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Immutep Announces that ImmuFact(R) has Successfully Completed Phase I Studies
Orsay, 30 May 2006 -
Immutep S.A. announced today that its lead product, ImmuFact(R) IMP321,
has successfully completed two large randomised Phase I clinical studies
assessing safety, tolerability and immune response in normal healthy
volunteers. ImmuFact(R) IMP321 is a potent natural human T cell
immunostimulatory factor designed to amplify the T cell immune response
in therapeutic vaccines.
The randomised single-blind
escalating-dose Phase I studies were conducted in healthy individuals
with ImmuFact(R) IMP321 alone and combined with antigens. Two
well-defined standard types of antigens were used: soluble influenza
virus antigens (a flu vaccine) and the particulate hepatitis B surface
antigen. Recruitment of 108 healthy volunteers started in April 2005 and
was completed in October 2005. The doses studied ranged from one
injection of 3 µg up to three injections of 100 µg.
The studies showed that
IMP321 is well tolerated with no adverse events at all dose levels
either alone or associated with potent antigens. Importantly, there were
no anti-IMP321 antibodies detected which means that repeat dosing should
be possible including protocols calling for 6 or more injections.
Analysis of the immune responses showed that, even with such potent
antigens, IMP321 gave rise to an increase in the number of responders,
associated with a substantial increase in antigen-specific T cells and a
shift to the Th1 response required for therapeutic vaccines.
The results from the early
part of the study allowed the Company to initiate its first therapeutic
clinical trial in metastatic renal cell carcinoma which started in
September 2005. The second therapeutic clinical trial, in melanoma, will
begin shortly.
Immutep and its partners
will use the resulting data in the development of immunostimulatory
treatments of cancer and infectious disease. ImmuFact(R) IMP321
can be used either alone or in combination with chemotherapy, or as an
immunopotentiator in therapeutic vaccines.
"We are delighted to
announce that IMP321 is safe both when used either alone or combined
with strong antigens, and efficacious at inducing stronger Th1 T cell
responses," said Frédéric Triebel, Scientific & Medical Director of
Immutep. "For cancer vaccines, the next step will be to associate IMP321
with tumour antigens which have been tested in the clinic with
suboptimal results and therefore need a non-inflammatory
immunopotentiator boost for repeated injections."
For further
information please visit the web-site
www.immutep.com
or e-mail John Hawken, CEO, at
JBHawken@immutep.com.
About Immutep S.A.
Immutep S.A. is a
biopharmaceutical company developing technologies for novel
immunotherapies for the treatment of cancer and chronic infectious
diseases and new approaches to immune response modulation. The Company's
technologies are based on the properties of LAG-3. Immutep is developing
its products both in-house and in partnership with pharmaceutical and
biotech companies. 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).
The Technology
The Company's range of
products is derived from LAG-3 (CD223), an immunomodulatory protein
expressed on the surface of activated T cells. The three unique
proprietary product platforms make use of the key roles played by this
natural human protein in the regulation of the immune system.
ImmuFact(R) - T
cell Immunostimulatory Factors for amplifying the T cell response
The lead product, ImmuFact(R)
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 dendritic cells (DC). This binding leads to DC
maturation, migration to the lymph nodes and enhanced cross-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
injected alone or in combination with antigens.
ImmuCcine(R) -
Immunostimulatory Vaccines
The Company is developing a
second 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.
ImmuTune(R) - Fine
Tuning of the Immune Response
The third technology uses
LAG-3-specific antibodies to control signalling of the membrane-bound
LAG-3 molecule into activated effector T cells or regulatory T cells (Tregs)
to modulate the T cell response.
Clinical Development (ImmuFact)
Immutep has completed two
randomised single-blind escalating-dose Phase I studies in 108 healthy
individuals with IMP321 alone and combined with two well-defined
standard types of antigens: soluble influenza virus antigens and
particulate hepatitis B surface antigen. A Phase I clinical trial in
metastatic renal cell carcinoma started in September 2005 with IMP321
injected alone. Recruitment of 9-12 patients started in September and
the trial will be completed in 2006. Each patient will receive 6
subcutaneous injections of IMP321 at two-weekly intervals. Dose levels
will range from 50 µg to 1,250 µg per injection. Additional patients
may be recruited into the trial if useful to provide more data on safety
or response rates.
For more information please
contact:
Andrew Lloyd & Associates
Andrew Lloyd / Heidi Thompson
Tel: +44 1273 675100
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