VALBONNE, France--(BUSINESS WIRE)--Regulatory News:
TxCell SA (Paris:TXCL) (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cell immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, today announces it is strengthening its management team with the recruitment or the promotion of five new vice presidents in key functions.
These appointments bring a wealth of significant experience in leadership within the biopharmaceutical industry. They also bring a proven track record of success in cell therapy as well as wider areas of the life science sector, including microbiology, cell physiology, immunotherapy and genetic vectorization. These appointments will add additional commercial business function support to TxCell including project management and business development.
TxCell completed a strategic review in October 2015, and decided to focus on its key strengths of research, clinical development and new partnerships. It will outsource all of its existing and future clinical and commercial manufacturing operations to contract manufacturing organizations (CMOs). In addition, TxCell has retained, as well as further strengthen its critical process development capabilities and GMP-proving activities with key recruitments and opening of a dedicated laboratory.
“TxCell has now entered a new stage of the development of the company, concentrating on discovery, research, clinical development and manufacturing process improvement. We have set ourselves very ambitious targets, including bringing at least three new products from our two platforms, including innovative Chimeric Antigen Receptor (CAR)-engineered Treg cell products, to clinical development within five years,” said Stephane Boissel, CEO, TxCell. “As a result, TxCell has made five new senior management appointments. The combination of these appointments gives us an additional depth and breadth of leadership experience to further speed up development of our products in line with our targets.”
Appointments effective immediately:
Nathalie Belmonte - VP Research Operations
Nathalie
Belmonte, 40, is appointed VP Research Operations. Nathalie has more
than 10 years of experience working in the field of cell therapy from
both an academic and biotech position. Specifically, she has significant
experience with the development of mesenchymal stem cells, hematopoietic
stem cells and T cells in the fields of regenerative medicine and
immunotherapy. Before joining TxCell in 2006 as a scientist, she was a
scientist in a French academic laboratory (INSERM) dedicated to the
development of cell therapies for fascioscapulohumeral muscular
dystrophy. Prior to this, Nathalie was a scientist at the San Raffaele
Hospital at the Telethon Institute for Gene Therapy (TIGET) in Milan,
working in the field of hematopoietic stem cells and muscle
regeneration. She started her career working in a French academic lab in
Nice (CNRS) working on embryonic stem cells and stem cells from adipose
tissue. Nathalie has a PhD in Cellular and Molecular Biology at the
University of Nice Sophia Antipolis.
Liliane Guilmin - VP Project Management
Liliane Guilmin, 50,
is appointed VP Project Management. Lilian has more than 20 years’
experience in the pharmaceutical industry. This includes over 10 years
in project management across all stages of drug development and brand
lifecycle as well as within different therapeutic areas. Prior to
joining TxCell in 2013 as project global team leader, she was
responsible for portfolio management at OM Pharma, the infectious
disease/OTX franchise of Vifor Pharma, where she managed 3 programs of
several projects. Previously, Liliane held several roles at Nicox SA
where she implemented its project management organization, conducted
several projects (phase 1/2/3), participated in several regulatory
briefing packages as well as to one FDA advisory committee meeting, and
contributed to in-licensing product candidates’ evaluation. Liliane
began her career at Theramex, a company of Merck KgAa group, dedicated
to women's health and gynecology. Liliane obtained a postgraduate
diploma in microbiology from the University of Aberdeen after an MSc in
Cell Physiology and Immunology from the University of Nice.
Pierre Heimendinger - VP Process Development
Pierre
Heimendinger, 53, is appointed VP Process Development. Pierre has over
29 years of experience in the pharmaceutical industry and specifically
in the field of biotechnology, immunotherapy, vaccines, plasma-derived
medicinal products and viral vectors. Pierre gained his experience of
manufacturing processes of development and analytical methods of control
through numerous positions he has held in research and development,
industrialization processes, production and quality control for products
for Phase 1, 2, and 3 clinical trials and for commercial products on the
market. He has improved the robustness of products as well as control
strategies as well as enrolling new drugs in clinical trials as
guidelines alter. He has achieved this by implementing quality by design
and process analytical technology by the development of regulatory
proceedings. Before joining TxCell in 2015, Pierre held a senior
director position at Transgene SA where he led the pharmaceutical
development team and was responsible for the development of new
processes, analytical methods and technology transfer immunotherapy
treatments using viral vectors. He started his career at Sanofi Pasteur
where he held several positions in R&D and production, then at Mérieux
and Octapharma. Pierre has a doctor of pharmacy degree complemented by a
postgraduate in cellular and genetic toxicology from the University of
Paris VII.
