Full Press Release Details
First in Man Proof of Concept to Be Presented at 2015 ASH Annual Meeting
NEW YORK--(BUSINESS WIRE)--November 5, 2015--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) today announced that Great Ormond
Street Hospital (GOSH) and University College London (UCL) will present
encouraging data from a first in man clinical use of UCART19, at the 57th
American Society of Hematology (ASH) Annual Meeting in Orlando during
GOSH has treated in June 2015 a young leukemia patient under a special
license from the Medicines & Healthcare products Regulatory Agency
(MHRA) with Cellectis' TALEN gene edited
allogeneic UCART19 product candidate because no other therapies were
available for refractory relapsed Acute Lymphoblastic Leukemia (ALL)
following mismatched allogeneic stem cell transplantation.
In response to an unsolicited request from Professor Waseem Qasim,
Consultant Immunologist at GOSH and Professor of Cell and Gene Therapy
at University College London (UCL) Institute of Child Health, Cellectis
gave its approval for the use of its UCART19 product candidate and
technologies under GOSH's "Specials" license and responsibility, for the
particular clinical needs of that individual patient.
Professor Qasim says: "The successful treatment of a patient with
UCART19 cells represents a landmark in the use of new gene engineering
technology. If replicated in other patients, it could represent a huge
step forward in treating leukaemia and other cancers."
"We are very glad for this young patient to have benefited from our
highly innovative TALEN gene edited allogeneic CAR T
therapy UCART19. We expect to accelerate our clinical development of
TALEN gene-edited allogeneic CAR-T therapies to further
confirm this encouraging clinical proof of concept," said Doctor Mathieu
Simon, MD, Executive Vice President, Chief Operating Officer at
"Our team aims to provide to patients, with unmet medical needs, access
to the first allogeneic CAR-T therapy, UCART19 made with Cellectis' TALEN
gene-editing technologies," said Doctor Andr Choulika, Founder,
Chairman and Chief Executive Officer of Cellectis. "Cellectis had, is
and will invest significant amounts of energy and creativity to provide
cancer patients with an accessible, cost-effective, off-the-shelf
allogeneic CAR-T therapies across all geographies. UCART19 has been
provided for to a patient who could not undergo an autologous CAR-T
therapy. Our goal is to make our product candidates accessible to
UCART19 is a potential best-in-class allogeneic
engineered T-cell product for treatment of CD19 expressing hematologic
malignancies, initially developed in Chronic lymphocytic leukemia (CLL)
and Acute lymphoblastic leukemia (ALL). Servier has an option under the
collaboration agreement to acquire the exclusive rights to further
develop and commercialize UCART19. Engineered allogeneic CD19 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 product.
About Great Ormond Street Hospital (GOSH)
Hospital for Children NHS Trust is the country's leading centre for
treating sick children, with the widest range of specialists under one
roof. With the UCL Institute of Child Health, they are the largest
centre for paediatric research outside the US and play a key role in
training children's health specialists for the future.
About the UCL department of hematology
The UCL department of
hematology is the major tertiary referral center in the UK for all types
of hematological malignancies. They have assumed a global leadership
position in stem cell transplantation and adoptive cell therapy for
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 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 is listed on
the Nasdaq 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 include, without
limitation, information regarding the potential efficacy and safety of
UCART19 product candidate and other Cellectis' UCART product candidates,
our possible or assumed future results of operations, and our
competitive position.
It should be noted that data related to UCART19 product candidate
contained in this press release and the data that will be presented at
the American Society of Hematology Annual Meeting are preliminary in
nature and need to be further confirmed in controlled clinical trials.
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 risks that the preliminary results from UCART19 as
mentioned in this press release will not continue or be repeated in
other potential compassionate uses or in planned clinical trials on
UCART19 or other Cellectis' UCART product candidates, 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 will not continue or will not be successful, and the risk
that any one or more product candidates will not be successfully