HOUSTON, July 1, 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 a peer-reviewed article published in Clinical Cancer
Research (Clin Cancer Res June 30
2020 DOI:10.1158/1078-0432.CCR-19-4092) reported findings that
Moleculin's STAT3 inhibitor, WP1066, used in combination with
traditional whole brain radiation therapy (WBRT) resulted in
long-term survivors and enhanced median survival time relative to
monotherapy in mice with implanted human brain tumors.
The paper can be accessed at:
https://clincancerres.aacrjournals.org/content/early/2020/06/30/1078-0432.CCR-19-4092.full-text.pdf
The study was performed by lead author Martina Ott, Ph.D., Instructor of Neurosurgery,
senior author Amy Heimberger, M.D.,
professor of Neurosurgery, and a team of researchers at The
University of Texas MD Anderson Cancer
Center. Heimberger also is the Principle Investigator of the
current investigator-initiated clinical trial of WP1066 for brain
tumors.
In the current study, C57BL/6 mice underwent intracerebral
implantation of GL261 glioma cells, WBRT, and treatment with
WP1066, a blood-brain barrier penetrant inhibitor of the STAT3
pathway, or the two in combination. The role of the immune system
was evaluated using tumor rechallenge strategies, immune
incompetent backgrounds, immunofluorescence, immune phenotyping of
tumor-infiltrating immune cells (via flow cytometry), and
nanostring gene expression analysis of 770 immune-related genes
from immune cells, including those directly isolated from the tumor
microenvironment.
The combination of WP1066 and WBRT resulted in long-term
survivors and enhanced median survival time relative to monotherapy
in the GL261 glioma model (combination vs. control p<0.0001).
Immunological memory appeared to be induced, because mice were
protected during subsequent tumor rechallenge. The therapeutic
effect of the combination was completely lost in immune incompetent
animals. Nanostring analysis and immunofluorescence revealed
immunological reprogramming in the
brain tumor microenvironment specifically affecting dendritic-cell
antigen presentation and T cell effector functions. The study
indicates that the combination of STAT3 inhibition and WBRT
enhances the therapeutic effect against gliomas in the CNS by
inducing dendritic-cell and T cell interactions in the brain tumor,
which seems to be a requirement for a fully functional immune
response
"This impressive study confirms preliminary data we announced
last year," commented Walter Klemp,
Chairman and CEO of Moleculin. "Importantly, the study indicated
that the combination of STAT3 inhibition with whole brain
radiotherapy had the capacity to enhance the therapeutic effect
against established tumors as well as developing immune memory that
appears to prevent recurrence."
The research was supported by the Cancer Prevention &
Research Institute of Texas
(IIRA-RP160482), the National
Institutes of Health (CA1208113, P50 CA093459, P50 CA127001 and P30
CA016672), the Ben and Catherine Ivy Foundation, MD Anderson's
Glioblastoma Moon Shot, and the Brockman Foundation.
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.
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 WP1066, alone
or in combination with WBRT, to show safety and efficacy in
patients with brain tumors. 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.