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CancerVax Licenses Phase 2 Oncology Product Candidate Targeting the
Epidermal Growth Factor Receptor -- EGFR -- Signaling Pathway
Encouraging Results Reported in Phase 1 and 2 Clinical Trials of Patients with
Advanced Stage Non-Small-Cell Lung Cancer
CARLSBAD, Calif., Jul 15, 2004 (BUSINESS WIRE) -- CancerVax Corporation (CNVX)
announced today 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. (CA:YM)(AIM:YMBA),
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."
Conference Call and Webcast Today at 1:00 p.m. Eastern Time
CancerVax management will host a conference call today to discuss the license
agreement at 1:00 p.m. Eastern Time. A live audio webcast of management's
presentation will be available at
http://ir.cancervax.com. Alternatively, callers may participate in the
conference call by dialing 888-396-2369 (domestic) or 617-847-8710
(international) and requesting the CancerVax Corporation call hosted by David
F. Hale, President and CEO. Following the call, the webcast will be archived
on the investor relations section of the CancerVax website.
Specific Active Immunotherapy and the EGFR Pathway
The SAI-EGF product candidate has been studied in Phase 1 and Phase 2 clinical
trials conducted in Canada, the United Kingdom and Cuba. Data from several of
these studies were recently published in the Annals of Oncology (Volume 14,
2003) and updated at the June 2004 American Society of Clinical Oncology
annual meeting, suggesting treatment with SAI-EGF was well-tolerated, resulted
in measurable immune responses, and may increase survival in patients with
advanced-stage non-small-cell lung cancer (NSCLC). In a trial of 50
advanced-stage NSCLC patients who received first line chemotherapy and then
were randomized to treatment with SAI-EGF or best supportive care, survival
was significantly greater (p less than 0.05) in patients receiving SAI-EGF
compared with randomized controls (mean: 19.54 vs. 13.35 months, respectively;
median: 17.33 vs. 10.27 months, respectively). In addition, a significant
survival benefit (p less than 0.006) was reported in patients with a good
antibody response, defined as at least 1:4000 anti-EGF antibody titers and a
fourfold increase in anti-EGF antibody titers from baseline, compared with
patients with a lesser antibody response (mean: 23.93 vs. 13.07 months,
respectively; median: not reached vs. 10.53 months, respectively). Combined
data from three pilot clinical studies evaluating a total of 75 patients with
advanced-stage NSCLC who received SAI-EGF was also presented and showed that
immunized patients experienced a significant increase in survival compared to
non-randomized control patients with a history of late-stage NSCLC who did not
receive SAI-EGF (mean: 9.13 vs. 4.85 months, respectively; median: 12.43 vs.
4.83 months, respectively). Further, reduction of serum EGF concentration to 7
pg/mL or less was associated with increased survival compared with patients
having greater serum EGF concentrations (mean: 14.54 vs. 5.23, respectively;
median: 12.43 vs. 4.83 months, respectively).
Dysregulation of the EGFR pathway is associated with the spread of tumors
(metastases), decreased survival, and decreased effectiveness of chemotherapy
and radiation. EGF and TGF-alpha are molecules that bind to and activate EGFR.
Increased stimulation, as a direct result of overexpression of EGFR, EGF or
TGF-alpha, may contribute to dysregulation of the EGFR pathway. In addition,
cancerous cells may secrete EGF and TGF-alpha, which in turn fuels their
growth and proliferation by increased activation of the EGFR pathway. The FDA
has approved two cancer drugs that target the EGFR signaling pathway,
including Iressa(TM) (gefitinib; AstraZeneca Pharmaceuticals LP), an EGFR
tyrosine kinase inhibitor for refractory stage IV NSCLC, and Erbitux(TM) (cetuximab;
ImClone Systems, Inc.), an EGFR monoclonal antibody for Stage IV refractory
colorectal cancer. Recently, Genentech, Inc., OSI Pharmaceuticals, Inc., and
Roche Holdings AG, announced positive results from a randomized, Phase 3
clinical trial in late-stage NSCLC for their EGFR tyrosine kinase inhibitor,
Tarceva(TM) (erlotinib HCl). Preliminary information indicates that treatment
with Tarceva(TM) increased overall survival in NSCLC patients with late-stage
disease.
