MyMD Pharmaceuticals Subsidiary Oravax Medical Preparing to Commence Clinical Trials for Oral COVID-19 Vaccine
August 10 2021 - 10:30AM
Business Wire
- Oravax’s virus-like particle (VLP) vaccine being tested against
COVID-19 variants including Delta
- Oral COVID-19 vaccine being developed as both a standalone
vaccine and a booster for people previously vaccinated
- MYMD is evaluating options for its investment in Oravax,
including distributing its holdings to shareholders
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the
Company”), a clinical stage pharmaceutical company committed to
extending healthy lifespan by focusing on developing two
therapeutic platforms, today reported that its subsidiary Oravax
Medical Inc. (“Oravax”), partially owned with its majority partner
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (“Oramed”), is preparing
to commence clinical trials for its oral COVID-19 vaccine, first in
Israel, then in additional clinical sites internationally. Oravax’s
COVID-19 vaccine is being developed for use both as a standalone
vaccine and as a booster for people who have been previously
vaccinated for COVID-19.
Oramed and MYMD are currently evaluating several options with
respect to their interest in Oravax including a potential
distribution of Oravax shares to both Oramed and MYMD shareholders.
This would make Oravax a publicly held company that may then apply
for listing on Nasdaq if eligible. MyMD’s ownership of Oravax
consists of 13% of Oravax’s outstanding shares of capital stock and
a 2.5% royalty on all future net sales.
“The potential spin-off of Oravax could be beneficial to MyMD
shareholders through our ownership stake and due to Oravax’s strong
position in the public markets as an oral vaccine developer,” said
Josh Silverman, Chairman of the Board of MyMD Pharmaceuticals.
“Oravax’s studies of its VLP vaccine for COVID-19 should be of
particular interest to MyMD shareholders given our own upcoming
Phase 2 clinical trial of MYMD-1 to treat immune mediated
depression and cytokine elevation in COVID-19 patients. We are
excited about the possibilities for both technologies in the global
fight against COVID-19.”
As a triple antigen targeting three SARS CoV-2 virus surface
proteins instead of one, including proteins less susceptible to
mutation, MYMD believes that Oravax’s COVID-19 vaccine candidate
could be a better candidate to provide protection even against
emerging mutated viruses. The oral delivery of the vaccine could
allow for widescale inoculation and easier distribution than
injection.
MyMD recently announced that a human cell research study of its
lead clinical compound MYMD-1 found the drug to be effective in
suppressing the cytokine storm, a major cause of severity and death
in COVID-19 patients. A Phase 2 trial of MYMD-1 as a therapy for
COVID-19-associated depression and cytokine elevation is expected
to begin by the fourth quarter of 2021 with initial trial data
expected in the first quarter of 2022.
About Oravax Medical
Oravax was established in March 2021 by Oramed Pharmaceuticals
Inc. (Nasdaq: ORMP), the largest shareholder in Oravax, along with
MYMD, 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 MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) is a clinical stage
pharmaceutical company committed to extending healthy lifespan in
humans by focusing on developing two therapeutic platforms. MYMD-1
is a drug platform based on a clinical stage small molecule that
regulates the immunometabolic system to control TNF-α and other
pro-inflammatory cytokines. MYMD-1 is being developed to treat
autoimmune diseases, including those currently treated with
non-selective TNF-α blocking drugs, and aging and longevity. The
Company’s second drug platform, Supera-CBD, is based on a novel
synthetic derivative of cannabidiol (CBD) that targets numerous key
receptors including CB2 and opioid receptors and inhibits monoamine
oxidase. Supera-CBD is being developed to address the rapidly
growing CBD market, that includes FDA approved drugs and CBD
products not currently regulated as a drug. For more information,
visit www.mymd.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release may contain forward-looking statements. These
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
expected future results, performance, or achievements.
Forward-looking statements speak only as of the date they are made
and none of MyMD nor its affiliates assume any duty to update
forward-looking statements. Words such as "anticipate," "believe,"
"could," "estimate," "expect," "may," "plan," "will," "would'' and
other similar expressions are intended to identify these
forward-looking statements. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, without limitation: the timing
of, and MyMD’s ability to, obtain and maintain regulatory approvals
for clinical trials of MyMD’s pharmaceutical candidates; the timing
and results of MyMD’s planned clinical trials for its
pharmaceutical candidates; the amount of funds MyMD requires for
its pharmaceutical candidates; increased levels of competition;
changes in political, economic or regulatory conditions generally
and in the markets in which MyMD operates; MyMD’s ability to retain
and attract senior management and other key employees; MyMD’s
ability to quickly and effectively respond to new technological
developments; MyMD’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 MyMD’s
proprietary rights; and the impact of the ongoing COVID-19 pandemic
on MyMD’s results of operations, business plan and the global
economy. A discussion of these and other factors with respect to
MyMD is set forth in the Quarterly Report on Form 10-Q for the
quarterly period ended March 31, 2021, filed by MyMD on May 18,
2021. Forward-looking statements speak only as of the date they are
made and MyMD disclaims any intention or obligation to revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20210810005679/en/
Investor Contact: Robert Schatz (646) 421-9523
rschatz@mymd.com www.mymd.com
Media Contact: Will Johnson 201-465-8019
MYMD@antennagroup.com www.antennagroup.com
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