New Infectious Disease Subsidiary to Apply Heat’s
Proprietary Platform Technology to Zika Virus and Other Infectious
Diseases
Heat Biologics, Inc. (Nasdaq:HTBX), a leader in the development of
gp96-based immunotherapies that activate a patient’s immune system
to fight cancer, announced that it has entered into an agreement
with the University of Miami for the license and development of a
portfolio of patents leveraging its gp96 platform to target the
Zika virus and other infectious diseases. Heat has formed a
wholly-owned subsidiary, Zolovax, Inc., to focus on the development
of gp96-based vaccines targeting Zika, HIV, West Nile, dengue and
yellow fever.
The Zika program emerged from the same
laboratory that originally developed Heat’s current platform
technologies, and will be developed at the University of Miami
Miller School of Medicine under the direction of Natasa Strbo,
M.D., D.Sc., a reproductive immunologist, who is focused on
researching the immune system’s interaction with the
placenta. Dr. Strbo is also a co-developer of Heat’s gp96
platform and has spent many years advancing the platform as a
vaccine against malaria and HIV.
Clinical and preclinical studies suggest that
Heat’s gp96 platform may have a role as a broad-based infectious
disease vaccine. Heat has treated more than 200 cancer patients to
date with its gp96-based therapeutic vaccines (HS-110 and HS-410),
which have induced strong antigen-specific immune response, with an
excellent safety profile.
Dr. Strbo and her team have shown that Heat’s gp96-based vaccine
for SIV (the primate equivalent of HIV) induces a dramatic
antigen-specific immune response in the mucous membranes. The
treated animals were 73 percent less likely to acquire a
particularly virulent form of the SIV virus. These data support
broader use of the vaccine in other diseases attacking the mucous
membranes and barrier organs, such as the placenta in Zika
infection
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594107).
In the case of Zika, the placenta is believed to
play a key role in virus transmission from mother to fetus.
Researchers have observed profound pathological changes in
Zika-infected placentas, suggesting that the placenta’s naturally
protective barrier function is impaired during Zika
infection. Heat believes that the robust mucosal immune
response generated by gp96 in ongoing studies supports the
development of a gp96 vaccine that could also stimulate a
Zika-specific immune response in the placenta, thus protecting the
fetus from virus transmission.
“Miami has become the epicenter for Zika
transmission in the U.S.,” said Dr. Strbo. “Current approaches
against Zika have not been shown to protect the placenta or
transmission of Zika to the fetus. In NIH-funded studies, a
gp96-based vaccine effectively protected primates from acquiring
the SIV virus and induced T-cells to infiltrate cancer tumors after
human vaccination. This led us to hypothesize that a gp96 vaccine
might stimulate a similar virus-specific response in the placenta
of Zika-infected women that could clear the virus and protect the
fetus. We are currently pursuing this approach in our preclinical
studies.”
"Innovations related to the gp96 platform
continue to emerge from the Department of Microbiology and
Immunology,” said Norma Kenyon, Ph.D., Vice Provost for Research at
the University of Miami and Chief Innovation Officer at the Miller
School of Medicine. “Dan Catron, Senior Licensing Associate
in the Office of Technology Transfer, worked with Dr. Strbo and
Heat to accelerate the path toward development and
commercialization via licensing of this technology, resulting in
the formation of a new UM startup. This is expected to lead
to more rapid development and testing of vaccines that can
ameliorate Zika and other infectious diseases."
“We are excited about our collaboration with the
University of Miami to develop a gp96-based vaccine designed to
prevent the spread of Zika and protect the fetuses of women who
contract it,” said Jeff Wolf, CEO of Heat Biologics. “Gp96-Ig is a
powerful vaccine platform that has been shown to induce a potent
and localized immune response and mucosal immunity, which may
protect against Zika and other infectious diseases. Zolovax, our
newly formed subsidiary, will focus exclusively on developing
gp96-based vaccines for infectious diseases, and we are actively
pursuing additional collaborative research partners to complement
these efforts.”
About Heat Biologics, Inc.
Heat Biologics, Inc. (Nasdaq:HTBX) is an
immuno-oncology company developing novel therapies that activate a
patient’s immune system against cancer utilizing an engineered form
of gp96, a protein that activates the immune system when cells die.
