Heat Biologics Announces New PTX-35 Preclinical Data in Organ Transplantation and Provides Update on HS-110
January 12 2022 - 8:00AM
Heat Biologics, Inc. (“Heat”)
(NASDAQ: HTBX), a clinical-stage
biopharmaceutical company focused on developing first-in-class
therapies to modulate the immune system, today announced promising
new preclinical data regarding PTX-35 has been accepted for
publication in the American Journal of Transplantation and is
available at:
https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajt.16940.
Key Findings:
- A single dose of the preclinical
version of PTX-35 (mPTX-35), was able to expand regulatory T cells
(Tregs) and significantly improve disease and graft survival
outcomes.
- Chemically induced pancreatic
failure (a model for type-1 diabetes) could be partially reversed
when mice were transplanted with beta-cell islet allografts and
treated with mPTX-35.
- Disease protection in preclinical
models was correlated with a significant expansion of Tregs and
protection of the allograft, resulting in euglycemia and a graft
survival benefit.
- Long-term surviving grafts showed a
marked increase in Treg infiltration which directly correlated with
mPTX-35 agonist activity.
PTX-35 is a novel, potential first-in-class
antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor
that is preferentially expressed by antigen-experienced T cells and
can be manipulated to expand regulatory T-cell subsets. PTX-35 is
the Company's first antibody-based product, currently in a Phase 1
clinical trial for the treatment of patients with solid tumors.
Dr. James Shapiro, Professor in the Department
of Surgery and Clinical Islet Transplant Program at the University
of Alberta, Edmonton, Canada, commented, “The study demonstrated
that a single dose of PTX-35 enabled prolonged graft survival in a
mouse model of pancreatic islet allotransplantation. Additionally,
PTX-35 could contribute to achieving lasting immunological
tolerance in organ transplantation.”
Jeff Wolf, Chief Executive Officer of Heat,
commented, “We are very encouraged by these results showing
pronounced Treg expansion and significantly prolonged graft
survival compared to control. PTX-35 has the potential to modulate
immunological responses and may facilitate minimization of
post-transplant immunosuppression, which supports further clinical
evaluation in the context of inflammatory disease. Similar
preclinical results have also been previously demonstrated for bone
marrow, corneal and cardiac transplantation using these and other
TNFRSF25 agonists.”
Mr. Wolf further noted, “We are also making
significant progress with HS-110 and expect to file for an End of
Phase 2 meeting with the FDA this quarter. Our goal for this
meeting is to discuss potential Phase 3 registration pathways for
HS-110. Although this submission is taking longer than expected, we
believe we have prepared a very comprehensive package and look
forward to the FDA’s feedback.”
About Heat Biologics, Inc.Heat
Biologics is a biopharmaceutical company focused on developing
first-in-class therapies and vaccines to modulate the immune
system. Heat’s gp96 platform is designed to activate immune
responses against cancer or infectious diseases. The Company has
multiple product candidates in development leveraging the gp96
platform, including HS-110, which has completed enrollment in a
Phase 2 trial, various infectious disease/biological threat
programs in preclinical development and a pipeline of proprietary
immunomodulatory antibodies and cell-based therapies, including
PTX-35 and HS-130 in Phase 1 clinical trials.
For more information, please
visit: www.heatbio.com, and also follow us
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Forward Looking StatementThis
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, expectation, and assumptions and include
statements such as the partially reversing chemically induced
pancreatic failure (a model for type-1 diabetes) when mice were
transplanted with beta-cell islet allografts and treated with
mPTX-35, PTX-35 contributing to achieving lasting immunological
tolerance in organ transplantation, the potential of PTX-35 to
modulate immunological responses and facilitate minimization or
withdrawal of immunosuppression post-transplant, which supports
further clinical evaluation in the context of inflammatory disease,
expected filing for HS-110 for an End of Phase 2 meeting with the
FDA this quarter, and the potential Phase 3 registration pathways
for HS-110. These statements are subject to a number of risks
and uncertainties, many of which are difficult to predict,
including the ability of Heat's therapies to perform as designed,
to demonstrate safety and efficacy, as well as results that are
consistent with prior results, Heat's vaccine platform to provide
protection against COVID-19, the ability to enroll patients and
complete the clinical trials on time and achieve desired results
and benefits, especially in light of COVID-19, Heat's ability to
obtain regulatory approvals for commercialization of product
candidates including a Phase 3 registration pathway for HS-110 or
to comply with ongoing regulatory requirements, regulatory
limitations relating to Heat'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, Heat'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,
its ability to continue to maintain its listing on the Nasdaq
Capital Market and its ability to retain its key scientists or
management personnel, and the other factors described in Heat's
most recent annual report on Form 10-K filed with the SEC, and
other subsequent filings with the SEC. The information in this
release is provided only as of the date of this release, and Heat
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.
Media and Investor Relations ContactDavid
Waldman+1 919 289 4017investorrelations@heatbio.com
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