HOUSTON, July 15, 2020 /PRNewswire/ -- Moleculin
Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a
clinical stage pharmaceutical company with a broad portfolio of
drug candidates targeting highly resistant tumors and viruses,
today announced that it has entered into an agreement with Sterling
Pharma USA LLC for US production
of WP1122 to support its expanded development efforts in
preparation for submitting a request to the US Food and Drug
Administration ("FDA") for Investigational New Drug ("IND") status
for WP1122 for the potential treatment of COVID-19.
"In light of the added complexity surrounding drug production
during the current COVID-19 pandemic, we wanted to make sure we had
a reliable source of drug supply located here in the US," commented
Walter Klemp, Chairman and CEO of
Moleculin. "We are expanding our planned preclinical studies for
the IND, including testing multiple analogs of WP1122 against
various viruses in vitro, and potentially, in vivo. The latter will
be difficult to time due to the current high demand for in vivo
testing for the treatment of COVID-19. Our contract with Sterling
Pharma Solutions should help provide us with sufficient product to
support this increased use in combination with our expected
clinical trials."
The planned tests are intended to provide additional comparative
data of WP1122 and its close analogs. Additionally, the results of
in vitro testing thus far led the Company to believe that
conventional methods of antiviral testing may not be ideally suited
to test the class of agents represented by 2-DG and WP1122 and
testing methods may need to be optimized to reflect the full
antiviral potential of these sugar antimetabolites. Management
believes the mechanism of action of 2-DG and WP1122 is very
different from other drugs being developed for COVID-19.
Specifically, because 2-DG has been shown to target glucose
metabolism and the process of glycosylation, in vitro testing
results are significantly affected by the concentration of natural
glucose in the microenvironment present during viral replication
and continued infection. For this reason, and consistent with
guidance from the FDA, the Company will seek to evaluate WP1122 in
an animal model for COVID-19 as a part of its IND preparation.
Mr. Klemp concluded: "It's also worth remembering that an
additional benefit of the IND-enabling work we are doing for WP1122
for the possible treatment of patients with COVID-19 is that this
also supports the necessary work for an IND for WP1122 for the
potential treatment of patients with other viral infections or
certain cancers."
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of oncology
drug candidates for the treatment of highly resistant tumors and
viruses. The Company's clinical stage drugs are: Annamycin, a Next
Generation Anthracycline, designed to avoid multidrug resistance
mechanisms with little to no cardiotoxicity, being studied for the
treatment of relapsed or refractory acute myeloid leukemia, more
commonly referred to as AML; WP1066, an Immune/Transcription
Modulator capable of inhibiting p-STAT3 and other oncogenic
transcription factors while also stimulating a natural immune
response, being studied for brain tumors, pancreatic cancer and
hematologic malignancies; and WP1220, an analog to WP1066, being
studied for the topical treatment of cutaneous T-cell lymphoma.
Moleculin is also engaged in preclinical development of additional
drug candidates, including additional Immune/Transcription
Modulators, as well as compounds capable of
Metabolism/Glycosylation Inhibition, such as WP1122. Moleculin has
the exclusive worldwide rights (subject to certain territories for
which it has issued sublicenses) to all of the above
technologies.
For more information about the Company, please visit
http://www.moleculin.com.
About Sterling Pharma Solutions
Sterling Pharma Solutions is a contract development and
manufacturing organisation (CDMO) with world class facilities in
both the UK and the US. Sterling has over 50 years'
experience in delivering comprehensive small molecule services
spanning pre-clinical development to full commercial cGMP
manufacturing.
Widely recognised for its expertise in complex, hazardous
chemistry and its service oriented customer experience, Sterling is
a proven and trusted partner to the world's most innovative
biotechs and leading pharmaceuticals.
For more information about the company, please
visit www.sterlingpharmasolutions.com | Twitter:
@sterling_pharma | Linkedin: /sterling-pharma-solutions.
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, the ability of WP1122 to show
sufficient antiviral potential in vitro and in vivo models, the
ability of Moleculin to file an IND submission by the end of 2020
and the ability of WP1122 to be shown safe and effective for the
treatment of COVID-19, other viral diseases, or cancer. Although
Moleculin believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
expectations may prove to have been materially different from the
results expressed or implied by such forward-looking statements.
Moleculin Biotech has attempted to identify forward-looking
statements by terminology including ''believes,'' ''estimates,''
''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,''
''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,''
''approximately'' or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements.
These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, including those discussed
under Item 1A. "Risk Factors" in our most recently filed Form 10-K
filed with the Securities and Exchange Commission ("SEC") and
updated from time to time in our Form 10-Q filings and in our other
public filings with the SEC. Any forward-looking statements
contained in this release speak only as of its date. We undertake
no obligation to update any forward-looking statements contained in
this release to reflect events or circumstances occurring after its
date or to reflect the occurrence of unanticipated events.
Contacts
James
Salierno / Carol Ruth
The Ruth Group
646-536-7028 / 7000
jsalierno@theruthgroup.com
cruth@theruthgroup.com
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SOURCE Moleculin Biotech, Inc.