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Immutep Enters Phase I/II
Clinical Trials With Immufact(R), A Novel Immunostimulatory Factor
Orsay, 25 April 2005
Immutep S.A. announced today that its lead product ImmuFact IMP321 has moved
into Phase I/II clinical trials. ImmuFact(R) IMP321 is a potent natural human T
cell immunostimulatory factor designed to amplify the T cell immune response in
therapeutic vaccines.
The two randomised single-blind escalating-dose Phase I/II studies are designed
to show first, safety and tolerability, and second, to assess the T cell immune
response. Studies are being conducted in healthy individuals with ImmuFact(R)
IMP321 alone and combined with antigens. Two well-defined standard types of
antigens are being used: soluble influenza virus antigens and the particulate
hepatitis B surface antigen. Immutep and its partners will use the resulting
data in the development of therapeutic vaccines against cancer and infectious
diseases. The Company has set up a state-of-the-art immunomonitoring facility to
measure a wide range of immune response parameters. Recruitment of 108 healthy
volunteers started in April and the trials will be completed in Q4 2005.
"We are delighted with the rapid progress of our lead product into a major
clinical study which will demonstrate the clinical potential of our approach,"
said Frédéric Triebel, Scientific & Medical Director of Immutep. "Fast and
successful production development, problem-free toxicology and a smooth
regulatory path enabled us to go from first financing to the clinic in 15
months."
The clinical study is being carried out at Aster-Cephac, a leading European
contract research organisation in Paris, specialised in early-stage drug
development.
The cGMP batch of IMP321 was produced by Henogen S.A. (Gosselies, Belgium) in
Chinese hamster ovary (CHO) cells. As IMP321 is used at low dose levels (<100
µg/injection), the batch will be sufficient for a number of clinical trials by
Immutep and its partners.
Immutep S.A. is a biopharmaceutical company primarily focussed on the discovery
and development of novel therapeutic vaccines for the treatment of cancer and
chronic infectious diseases. The Company's technologies are based on the
properties of LAG-3, a key mediator of the T cell immune response. One of
LAG-3's major roles is to stimulate dendritic cells leading to the T cell immune
response required to kill tumours and infected cells. Immutep is developing
therapeutic vaccines both in-house and in partnership with pharmaceutical and
biotech companies.
For further information please visit the web-site www.immutep.com or e-mail John
Hawken, CEO, at JBHawken@immutep.com.
Immutep S.A.
The Company was formed in 2001 by Frédéric Triebel, the scientific founder,
and John B. Hawken, a specialist in the management of biotech start-ups, and has
its headquarters and research facilities near Paris, France. Immutep is backed
by the Paris-based venture capital firm Innoven Partenaires and the venture
capital fund H2I, a specialist Biotech fund managed by Unicorn Biotutors/Equitis
(Paris). Further support for the Company's development came from grants from the
French Ministry of Research and Anvar Ile de France Ouest.
The Technology
Immutep S.A. is developing a range of products derived from LAG-3 (CD223),
an immunomodulatory protein expressed on the surface of T cells. LAG-3 was
discovered by Professor Triebel in his Inserm laboratory at Institut Gustave
Roussy (IGR, Villejuif, France) and his laboratory at the Faculty of Pharmacy in
Châtenay-Malabry (University Paris 11). The Company has three unique proprietary
product platforms making use of the key roles played by this natural human
protein in the regulation of the immune system. The first two technologies (ImmuFact
and ImmuCcine) take advantage of the immunostimulatory properties of the free
molecule to create potent therapeutic vaccines. The principal difficulty in
designing effective therapeutic vaccines is that the antigens displayed on the
surface of a tumour or an infected cell are insufficiently immunogenic.
Dendritic cells (DC) are key mediators in determining the strength of the immune
response to an antigen. Immutep's first two technologies provide solutions to
the problem of insufficient immunogenicity by dramatically increasing the
efficiency of DC as antigen presenting cells. Immutep's third technology
exploits LAG-3-specific antibodies to modulate signalling of the membrane-bound
molecule into activated T cells or regulatory T cells (Treg cells) to control
the T cell response.
ImmuFact - T cell Immunostimulatory Factors for amplifying the T cell
response to any antigen
The Company's lead product, IMP321, is a highly potent T cell immunostimulatory
factor derived from the soluble form of LAG-3 that binds, with high affinity, to
MHC class II molecules expressed by DC. This binding leads to DC maturation,
migration to the lymph nodes and enhanced presentation of antigens to T cells.
As a result, strong and sustained anti-tumour or anti-viral cytotoxic T cell
responses are obtained when IMP321 is coinjected with either tumour cells or
protein or DNA antigens.
ImmuCcine - Immunostimulatory Vaccines
The Company is developing a second patented technology that will make it
possible to design novel therapeutic vaccines with even greater potency and
efficacy. Covalently linking an antigen to IMP321 in a fusion protein results in
both vectorisation of the antigen to the DC as well as the immunostimulatory
effect described above. These dual action vaccines will be particularly useful
in very difficult cases like HIV.
Therapeutic vaccines
Therapeutic vaccines, also known as "Specific Active Immunotherapies", are a new
therapeutic approach to diseases like cancer and chronic infection. Therapeutic
vaccines harness the patient's immune system to attack the tumour or infected
cell. A long period of trial and error has taught the industry that the assembly
of a therapeutic vaccine is critical and necessitates combining several key
components. Typically these include validated antigens with or without a
vectorisation system and a powerful immune potentiator. The first therapeutic
vaccines approved for marketing are cell-based vaccines and several more may be
registered in the next 12-18 months marking the beginning of the most
significant therapeutic innovation in the field of immunotherapy since the
registration of the first therapeutic monoclonal antibodies in the late 90's for
"passive immunotherapy".
aster.cephac
aster.cephac is a full service provider of clinical pharmacology trials and
bioanalytical services. Since 1975, aster.cephac has served the pharmaceutical
and biotechnology industries with expertise and innovation as an early phase
clinical trial specialist with strong cardiovascular expertise (QT/QTc) and has
become the largest bioanalytical unit in Europe. (www.aster-cephac.com)
Henogen S.A.
Henogen is a biotech company addressing biomanufacturing issues under the
general umbrella "from gene to clinical product". The Company has extensive
knowledge in performing and/or accompanying partners through the R&D, process
development, cGMP production and Phase I to III clinical trials. Among the
products previously developed and produced are recombinant proteins, gene
therapy viral vectors, vaccines and monoclonal antibodies. (
www.henogen.com
)
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Rejoice Itembu
ANDREW LLOYD & ASSOCIATES
www.ala.com
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Email address: rejoice@ala.com
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