Phase 2 randomized trial will study Yervoy® and
Prophage combination for metastatic melanoma
First checkpoint inhibitor combination trial
with Prophage vaccine
Agenus 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 and OX40, 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.
About Melanoma
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.
About Agenus
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,
LinkedIn, Twitter and Google+. For more information, please visit
www.agenusbio.com.
Forward-Looking Statement
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
uncertainties.
Yervoy is a registered trademark of Bristol-Myers Squibb.
References
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.
Agenus Inc.Media and Investor:Jonae R. Barnes,
617-818-2985Vice President Investor Relations and Corporate
Communicationsjonae.barnes@agenusbio.com
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