Full Press Release Details
GMP Production Process for UCART19
NEW YORK--(BUSINESS WIRE)--October 28, 2015--Regulatory News:
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS - Nasdaq: CLLS)
today announced that a series of three production runs of UCART19, its
lead TALEN gene edited product candidate, was
performed, confirming the implementation of Cellectis' manufacturing
process in GMP conditions.
The manufacturing process for Cellectis' allogeneic CAR T-cell product
line, Universal CARTs or UCARTs, yields frozen, off-the-shelf,
allogeneic, engineered CAR T-cells. UCARTs are meant to be readily
available CAR T-cells for a large patient population. The TALEN -based
gene editing (knock-out of the TCR-alpha and CD52 genes) is designed to
suppress T-cell alloreactivity and confer resistance to alemtuzumab to
the T-cells. This important milestone shows that UCARTs can be
manufactured in GMP conditions. It also demonstrates the industrial
production of UCART19, as well as the capacity of Cellectis' pipeline of
UCART product candidates to be manufactured for clinical investigations.
"It is very exciting to lead a novel allogeneic gene therapy platform at
the critical time when a R&D concept is translated into a GMP clinical
grade industrial product to be investigated in clinical studies," said
Arjan Roozen, Vice President, GMP Solutions and Manufacturing.
"Cellectis has reached a critical milestone both for the Company and our
industry, creating new opportunities for patients. Historically,
cell-based therapies have grown in the world of individual grafts. With
TALEN -based gene editing they have now started moving
toward that of industrial pharmaceutical products broadly available to
patients, and Cellectis, as a leading company in the field of gene
editing, is at the forefront of this evolution," added David J.D.
Sourdive, Executive Vice President, Corporate Development.
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.
Arjan Roozen, Vice President GMP Solutions and Manufacturing
Arjan Roozen received a BSc degree in molecular microbiology from
Larenstein, Velp in The Netherlands. Arjan joined Cellectis in March
2015. In his present position of VP GMP Solutions & Manufacturing, he is
responsible for all GMP pharmaceutical manufacturing activities
including the biological raw materials.
Before joining Cellectis, Arjan worked for over 20 years at different
biotechnology departments at Centocor, Solvay Pharmaceuticals, Biogen
Idec, Crucell, Proxy laboratories and Pharmacell and gained significant
experience in QC, QA and manufacturing GMP aspects. The last 4 years
within Pharmacell, Arjan Roozen was responsible for GMP operations
involved in significant number of cell therapy technology transfer
projects as well as responsible for cell therapy commercial products. He
was also involved in regulatory audit and filings for EMA and FDA.
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.
registered trademark owned by the Cellectis Group.
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, VP Communications
email: media@cellectis.com
Kasunich / Dixon Moretz
KCSA Strategic Communications
Simon Harnest, VP Finance and Investor
email: simon.harnest@cellectis.com