-- TYME-19 demonstrated an antiviral effect
against SARS CoV-2 in human lung epithelial cells, a model
frequently used for drug screening for antiviral efficacy --
-- Completed toxicity studies with TYME-19 that
are expected to enable an Investigational New Drug (IND)
application and support a forthcoming clinical trial --
-- Independent research indicates that the
TYME-19 bile acid may have differentiated mechanisms from the
emerging oral therapies in development based on the way it
interrupts viral hijacking of cellular protein synthesis --
-- TYME plans to advance toward an IND for
TYME-19 in COVID-19, targeting a patient population for whom there
remains unmet need --
TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an
emerging biotechnology company developing cancer metabolism-based
therapies (CMBTs™), today announced encouraging preclinical data on
the effect of TYME-19 in SARS CoV-2 infections.
The Company believes that TYME-19, a synthetic bile acid, may
have differentiated mechanisms that could offer alternatives for
COVID-19 infected patients who may not be served by current and
emerging oral agents. Bile acids can act to help overcome the viral
hijacking of cells’ translational machinery and the production and
replication of virus proteins and particles. Based on these
properties and recent research on COVID-19 disease processes, the
Company anticipates that the TYME-19-based mechanisms of action may
be independent of genetic shifts in the spike protein and,
therefore, could have utility against a variety of current and
future variants of SARS CoV-2, such as Alpha, Beta, Delta, and
Omicron, regardless of their spike protein characteristics. As a
result, the Company believes this has the potential to be a
complementary effective mechanism to current and emerging
therapeutic options in COVID-19.
“COVID-19 has affected virtually every aspect of our personal
and business lives and is likely to be an endemic disease,
requiring safe and effective treatments that work across a range of
current and future variants. The pandemic has already exacted an
enormous toll, and with the recent emergence of the Delta and
Omicron variants, there is an even more urgent need to find novel
and sustained antiviral treatments. As an organization, TYME aims
to contribute to the body of knowledge in identifying novel
treatment options to improve the outcomes of patients with this
disease,” stated Richie Cunningham, Chief Executive Officer of
TYME.
The Company has retained virology experts at Evotec to assess
the mechanisms of TYME-19. Evotec is one of a select number of
global drug development companies with the capabilities to access
the multiple emerging variants of the COVID-19 virus. TYME and
Evotec are testing the ability of TYME-19 to interrupt the cellular
pathways commonly used by viruses to produce viral proteins that
would lead to the interruption of COVID-19’s viral particle
production and the shedding of such particles from infected cells.
We expect the work by Evotec will provide us with critical
information allowing us to assess the current and potential future
utility of TYME-19 in this disease.
In this initial preclinical study, TYME-19 was tested
post-COVID-19 infection in human lung epithelial cells (A549
cells), examining changes in viral mRNA levels. This cell model is
well understood and frequently used for screening for antiviral
effects for drugs against respiratory viruses.
As part of the study, a range of doses of TYME-19 were tested
and were exposed to A549 cells one hour after the cells’ exposure
to the COVID-19 virus. At certain doses, viral mRNA inhibition of
up to 90% was observed with TYME-19 treatment after 72 hours of
exposure.
“We are encouraged by the A549 study, as well as recent
toxicology studies that support the safety of our approach.
Moreover, we are excited about the prospect that TYME-19 may offer
different mechanisms of action from those currently in development.
As we continue to gain a greater understanding of TYME-19’s
mechanisms of action, we believe it will provide us the necessary
insight to position this product in the ever-changing SARS CoV-2
landscape,” concluded Cunningham.
About TYME Technologies, Inc.
TYME is an emerging biotechnology company developing cancer
metabolism-based therapies (CMBTs™) that are intended to be
effective across a broad range of solid tumors and hematologic
cancers, while also maintaining patients’ quality of life through
relatively low toxicity profiles. Unlike targeted therapies that
attempt to regulate specific mutations within cancer, the Company’s
therapeutic approach is designed to take advantage of a cancer
cell’s innate metabolic weaknesses to cause cancer cell death.
The Company is currently developing its lead novel compound,
SM-88. The Company believes that early clinical results
demonstrated by SM-88 in multiple advanced cancers, including
pancreatic, prostate, sarcomas and breast, reinforce the potential
of its emerging CMBT™ pipeline.
