Inc. (NASDAQ:AGEN), a biotechnology company developing novel immune
system activating treatments for cancers and infectious diseases, today
announced initiation of a randomized Phase 2 trial with Prophage for
melanoma, and Bristol-Myers Squibb's Yervoy® (ipilimumab) for
the treatment of Stage III and IV metastatic melanoma. The combination
has the potential to trigger a more effective immune response against
the tumor than Yervoy alone.
"Agenus' Prophage vaccines are designed to help patients mount a
stronger anti-cancer immune response, while checkpoint antibodies, like
Yervoy, have the ability to increase cancer cells' exposure to immune
attack. We are excited about this study and the potential opportunity to
improve outcomes for patients when the two approaches are combined,"
said Garo Armen, Ph.D., CEO and chairman of Agenus. "Checkpoint
antibodies represent a new paradigm in the treatment of cancer. Our
definitive agreement to acquire 4-Antibody, a checkpoint antibody
company, will uniquely position us to pursue cancer immunotherapy with a
broad portfolio of innovative approaches."
The Phase 2, randomized, open label, single-center,
investigator-sponsored trial is designed to evaluate the safety,
feasibility and immunogenicity of the combination of Prophage vaccine
and Yervoy with or without low dose cyclophosphamide (a chemotherapy
agent used in this study as an immunomodulator of regulatory cells) in
25 patients with unresectable Stage III or IV metastatic melanoma. The
trial will be conducted at the University of Texas Health Science Center
at Houston and led by clinical investigator Jorge Quesada, M.D.
In order to fully understand the effects of Prophage vaccine and Yervoy,
the study will include translational studies characterizing anti-cancer
immune responses, in addition to clinical outcomes.
"The combination may improve the prospects for patients who do not
respond to ipilimumab alone, which is approximately 70% of the
metastatic melanoma patients," said Jorge Quesada, M.D., Associate
Professor, Department of Internal Medicine, Division of Oncology at The
University of Texas Health Science Center in Houston and Principal
Investigator of the study.
About Checkpoint Inhibitors
Agenus announced on January 13, 2014 that it entered into a definitive
agreement to acquire 4-Antibody AG, a private European-based
biopharmaceutical company. 4-Antibody has a technology platform for the
rapid discovery and optimization of fully-human antibodies against a
wide array of molecular targets of interest. These targets include
checkpoint molecules that regulate immune response to cancers and other
diseases. The company has multiple preclinical immune checkpoint
antibody programs targeting numerous checkpoint molecules, including GITR
as well as four additional undisclosed checkpoint programs. These
checkpoint programs are being pursued through a strategic collaboration
with the Ludwig
Institute for Cancer Research and Memorial
Sloan-Kettering Cancer Center (MSKCC) in New York. The transaction
is expected to be completed by the end of February 2014, subject to
customary closing conditions.
Considerable recent interest in the field of cancer immunotherapy has
been generated by promising clinical data with monoclonal antibodies
that bind to checkpoint molecules, such as cytotoxic T lymphocyte
antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1). Blocking
these checkpoint molecules unlocks breaking mechanisms that get in the
way of immune cells attacking cancer cells. Other checkpoint molecules,
such as GITR and OX40, act to stimulate immune function.
