Pfizer, Inc and AVANT Immunotherapeutics, acting through its wholly-owned subsidiary Celldex Therapeutics, Inc. have entered into an agreement under which Pfizer would be granted an exclusive worldwide license to a therapeutic cancer vaccine candidate, CDX-110, in phase II development for the treatment of glioblastoma multiforme (GBM). This agreement also gives Pfizer exclusive rights to the use of EGFRvIII vaccines in other potential indications.

CDX-110, which has been granted both Fast Track and Orphan Drug designations by the US Food and Drug Administration (FDA), is an investigational immunotherapy that targets the tumour-specific molecule EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), which is a protein that has been well validated as a target for cancer therapy in certain tumour types.

EGFRvIII is only expressed in cancer cells and not in normal tissue and is a transforming oncogene that can directly contribute to cancer cell growth, as it does in about 40 percent of GBM tumours.

"We are excited about the potential for CDX-110 and intend to partner with AVANT and academic physician-scientists to investigate this novel vaccine candidate with the hope of providing patients and doctors with a new treatment option for this devastating disease," said Dr. Briggs Morrison, senior vice president for clinical development, Pfizer.

Under the licensing and development agreement, Pfizer will make an upfront payment to AVANT of $40 million and will make a $10 million equity investment in AVANT. Pfizer will fund all development costs for these programs. AVANT is also eligible to receive milestone payments exceeding $390 million for the successful development and commercialization of CDX-110 and additional EGFRvIII vaccine products, as well as double-digit royalties on any product sales. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (as amended) and is expected to close in the second quarter of 2008.

"This partnership advances the therapeutic potential for CDX-110, particularly for patients with GBM. We are very pleased to initiate this relationship to expand our clinical development activities for GBM and toward other cancers," said Ron Newbold, Ph.D., senior vice president, business development, AVANT Immunotherapeutics. Una Ryan, CEO, AVANT, added, "We see this as an important milestone for the immunotherapy field, and we look forward to Pfizer's commitment to help even more cancer patients in the future."

CDX-110 is designed to induce or enhance the body's immune responses against EGFRvIII resulting in destruction of tumour cells that express the variant receptor. Early efficacy and safety data from single arm Phase 2 clinical trials of CDX-110 in combination with the current standard treatment for patients with GBM are very encouraging. Progression-free survival and overall survival data from these trials compare very favourably with historical control data. A randomized Phase 2 trial is ongoing.

GBM is the most common and aggressive form of primary brain tumour, with very poor prognosis. There are an estimated 10,000 new cases of GBM annually in the United States, which predominantly affects adults aged 45 to 70. The current standard treatment for patients with GBM includes surgical resection, radiotherapy with concurrent temozolomide and then adjuvant temozolomide chemotherapy.