NEW YORK, July 21, 2021 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE:
ORMP) (www.oramed.com), a clinical-stage pharmaceutical
company focused on the development of oral drug delivery systems,
today announced several updates for its majority-owned company
Oravax Medical Inc.
Oravax capitalizes on Oramed's proprietary protein oral delivery
(POD™) technology in the development of oral vaccines that are now
only available via injection. Oravax is the exclusive owner of a
virus-like particle (VLP) vaccine technology that targets three
SARS CoV-2 virus surface proteins, including proteins less
susceptible to mutation, thus making the vaccine potentially
effective against current and future variants of the COVID-19
virus. The VLP vaccine is being tested in preclinical studies
against COVID-19 variants including the Delta variant. Oravax's VLP
vaccine technology is highly scalable with a low cost of goods and
easily transferable.
Clinical Trial of Oral COVID-19 Vaccine Moving
Forward
Oravax is gearing up to commence clinical trials for its oral
COVID-19 vaccine, first in Israel,
then in additional clinical sites internationally. The study
protocol has been approved by the Institutional Review Board (IRB)
at Ichilov Hospital in Tel Aviv,
Israel and is now pending approval from the Israeli Ministry
of Health. GMP manufacturing for the oral vaccine is under way.
The oral VLP COVID-19 vaccine is being developed for use both as
a standalone vaccine as well as a booster for people who have been
previously vaccinated for COVID-19. Experts including at the World
Health Organization expect booster shots will be needed for both
general and at-risk populations. If successful, an oral
vaccine would offer enormous logistical, financial, and
environmental benefits for the billions of people slated to receive
them, particularly in parts of the world where access to healthcare
is limited.
"Our vaccine is a particularly strong candidate against the
evolving COVID-19 virus due to its unique targeting of three
proteins rather than one. With the Delta and other variants proving
a challenge to health administrators globally, Oravax's VLP
technology could prove even more important in the effort to combat
COVID," said Nadav Kidron, CEO of
Oramed.
Oravax Holdings
Oramed is currently evaluating several options with respect to
its interest in Oravax, including distributing a portion of its
holdings to its shareholders. Subject to applicable law, Oramed
will keep shareholders advised of developments.
Premas to Develop and Commercialize VLP Injectable Technology
in India
Oravax, the exclusive owner of the VLP technology, has
out-licensed certain rights in the territory of India to Premas Biotech, the original
developer of the novel vaccine. As Oravax maintains its focus
on oral vaccines, it has licensed to Premas the right to develop an
injectable version of its VLP technology with an aim to address the
urgent need for a vaccine which is effective against the Delta
variant. Oravax is entitled to royalties upon commercialization of
this vaccine in India.
"Oravax's VLP platform technology can be delivered either via
injection or orally. Because Oravax is focused on oral vaccines, we
saw a clear benefit to out-licensing rights to the injectable
version in India, where there is
an urgent need for vaccines," Kidron added.
Premas plans to manufacture, test, and potentially commercialize
the injectable version of the VLP vaccine in India where the COVID-19 vaccine market is
anticipated to grow to over $2.3
billion by 2027. India is
currently in a race to speed up the pace of COVID-19 vaccinations
for its population of 1.4 billion as the country's death toll from
the pandemic has topped 400,000 with 31 million cases.
About Oravax Medical Inc.
Oravax was established in 2021 by Oramed Pharmaceuticals Inc.,
the largest shareholder in Oravax, along with Premas Biotech and
certain other shareholders with a mission to bring an oral COVID-19
vaccine to the market. Oravax combines cutting-edge vaccine
technology acquired from Premas Biotech and the proprietary POD™
oral delivery technology of Oramed Pharmaceuticals. For more
information, please visit www.ora-vax.com
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform
technology pioneer in the field of oral delivery solutions for
drugs currently delivered via injection. Established in 2006, with
offices in the United States and Israel, Oramed has
developed a novel Protein Oral Delivery (POD™) technology. Oramed
is seeking to transform the treatment of diabetes through its
proprietary lead candidate, ORMD-0801, which is being
evaluated in two pivotal Phase 3 studies and has the potential to
be the first commercial oral insulin capsule for the
treatment of diabetes. In addition, Oramed is developing an oral
GLP-1 (Glucagon-like peptide-1) analog capsule.
For more information, please visit www.oramed.com.
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss the potential of the
Oravax vaccine or booster to be effective against COVID-19 and
other potential benefits of an oral COVID-19 vaccine, future
clinical trials and approvals, potential options with respect to
Oramed's interest in Oravax, the potential for royalties and other
benefits from the license to Premas, the potential of ORMD-0801 to
be the first commercial oral insulin capsule for the treatment of
diabetes or revolutionizing the treatment of diabetes with our
products. In addition, historic results of scientific research and
clinical trials do not guarantee that the conclusions of future
research or trials will suggest identical or even similar
conclusions. These forward-looking statements are based on the
current expectations of the management of Oramed only, and are
subject to a number of factors and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements, including the risks and uncertainties
related to the progress, timing, cost, and results of clinical
trials and product development programs; difficulties or delays in
obtaining regulatory approval or patent protection for our product
candidates; competition from other pharmaceutical or biotechnology
companies; and our ability to obtain additional funding required to
conduct our research, development and commercialization activities.
In addition, the following factors, among others, could cause
actual results to differ materially from those described in the
forward-looking statements: changes in technology and market
requirements; delays or obstacles in launching our clinical trials;
changes in legislation; inability to timely develop and introduce
new technologies, products and applications; lack of validation of
our technology as we progress further and lack of acceptance of our
methods by the scientific community; inability to retain or attract
key employees whose knowledge is essential to the development of
our products; unforeseen scientific difficulties that may develop
with our process; greater cost of final product than anticipated;
loss of market share and pressure on pricing resulting from
competition; laboratory results that do not translate to equally
good results in real settings; our patents may not be sufficient;
and finally that products may harm recipients, all of which could
cause the actual results or performance of Oramed to differ
materially from those contemplated in such forward-looking
statements. Except as otherwise required by law, Oramed undertakes
no obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated
events. For a more detailed description of the risks and
uncertainties affecting Oramed, reference is made to Oramed's
reports filed from time to time with the Securities and Exchange
Commission.
Company Contact:
Estee
Yaari
+1-844-9-ORAMED
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.