T or NK mobiles. CARMA offers the possibility of safer mobile therapy, following a brief expression of the recipient and a non-viral delivery approach. In early 2020, MaxCyte created CARMA Cell Therapies as a 100% subsidiary to facilitate indefinite investments and new partnerships to advance the CARMA platform. MaxCyte has hired Locust Walk, a global transaction firm and strategic life sciences consulting. The Company expects CARMA to self-finance until the end of 2020. For more information, https://www.maxcyte.com/carma-mobile-treatments/.
About MaxCyte
MaxCyte is a global clinical society of mobile treatment and life sciences. As inventors of the company’s first generation of enabling mobile engineering, the Company is helping to realize the promise of next-generation mobile treatments and gene editing. Lately, corporate generation is being implemented through leading drug developers around the world, adding the ten largest biopharmaceutical companies in the world. MaxCyte’s licenses have been licensed for more than 120 mobile treatment programs, adding up to more than 90 for clinical use, and the company has entered 11 clinical/commercial licensing partnerships with leading developers in mobile treatment and gene editing. MaxCyte was founded in 1998 and was founded in Gaithersburg, Maryland, USA. For more information, visit www.maxcyte.com.
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SOURCE MaxCyte, Inc.