NEW YORK–(BUSINESS WIRE)– Regulatory News:
(Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a
biopharmaceutical company focused on developing immunotherapies based on
gene-edited allogeneic CAR T-cells (UCART), announced that it has
entered into a lease agreement to build an 82,000 square foot
commercial-scale manufacturing facility named IMPACT (Innovative
Manufacturing Plant for Allogeneic Cellular Therapies) in Raleigh, North
Carolina, for clinical and commercial production of Cellectis’ leading
allogeneic UCART products. In addition, Cellectis started building a
14,000 square foot manufacturing facility in Paris, France named SMART
(Starting Material Realization for CAR-T products) to produce
Cellectis’ critical starting material supply for UCART clinical studies
and commercial products.
These new manufacturing plants will allow GMP manufacturing for both
clinical supplies and commercial products according to the Food and Drug
Administration (FDA) and European Medicines Agency (EMA) guidelines, and
will be fully equipped to support a potential regulatory approval.
“As announced in 2018, we are entering an exciting phase for Cellectis,
internalizing manufacturing capabilities and capacity. We have perfected
our manufacturing process throughout the past years and successfully
produced several GMP campaigns at our CMOs, which have been and will
remain key partners,” said Dr. André Choulika, Chairman and CEO of
Cellectis. “Now is the right time to create our own supply competencies.
By combining the state-of-the-art capabilities that IMPACT and SMART
plants will provide, Cellectis will gain autonomy, control and expertise
in manufacturing operations, allowing us to continue to build
competitive advantage and remain the leader in our field.”
Cellectis’ leading allogeneic approach begins with harvesting T-cells
from healthy donors. These T-cells are then edited using the Company’s
proprietary cutting-edge, gene-editing technology, TALEN®, to
develop engineered T-cells that express a Chimeric Antigen Receptor
(CAR). The engineered T-cells can recognize specific proteins or
antigens that are present on the surface of target cancer cells and
eliminate them, without being rejected by the body. Once engineered, our
UCART products are cryopreserved and ready to be shipped to hospitals
across all geographies.
Cellectis currently manufactures its allogeneic UCART clinical trial
supply and starting materials through contract manufacturing
organizations (CMO). These CMOs will continue to be strategic business
partners, complementing IMPACT and SMART plants in assuring a robust
supply chain for the manufacture of Cellectis’ allogeneic UCART
The SMART facility is co-located with the Cellectis headquarters in
Paris, France. The engineering team of Laporte Euro is assisting for the
design and construction.
The IMPACT facility is part of the Sumner Business Park located at 2500
Sumner Boulevard in Raleigh, North Carolina. Colliers International
assisted in the real estate transaction.
Cellectis is a clinical-stage biopharmaceutical company focused on
developing a new generation of cancer immunotherapies based on
gene-edited T-cells (UCART). By capitalizing on its 19 years of
expertise in gene editing – built on its flagship TALEN® technology and
pioneering electroporation system PulseAgile – Cellectis uses the power
of the immune system to target and eradicate cancer cells.
Using its life-science-focused, pioneering genome engineering
technologies, Cellectis’ goal is to create innovative products in
multiple fields and with various target markets.
Cellectis is listed on the Nasdaq (ticker: CLLS) and on Euronext Growth
(ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com
Talking about gene editing? We do it. TALEN® is a registered trademark
owned by Cellectis.
This press release contains “forward-looking” statements that are based
on our management’s current expectations and assumptions and on
information currently available to management. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements.
Further information on the risk factors that may affect company business
and financial performance is included in Cellectis’ Annual Report on
Form 20-F and the financial report (including the management report) for
the year ended December 31, 2017 and subsequent filings Cellectis makes
with the Securities Exchange Commission from time to time. Except as
required by law, we assume no obligation to update these forward-looking
statements publicly, or to update the reasons why actual results could
differ materially from those anticipated in the forward-looking
statements, even if new information becomes available in the future.
For further information, please contact:
Simon Harnest, VP of Corporate Strategy and
Finance, 646-385-9008, firstname.lastname@example.org