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Cellectis Files First Clinical Trial Application for UCART19, an Allogeneic Gene Edited CAR T-Cell Product for Hematological Malignancies NEW YORK--(BUSINESS WIRE)

Key Takeaway: Files First Clinical Trial Application for UCART19, an Allogeneic Gene Edited CAR T-Cell Product for Hematological Malignancies NEW YORK--(BUSINESS WIRE)--December 23, 2015--Regulatory News: Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS) today announc

Full Press Release Details

Files First Clinical Trial Application for UCART19, an Allogeneic Gene
Edited CAR T-Cell Product for Hematological Malignancies
NEW YORK--(BUSINESS WIRE)--December 23, 2015--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS)
today announced the submission of a clinical trial application (CTA) to
the Medicines & Healthcare products Regulatory Agency (MHRA) requesting
approval to initiate UCART19 First-in-Human clinical investigation in
leukemia in the United Kingdom.
This study aims to include CD19-positive Acute Lymphoblastic Leukemia
(ALL) patients. Other eligibility criteria to enter clinical trials will
be assessed by the investigators.
"It has been a privilege preparing this application with our team,
partners, investigators and subcontractors, in close interaction with
MHRA, rewarding many years of intense work to overcome the challenges
that are inherent to advanced therapy medicinal products. This
achievement marks an important step toward making UCART19 available to
patients," said Stephan Reynier, Chief Regulatory and Compliance
"The UCART19 CTA filing is a great recognition for the Company's
preclinical and manufacturing accomplishments in developing a
therapeutic for Acute Lymphoblastic Leukemia. We are all pleased with
Cellectis' progress to date with UCART19, including the filing of this
CTA, and we look forward to following the progress of this program
through the course of its clinical development," said Dr. Mathieu Simon,
EVP, Chief Operating Officer, Cellectis.
UCART19 is a potential best-in-class allogeneic TALEN gene edited
T-cell product for treatment of CD19 expressing hematological
malignancies, initially developed in Chronic lymphocytic leukemia (CLL)
and Acute lymphoblastic leukemia (ALL). Engineered allogeneic CD19 CAR
T-cells currently stand out as a real therapeutic innovation for
treating various types of leukemia and lymphoma. Cellectis' approach
with UCART19 is based on the preliminary positive results from clinical
trials using products based on the CAR technology and has the potential
to overcome the limitation of the autologous current approach by
providing an allogeneic frozen, "off the shelf" T-cell based medicinal
On November 18, 2015 Servier exercised its worldwide option to license
UCART19 and entered into a global development and commercialization
collaboration with Pfizer on UCART19. According to their recent
agreement, Cellectis will hand over the clinical development of UCART19
to Servier and their US partner Pfizer. Due to the early exercise,
Cellectis is no longer responsible for funding the UCART19 Phase I
Information about ongoing clinical trials are publically available on
dedicated websites such as:
Cellectis is a biopharmaceutical company focused on developing
immunotherapies based on gene edited engineered 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 15 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.
This press release contains "forward-looking" statements that are based
on our management's beliefs 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.
The risks and uncertainties include, but are not limited to the risk of
not obtaining regulatory approval to commence clinical trials on our
UCART product candidates, including UCART19, the risk that our
collaboration with Servier or our relationships with the principal
investigator will not continue or will not be successful, and the risk
that any one or more product candidates will not be successfully
developed and commercialized.
You should read the Company's Prospectus, including the Risk Factors set
forth therein and the exhibits thereto, completely and with the
understanding that our actual future results may be materially different
from what we expect. Except as required by law, we assume no obligation
to update these forward-looking statements publicly, or to update the
reasons actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
Jennifer Moore, 917-580-1088
Caitlin Kasunich, 212-896-1241
Harnest, 646-385-9008
VP Finance and Investor Relations
Last updated: Dec 23, 2015