HOUSTON, July 10,
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
completion of its End of Phase 2 (EOP2) meeting with the U.S. Food
and Drug Administration (FDA) for its Phase 1B/2 clinical trial evaluating Annamycin in
combination with Cytarabine (also known as "Ara-C" and for which
the combination of Annamycin and Ara-C is referred to as AnnAraC)
for the treatment of subjects with AML as both first line therapy
and for subjects who are refractory to or relapsed after induction
therapy (MB-106). The Company expects to report outcomes from the
EOP2 meeting upon receipt of official minutes from FDA which is
expected by the end of Q3 2024.
"The Moleculin team, along with our regulatory advisors and key
opinion leaders, discussed with FDA the MB-106 safety and efficacy
clinical findings and proposed next steps for our AML clinical
development program," commented Walter
Klemp, Chairman and Chief Executive Officer of Moleculin.
"We are grateful to the FDA for what we consider to be a very
productive meeting and look forward to reporting its outcome before
the end of August."
The EOP2 meeting was supported by second-line treatment results
from the Company's ongoing MB-106 clinical trial. As recently
reported on June 14, 2024, a total of
22 subjects have been enrolled (the Intent-to-Treat population,
ITT), 20 (Lines 1st-7th) of whom have
completed efficacy evaluations with 9 subjects (45%) achieving a
composite complete remission (CRc or CR/CRi), consisting of 8 (40%)
subjects with complete remission (CR) and one subject with complete
remission with an incomplete recovery of peripheral blood counts
(CRi), following treatment with AnnAraC. Efficacy outcomes for 2
additional subjects (enrolled and treated) are pending.
Of the 10 ITT subjects for whom AnnAraC was administered in the
2nd line setting, 5 achieved a CR (50%) and 6 achieved a
CRc (60%). Of the 13 subjects in the ITT evaluable population
that were 1st or 2nd line treatment, 7
achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9
subjects who achieved a CRc is approximately 7 months and
climbing.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the U.S. Food and Drug Administration for the
treatment of relapsed or refractory acute myeloid leukemia, in
addition to Orphan Drug Designation for the treatment of soft
tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation
for the treatment of relapsed or refractory acute myeloid leukemia
from the European Medicines Agency (EMA). For more information
about the ongoing MB-106 Phase 1B/2
trial, visit clinicaltrialsregister.eu and reference EudraCT
2020-005493-10 or clinicaltrials.gov and reference NCT05319587.
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 and to eliminate the
cardiotoxicity common with currently prescribed anthracyclines.
Annamycin is currently in development for the treatment of acute
myeloid leukemia (AML) and soft tissue sarcoma (STS) lung
metastases. All interim and preliminary data related to its active
clinical trials are subject to change.
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. Moleculin is also engaged in the development of a
portfolio of antimetabolites, including WP1122 for the potential
treatment of viruses, as well as certain cancer indications.
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
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SOURCE Moleculin Biotech, Inc.