Agenus Announces Phase 2 Checkpoint inhibitor Combination Trial with Prophage Cancer Vaccine for Melanoma

  Agenus Announces Phase 2 Checkpoint inhibitor Combination Trial with
  Prophage Cancer Vaccine for Melanoma

  Phase 2 randomized trial will study Yervoy^® and Prophage combination for
                             metastatic melanoma

      First checkpoint inhibitor combination trial with Prophage vaccine

Business Wire

LEXINGTON, Mass. -- January 14, 2014

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 year^3
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, 2013
5. 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.

Contact:

Agenus Inc.
Media and Investor:
Jonae R. Barnes, 617-818-2985
Vice President Investor Relations and Corporate Communications
jonae.barnes@agenusbio.com
 
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