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immatics to Receive Support From Pfizer for its Pivotal Phase III Study (IMPRINT) With IMA901, a Therapeutic Vaccine for Advanced Renal Cell Cancer Patients

April 11, 2011

TUEBINGEN, Germany, April 11, 2011 /PRNewswire/ — immatics
biotechnologies GmbH, a clinical-stage biopharmaceutical company developing
advanced therapeutic vaccines that are active against cancer, today announced
that Pfizer has agreed to support its pivotal Phase III trial (IMPRINT =
IMA901 Multi-Peptide vaccine Randomized INTernational study) with IMA901, its
therapeutic cancer vaccine for advanced renal cell carcinoma.

The pivotal Phase III study will evaluate as the primary endpoint the
overall survival of advanced renal cell carcinoma patients treated with
IMA901 in combination with Pfizer’s Sutent(R) (sunitinib malate) versus
Sutent(R) alone. The study is expected to enroll approximately 330 patients
across Europe and in the US.

Pfizer will support the trial by supplying Sutent(R) for all the patients
enrolled in the pivotal study. The first patients are expected to start
treatment in April 2011.

Paul Higham, CEO of immatics, said: “We are extremely pleased that Pfizer
has committed to supporting our pivotal Phase III trial with IMA901 with the
supply of Sutent. Their decision reflects the growing interest in IMA901 and
its potential to be an important breakthrough in the treatment of renal cell
carcinoma patients.”

IMA901 has generated encouraging overall survival data, which compare
favorably with historical comparisons of currently available treatments, in a
Phase II trial in advanced renal cell carcinoma patients. Importantly, the
Phase II study also showed an association between survival and the patient’s
immune response to IMA901, as well as confirming the favorable safety profile
observed in an earlier Phase I study.

“Pfizer is pleased to provide Sutent to support immatic’s clinical
development program in advanced renal cell carcinoma patients,” said Craig
Eagle
, Vice President of Strategic Alliances and Partnerships for Pfizer
Oncology. “This collaboration underscores Pfizer’s ongoing commitment to the
discovery, investigation and development of innovative treatment options to
improve the outlook for cancer patients worldwide.”

For more information on SUTENT and Pfizer please visit
http://www.pfizer.com.

About IMA901

IMA901 is a therapeutic cancer vaccine comprising 10 tumor-associated
peptides (TUMAPs) that are frequently found to be over-expressed in the
majority of patients suffering from renal cell carcinoma. As with all
immatics’ vaccines, IMA901 has been designed to elicit a strong, clinically
relevant immune response to a specific tumor type. The TUMAPs were selected
from over 2,000 peptides identified via immatics’ unique XPRESIDENT(TM)
platform. TUMAPs included in IMA901 are from targets with vital functions for
the tumor, for example invasion, neo-angiogenesis.

About SUTENT((R)) (sunitinib malate)

SUTENT is an oral multi-kinase inhibitor approved for the treatment of
advanced/metastatic renal cell carcinoma (RCC), unresectable and/or
metastatic malignant gastrointestinal stromal tumor (GIST) after failure of
imatinib mesilate treatment due to resistance or intolerance.

In Europe, SUTENT is also indicated for the treatment of unresectable or
metastatic, well-differentiated pancreatic neuroendocrine tumours with
disease progression in adults. Experience with SUTENT as first-line treatment
is limited.

SUTENT works by blocking multiple molecular targets implicated in the
growth, proliferation and spread of cancer. Two important SUTENT targets,
vascular endothelial growth factor receptor (VEGFR) and platelet-derived
growth factor receptor (PDGFR), are expressed by many types of solid tumors
and are thought to play a crucial role in angiogenesis, the process by which
tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT
also inhibits other targets important to tumor growth, including KIT, FLT3
and RET.

Important SUTENT((R)) (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketing
experience. Cases of hepatic failure, some with a fatal outcome, were
observed in <1% of solid tumor patients treated with SUTENT. It is
recommended to monitor liver function tests before initiation of treatment,
during each cycle of treatment, and as clinically indicated. If signs or
symptoms of hepatic failure are present, sunitinib should be discontinued and
appropriate supportive care should be provided.

Women of child bearing age who are (or become) pregnant during therapy
should be informed of the potential for fetal harm while on SUTENT.

Decreases in left ventricular ejection fraction (LVEF) to below the lower
limit of normal (LLN) have been observed. Patients with concomitant cardiac
conditions should be carefully monitored for clinical signs and symptoms of
congestive heart failure. Patients should be monitored for hypertension and
treated as needed with standard antihypertensive therapy. Complete blood
counts (CBCs) with platelet count and serum chemistries should be performed
at the beginning of each treatment cycle for patients receiving treatment
with SUTENT.

The most common adverse reactions in GIST, RCC and pancreatic NET
clinical trials were diarrhea, fatigue, asthenia, nausea,
mucositis/stomatitis, anorexia, vomiting, neutropenia, hypertension,
dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin
discoloration, hair color changes, altered taste and bleeding. For more
information on SUTENT and Pfizer Oncology, including full prescribing
information for SUTENT (sunitinib malate), please visit www.pfizer.com.

About immatics

immatics biotechnologies is a clinical-stage biopharmaceutical company
developing rationally designed therapeutic vaccines that are active against
cancer. immatics’ lead product, IMA901, has completed a successful phase II
trial in renal cell carcinoma. immatics’ pipeline also includes IMA910, in
phase II for colorectal cancer, and IMA950 which is in phase I for glioma.

immatics’ XPRESIDENT(TM) technology platform rapidly generates defined
therapeutic cancer vaccines, based on multiple tumor-associated peptides
(TUMAPs), that have 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. immatics’
products are ‘drug like’ with stable, off-the-shelf formulations and robust
easily scalable manufacturing.

    immatics is based in Tuebingen and Munich, Germany.

    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: media@immatics.com

    David Dible / Chris Gardner / Sita Shah
    Citigate Dewe Rogerson
    Phone: +44-207-638-9571
    E-mail: david.dible@citigatedr.co.uk

SOURCE immatics


Source: newswire



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