MaxCyte, Inc. FDA IND Clearance for First Clinical Programme (6677U)
July 16 2018 - 2:00AM
UK Regulatory
TIDMMXCT TIDMMXCR
RNS Number : 6677U
MaxCyte, Inc.
16 July 2018
MaxCyte, Inc.
("MaxCyte" or the "Company")
MaxCyte Receives US FDA Investigational New Drug Clearance
for First Clinical Programme
Company to conduct Phase I clinical study of MCY-M11, a CAR
therapeutic,
in patients with ovarian cancer and peritoneal mesothelioma
Gaithersburg, Maryland - 16 July 2018: MaxCyte (LSE: MXCT, MXCR)
announced that it has received Investigational New Drug (IND)
clearance from the US Food and Drug Administration (FDA) to begin a
clinical study in the United States with its first wholly-owned
chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11.
MaxCyte also today provided an update on trading for the six
months ended 30 June 2018. The Company is trading in line with
expectations and seeing a significant acceleration in the number of
partner programs advancing towards commercialisation-stage.
"The IND clearance marks an important milestone for MaxCyte. We
are excited to advance MCY-M11, our first therapeutic candidate in
solid tumours into the clinic and we hope that the upcoming study
will serve as validation of our proprietary CARMA(TM) (CAR
therapeutic) drug platform as a whole," said MaxCyte CEO Doug
Doerfler. "This initial study will help determine the safety and
potential effectiveness of the CARMA platform, and if successful,
will mark its place as a new autologous cell-therapy platform for
developing improved targeted cell-based immune therapies."
The IND allows for a Phase I clinical study to evaluate the
safety of MCY-M11 in individuals with relapsed/refractory ovarian
cancer and peritoneal mesothelioma. The clearance is for the
Company's first clinical study with MCY-M11, which is a drug
candidate for next-generation CAR-engineered cell therapy. MCY-M11
is differentiated from traditional CAR therapies by its use of
messenger RNA (mRNA) to engineer fresh peripheral blood mononuclear
cells, allowing rapid manufacture and delivery back to the patient,
without the need for a viral component or cell expansion. This cell
therapy provides for transient expression, engineered with the
potential to minimize the adverse side-effects seen in viral-based
CAR therapies. MaxCyte anticipates commencing dosing of patients in
H2 2018.
About the CARMA (CAR Therapy) Platform
CARMA is MaxCyte's unique and proprietary CAR therapy platform
in immuno-oncology. The platform is used to develop CAR therapies
for a broad range of cancer indications. It offers the potential to
deliver autologous cell therapies across a wide range of targets
with a much quicker turnaround to the patient than traditional
autologous cell therapies. More information on MaxCyte's CARMA
programme is available at https://www.maxcyte.com/car/.
About MaxCyte
MaxCyte is a global cell-based medicines and life sciences
company applying its patented cell engineering technology to help
patients with high unmet medical needs in a broad range of
conditions. MaxCyte is developing novel CARMA therapies for its own
pipeline. CARMA is MaxCyte's mRNA-based proprietary platform for
autologous cell therapy. In addition, through its core business,
the Company leverages its Flow Electroporation(R) Technology to
enable its partners across the biopharmaceutical industry to
advance the development of innovative medicines, particularly in
cell therapy, including gene editing and immuno-oncology. The
Company has placed its cutting-edge flow electroporation
instruments worldwide, including with nine of the top 10 global
biopharmaceutical companies, and has more than 55 partnered
programme licenses in cell therapy including more than 25 licensed
for clinical use. With its robust delivery technology, 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
Ryan McCarthy
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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END
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