Appointments effective in January 2016:
Catherine Mathis - VP Regulatory Affairs
Catherine Mathis,
50, is appointed VP Regulatory Affairs. Catherine has more than
25 years’ experience working in clinical research and regulatory affairs
with pharma and biotech companies, including in the areas of immunology
and oncology. Specifically, she developed the strategies of innovative
healthcare products from Phase 1 to phase 3 studies with an excellent
product knowledge concerning US and EU regulations. She conducted many
regulatory processes with interactions with the US FDA and the European
health authorities (EMA and national competent authorities). It has also
included interactions with European payers (HTA bodies). She acquired
expertise in the regulation of personalized medicine by developing
companion diagnostic assays associated with innovative immunotherapy
products. Prior to joining TxCell in 2015, Catherine served as a senior
director, for Voisin Consulting the international consulting company.
She also advised several biotech and pharma companies developing gene
and cell therapy products. Catherine also served for several years as a
senior director, head of regulatory affairs at Transgene, a French
biotech company developing immunotherapy products based on recombinant
viruses. She started her career at Ipsen/Beaufour and Sanofi Pasteur in
clinical research. Catherine completed pharmacy studies and then earned
a master degree in applied and basic toxicology from the University of
Paris VII.
Maud Bouvier - VP Business Development
Maud Bouvier, 38, is
appointed VP Business Development. Maud brings 10 years of experience
and expertise in the biotech business development field. Prior to
joining TxCell in 2015, she has served as alliance manager in Erytech
Pharma, a clinical-stage biopharmaceutical company developing innovative
therapies for rare forms of cancer and orphan diseases. Maud has managed
and actively contributed to the strategic alliances with Teva and Orphan
Europe/Recordati Group. She joined Erytech in 2005 as a competitive
intelligence team manager and then served for several years as a
business development. She received her PhD in molecular biology from
Joseph Fourier University in France and a master degree in management of
biotechnology companies from the Grenoble Management School.
About TxCell: http://www.txcell.com
TxCell
is a publicly listed biotechnology company that develops platforms for
innovative, personalized T cell immunotherapies for the treatment of
severe chronic inflammatory and autoimmune diseases with high unmet
medical need. TxCell is the only clinical stage cellular therapy company
dedicated to the science of regulatory T lymphocytes (Tregs). Tregs are
a recently discovered T cell population for which anti-inflammatory
properties have been demonstrated. Ovasave®, TxCell’s lead product
candidate, is currently in a phase IIb clinical trial in refractory
Crohn’s disease patients. Col-Treg, its second product candidate, for
the treatment of autoimmune uveitis, should enter clinical trials in
2016. Based in Sophia-Antipolis, France, TxCell is listed on Euronext
Paris and currently has 62 employees.
Disclaimer:
This press release contains certain
forward-looking statements concerning TxCell and its business. Such
forward-looking statements are based on assumptions that TxCell
considers to be reasonable. However, there can be no assurance that the
anticipated events contained in such forward-looking statements will
occur. Forward-looking statements are subject to numerous risks and
uncertainties including the risks set forth in the registration document
of TxCell registered by the French Financial Markets Authority (Autorité
des marchés financiers) on June 11, 2015 under number R. 15-049 and in
the half year financial report of TxCell as of June 30, 2015 (a copy of
which is available on www.txcell.com)
and to the development of economic conditions, financial markets and the
markets in which TxCell operates. The forward-looking statements
contained in this press release are also subject to risks not yet known
to TxCell or not currently considered material by TxCell. The occurrence
of all or part of such risks could cause actual results, financial
conditions, performance or achievements of TxCell to be materially
different from such forward-looking statements.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, TxCell shares in any country.
