Data recently presented at the International
Association for the Study of Lung Cancer (IASLC) 2024 World
Conference on Lung Cancer
Treatment with Annamycin results in
statistically significant inhibition of tumor growth and extension
of survival in orthotopic lung cancer models
Annamycin continues to be 100%
non-cardiotoxic
HOUSTON, Sept. 23,
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
recent presentation of positive in vivo efficacy data of
Annamycin in orthotopic and experimental lung metastatic models of
sarcoma.
The poster titled "Annamycin: Opening New Doors for
Organotropic Targeting of Primary and Metastatic Lung
Cancer," authored by Waldemar
Priebe, PhD (Founder, Founding Scientist, and Chair of
Scientific Advisory Board for Moleculin) and coworkers was recently
presented at the IASLC 2024 World Conference on Lung Cancer. The
presented poster outlined results from the efficacy assessment
studies of Annamycin, Moleculin's next-generation anthracycline in
orthotopic models of lung cancer and sarcoma lung metastasis models
in comparison with doxorubicin (a commonly prescribed
anthracycline).
"Annamycin continues to exhibit consistent activity against
different type of cancers including therapy resistant cancers such
as soft tissue sarcoma lung metastases while also avoiding
cardiotoxicity, which continues to be a significant side effect
limiting the clinical use of anthracyclines. Importantly, the
presented data demonstrates that treatment with Annamycin results
in statistically significant inhibition of tumor growth and
extension of survival in orthotopic lung cancer models, which is
consistent with the preliminary results we are seeing in our
sarcoma clinical trials. This further underscores Annamycin's
potential to provide a much-needed treatment option for patients
with primary or metastatic lung cancers, as a single agent and in
combination with currently used therapeutics. Combined with the
encouraging growing body of clinical data from our ongoing studies,
we remain confident in Annamycin's potential to address significant
unmet needs in a wide range of cancers," commented Walter Klemp, Chairman and Chief Executive
Officer of Moleculin.
Key Highlights
- Annamycin demonstrated high uptake and retention in lung
parenchyma of mice and rats.
- The therapeutic effects of doxorubicin (DOX) are diminished due
to low lung DOX uptake as demonstrated in the tested in vivo
models. In contrast, Annamycin exhibits consistent efficacy in
vivo in orthotopic and experimental lung metastatic models of
sarcoma, breast, and colon cancer. This correlated with high
Annamycin concentration in lungs, which exceeded DOX levels by 10-
to 30-fold.
- Preclinical tests clearly demonstrate a better cardiac safety
profile of Annamycin when compared to DOX and no cardiotoxicity of
Annamycin in the in vivo models. No cardiotoxicity of
Annamycin has been noted in ongoing clinical studies.
- The observed organotropic properties of Annamycin, its efficacy
in vivo, and its promising safety profile warrant further
translational studies to evaluate Annamycin in patients with
primary or metastatic lung cancers, as a single agent and in
combination with currently used therapeutics.
Annamycin is currently being evaluated in ongoing clinical
trials for the treatment of relapsed or refractory acute myeloid
leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the FDA 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).
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage
pharmaceutical company advancing a pipeline of therapeutic
candidates addressing 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 relapsed or refractory acute myeloid leukemia (AML)
and soft tissue sarcoma (STS) lung metastases.
The Company is initiating the MIRACLE (Moleculin
R/R AML AnnAraC Clinical Evaluation)
Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating
Annamycin in combination with cytarabine, together referred to as
AnnAraC, for the treatment of relapsed or refractory acute myeloid
leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the
Company believes it has substantially de-risked the development
pathway towards a potential approval for Annamycin for the
treatment of AML. This study is subject to appropriate future
filings with potential additional feedback from the FDA and their
foreign equivalents.
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 pathogenic viruses, as well as certain cancer
indications.
For more information about the Company, please visit
www.moleculin.com and connect on X, 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, whether the results shown in
the animal models can be replicated in clinical trials.
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
(908) 824-0775
MBRX@jtcir.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/moleculin-announces-positive-in-vivo-efficacy-data-of-annamycin-in-orthotopic-and-experimental-lung-metastatic-models-of-sarcoma-302254901.html
SOURCE Moleculin Biotech, Inc.