Melanoma is the most aggressive form of all skin cancers and its
incidence is rising at a rate exceeding most other cancers.1,2
Worldwide, it is believed that approximately 160,000 people will be
diagnosed with melanoma each year3 and an estimated 9,480
people will die of melanoma in 2013.4 If detected in its
earliest stages and treated properly, melanoma is often curable;
however, melanoma is more likely than other skin tumors to spread to
other parts of the body. There are limited options for patients with
advanced melanoma,5 highlighting an area of high unmet
medical need. Yervoy has been shown to prolong median overall survival
and provide benefit (tumor response or stability) for about 30% of
patients with advanced melanoma.6
About Prophage Series Vaccines
Agenus' Prophage Series vaccines are tailor-made for each patient by
processing tumor removed from the patient. Malignant cells express
proteins, which can be recognized as non-self by the immune system. This
recognition by T-lymphocytes can trigger the immune system to attack the
cancerous tissue, and under favorable circumstances help the patient
fight the cancer. Because each patient's cancer cells contains their own
set of genetic changes, the best chance to mount an effective immune
attack on the cancer resides in stimulating the immune response to the
abnormal proteins expressed in that patient's cancer. Agenus' heat shock
protein vaccines are processed by the company and then re-introduced
into the patient as a vaccine which is intended to stimulate a targeted
immune attack on their cancer cells.
Prophage Series vaccines are based on Agenus' heat shock protein
platform technology. Prophage Series G-100 and G-200 vaccines are
currently in Phase 2 programs for the treatment of newly diagnosed and
recurrent glioblastoma multiforme. For more information about Prophage
Series vaccines and Agenus' heat shock protein platform, please visit http://agenusbio.com/science/prophage.php.
Agenus Inc. is a biotechnology company developing treatments for cancers
and infectious diseases. The company has multiple immunotherapeutic
products based on strong technology platforms that are advancing through
the clinic. Agenus' technology is further validated through partnerships
with major pharmaceutical companies, with several product candidates in
late-stage clinical trials with corporate partners. Between Agenus and
its partners, 23 programs are in clinical development. For more
information, please visit www.agenusbio.com,
or connect with the company on Facebook,
For more information, please visit www.agenusbio.com.
This press release contains forward-looking statements, including
statements regarding clinical trial activities, the publication of data,
the proposed acquisition of 4-Antibody, and the potential application of
the two companies' technologies and product candidates in the prevention
and treatment of diseases. These forward-looking statements are subject
to risks and uncertainties that could cause actual results to differ
materially. These risks and uncertainties include, among others, the
factors described in our periodic report on Form 8-K filed with the Securities
and Exchange Commission ("SEC") on January 13, 2014 and under the Risk
Factors section of our Quarterly Report on Form 10-Q filed with the SEC
for the period ended September 30, 2013. Agenus cautions investors not
to place considerable reliance on the forward-looking statements
contained in this release. These statements speak only as of the date of
this document, and Agenus undertakes no obligation to update or revise
the statements. All forward-looking statements are expressly qualified
in their entirety by this cautionary statement. Agenus' business is
subject to substantial risks and uncertainties, including those
identified above. When evaluating Agenus' business and securities,
investors should give careful consideration to these risks and
Yervoy is a registered trademark of Bristol-Myers Squibb.
1. Lens MB, Dawes M Global perspectives of contemporary epidemiological
trends of cutaneous malignant melanoma. Br J Dermatol 2004; 150:179-185.2.
Fitzgerald K. Mechanisms of metastasis. Cellix's VenaFlux platform
pursue metastatic movement. Screening 2008; 2: 2-3.3. Ferlay J,
Bray F, Pisani P et al. GLOBOCAN 2002 Cancer Incidence, Mortality and
Prevalence Worldwide. IARC CancerBase No. 5, version 2.0. IARCPress,
Lyon, 2004.4. www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf.
Accessed August 1, 20135. Tarhini AA, Agarwala SS. Cutaneous
melanoma: available therapy for metastatic disease. Dermatologic Therapy
2006; 19(1): 19-25.6. F. Stephen Hodi, M. D., Steven J. O'Day,
M.D., David F. McDermott, M.D., Robert W. Weber, M.D., Jeffrey A.
Sosman, M.D., John B. Haanen, M.D., Rene Gonzalez, M.D., Caroline
Robert, M.D., Ph.D., Dirk Schadendorf, M.D., Jessica C. Hassel, M.D.,
Wallace Akerl (2010). Improved Survival with Ipilimumab in Patients with
Metastatic Melanoma, NEJM.
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