CancerVax Corporation has announced that its wholly owned subsidiaries, Tarcanta, Inc., and Tarcanta, Ltd. (Ireland), have obtained the exclusive rights to complete the clinical development of three specific active immunotherapeutic (SAI) product candidates that target the epidermal growth factor receptor (EGFR) signaling pathway for the treatment of cancer.
Under the agreements, CancerVax rights include commercialization of successful product candidates within the U.S., Western Europe, Canada, Japan, Australia, New Zealand and Mexico. Published data from early Phase 1 and 2 studies of the lead product candidate, SAI-EGF, suggest that SAI-EGF was well tolerated and may increase the survival of patients with advanced stage non-small-cell lung cancer (Source: ASCO 2004; Annals of Oncology (Vol. 14, 2003)).
The EGFR signaling pathway is known to be an important factor in cancer cell growth in a number of solid tumors, such as lung, glioma, breast, bladder, colorectal, head and neck, ovarian, pancreatic and prostate cancers. In addition to the Phase 2 product candidate, SAI-EGF, which targets epidermal growth factor (EGF), the licensing agreements also include rights to SAI-TGF-alpha, which targets transforming growth factor-alpha (TGF-alpha) that binds to and activates EGFR, and SAI-EGFR-ECD, which targets the extracellular domain of EGFR, both of which are in preclinical development.
The execution of license agreements for the three product candidates followed the receipt of a license from the U.S. Department of Treasury's Office of Foreign Assets Control, authorizing CancerVax and its Tarcanta subsidiaries to enter into the transactions with CIMAB, S.A., a Cuban biotechnology company, and YM BioSciences Inc., a Canadian company.
"We are very excited about the potential of these novel product candidates in the treatment of patients with solid tumors. We plan to advance the clinical development of the lead Phase 2 product candidate, SAI-EGF, in the treatment of non-small-cell lung cancer. The SAI-EGF product candidate, along with the SAI-TGF-alpha and SAI-EGFR-ECD product candidates that are currently in preclinical development, gives CancerVax a pipeline of novel approaches to this important pathway," said David F. Hale, President and CEO of CancerVax.
"Our efforts to obtain approval to enter into this transaction received bipartisan support in the U.S. Congress, and for that we are most appreciative," stated Hale. "We also appreciate the support we received from several leading researchers in the field of oncology, who confirmed the potential medical benefits of this technology, as well as from the diligent professionals at the Departments of State and Treasury for working with us over the past two years to accomplish this result. They were able to carefully balance important U.S. interests with the humanitarian aspects of this project and grant us a license that will permit us to develop these product candidates for the benefit of patients with cancer."
Under the terms of the license agreements, CancerVax will provide upfront access fees, technology transfer fees, development and commercialization milestones and royalties upon commercial sales, if any. With the execution of these agreements, CancerVax is obligated to make access and technology transfer payments of approximately $6 million over the next three years. If the three product candidates are approved for commercialization in the U.S., Europe and Japan, CancerVax is also obligated to pay additional milestone payments, up to a maximum of approximately $35 million, based upon meeting specified regulatory, clinical and commercialization milestones, and royalties on future net sales of product, if any. Prior to the commercialization of any of the product candidates, all of the milestone and other payments owed to CIMAB under the license agreements will be made in U.S.-origin food, medicines and/or medical supplies for the public health purposes of the Cuban people.
"CancerVax has built a portfolio of novel oncology therapies and platforms, including our product candidate, Canvaxin(TM), which is in international Phase 3 clinical trials for the treatment of patients with Stage III or Stage IV, or advanced-stage, melanoma. We are nearing the completion of enrollment of patients with Stage III melanoma," said Hale. "Since each of our three new SAI product candidates is intended to interact with the EGFR signaling pathway in a separate and unique manner, they may potentially be complementary to each other, to other cancer treatments in our pipeline, and to other EGFR, chemotherapy or biological products, which are currently marketed or in clinical development."
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