Tuebingen, March 2, 2009 – immatics biotechnologies GmbH today announced having
completed patient recruitment in a phase II trial with its cancer vaccine IMA901 in
patients with advanced renal cell cancer (RCC). IMA901 is the most advanced of the
innovative cancer vaccines developed by immatics.
A total of 68 metastatic RCC patients who had not responded to standard treatment,
i.e. cytokine or tyrosine kinase inhibitor therapy, have been recruited. The primary
objective of the trial is to measure the disease control rate after six months of
treatment to assess if the vaccination is able to slow down or halt the tumor
progression. The tumor assessments will be conducted via an independent central
review process. Final results are expected for early 2010.
“We are very much looking forward to the results of this trial” said Dr Harpreet Singh,
Chief Scientific Officer of immatics. "IMA901 is the first product candidate developed
on the basis of our XPRESIDENT™ discovery platform. To our knowledge it is therefore
the first cancer vaccine containing multiple peptides which have been confirmed to
actually exist in human tumors."
Paul Higham, CEO of immatics, added: “The completion of recruitment in this our most
advanced product is another important milestone for the company. It demonstrates
continued good progress of our clinical development activities. Should we succeed in
demonstrating good clinical effects, this trial may allow us to enter into earlier disease
stages where there remains a very high unmet need for therapies that are both
effective and well tolerated.”
IMA901 is an off-the-shelf peptide-based therapeutic vaccine specifically developed for
the treatment of renal cell cancer (RCC). It consists of ten fully synthetic tumor-
associated peptides (TUMAPs) representing tumor antigens relevant for renal cell
cancer. These TUMAPs were identified based on the analysis of primary tumor tissue
with immatics’ proprietary XPRESIDENT™ platform. Thus, they were confirmed to be
naturally presented in human tumors. In addition, the peptides were chosen due to
their ability to activate immune effector cells, i.e. cytotoxic T cells and T helper cells,
against renal cell cancer.
About the study
The study is designed as an open label, randomized European multicenter phase II trial
for patients with advanced renal cell cancer who did not respond to first-line cytokine
therapy (interferon and/or interleukin-2) or tyrosine kinase inhibitor therapy (Sutent®
or Nexavar®). The study examines the effect of a second-line systemic treatment with
IMA901 plus GM-CSF as immunmodulator. It also investigates whether pre-treatment
with a single low-dose application of cyclophosphamide (Endoxan®) can further
improve the response to IMA901 and GM-CSF. The primary endpoint of the study is the
disease control rate at six months after the first vaccination. The tumor assessments
will be made via an independent central review process. The secondary endpoints
include safety as well as various immune response and other biological parameters.
The study has recruited 68 patients in ten European countries. Final results are
expected for early 2010.
immatics biotechnologies is an independent biopharmaceutical company dedicated to
the development of active immunotherapies against cancer. immatics' therapeutic
vaccines are based on multiple tumor-associated peptides (TUMAPs) which specifically
stimulate the immune system against cancer cells. Its lead products – IMA901 for the
therapy of renal cell cancer and IMA910 for the treatment of colon cancer – are
currently investigated in international phase II clinical studies. Since its foundation in
2000, immatics has raised more than €54 million (US$ 72million) in private equity in
two financing rounds. The company has a headcount of more than 65 people and is
based in Tuebingen and Munich, Germany.