For more information about the Company, visit www.tymeinc.com
and connect on Facebook, LinkedIn, and Twitter.
About TYME-19
TYME-19 is an oral synthetic member of the bile acid family.
Because of its expertise in metabolic therapies, the Company was
able to identify TYME-19 as a potent, well characterized antiviral
bile acid and has performed preclinical experiments establishing
effectiveness against COVID-19. Bile acids have primarily been used
for liver disease; however, like all steroids, they are messenger
molecules that modulate a number of diverse critical cellular
regulators. Bile acids modulate lipid and glucose metabolism and
can remediate dysregulated protein folding, with potentially
therapeutic effects on cardiovascular, neurologic, immune, and
other metabolic systems. Some agents in this class also have
antiviral properties. In preclinical testing, TYME-19 repeatedly
prevented COVID-19 viral replication without attributable
cytotoxicity to the treated cells. Previous preclinical research
has also shown select bile acids like TYME-19 have had broad
antiviral activity. The United States Patent and Trademark Office
granted U.S. Patent No. 10,905,698 directed to methods for treating
COVID-19.
Forward-Looking Statements
In addition to historical information, this press release
contains forward-looking statements under the Private Securities
Litigation Reform Act that involve substantial risks and
uncertainties. Such forward-looking statements within this press
release include, without limitation, statements regarding our drug
candidates (including SM-88 and TYME- 18) and their clinical
potential and non-toxic safety profiles, our drug development plans
and strategies, ongoing and planned preclinical or clinical trials,
preliminary data results and the therapeutic design and mechanisms
of our drug candidates. The words “believes,” “expects,” “hopes,”
“may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,”
“would,” “continue,” “seeks,” “anticipates,” and similar
expressions (including their use in the negative) are intended to
identify forward-looking statements. Forward-looking statements can
also be identified by discussions of future matters such as: the
effect of the COVID-19 pandemic and the associated impact on the
national and global economy as well as impacts on the Company's
ongoing clinical trials and ability to analyze data from those
trials; the cost of development and potential commercialization of
our lead drug candidate and of other new product candidates;
expected releases of interim or final data from our clinical trials
or related regulatory submissions; possible collaborations; the
timing, scope, status, objectives of our ongoing and planned
trials; the success of management transitions and strategic
initiatives; and other statements that are not historical. The
forward-looking statements contained in this press release are
based on management’s current expectations and projections which
are subject to uncertainty, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. These statements involve known and unknown risks,
uncertainties and other factors which may cause the Company’s
actual results, performance or achievements to be materially
different from any historical results and future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties include
but are not limited to: the severity, duration, and economic impact
of the COVID-19 pandemic; our ability to achieve the intended
benefits of our strategic initiatives; that certain information is
of a preliminary nature and may be subject to change; uncertainties
inherent in the cost and outcomes of research and development,
including the cost and availability of acceptable-quality clinical
supply, and in the ability to achieve adequate start and completion
dates, as well as uncertainties in clinical trial design and
patient enrollment, dropout or discontinuation rates; the
possibility of unfavorable study results, including unfavorable new
clinical data and additional analyses of existing data; risks
associated with early, initial data, including the risk that the
final data from any clinical trials may differ from prior or
preliminary study data or analyses and may not support further
clinical development; and that past reported data are not
necessarily predictive of future patient or clinical data outcomes;
whether and when any applications or other submissions for SM-88 or
other drug candidates may be filed with regulatory authorities;
whether and when regulatory authorities may approve any
applications or submissions; decisions by regulatory authorities
regarding labeling and other matters that could affect commercial
availability of SM-88 or other drug candidates; the ability of TYME
and its collaborators to develop and realize collaborative
synergies; competitive developments; and the factors described in
the section captioned “Risk Factors” of TYME’s Annual Report on
Form 10-K for the fiscal year ended March 31, 2021 filed with the
U.S. Securities and Exchange Commission on June 10, 2021 as well as
subsequent reports we file from time to time with the U.S.
Securities and Exchange Commission available at www.sec.gov.
The information contained in this press release is as of its
release date and TYME assumes no obligation to update
forward-looking statements contained in this release as a result of
future events or developments.
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version on businesswire.com: https://www.businesswire.com/news/home/20211214005347/en/
Investor Relations: Lisa M. Wilson, In-Site
Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com
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