MaxCyte, Inc. Expansion of CARMA's Phase I Trial of MCY-M11 (3824W)
August 18 2020 - 2:00AM
UK Regulatory
TIDMMXCT TIDMTTM
RNS Number : 3824W
MaxCyte, Inc.
18 August 2020
CARMA Cell Therapies(TM) Expands Phase I Trial of
Anti-Mesothelin mRNA CAR-PBMC Cell Therapy MCY-M11
-- New parallel cohort will broaden evaluation of MCY-M11 in
patients through inclusion of a preconditioning regimen and
multiple dosing cycles
-- Clinicians at Massachusetts General Hospital and Hackensack
University Medical Center will join those at National Cancer
Institute and Washington University at St. Louis to evaluate
MCY-M11 in the ongoing Phase I clinical trial
-- To date, ongoing first-in-human study has demonstrated
promising tolerability of MCY-M11 and feasibility of rapid, one-day
autologous manufacturing
GAITHERSBURG, MD, 18 AUGUST 2020 - MaxCyte, Inc., (LSE: MXCT,
MXCL), a global cell-based therapies and life sciences company,
today announces the expansion of subsidiary CARMA Cell Therapies'
ongoing Phase I intraperitoneal delivery and dose-escalation trial
of MCY-M11, its lead anti-mesothelin CAR-PBMC cell therapy
candidate. The expansion will involve a new parallel cohort of
patients and the initiation of two additional clinical sites.
The new parallel Phase I cohort will evaluate intraperitoneal
delivery of MCY-M11 at escalating doses in additional patients with
relapsed/refractory ovarian cancer and malignant peritoneal
mesothelioma, with the addition of a preconditioning regimen of
cyclophosphamide prior to MCY-M11 infusion. This parallel Phase I
cohort with preconditioning will progress independently from the
ongoing evaluation of MCY-M11 in the existing no-preconditioning
Phase I cohort. The MCY-M11 Phase I trial will also allow for
multiple treatment cycles where indicated for both future
preconditioning and no-preconditioning patients.
New clinical sites for the study at Massachusetts General
Hospital/Harvard Medical School and Hackensack University Medical
Center are joining existing sites at the National Cancer Institute
at the National Institutes of Health and Washington University in
St. Louis.
In May, encouraging preliminary results for MCY-M11, which
support this study expansion and the pursuit of new strategies with
the therapy, such as the addition of a preconditioning regimen and
delivering multiple cycles of treatment to further enhance
efficacy, were presented at the virtual ASCO meeting. Results to
date also support the continued validation of MaxCyte's proprietary
CARMA autologous cell therapy platform.
For the ASCO abstract, please visit:
https://meetinglibrary.asco.org/record/185279/abstract .
Following the expansion of the Phase I trial, preliminary
clinical data for the existing no-preconditioning MCY-M11 trial are
anticipated in H2 2020.
"We are very pleased with the progress of this first-in-human
trial to date, and have great hopes that we are moving closer
towards bringing a more effective immunotherapeutic option for
patients with solid tumors," said
Claudio Dansky Ullmann, MD, Chief Medical Officer of MaxCyte.
About MCY-M11
MCY-M11 is a non-viral, mRNA-based anti-mesothelin CAR-PBMC cell
therapy manufactured using un-manipulated peripheral blood
mononuclear cells (PBMC). It is being evaluated in the clinic as
treatment for high mesothelin expressing solid tumors. It is under
ongoing development in a first-in human multi-center,
non-randomized, open label, dose-escalation Phase I clinical trial
evaluating the safety and preliminary efficacy 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 27 study participants will be enrolled across the
existing and the new parallel cohort. Interim results presented at
the ASCO 2020 meeting show that intraperitoneal infusion of MCY-M11
is feasible, safe, and well tolerated. There have been no
dose-limiting toxicities and no treatment related discontinuations
or deaths and most reported treatment related adverse events have
been Grades 1-2 per NCI CTCAE in three completed dose levels as a
single agent in the existing cohort. Enrollment in the fourth dose
level of the existing cohort is in progress and will run alongside
with enrollment in the new parallel cohort that includes a
preconditioning regimen. Multiple cycles of treatment will be
allowed in both the fourth dose level of the existing cohort and at
all dose levels in the new parallel preconditioning cohort. We
currently anticipate preliminary clinical data in H2 2020. More
information about the study can be found at ClinicalTrials.gov
(Identifier: NCT03608618).
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.
CARMA is 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(R) 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. 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,
visithttps://www.maxcyte.com/carma-cell-therapies/.
About MaxCyte
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 licences have been granted for
more than 120 cell therapy programmes, with more than 90 licensed
for clinical use, and the Company has now entered into eleven
clinical/commercial license partnerships with leading cell therapy
and gene editing developers. MaxCyte was founded in 1998, is listed
on the London Stock Exchange (AIM:MXCT, MXCL) and is headquartered
in Gaithersburg, Maryland, US. For more information, visit
www.maxcyte.com .
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 (MAR).
Contacts:
MaxCyte Inc.
Doug Doerfler, Chief Executive Officer
Ron Holtz, Chief Financial Officer +1 301-944-1660
Nominated Adviser and Joint Corporate
Broker
Panmure Gordon
Emma Earl
Freddy Crossley
Corporate Broking
James Stearns +44 (0)20 7886 2500
Joint Corporate Broker
Numis Securities Limited
James Black
Duncan Monteith +44 (0)20 7260 1000
Financial PR Adviser +44 (0)203 709 5700
Consilium Strategic Communications maxcyte@consilium-com
Mary-Jane Elliott
Chris Welsh
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