PDS Biotech Announces Preclinical Data for PDS0203, a T-Cell Activating Recombinant Protein Vaccine Against COVID-19
July 27 2020 - 8:30AM
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology, today announced
preclinical data for its COVID-19 vaccine candidate,
Versamune-CoV-2 (PDS0203). PDS0203 pairs the Versamune®
platform with a recombinant protein recognized by the human immune
system that is derived from the Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2) virus that causes COVID-19. The
protein included in PDS0203 encompasses SARS-CoV-2 sections that
induce an antibody response, as well as sections that are
recognized by CD8 and CD4 T-cells.
PDS Biotech has generated robust preclinical
data confirming that PDS0203 elicits induction of highly active and
potent virus-specific CD8 killer and CD4 helper T-cells within 14
days of treatment. Importantly, the study also demonstrated
induction of the long-lasting virus-specific memory T-cells
necessary for longer term protection. PDS0203 demonstrated a
30-45 fold increase in COVID-19 specific T-cells by Day 14 when
compared to the vaccine without Versamune®. These preclinical
studies also confirmed induction of strong anti-SARS-CoV-2
neutralizing antibodies within 14 days, with a 20-25-fold increase
when compared to the vaccine without Versamune®. Lastly,
these preclinical studies showed a further substantial increase in
neutralizing antibody levels continuing more than 30 days after
vaccination. PDS Biotech plans to submit details of the
preclinical studies to a peer reviewed scientific journal.
"Recent COVID-19 research has highlighted the
critical importance of developing vaccines capable of generating
high levels of targeted CD8 and CD4 T-cells, in addition to
neutralizing antibodies, to achieve durable protection against
COVID-19 infection. Our preclinical data shows PDS0203’s ability to
rapidly induce both protective antibodies and long-lasting T-cells
specific for COVID-19,” commented Dr. Frank Bedu-Addo, CEO of PDS
Biotech, “Due to the mechanism by which Versamune® activates a
disease-specific immune response, our PDS0101 program demonstrated
successful translation of T-cell induction and safety data from
preclinical models to humans. We therefore believe that this
encouraging PDS0203 preclinical data may similarly translate to
humans. If so, then it may present unique potential to
provide the breadth and level of immune responses necessary for a
safe and effective vaccine with long-term protection against
COVID-19."
As previously announced, the Company has also
initiated preclinical development of Versamune®-CoV-2FC (PDS0204),
a COVID-19 vaccine candidate being developed in partnership with
Brazil-based Farmacore Biotechnology, which combines the
immune-activating Versamune® platform with a Farmacore-developed
SARS-CoV-2 recombinant fusion protein.
About the Versamune® technology
platform
The Versamune® technology is based on
proprietary immune activating lipids that uniquely activate an
important immunological signaling pathway, called the Type 1
interferon signaling pathway, known to be important in the
induction of both anti-viral and anti-tumor immune responses.
It also promotes efficient access of the disease-specific
immunologically recognized protein (antigen) into two important
immunological pathways called the Class I and II MHC pathways,
therefore enabling powerful induction and activation if CD8
(Killer) and CD4 (helper) T-cells that can recognize, kill and
protect against the specific disease. The technology is
protected by multiple international composition and application
patents.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a
growing pipeline of cancer immunotherapies and infectious disease
vaccines based on the Company’s proprietary Versamune® T-cell
activating technology platform. Versamune® effectively delivers
disease-specific antigens for in vivo uptake and processing, while
also activating the critical type 1 interferon immunological
pathway, resulting in production of potent disease-specific killer
T-cells as well as neutralizing antibodies. PDS Biotech has
engineered multiple therapies, based on combinations of Versamune®
and disease-specific antigens, designed to train the immune system
to better recognize disease cells and effectively attack and
destroy them. To learn more, please visit www.pdsbiotech.com or
follow us on Twitter at @PDSBiotech.
