Pfizer and AVANT Enter into Licensing and Development Agreement for Novel Therapeutic Vaccine Candidate for Brain Cancer
Wednesday April 16, 4:37 pm ET
NEW YORK & NEEDHAM, Mass.--(BUSINESS WIRE)--Pfizer, Inc (NYSE: PFE - News) and AVANT Immunotherapeutics (Nasdaq: AVAN - News), acting through its wholly-owned subsidiary Celldex Therapeutics, Inc. today announced that they have entered into an agreement under which Pfizer will be granted an exclusive worldwide license to a therapeutic cancer vaccine candidate, CDX-110, in Phase 2 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.
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CDX-110, which has been granted both Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA), is an investigational immunotherapy that targets the tumor-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 tumor 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 tumors.
“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 at 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 of Business Development of AVANT Immunotherapeutics. Una Ryan, CEO of 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 tumor 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 favorably with historical control data. A randomized Phase 2 trial is ongoing.
GBM is the most common and aggressive form of primary brain tumor, 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.
About Pfizer Inc
Pfizer discovers and develops innovative medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality healthcare and health system support.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics and Celldex Therapeutics combined during the first quarter of 2008. AVANT is a NASDAQ-listed company discovering and developing innovative vaccines and targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. AVANT focuses on the use of tumor-specific targets and human monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through its novel “targeted immunization” approach. In addition, AVANT is exploiting its access to proprietary human antibody technology for development of therapeutic monoclonal antibodies (mAbs). AVANT’s deep product pipeline consists of products in varying stages of development. Identification of the potential of EGFRvIII in cancer diagnosis, prevention and therapy was based on the collaborative efforts of Dr. Bert Vogelstein and Dr. Albert Wong at Johns Hopkins University and Dr. Darell Bigner at Duke University. Application of this discovery toward the development of the CDX-110 vaccine was further advanced by Dr. John Sampson and his colleagues at the Duke University Brain Tumor Center in collaboration with Dr. Amy Heimberger at the MD Anderson Cancer Center. AVANT also has several product candidates in its development pipeline including:
CDX-1307, a product based on its proprietary APC Targeting Technology™, which is in two Phase 1 clinical trials for patients with advanced pancreatic, bladder, breast and colon cancer;
TP10, a complement inhibitor, in development for transplantation and other indications; and
Three candidates based on its oral, rapidly-protecting, single-dose and temperature-stable vaccine technology, including combination vaccines for travelers, the military and global health needs.
AVANT has three commercialized products, including Rotarix® (partnered with GSK) for the prevention of rotavirus infection and two human food safety vaccines for reducing salmonella infection in chickens and eggs. Additional information on AVANT Immunotherapeutics, Inc. can be obtained through its web site avantimmune.com.
For more information on Pfizer or AVANT please visit www.pfizer.com or www.avantimmune.com |
