- Data from the translationally relevant study reported ability
of MYMD-1 to inhibit key biomarkers associated with fibrotic
diseases including idiopathic pulmonary fibrosis (IPF) and
interstitial lung disease (ILD)
- Eurofins Discovery human phenotypic screening platform revealed
potential of MYMD-1 to be developed as a therapy for fibrosis
Akers Biosciences, Inc. (Nasdaq: AKER), with its proposed merger
partner MyMD Pharmaceuticals, Inc. (“MyMD”), a clinical stage
pharmaceutical company committed to extending healthy lifespan by
focusing on developing two therapeutic platforms, today announced
new data from a study conducted by Eurofins Discovery Phenotypic
Center of Excellence.
MYMD-1 is being developed to treat autoimmune and age-related
diseases, including extending the human lifespan, and has been
shown to be effective in regulating the immune system in
preclinical studies.
The findings of the Eurofins Discovery study indicate the
potential of MYMD-1 to limit the fibrotic biology associated with
idiopathic pulmonary fibrosis (IPF). Hallmark activities of MYMD-1
included inhibition of transforming growth factor-beta (TGF-beta),
a driver for fibrosis, and of tumor necrosis factor (TNF),
associated with inflammation. This dual pattern of anti-fibrotic
and anti-inflammatory activities are consistent with the potential
for MYMD-1 to be developed as a therapeutic candidate for
fibrosis-related diseases.
Fibrotic disorders are implicated in nearly 45% of all deaths in
the developed world, and may involve multiple physiological systems
including the skin, liver, kidney, heart and lungs. In particular,
IPF has an insidious, relentless and chronic course, with a median
survival of two to five years. Thus there is a great need to
develop new and effective therapeutics for treating patients.
"Nearly 100,000 people in the United States have IPF, and
although cases continue to climb, there is still a significant
unmet need in treatment options for this chronic disease,” said
Chris Chapman, M.D., President and Chief Medical Officer of MyMD.
“MYMD-1 continues to demonstrate broad utility and capability to
inhibit inflammation in preclinical data, which is linked to myriad
diseases including IPF. This study stirs hope for those affected by
the disease and gives MYMD-1 an additional path forward.”
The study was completed using the BioMAP Phenotypic Screening
and Profiling Platform from Eurofins Discovery. This platform
addresses the need for translationally relevant, predictive in
vitro models of human disease, including fibrosis. The BioMAP
Fibrosis Panel models complex human tissue and disease biology
driving the aberrant inflammation involved in fibrosis and wound
healing, and preserves the complex multicellularity of organs such
as the lung and kidney with their cell-cell physical communications
and signaling events that occur to influence disease. The panel
provided information on MYMD-1 mechanistic signatures,
identification of unexpected activities, competitor analysis,
guidance on non-cytotoxic concentrations and more.
“The activities in this study immediately caught our attention
as they spoke to impacts on fibrosis disease biology that remain an
unmet clinical need,” said Alison O’Mahony, Ph.D, Vice President of
Translational Biology at Eurofins Discovery. “We have learned over
the years from testing both approved fibrosis drugs and failed
candidates, that efficacy requires not only anti-fibrotic impacts,
but also anti-inflammatory activities. During the study, MYMD-1
inhibited both aspects of fibrosis biology. We were also able to
determine well-tolerated treatment concentrations as part of the
study.”
“There are many adverse outcomes from inappropriate inflammation
and dysregulated wound healing responses, including IPF,” said Adam
Kaplin, M.D., Ph.D, Chief Scientific Officer for MyMD
Pharmaceuticals. “We selected Eurofins to run the study knowing the
credibility and breadth of their platform, and were pleased to see
the readouts specifically showed inhibition of disease biology
among key biomarkers associated with IPF, especially through
Eurofins’ human phenotypic screening platform, allowing us to see
patient-specific cell activity.”
MyMD plans to move forward in testing combinations of MyMD-1
with approved fibrosis drugs to determine how the agents interact
to impact disease biology of IPF. For more information on MyMD,
visit mymd.com.
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.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. Eurofins is a global leader in
food, environment, and pharmaceutical product testing. It is also
one of the market leaders in testing and laboratory services for
genomics, discovery pharmacology, forensics, advanced material
sciences and has a rapidly developing presence in highly
specialised and molecular clinical diagnostic testing.
With over 50,000 staff across a network of more than 800
laboratories in over 50 countries, Eurofins’ companies offer a
portfolio of over 200,000 analytical methods.
Eurofins Shares are listed on Euronext Paris Stock Exchange.
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 has filed with the SEC a registration statement on Form
S-4 that includes a preliminary joint proxy statement of Akers and
MyMD that also constitutes a prospectus of Akers and the definitive
joint proxy statement statement/prospectus will be mailed to
shareholders of Akers and MyMD. Akers and MyMD also plan to file
other relevant documents with the SEC regarding the proposed
transaction. 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, 1185 Avenue of the Americas, 3rd Floor,
New York, New York USA 10036. 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, are more fully discussed in the proxy
statement/prospectus that is included in the registration statement
that was 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/20210223005214/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
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