CancerVax may increase the
survival of patients with advanced stage non-small-cell lung cancer
July 19, 2004
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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