– Preliminary positive safety and efficacy
data from second Phase 1 AML study validate advancement to Phase
1/2 of Annamycin in combination with Cytarabine
– Preclinical animal research demonstrated a
68% increase in OS with Annamycin and Cytarabine combined compared
to Annamycin as a single agent and a 241% increase in OS compared
to Cytarabine alone
– Trial expected to commence this
quarter
HOUSTON, May 5, 2022
/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 received allowance from the Polish Department of
Registration of Medicinal Products (URPL), as well as the requisite
Ethics Committee approval, to proceed with its Phase 1/2 clinical
trial in Poland of Annamycin
(L-ANN) in combination with Cytarabine (Ara-C) in the treatment of
subjects with acute myeloid leukemia (AML) who are refractory to or
relapsed after induction therapy.
The Phase 1/2 L-ANN /ARA-C combination (AnnAraC) trial (MB-106),
an open label trial, builds on the safety and dosage data from the
two successfully concluded single agent Annamycin AML Phase 1
trials (MB-104 and MB-105) in the U.S. and Europe and the preclinical data discussed
below. The study is expected to commence patient enrollment in the
first half of 2022.
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "We are pleased with
the positive feedback from the URPL and are excited to take another
step toward initiating this important trial. Bolstered by the
encouraging data seen to-date, we believe the combination of
Annamycin with Cytarabine has the ability to synergistically
improve activity against AML. With this allowance to proceed now in
hand, our team is working to get this trial up and running as
quickly and efficiently as possible. Based on the continued support
received from local physicians in Poland for this AnnAraC trial, we believe we
will be able to remain on track to get the trial underway this
quarter and build momentum with patient recruitment. We are also
working to potentially expand this trial to additional countries in
Europe to help further accelerate
the rate of recruitment."
Importantly, Annamycin has also demonstrated a lack of
cardiotoxicity in multiple human clinical trials, including ongoing
trials for the treatment of relapsed or refractory AML and soft
tissue sarcoma (STS) lung metastases. Annamycin is the Company's
next-generation anthracycline that has been shown in animal models
to accumulate in the lungs at up to 30-fold the level of
doxorubicin, as well as demonstrating the ability to avoid the
multidrug resistance mechanisms that typically limit the efficacy
of doxorubicin and other currently prescribed anthracyclines.
Furthermore, based on additional preclinical animal data from
sponsored research, Annamycin in combination with Cytarabine
demonstrated a 68% improvement in the median overall survival (OS)
compared to Annamycin as a single agent and a 241% increase in OS
compared to Cytarabine alone. These data were recently presented at
the 62nd Annual Meeting & Exposition of the American Society
for Hematology ("ASH") under the title: "High Efficacy of Liposomal
Annamycin (L-ANN or Annamycin) in Combination with Cytarabine in
Syngeneic p53-null AML Mouse Model."1
In January 2022, the Company
reported that it had received an updated independent safety review
of certain preliminary data for the first 30 patients in its three
Phase 1 clinical trials with Annamycin targeting AML (MB-104 and
MB-105) and the metastases of soft tissue sarcoma to the lungs (STS
Lung) or MB-107, which concluded there was no evidence of
cardiotoxicity. Based on the preliminary data seen in the fifth and
final dose escalation cohort of the MB-105 trial, the Company
reported Annamycin demonstrated an overall response rate (ORR) of
60%. This included two partial responses (PRs) and one complete
response with incomplete recovery of neutrophils and/or platelets
(CRi). Upon safely reaching the RP2D of 240 mg/m2 in the
MB-105 trial, the Company concluded recruitment for the trial.
About Annamycin
Annamycin is the Company's next-generation anthracycline that
has been shown in animal models to accumulate in the lungs at up to
30-fold the level of doxorubicin. Importantly, Annamycin has also
demonstrated a lack of cardiotoxicity in multiple human clinical
trials, including ongoing trials for the treatment of relapsed or
refractory acute myeloid leukemia (AML) and soft tissue sarcoma
(STS) lung metastases, and the Company believes that the use of
Annamycin may not face the same usage limitations imposed on
doxorubicin, one of the most common currently prescribed
anthracyclines. Annamycin is currently in development for the
treatment of AML and STS lung metastases and the Company believes
it may have the potential to treat a number of additional
indications.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the U.S. Food and Drug Administration for the
treatment of STS lung metastases, in addition to Orphan Drug
Designation for the treatment of relapsed or refractory acute
myeloid leukemia. For more information about the Phase 1b/2 study evaluating Annamycin for the treatment
of STS lung metastases, please visit clinicaltrials.gov and
reference identifier NCT04887298.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical
company focused on the development of a broad portfolio of drug
candidates for the treatment of highly resistant 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 release
include, without limitation, Moleculin's ability to commence the
clinical trial this quarter, to successfully recruit patients and
to potentially expand this trial to additional countries in
Europe. 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.
1 Zal T, Zielinski R, Grela K, Cardenas-Zuniga R,
Skora S, Fokt I, Zal A, Andreeff M, Gil L Shephard R, Priebe W,
High Efficacy of Liposomal Annamycin (L-ANN) in Combination with
Cytarabine in Syngeneic p53-Null AML Mouse Model, Blood (2020) 136
(Supplement 1): 6-7. https://doi.org/10.1182/blood-2020-143344
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.