Full Press Release Details
Enters into New Agreement with CELLforCURE
for the cGMP Manufacturing of UCART123 for Hematological Malignancies
NEW YORK & LES ULIS, France--(BUSINESS WIRE)--January 19,
2016--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS),
a biopharmaceutical company focused on developing immunotherapies based
on gene edited CAR T-cells (UCART), announced that it entered into a new
agreement for the cGMP manufacturing of UCART123 clinical batches,
Cellectis' lead product candidate, with CELLforCURE, an LFB
group company and the largest industrial facility for clinical and
commercial production of innovative cell therapies in Europe. CELLforCURE
will be in charge of implementing cGMP manufacturing processes designed
and developed by Cellectis.
Following the recent successful production of UCART19, pursuant to this
second agreement CELLforCURE will be responsible for the
manufacturing of cGMP clinical batches for UCART123, the lead engineered
T-cell product candidate in Cellectis' wholly owned portfolio. UCART123
targets CD123, an antigen expressed on the surface of cancer cells in
malignancies, such as acute myeloid leukemia (AML) and blastic
plasmacytoid dendritic cells neoplasm (BPDCN).
UCARTs (Universal Chimeric Antigen Receptor T-cells) are "off-the-shelf"
allogeneic product candidates. Their production can be industrialized
and standardized with consistent pharmaceutical release criteria, over
time and from batch to batch.
Peripheral Blood Monoculear Cells from healthy donors are transduced and
genetically edited with Cellectis' TALEN technology to seek and destroy
cancer cells. This approach could lead to a drug that would be
cost-effective, made readily available - "off the shelf" - to broad
patient populations in hospitals without need for local CAR-T processing
facilities and easily distributed across all geographies.
Dr. David J.D. Sourdive, Executive Vice President Corporate Development,
Cellectis, stated: "The manufacturing campaign for UCART123 consolidates
Cellectis' GMP processes and our expertise in its industrialization
while allowing Cellectis to further enhance and improve the
manufacturing of its UCART product candidates."
Dr. Andr Choulika, Chairman & CEO, Cellectis, added: "We are very
pleased with our continued collaboration with CELLforCURE, a
unique industrial platform dedicated to cell and gene therapies and
equipped with a state-of-the-art cGMP manufacturing facility to foster
the clinical development of UCART123. Cellectis' cGMP manufacturing of
allogeneic CAR T-cells is a paradigm change in cancer adoptive
immunotherapies, for the patient's benefit."
Pierre-No l Lirsac, CEO of CELLforCURE stated: "The
technical and pharmaceutical experience of the CELLforCURE team
is a real asset, bringing its expertise to manufacture Cellectis'
cost-effectively CAR T-cell products, thus helping to make them broadly
and immediately available to patients."
Leopold Bertea, Head of the Global bioproduction division of the LFB
group, added: "This new agreement confirms the excellence of the
collaboration between Cellectis and CELLforCURE. We are proud to
contribute to such an exciting challenge."
Cellectis is a biopharmaceutical company focused on developing
immunotherapies based on gene edited CAR-T cells (UCART). The company's
mission is to develop a new generation of cancer therapies based on
engineered T-cells. Cellectis capitalizes on its 16 years of expertise
in genome engineering - based on its flagship TALEN products and
meganucleases and pioneering electroporation PulseAgile technology - to
create a new generation of immunotherapies. CAR technologies are
designed to target surface antigens expressed on 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 S.A. is listed on the Nasdaq
Global Market (ticker: CLLS) and on the NYSE Alternext market (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 the Cellectis Group.
CELLforCURE is an LFB group company dedicated to Advanced Therapy
Medicinal Products. CELLforCURE brings solutions to its customers
for industrial development of cell and gene therapy processes, contract
manufacturing services for clinical trials and market, and provides
regulatory and pharmaceutical services. CELLforCURE operates in a large
scale facility located at Les Ulis (France) and currently employs 43
LFB is a biopharmaceutical group that develops, manufactures, and
markets medicinal products indicated in the treatment of serious and
often rare diseases in hemostasis, immunology, and intensive care.
Number one in France and in 6th place worldwide in the field
of plasma-derived medicinal products, the LFB group is also one of the
leading European companies in the development and production of proteins
and of innovative treatments based on biotechnology.
With a sustained research effort, the LFB group has a growth strategy
that seeks to extend its activities at an international level. The LFB
group currently markets products in 40 countries around the world and
had a global turnover of 502 million euros in 2014. www.lfb.fr
This press release and the information contained herein do not
constitute an offer to sell or subscribe, or a solicitation of an offer
to buy or subscribe, for shares in Cellectis in any country. This press
release contains forward-looking statements that relate to the Company's
objectives based on the current expectations and assumptions of the
Company's management only and involve risk and uncertainties that could
cause the Company to fail to achieve the objectives expressed by the
forward-looking statements above.
Jennifer Moore, 917-580-1088
KCSA Strategic Communications
Harnest, 646-385-9008
VP Finance and Investor Relations
Sandrine Charri res, +33 (1) 69 82 72 80
Corporate Communications
Jeanne Bariller, +33 (6) 15 51 49 40