TUEBINGEN, Germany, April 11, 2011 /PRNewswire/ — immaticsbiotechnologies GmbH, a clinical-stage biopharmaceutical company developingadvanced therapeutic vaccines that are active against cancer, today announcedthat Pfizer has agreed to support its pivotal Phase III trial (IMPRINT =IMA901 Multi-Peptide vaccine Randomized INTernational study) with IMA901, itstherapeutic cancer vaccine for advanced renal cell carcinoma.
The pivotal Phase III study will evaluate as the primary endpoint theoverall survival of advanced renal cell carcinoma patients treated withIMA901 in combination with Pfizer's Sutent(R) (sunitinib malate) versusSutent(R) alone. The study is expected to enroll approximately 330 patientsacross Europe and in the US.
Pfizer will support the trial by supplying Sutent(R) for all the patientsenrolled in the pivotal study. The first patients are expected to starttreatment in April 2011.
Paul Higham, CEO of immatics, said: "We are extremely pleased that Pfizerhas committed to supporting our pivotal Phase III trial with IMA901 with thesupply of Sutent. Their decision reflects the growing interest in IMA901 andits potential to be an important breakthrough in the treatment of renal cellcarcinoma patients."
IMA901 has generated encouraging overall survival data, which comparefavorably with historical comparisons of currently available treatments, in aPhase II trial in advanced renal cell carcinoma patients. Importantly, thePhase II study also showed an association between survival and the patient'simmune response to IMA901, as well as confirming the favorable safety profileobserved in an earlier Phase I study.
"Pfizer is pleased to provide Sutent to support immatic's clinicaldevelopment program in advanced renal cell carcinoma patients," said CraigEagle, Vice President of Strategic Alliances and Partnerships for PfizerOncology. "This collaboration underscores Pfizer's ongoing commitment to thediscovery, investigation and development of innovative treatment options toimprove the outlook for cancer patients worldwide."
for more information on SUTENT and Pfizer please visitpfizer.com.
about IMA901
IMA901 is a therapeutic cancer vaccine comprising 10 tumor-associatedpeptides (TUMAPs) that are frequently found to be over-expressed in themajority of patients suffering from renal cell carcinoma. as with allimmatics' vaccines, IMA901 has been designed to elicit a strong, clinicallyrelevant immune response to a specific tumor type. The TUMAPs were selectedfrom over 2,000 peptides identified via immatics' unique XPRESIDENT(TM)platform. TUMAPs included in IMA901 are from targets with vital functions forthe tumor, for example invasion, neo-angiogenesis.
about SUTENT((R)) (sunitinib malate)
SUTENT is an oral multi-kinase inhibitor approved for the treatment ofadvanced/metastatic renal cell carcinoma (RCC), unresectable and/ormetastatic malignant gastrointestinal stromal tumor (GIST) after failure ofimatinib mesilate treatment due to resistance or intolerance.
In Europe, SUTENT is also indicated for the treatment of unresectable ormetastatic, well-differentiated pancreatic neuroendocrine tumours withdisease progression in adults. Experience with SUTENT as first-line treatmentis limited.
SUTENT works by blocking multiple molecular targets implicated in thegrowth, proliferation and spread of cancer. Two important SUTENT targets,vascular endothelial growth factor receptor (VEGFR) and platelet-derivedgrowth factor receptor (PDGFR), are expressed by many types of solid tumorsand are thought to play a crucial role in angiogenesis, the process by whichtumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENTalso inhibits other targets important to tumor growth, including KIT, FLT3and RET.
important SUTENT((R)) (sunitinib malate) Safety Information
Hepatotoxicity has been observed in clinical trials and post-marketingexperience. Cases of hepatic failure, some with a fatal outcome, wereobserved in <1% of solid tumor patients treated with SUTENT. it isrecommended to monitor liver function tests before initiation of treatment,during each cycle of treatment, and as clinically indicated. if signs orsymptoms of hepatic failure are present, sunitinib should be discontinued andappropriate supportive care should be provided.
Women of child bearing age who are (or become) pregnant during therapyshould be informed of the potential for fetal harm while on SUTENT.
Decreases in left ventricular ejection fraction (LVEF) to below the lowerlimit of normal (LLN) have been observed. Patients with concomitant cardiacconditions should be carefully monitored for clinical signs and symptoms ofcongestive heart failure. Patients should be monitored for hypertension andtreated as needed with standard antihypertensive therapy. Complete bloodcounts (CBCs) with platelet count and serum chemistries should be performedat the beginning of each treatment cycle for patients receiving treatmentwith SUTENT.
The most common adverse reactions in GIST, RCC and pancreatic NETclinical trials were diarrhea, fatigue, asthenia, nausea,mucositis/stomatitis, anorexia, vomiting, neutropenia, hypertension,dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skindiscoloration, hair color changes, altered taste and bleeding. for moreinformation on SUTENT and Pfizer Oncology, including full prescribinginformation for SUTENT (sunitinib malate), please visit pfizer.com.
about immatics
immatics biotechnologies is a clinical-stage biopharmaceutical companydeveloping rationally designed therapeutic vaccines that are active againstcancer. immatics' lead product, IMA901, has completed a successful phase IItrial in renal cell carcinoma. immatics' pipeline also includes IMA910, inphase II for colorectal cancer, and IMA950 which is in phase I for glioma.
immatics' XPRESIDENT(TM) technology platform rapidly generates definedtherapeutic cancer vaccines, based on multiple tumor-associated peptides(TUMAPs), that have the ability to specifically stimulate the immune systemagainst cancer cells. these vaccines – comprising multiple peptides confirmedto be naturally presented by real tumor tissue – offer the prospect ofgreater effectiveness than existing cancer vaccine approaches. immatics'products are 'drug like' with stable, off-the-shelf formulations and robusteasily scalable manufacturing.
immatics is based in Tuebingen and Munich, Germany. for additional information on immatics please visit immatics.com or contact: Paul Higham, CEO Katrin Eckert, Assistant to the Management immatics biotechnologies GmbH Phone: +49-7071-5397-110 E-mail: David Dible / Chris Gardner / Sita Shah Citigate Dewe Rogerson Phone: +44-207-638-9571 E-mail: david.dible@citigatedr.co.uk