Akers Biosciences and Premas Biotech Announce SARS CoV-2 Positive Proof of Concept Results
August 27 2020 - 9:00AM
Akers Biosciences, Inc. (the “Company”) (NASDAQ: AKER), a developer
of rapid health information technologies, today announced with its
partner, Premas Biotech, positive proof of concept results from
Animal Studies conducted during a 4 week test of its SARS-CoV-2
vaccine candidate in mice. The test had two primary endpoints,
safety and immune response, both of which were met. The candidate
was well tolerated and safe in mice that received the intramuscular
injection. A robust immune response was also observed.
The study consisted of 50 mice, divided into 10
cohorts dosed with 5, 10 and 20 micrograms of the PRAK-03202
vaccine candidate. The vaccine candidate was generally well
tolerated and safe at all doses, with no adverse events reported.
The vaccine candidate was safe even at higher doses and generated a
robust immune response against the three SARS-Cov2 antigens, S, E,
and M. PRAK3202 elicited neutralizing antibody titers levels in all
the dose cohorts starting from 5 microgram to 20 microgram dose
regimens. After three doses in mice, all the groups' cohorts showed
binding antibody levels similar to convalescent patients’
levels.
Prabuddha Kundu, Co-Founder and Managing
Director at Premas Biotech, commented: “We are happy to report that
the vaccine candidate study in mice has gone on well, and the
results are positive and encouraging. We have engaged with the
regulatory authorities in India and are working towards the next
steps under their guidance.”
Premas will seek to further characterize the
immune response in the near term, while pursuing additional safety
studies and later stage animal testing with the goal of an
investigational new drug (IND) submission to follow in the U.S.
Premas continues to be engaged formally with authorities and the
Drug Controller in India. Both Akers and Premas are also
communicating with regulators in the United States.
Christopher Schreiber, Executive Chairman of
Akers, stated, “We are very encouraged by the immune response and
safety milestones met in this study organized with our partner,
Premas. We are currently moving towards enhanced dialogue with
regulatory bodies in both India and the United States and look
forward to communicating updates with our investors in the near
term.”
About Premas Biotech
Premas Biotech develops novel technologies and
partners with global biopharmaceutical companies to build and
develop novel biotherapeutic & vaccine candidates. Premas' key
focus areas are infectious diseases, cancer, metabolic
disorders and inflammation. Besides D-CryptTM the difficult to
express proteins expression platform, Premas’ leading technologies
include Axtex-4D™: an ex-vivo tissueoid generation platform and
C-Qwence™: a fully human naive India based scFv antibody library.
Further information is available on the Company’s
website: www.premasbiotech.com
Contact email: contact@premasbiotech.com
About Akers Biosciences
Inc.
Akers Biosciences is pursuing rapid development
and manufacturing of a COVID-19 vaccine candidate in collaboration
with Premas Biotech PVT Ltd. . In addition, the Company’s
board of directors continues to evaluate strategic alternatives for
the company to maximize shareholder value.
Forward-Looking Statements
Certain statements in this press release that
are forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements of historical fact, and may be identified by words such
as “anticipates,” “assumes,” “believes,” “can,” “could,”
“estimates,” “expects,” “forecasts,” “guides,” “intends,” “is
confident that”, “may,” “plans,” “seeks,” “projects,” “targets,”
and “would,” and their opposites and similar expressions are
intended to identify forward-looking statements. Such
forward-looking statements are based on the beliefs of management
as well as assumptions made by and information currently available
to management. Actual results could differ materially from those
contemplated by the forward-looking statements as a result of
certain factors, including, but not limited to, the company’s
ability to achieve the expected benefits and costs of the
transactions related to the acquisition of Cystron Biotech, LLC,
including, the timing of, and the company’s ability to, obtain and
maintain regulatory approvals for clinical trials of the company’s
vaccine product candidate, the timing and results of the company’s
planned clinical trials for its vaccine product candidate, the
amount of funds the company requires for its vaccine product
candidate, and the company’s ability to maintain its license with
Premas Biotech PVT Ltd; challenges we may face in identifying,
acquiring and operating new business opportunities; the outcome of
litigation or other proceedings to which the company is subject or
which it may become subject to in the future; increased levels of
competition; changes in political, economic or regulatory
conditions generally and in the markets in which the company
operates; the company’s ability to retain and attract senior
management and other key employees; the company’s ability to
quickly and effectively respond to new technological developments;
the company’s ability to protect its trade secrets or other
proprietary rights, operate without infringing upon the proprietary
rights of others and prevent others from infringing on the
company’s proprietary rights; and the impact of the ongoing
COVID-19 pandemic on the company’s results of operations, business
plan and the global economy. A discussion of these and other
factors, including risks and uncertainties with respect to the
company, is set forth in the company’s filings with the SEC,
including its annual report on Form 10-K filed with the Securities
and Exchange Commission, as may be supplemented or amended by the
company’s Quarterly Reports on Form 10-Q. The company disclaims any
intention or obligation to revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Additional information on the company and its
products can be found at www.akersbio.com.
Contact:
Investor Relations: Hayden IR
Brett Mass, Managing PartnerPhone: (646)
536-7331Email: brett@haydenir.comwww.haydenir.com
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