MaxCyte, Inc. Phase I Clinical Trial of MCY-M11 Progressed (2936Y)
08 May 2019 - 4:00PM
UK Regulatory
TIDMMXCT TIDMTTM
RNS Number : 2936Y
MaxCyte, Inc.
08 May 2019
MaxCyte, Inc.
("MaxCyte" or the "Company")
MaxCyte Progresses Phase I Clinical Trial of Lead mRNA-based
Cell Therapy
from its CARMA(TM) Platform
- No dose-limiting toxicities or safety concerns observed in first cohort of treated patients
- Feasibility of streamlined, faster CAR therapy manufacturing process confirmed
- Dosing initiated in second cohort of patients
Gaithersburg, Maryland - 8 MAY 2019: MaxCyte (LSE: MXCT, MXCS),
the global clinical-stage, cell-based therapies and life sciences
company, announced today that it has initiated dosing for the
second cohort of patients in its US Phase I clinical trial with
MCY-M11, the lead, wholly owned, non-viral mRNA-based cell therapy
candidate from its CARMA platform. MCY-M11 is a
mesothelin-targeting chimeric antigen receptor (CAR) therapy being
tested in individuals with relapsed/refractory ovarian cancer and
peritoneal mesothelioma.
The dose escalation trial is evaluating the safety and
tolerability of MCY-M11 in approximately 15 patients across a
series of cohorts.
"Successfully completing patient dosing in our first cohort and
initiating dosing in a second higher-dose cohort are important
milestones for MaxCyte, representing tangible progress for our lead
CAR therapeutic and our proprietary CARMA autologous cell therapy
platform," said Claudio Dansky Ullmann, MD, Chief Medical Officer.
"We are very excited about the potential of MCY-M11 as a new,
effective therapeutic in solid tumours where the majority of
patients still have very limited treatment options."
The manufacturing process for MCY-M11 utilizes MaxCyte's
proprietary Flow Electroporation(R) technology to transfect mRNA
into fresh (i.e., unexpanded) peripheral blood mononuclear cells
(PBMCs). This streamlined, faster manufacturing process for an
autologous cell therapy is an important differentiator from other
CAR technologies. In addition, the CARMA platform's utilization of
Flow Electroporation rather than viral vectors enables repeat
dosing of patients, a feature that may be key for the successful
treatment of solid tumours with a cell therapy. Another
distinguishing feature of MaxCyte's CARMA platform is the insertion
of the CAR as mRNA into cells rather than as DNA. The transient
nature of mRNA could help alleviate some of the safety limitations
of other CAR treatment approaches.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
About the Phase I Clinical Trial
The multi-center, non-randomized, open label, dose-escalation
Phase I clinical trial is evaluating 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). More information
about the study can be found at ClinicalTrials.gov.
About the CARMA Platform
CARMA is the autologous, mRNA-based CAR therapeutic platform
developed by MaxCyte, Inc. that can be applied toward a broad range
of diseases, including solid tumours. Utilizing a streamlined
manufacturing process, CARMA allows for a faster turnaround of cell
therapy to patients compared to traditional CAR therapies and works
to trigger a patient's own immune system to fight disease.
MaxCyte's first CARMA drug candidate, MCY-M11, is currently in a
Phase I clinical trial in individuals with advanced ovarian cancer
and peritoneal mesothelioma. More information on MaxCyte's CARMA
platform and pipeline is available at www.maxcyte.com/car/.
About MaxCyte
MaxCyte is a global clinical-stage cell-based therapies and life
sciences company applying its proprietary cell engineering platform
to deliver the advances of cell-based therapy 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 programme 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 plus significant additional
potential milestones from the multi-drug commercial agreement with
Kite announced 1 March 2019. 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.
For further information, please contact:
MaxCyte Inc.
Doug Doerfler, Chief Executive Officer
Ron Holtz, Chief Financial Officer +1 301 944 1660
Nominated Adviser and Broker
Panmure Gordon
Emma Earl
Freddy Crossley
Corporate Broking
James Stearns +44 (0)20 7886 2500
Financial PR Adviser
Consilium Strategic Communications +44 (0)203 709 5700
Mary-Jane Elliott maxcyte@consilium-comms.com
Chris Welsh
Sukaina Virji
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