– Investigator-Initiated Phase 2 study is
being conducted at Northwestern
University in cooperation with Moleculin
– Trial combines WP1066 and radiation, which
demonstrated both significant therapeutic response and immune
"memory" in glioblastoma animal models
HOUSTON, May 15, 2024
/PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX)
("Moleculin" or the "Company), a clinical-stage pharmaceutical
company with a broad portfolio of drug candidates targeting
hard-to-treat tumors and viruses, today announced the commencement
of an Investigator-initiated Phase 2 study evaluating WP1066 in
combination with radiation therapy for the treatment of adults with
glioblastoma (NU 21C06) in cooperation with the Company. The study
is being conducted under Northwestern
University's Investigative New Drug application (IND) which
cross references the Company's own IND, which received clearance
from the U.S. Food and Drug Administration (FDA) in April 2022. This trial is funded by the National
Institutes of Health (NIH) and BrainUp®, a non-profit organization
dedicated to bringing awareness to brain cancer.
Dr. Priya Kumthekar, Associate
Professor and the Co-Investigator for the study commented, "There
remains a significant unmet need in the treatment of glioblastoma.
Based on the data seen to date, we believe that WP1066 in
combination with radiation therapy has the potential to address
this need and provide patients with a much-needed treatment option.
We are pleased to commence this important study with
Moleculin."
WP1066 is Moleculin's flagship Immune/Transcription Modulator
designed to stimulate the immune response to tumors by inhibiting
the errant activity of regulatory T cells while also inhibiting key
oncogenic transcription factors, including p-STAT3 (phosphorylated
signal transducer and activator of transcription 3), c-Myc (a
cellular signal transducer named after a homologous avian virus
called Myelocytomatosis) and HIF-1α (hypoxia-inducible factor 1α).
These transcription factors are widely sought targets because of
their role in cancer cell survival and proliferation, angiogenesis
(coopting vasculature for blood supply), invasion, metastasis, and
inflammation associated with tumors.
The NU 21C06 trial is a Phase 2, open-label, multi-arm trial of
radiation therapy in combination with WP1066 in newly diagnosed IDH
(isocitrate dehydrogenase) wild-type, MGMT-unmethylated
glioblastoma patients. The primary outcome measure for the study is
progression-free survival and secondary outcome measures include
tumor microenvironment analysis.
"To date, WP1066 has demonstrated significant anti-tumor
activity in a wide range of tumor cell lines and increased survival
in multiple animal models. The combination of WP1066 with radiation
in glioma models demonstrated both therapeutic responses and
compelling alteration of the immune surveillance within the gliomas
which we hope will be replicated in human subjects," according to
Dr. Amy Heimberger at Northwestern University.
"We are continuing to evaluate WP1066 in additional indications
including for the treatment of pediatric brain tumors and look
forward to its continued development," added Mr. Walter Klemp, Chairman and Chief Executive
Officer of Moleculin.
Glioblastoma is a common type of tumor originating in the brain.
The average annual age-adjusted incidence rate of glioblastoma is
3.19 per 100,000 persons in the United
States.1 Glioblastoma is the most aggressive
malignant primary brain tumor with a median survival of only 15
months2. It is the most common malignant primary brain
tumor making up 54% of all gliomas and 16% of all primary brain
tumors.3 Despite advancements for other cancers, the
survival rate for glioblastoma has not changed significantly
in the last three decades.4
Moleculin has received Orphan Drug Designation for WP1066 for
the treatment of brain tumors, as well as Rare Pediatric Disease
designation for three other pediatric indications. For more
information about the NU 21C06 Phase 2 study, visit
clinicaltrials.gov and reference identifier NCT05879250.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company with a growing pipeline, including Phase 2 clinical
programs, for hard-to-treat tumors and viruses. The Company's lead
program, Annamycin is a next-generation anthracycline designed to
avoid multidrug resistance mechanisms with little to no
cardiotoxicity. Annamycin is currently in development for the
treatment of relapsed or refractory acute myeloid leukemia and soft
tissue sarcoma lung metastases.
Additionally, the Company is developing WP1066, an
Immune/Transcription Modulator capable of inhibiting p-STAT3 and
other oncogenic transcription factors while also stimulating a
natural immune response, targeting brain tumors, pancreatic and
other cancers, and WP1220, an analog to WP1066, for the topical
treatment of cutaneous T-cell lymphoma. Moleculin is also engaged
in the development of a portfolio of antimetabolites, including
WP1122 for the potential treatment of viruses, as well as cancer
indications including brain tumors, pancreatic and other
cancers.
For more information about the Company, please
visit www.moleculin.com and connect on Twitter, LinkedIn and
Facebook.
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. 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 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
1 Thakkar J, Dolecek TA, Horbinski C, Ostrom QT,
Lightner DD, Barnholtz-Sloan JS, et al. Epidemiologic and molecular
prognostic review of glioblastoma. Cancer Epidemiol. Biomarkers
Rev. 2014;23(10):1985-96.
2 Koshy M, Villano JL, Dolecek TA, Howard A,
Mahmood U, Chmura SJ, et al. Improved survival time trends of
glioblastoma using the SEER 17 population-based registries. J Neuro
Oncol. 2012;107(1):207-12
3 Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen
Y, Wolinsky Y, et al. CBTRUS statistical report: Primary brain and
central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol.
2013;15 Suppl:2ii-56.
4 De Vleeschouwer S, editor. Brisbane (AU): Codon Publications; 2017 Sep
27.
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SOURCE Moleculin Biotech, Inc.