– Phase 1B
portion of Phase 1B/2 study
demonstrated preliminary CR/CRi rate of 33% (n=6)
– Annamycin has Fast Track Status and Orphan
Drug Designation from FDA for the treatment of AML
HOUSTON, Oct. 2, 2023
/PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX)
(Moleculin or the Company), a clinical stage pharmaceutical
company with a growing pipeline, including Phase 2 clinical
programs, for hard-to-treat cancers and viruses, today announced
the initial subjects have been treated in the Phase 2 portion of
the Company's Phase 1B/2 trial
evaluating Annamycin in combination with Cytarabine (Ara-C) for the
treatment of subjects with AML (MB-106).
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "This milestone marks an
important step in advancing the development of Annamycin for the
treatment of AML. Based on the positive preliminary results
demonstrated in the Phase 1B portion
of this trial, we continue to believe that Annamycin has the
potential to be a meaningful treatment option for the treatment of
AML. Our team is dedicated to building on the momentum and
encouraging results to bring this study across the finish line and
towards late-stage development."
The Phase 1B/2 MB-106 trial is an
open label trial that builds on the safety and dosage data from the
two successfully concluded single agent Annamycin AML Phase 1
trials, MB-104 and MB-105, conducted in the U.S. and Europe, respectively.
As previously announced, Moleculin successfully and safely
completed the Phase 1B portion of the
trial at 230 mg/m2 of Annamycin in this combination
study in August 2023. The total
complete response (CR) or complete response with incomplete
recovery of peripheral blood count (CRi) demonstrated in the Phase
1B portion of this combination trial
was two out of six subjects or 33%. The median age of these
subjects was 66 years of age. These data are preliminary and
subject to change. In light of the safety and encouraging efficacy
seen in the Phase 1B portion of this
trial and the final (240 mg/m2) cohort of the MB-105
single agent trial, the safety review committee have concluded (and
the Company concurs) that the Phase 2 portion will be conducted at
the 230 mg/m2 level of Annamycin dosing.
Annamycin is the Company's next-generation anthracycline that
has been designed to be non-cardiotoxic and has been shown in
animal models to accumulate in the lungs at up to 30-fold the level
of doxorubicin (a commonly prescribed anthracycline), as well as
demonstrating the ability to avoid the multidrug resistance
mechanisms that typically limit the efficacy of doxorubicin and
other currently prescribed anthracyclines. Annamycin is currently
in development for the treatment of relapsed or refractory AML and
soft tissue sarcoma (STS) lung metastases and the Company believes
it may have the potential to treat additional indications.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the US Food and Drug Administration (FDA) for the
treatment of STS lung metastases and the treatment of relapsed or
refractory AML. For more information about the MB-106 Phase 1/2
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 with little to no
cardiotoxicity. Annamycin is currently in development for the
treatment of relapsed or refractory acute myeloid leukemia (AML)
and soft tissue sarcoma (STS) 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 COVID-19 and other 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. Forward-looking statements in this press
release include, without limitation, Moleculin's ability to
continue the Phase 2 portion of the clinical trial on a timely
basis. 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.