First Patients are Vaccinated in IMPRINT*, immatics’ Pivotal Phase III Trial With IMA901 in Patients With Renal Cell Carcinoma (RCC)
TUEBINGEN, Germany, June 15, 2011 /PRNewswire/ –
igoommatics biotechnologies GmbH, a biopharmaceutical company developing
advanced therapeutic vaccines that are active against cancer, announced
today that the first patients have been vaccinated in the IMPRINT study, a
pivotal Phase III trial with IMA901, the company’s lead cancer vaccine for
the treatment of renal cell carcinoma (RCC).
The trial is designed to demonstrate the overall survival benefit of
IMA901 in combination with standard first-line therapy in RCC patients. The
study builds on the promising survival and immune response data observed in
the Phase II study with IMA901 in advanced RCC patients. Data from the Phase
II study were presented at ASCO in June 2010 and at ESMO in October 2010.
IMPRINT is a global multicenter, randomized, controlled Phase III study
in patients with metastatic and/or locally advanced RCC who are candidates
for receiving standard first-line therapy with sunitinib (Sutent(R),Pfizer).
The trial will include approximately 330 patients across the US and Europe.
The primary endpoint of the Phase III study is overall survival in
patients receiving IMA901 in combination with sunitinib versus sunitinib
alone. Overall survival will also be tested in patients who are positive for
a prospectively defined biomarker signature. This signature was identified
as being predictive for improved clinical outcome in IMA901-vaccinated
patients in the previous Phase II study. Details on the biomarker signature
were presented in the plenary session of the Annual Meeting of Association
for Cancer Immunotherapy (CIMT) in late May 2011.
Further secondary endpoints include progression-free survival, safety
and tolerability, and cellular immunomonitoring to assess the T-cell
response to the peptides contained in IMA901. Data from the reported Phase
II trial showed that the intensity of the immune response against the IMA901
TUMAPS vaccine was predictive for improved overall survival.
The first overall survival results of the study are expected in late
2013. The chief investigator of the trial is Professor Brian Rini, Associate
Director for Clinical Research at the Cleveland Clinic Taussig Cancer
Institute, Cleveland, Ohio and Professor Tim Eisen, Clinical Director of
Medical Oncology at Addenbrooke’s Hospital, University of Cambridge, UK, is
the European lead investigator.
Carsten Reinhardt, CMO of immatics, said: “The start of this Phase III
trial with IMA901 is a key milestone in immatics’ clinical development. The
protocol for this trial builds on the encouraging insights gained from the
Phase II study and feedback from key opinion leaders as well as successful
meetings with regulatory agencies both in Europe and the US. We look forward
to confirming the positive overall survival data seen in the phase II study
as advanced renal cell cancer still has a very high unmet medical need.”
Paul Higham, CEO of immatics, added: “An overall survival benefit
combined with a stable and easy to manufacture formulation would make IMA901
an important breakthrough in the development of therapeutic cancer
*IMPRINT = IMA901 Multi-Peptide vaccine Randomized INTernational study
IMA901 is a rationally designed cancer vaccine comprising 10 different
tumor-associated peptides (TUMAPs) that are found to be highly
over-expressed in the majority of patients suffering from RCC. IMA901 is a
peptide-based vaccine with a stable, off-the-shelf formulation and robust
and easily scalable manufacturing.
immatics biotechnologies is a clinical-stage biopharmaceutical company
developing advanced therapeutic vaccines that are active against cancer.
immatics’ lead product, IMA901, is in a pivotal Phase III study after
completing a successful Phase II trial in renal cell carcinoma.
immatics’pipeline also includes IMA910, in Phase II for colorectal cancer,
and IMA950, which is being developed for glioma.
immatics’technology platform rapidly generates defined therapeutic
cancer vaccines which are based on multiple tumor-associated peptides
(TUMAPs) with the ability to specifically stimulate the immune system
against cancer cells. These vaccines – comprising multiple peptides
confirmed to be naturally presented by real tumor tissue – offer the
prospect of greater effectiveness than existing cancer vaccine approaches
combined with fewer side effects. immatics’products are ‘drug like’ with
stable, off-the-shelf formulations and robust easily scalable manufacturing.
immatics is based in Tuebingen and Munich, Germany, immatics is based in
Tuebingen and Munich, Germany, and has raised EUR108 million (US$158
million) in private equity in three financing rounds to date, with the last
EUR54 million completed in September 2010.
For additional information on immatics please visit http://www.immatics.com or contact: Paul Higham, CEO Katrin Eckert, Assistant to the Management immatics biotechnologies GmbH Phone: +49-7071-5397-110 E-mail: firstname.lastname@example.org Citigate Dewe Rogerson David Dible / Chris Gardner / Sita Shah Phone: +44-207-638-9571 E-mail: email@example.com