- Patent protects methods of regulating TNF-α to treat cancers,
autoimmune disorders, and other disorders associated with chronic
inflammation
Akers Biosciences, Inc. (Nasdaq: AKER), today announced that its
proposed merger partner MyMD Pharmaceuticals, Inc. (“MyMD”) was
issued US Pat. No. 10,835,523 B2, titled “Method of Regulating
Tumor Necrosis Factor-Alpha (TNF-α) for Treating Cancers,
Autoimmune Disorders, and Other Disorders Associated with Chronic
Inflammation” by the United States Patent & Trademark Office
(USPTO). The patent is a continuation of U.S. patent application
No. 15/558,094, which was granted as U.S. Patent No. 10,588,899
with claims for treating diabetes.
"We are thrilled to continue building on the foundation that
MyMD currently has around regulating TNF-α as a method of treating
disorders associated with chronic inflammation,” said Chris
Chapman, M.D., Chief Medical Officer of MyMD. “The issuance of this
patent supports the continued expansion of indications that our
lead compound, MYMD-1, has shown success in treating during
preclinical studies."
MYMD-1 is being developed to treat autoimmune and age-related
diseases, including extending the human lifespan. MYMD-1 has been
shown to be effective in regulating the immune system from causing
age-related diseases in preclinical studies evaluating impact on
autoimmune thyroiditis and experimental autoimmune
encephalomyelitis. MyMD believes that it is the first oral small
molecule selective regulator of TNF-α capable of crossing the
blood-brain barrier.
The mechanism of action for MYMD-1 involves regulating the
production of TNF-α, offering the potential to reshape clinical
guidelines and treatment approaches for a number of autoimmune
diseases including diabetes, rheumatoid arthritis and multiple
sclerosis, as well as aging, addiction and depression. MyMD has
continued to leverage its foundational work in the area of
programmed cell death and was previously issued US Pat. No.
10,517,856 B2, titled “Methods of altering programmed cell death
and extending cell life,” which showed the method of beneficially
altering programmed cell death (or modulating programmed cell life)
and how it may postpone the onset of various diseases, extend
lifespan, and/or reverse the normal aging process in an individual.
These patents, coupled with studies to date have laid the
groundwork for the Phase 2 trials for depression in COVID and
sarcopenia, expected to be initiated in the first quarter of
2021.
The issuance is the ninth granted patent for MYMD-1, with an
additional 20 applications currently pending worldwide.
As previously announced, Akers Biosciences and MyMD
Pharmaceuticals announced a definitive merger agreement, whereby
the two companies will join as one to focus on developing and
commercializing MyMD’s novel immunotherapy pipeline assets. Upon
closing the transaction, the combined company is expected to be
renamed MyMD Pharmaceuticals Inc and remain listed on the NASDAQ
under the new ticker symbol “MYMD.” The closing of merger, however,
remains subject to the approval of Akers’ shareholders, as well as
other customary closing conditions.
About MyMD Pharmaceuticals, Inc:
MyMD is a clinical stage pharmaceutical company committed to
extending healthy lifespan 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. SUPERA-1R is a drug platform based on a
novel (patent pending) synthetic derivative of cannabidiol (CBD)
that targets numerous key receptors including CB2 and opioid
receptors and inhibits monoamine oxidase. SUPERA-1R 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.
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.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No public offer of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transaction between Akers and
MyMD, Akers intends to file relevant materials with the SEC,
including a registration statement that will contain a proxy
statement and prospectus. AKERS URGES INVESTORS AND STOCKHOLDERS TO
READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT AKERS, THE PROPOSED TRANSACTION AND RELATED MATTERS.
Investors and shareholders will be able to obtain free copies of
the proxy statement, prospectus and other documents filed by Akers
with the SEC (when they become available) through the website
maintained by the SEC at www.sec.gov. In addition, investors and
shareholders will be able to obtain free copies of the proxy
statement, prospectus and other documents filed by Akers with the
SEC by contacting Investor Relations by mail at Akers Biosciences,
Inc., Attn: Investor Relations, 201 Grove Road, West Deptford, NJ
08086. Investors and stockholders are urged to read the proxy
statement, prospectus and the other relevant materials when they
become available before making any voting or investment decision
with respect to the proposed transaction.
Participants in the Solicitation
Akers and MyMD, and each of their respective directors and
executive officers and certain of their other members of management
and employees, may be deemed to be participants in the solicitation
of proxies in connection with the proposed transaction. Information
about Akers’ directors and executive officers is included in Akers’
Annual Report on Form 10-K for the year ended December 31, 2019,
filed with the SEC on March 25, 2020, as amended on October 21,
2020, and the proxy statement for Akers’ 2020 annual meeting of
stockholders, filed with the SEC on July 29, 2020. Additional
information regarding these persons and their interests in the
transaction will be included in the proxy statement relating to the
transaction when it is filed with the SEC. These documents can be
obtained free of charge from the sources indicated above.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements contained in this communication regarding
matters that are not historical facts are forward-looking
statements within the meaning of Section 21E of the Securities and
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, known as the PSLRA. These include
statements regarding management’s intentions, plans, beliefs,
expectations or forecasts for the future, and, therefore, you are
cautioned not to place undue reliance on them. No forward-looking
statement can be guaranteed, and actual results may differ
materially from those projected. Akers and MyMD undertake no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise,
except to the extent required by law. We use words such as
“anticipates,” “believes,” “plans,” “expects,” “projects,”
“future,” “intends,” “may,” “will,” “should,” “could,” “estimates,”
“predicts,” “potential,” “continue,” “guidance,” and similar
expressions to identify these forward-looking statements that are
intended to be covered by the safe-harbor provisions of the PSLRA.
Such forward-looking statements are based on our expectations and
involve risks and uncertainties; consequently, actual results may
differ materially from those expressed or implied in the statements
due to a number of factors, including, but not limited to, risks
relating to the completion of the merger, including the need for
stockholder approval and the satisfaction of closing conditions;
the cash balances of the combined company following the closing of
the merger; the ability of Akers to remain listed on the Nasdaq
Capital Market in connection with the merger; and expected
merger-related cash outlays, including the timing and amount of
those outlays. Risks and uncertainties related to MyMD that may
cause actual results to differ materially from those expressed or
implied in any forward-looking statement include, but are not
limited to: 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.
New factors emerge from time to time and it is not possible for
us to predict all such factors, nor can we assess the impact of
each such factor on the business or the extent to which any factor,
or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
These risks, as well as other risks associated with the
combination, will be more fully discussed in the proxy
statement/prospectus that will be included in the registration
statement that will be filed with the SEC in connection with the
proposed transaction. Additional risks and uncertainties are
identified and discussed in the “Risk Factors” section of Akers’
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
other documents filed from time to time with the SEC.
Forward-looking statements included in this release are based on
information available to Akers and MyMD as of the date of this
release. Neither Akers nor MyMD undertakes any obligation to update
such forward- looking statements to reflect events or circumstances
after the date of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201202005600/en/
Investor Contact: Brett Mass 646-536-7331
brett@haydenir.com www.haydenir.com
Media Contact: Will Johnson 201-465-8019
MYMD@antennagroup.com www.antennagroup.com
Akers Biosciences (NASDAQ:AKER)
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