Specific active immunotherapy is an approach where cells, cell fragments or
proteins are utilized as antigens to stimulate the immune system. SAI-EGF and
SAI-TGF-alpha stimulate the immune system to develop antibodies that
specifically target circulating EGF and TGF-alpha, respectively, which may
reduce activation of the EGF receptor, as opposed to targeting the receptor
itself. As a result, SAI-EGF and SAI-TGF-alpha may be complementary to
existing EGFR pathway inhibitors, such as monoclonal antibodies and tyrosine
kinase inhibitors. The concept of targeting EGF or TGF-alpha is analogous to
the approach taken by Genentech, Inc. with the cancer drug Avastin(TM) (bevacimzumab),
which binds to vascular endothelial growth factor (VEGF), the molecule that
activates the VEGF receptor. The third product candidate, SAI-EGFR-ECD, may
stimulate the immune system to develop antibodies that target a portion of the
EGFR that resides outside of the cell membrane, i.e., the extracellular
domain. Stimulating the immune system with an SAI against the receptor may
offer a unique approach for targeting the EGFR pathway. By recruiting the
patient's own defense mechanisms, these product candidates may provide a
multi-faceted immune response that may result in broad activity at the target.
About CancerVax Corporation (www.cancervax.com)
CancerVax Corporation is a biotechnology company focused on the research,
development and commercialization of novel biological products for the
treatment and control of cancer. The Company's lead product candidate,
Canvaxin(TM), is one of a new class of products being developed in the area of
specific active immunotherapy, also known as therapeutic cancer vaccines.
Canvaxin(TM) is currently being studied in two international Phase 3 clinical
trials for the treatment of patients with Stage III or Stage IV, or
advanced-stage, melanoma. CancerVax anticipates that enrollment in the Phase 3
clinical trial of Canvaxin(TM) for patients with Stage III melanoma will be
completed in 2004. The Company is also finalizing the design of exploratory
Phase 2 clinical trials for patients with other advanced-stage solid tumors.
In addition to Canvaxin(TM), CancerVax has licensed three specific active
immunotherapeutic product candidates targeting EGFR, including one product
candidate in Phase 2 clinical trials. The Company plans to identify and
develop new product candidates based on its proprietary specific active
immunotherapy, anti-angiogenesis and T-oligonucleotide, or telomere homolog
oligonucleotide, technology platforms, as well as on its human monoclonal
antibodies. CancerVax's corporate headquarters and research and development
facility is located in Carlsbad, Calif., and its biologics manufacturing
facility is located in the Los Angeles area.
Forward-Looking Statements
CancerVax cautions you that statements included in this press release that are
not a description of historical facts are forward-looking statements. The
inclusion of forward-looking statements should not be regarded as a
representation by CancerVax that any of its plans will be achieved. Actual
results may differ materially from those set forth in this release due to the
risks and uncertainties inherent in CancerVax's business including, without
limitation, statements about: the progress and timing of its clinical trials;
difficulties or delays in developing, testing, obtaining regulatory approval,
producing and marketing its technologies and product candidates; unexpected
adverse side effects or inadequate therapeutic efficacy of its products that
could delay or prevent product development or commercialization, or that could
result in recalls or product liability claims; the scope and validity of
patent protection for its products; competition from other pharmaceutical or
biotechnology companies; its ability to obtain additional financing to support
its operations; its ability to attract and maintain experienced scientists and
management; its ability to maintain the U.S. government approvals necessary to
develop, test and commercialize three specific active immunotherapeutic agents
that target the epidermal growth factor receptor, or EGFR, signaling pathways;
and other risks detailed in CancerVax's Securities and Exchange Commission
filings, including CancerVax's Annual Report on Form 10-K for the fiscal year
ended December 31, 2003 and its Quarterly Report on Form 10-Q for the fiscal
quarter ended March 31, 2004. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this cautionary
statement and CancerVax undertakes no obligation to revise or update this news
release to reflect events or circumstances after the date hereof.
CancerVax(R) is a
registered trademark of CancerVax Corporation.
Canvaxin(TM) is a
trademark of CancerVax Corporation.
SOURCE: CancerVax Corporation
CancerVax Corporation
Julie Ames, 760-494-4252
or
Vince Reardon, 760-494-4850
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