Heat’s highly specific T cell-stimulating therapeutic vaccine
platform technologies, ImPACT and ComPACT, form the basis of its
product candidates. These platforms, in combination with other
therapies, such as checkpoint inhibitors, are designed to address
three distinct but synergistic mechanisms of action: robust
activation of CD8+ “killer” T cells (one of the human immune
system’s most potent weapons against cancer); reversal of
tumor-induced immune suppression; and T cell co-stimulation to
further enhance patients’ immune response. Currently, Heat is
conducting a Phase 2 trial with its HS-410 (vesigenurtacel-L) in
patients with non-muscle invasive bladder cancer (NMIBC) and a
Phase 1b trial with its HS-110 (viagenpumatucel-L) in combination
with an anti-PD-1 checkpoint inhibitor to treat patients with
non-small cell lung cancer (NSCLC). For more information,
please visit www.heatbio.com.
About Zolovax, Inc.
Zolovax Inc. is developing therapeutic and
preventative vaccines to treat infectious diseases based on gp96
vaccine technology. Zolovax is currently focused on vaccines
targeting the Zika virus and HIV, and has a patent portfolio that
also includes West Nile virus, Dengue and yellow fever. Zolovax is
a wholly-owned subsidiary of Heat Biologics.
Forward Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 on our current expectations and projections
about future events. In some cases, forward-looking
statements can be identified by terminology such as "may,"
"should," "potential," "continue," "expects," "anticipates,"
"intends," "plans," "believes," "estimates," and similar
expressions. These statements are based upon current beliefs,
expectations and assumptions and include statements regarding the
suggestion that Heat’s gp96 platform may have a role as a
broad-based infectious disease vaccine, the belief that in Zika the
placenta plays a key role in virus transmission from mother to
fetus, the potential use of gp96 as a vaccine for diseases
attacking the mucous membranes and barrier organs, such as the
placenta in Zika infection, the suggestion that the placenta’s
naturally protective barrier function is impaired during Zika
infection and the belief that the mucosal immune response generated
by gp96 in ongoing studies, supports the development of a gp96
vaccine that could also stimulate a Zika-specific immune response
in the placenta, protecting the fetus from virus transmission,
the hypothesis that a gp96 vaccine might stimulate a similar
virus-specific response in the placenta of Zika-infected women that
could clear the virus and protect the fetus, the expectation that
the new UM start-up will ultimately lead to more rapid development
and testing of vaccines that can ameliorate Zika and other
infectious disease and the potential of Heat’s ImPACT and ComPACT
therapies. These statements are based on management’s
expectations and assumptions as of the date of this press release
and are subject to a number of risks and uncertainties, many of
which are difficult to predict that could cause actual results to
differ materially from current expectations and assumptions from
those set forth or implied by any forward-looking statements,
including the ability of Heat's ImPACT and ComPACT therapies and
any gp96 vaccine developed to treat Zika to perform as designed, to
demonstrate safety and efficacy, as well as results that are
consistent with prior results, the ability to enroll patients and
complete the clinical trials on time and achieve desired results
and benefits, the company’s ability to obtain regulatory approvals
for commercialization of product candidates or to comply with
ongoing regulatory requirements, regulatory limitations relating to
the company’s ability to promote or commercialize its product
candidates for specific indications, acceptance of its product
candidates in the marketplace and the successful development,
marketing or sale of products, the company’s ability to maintain
its license agreements, the continued maintenance and growth of its
patent estate, its ability to establish and maintain
collaborations, its ability to obtain or maintain the capital
or grants necessary to fund its research and development
activities, and its ability to retain its key scientists or
management personnel and the other factors described in the
company’s annual report on Form 10-K for the year ended December
31, 2015 and other filings with the SEC. The information in
this release is provided only as of the date of this release and
the company undertakes no obligation to update any forward-looking
statements contained in this release based on new information,
future events, or otherwise, except as required by law.
CONTACT:
For Investor Inquiries:
David Waldman
919-240-7133
Investorrelations@heatbio.com
For Media Inquiries:
Deanne Eagle
Planet Communications
917-837-5866
deanne@planetcommunications.nyc
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