About PDS0203
PDS0203 is a COVID-19 vaccine candidate that
combines the utility of the Versamune® platform with a recombinant
native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
protein. The World Health Organization (WHO) declared the
COVID-19 outbreak caused by a novel coronavirus, Severe Acute
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health
emergency in January of 2020. Within three months of initial
discovery COVID-19 was declared a global pandemic, reflecting
alarming levels of spread and severity and resulting in
unprecedented action by local and national governments to restrict
the movement of citizens to contain the spread. Building
immunity to the disease is the key to stopping its spread. A
COVID-19 vaccine would train the immune system to recognize and
destroy the virus without the vaccinated person getting sick.
About PDS0204
PDS0204 is a COVID-19 vaccine candidate that
combines the utility of the Versamune® platform with a
Farmacore-developed recombinant fusion protein of Severe Acute
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The World
Health Organization (WHO) declared the COVID-19 outbreak caused by
a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus
2 (SARS-CoV-2), a global health emergency in January of 2020.
Within three months of initial discovery COVID-19 was declared a
global pandemic, reflecting alarming levels of spread and severity
and resulting in unprecedented action by local and national
governments to restrict the movement of citizens to contain the
spread. Building immunity to the disease is the key to
stopping its spread. A COVID-19 vaccine would train the immune
system to recognize and destroy the virus without the vaccinated
person getting sick.
Forward Looking Statements
This communication contains forward-looking
statements (including within the meaning of Section 21E of the
United States Securities Exchange Act of 1934, as amended, and
Section 27A of the United States Securities Act of 1933, as
amended) concerning PDS Biotechnology Corporation (the “Company”)
and other matters. These statements may discuss goals, intentions
and expectations as to future plans, trends, events, results of
operations or financial condition, or otherwise, based on current
beliefs of the Company’s management, as well as assumptions made
by, and information currently available to, management.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as “may,” “will,” “should,”
“would,” “expect,” “anticipate,” “plan,”
“likely,” “believe,” “estimate,” “project,” “intend,” and
other similar expressions among others. Statements that are not
historical facts are forward-looking statements. Forward-looking
statements are based on current beliefs and assumptions that are
subject to risks and uncertainties and are not guarantees of future
performance. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: the Company’s ability to
protect its intellectual property rights; the Company’s anticipated
capital requirements, including the Company’s anticipated cash
runway and the Company’s current expectations regarding its plans
for future equity financings; the timing for the Company or its
partners to initiate the planned clinical trials for its lead
assets, PDS0101; the preclinical results of the Company’s
PDS0203 and PDS0204 product candidates, which will be subject to
more rigorous testing and which are not necessarily indicative of
future clinical results; the successful implementation of the
Company’s research and development programs and collaborations,
including any collaboration studies concerning PDS0101, PDS0203 and
PDS0204, and the Company’s interpretation of the results and
findings of such programs and collaborations and whether such
results are sufficient to support the future success of the
Company’s product candidates; the acceptance by the market of the
Company’s product candidates, if approved, and the overall
performance and success of the Company’s product
candidates; the number or type of studies or nature of results
necessary to support the filing of a new drug application for any
of the Company’s current product candidates; the timing of and the
Company’s ability to obtain and maintain U.S. Food and Drug
Administration or other regulatory authority approval of, or
other action with respect to, the Company’s product
candidates; and other factors, including legislative,
regulatory, political and economic developments not within the
Company’s control, including unforeseen circumstances or other
disruptions to normal business operations arising from or related
to COVID-19. The foregoing review of important factors that could
cause actual events to differ from expectations should not be
construed as exhaustive and should be read in conjunction with
statements that are included herein and elsewhere, including the
risk factors included in the Company’s annual and periodic reports
filed with the SEC. The forward-looking statements are made only as
of the date of this press release and, except as required by
applicable law, the Company undertakes no obligation to revise or
update any forward-looking statement, or to make any other
forward-looking statements, whether as a result of new information,
future events or otherwise.
Media & Investor Relations
Contact:
Deanne RandolphPDS BiotechPhone: +1 (908)
517-3613Email: drandolph@pdsbiotech.com
Alexander LoboThe Ruth GroupPhone: +1 (646)
536-7037Email: alobo@theruthgroup.com
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