PHILLIPSBURG, N.J., June 6 /PRNewswire/ -- Celldex Therapeutics, Inc. today announced that new data from a Phase 2 clinical trial evaluating epidermal growth factor receptor variant III (EGFRvIII) peptide vaccination in primary glioblastoma (GBM) will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), June 2-6 in Atlanta. The data will be included in a poster session entitled, “Developmental Therapeutics: Immunotherapy,” being held from 8:00 a.m. - 12:00 p.m. EDT today. During the session, Jeffrey S. Weber, MD, PhD, Associate Director for Clinical Research at the University of Southern California Norris Comprehensive Cancer Center and Chief of Oncology at the Keck School of Medicine of USC, will moderate a discussion including the EGFRvIII vaccination data from 11:30 - 11:45 a.m.
Data from the abstract, entitled, “Tumor-specific Peptide Vaccination in Newly-diagnosed Patients with GBM” (A. Heimberger, M.D., John Sampson, M.D. Ph.D., et al.), demonstrated minimal toxicity without evidence of autoimmunity, and generated both humoral and cellular responses against the EGFRvIII peptide.
Additionally: -- Median time to progression (TTP) from surgery in vaccine-treated patients was 12 months (n=12), comparing favorably with a historical matched unvaccinated cohort that had a median TTP of 7.1 months (n=39) (p=0.0058). These results also compare favorably with those reported for concurrent temozolomide and radiation followed by adjuvant temozolomide, with a median TTP of 6.9 months. -- Median survival has so far exceeded 18 months. -- Among recurrent tumors evaluated by immunohistochemistry, 100% no longer expressed EGFRvIII, suggesting immunological activation that may have eliminated EGFRvIII-expressing tumor cells.
The investigators concluded that EGFRvIII peptide vaccination warrants further investigation in a larger randomized clinical trial in patients with EGFRvIII-expressing tumors -- a study which Celldex plans to commence before year end with the EGFRvIII vaccine CDX-110.
“EGFRvIII peptides are specifically expressed on the surface of approximately 40% of all glioblastoma tumors,” said Thomas Davis. M.D., Chief Medical Officer of Celldex Therapeutics. “These initial data suggest that immunological therapy targeting the EGFRvIII peptide may offer therapeutic benefit against the most frequent type of brain tumors. Celldex is excited to be developing CDX-110, the EGFRvIII vaccine, in collaboration with Drs. Heimberger and Sampson.”
Additional Study Details
The Phase I study included 19 newly-diagnosed glioblastoma patients who had previously undergone radiation with concurrent temozolomide without tumor progression. All patients enrolled in the study met inclusion criteria of a gross-total resection, a KPS greater than or equal to 70, and EGFRvIII+. Patients received EGFRvIII peptide injection with GM-CSF. The primary endpoint of the study was safety. The study was conducted at the University of Texas M.D. Anderson Cancer Center and Duke University Medical Center.
For more information about the American Society of Clinical Oncology and this poster session, please visit http://www.asco.org.
About EGFRvIII
EGFRvIII is a tumor specific variant of the EGF receptor, originally found and cloned from glioblastoma multiforme tumors. Subsequent clinical work has demonstrated that EGFRvIII can also be found in other types of solid tumors. EGFRvIII has been detected in non-small cell lung, breast, ovarian and metastatic prostate cancers, however, it has minimal expression in normal human tissues. Unlike many antigens targeted by immune approaches to cancer, EGFRvIII has significant properties that are likely to enhance its ability to act as an effective therapeutic.
About Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. is a biotechnology company focused on developing fully human antibody-based products which target and stimulate the body’s immune system for the treatment of cancer, infectious and auto-immune diseases. The Company has three product candidates already in or about to enter clinical development targeting brain cancer (glioblastoma), multiple cancers and Hepatitis B. A further four product candidates are in preclinical development for cancer and autoimmune disease. Celldex’s proprietary technology platform uses fully human monoclonal antibodies to target and stimulate dendritic cells -- key cells within the immune system.
Celldex was formed in 2004 as a spin-out from Medarex, Inc and in October 2005, acquired Lorantis Limited and the assets of Alteris Therapeutics, Inc. The Company has operations in Phillipsburg, New Jersey and Cambridge, UK.
For more information, please visit the website: http://www.celldextherapeutics.com.
Celldex Therapeutics, Inc.
CONTACT: Celldex Therapeutics Inc. - Robert Burns, Chief ExecutiveOfficer, US: +1-908-454-7120, UK: +44-1223-702500, or Anthony Marucci,Chief Financial Officer, US: +1-908-454-7120, UK: +44-1223-702500; TheHogarth Partnership - Melanie Toyne-Sewell, +44-207-357-9477, or SarahRichardson, +44-207-357-9477; BMC Communications - Dan Budwick,+1-212-477-9007 x14
