Annamycin exhibited robust antitumor activity
in experimental colorectal cancer liver and lung metastasis
models
Results support advancement of preclinical
development toward initiating clinical studies in metastatic
colorectal cancer patients
HOUSTON, April 8,
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
preclinical data of Annamycin tested in syngeneic models of
metastatic colorectal cancer established in lungs or liver was
accepted for poster presentation at the American Association for
Cancer Research (AACR) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana.
Details of the poster presentation are as follows:
Title: New approach to target metastatic colorectal
cancer organotropism with L-Annamycin
Track: Experimental and Molecular Therapeutics
Poster Number: 4048
Session: PO.ET06.05 - New Chemotherapy Agents
Presentation Type: E-Poster presentation
Session Date and Time: Wednesday,
April 13, 2022, from 9:00 am –
12:30 p.m. CDT
Section: 27
The objective of this study was to assess the efficacy of
Annamycin in experimental colorectal cancer liver and lung
metastasis models. The efficacy of Annamycin was tested in
syngeneic models of metastatic colorectal cancer established in
lungs or liver. For lung metastasis model, CT26-Luc cells were
injected intravenously (IV) into Balb/c mice, followed by weekly IV
treatment of Annamycin (4 and 6 mg/kg). The liver metastatic model
was established using intrasplenic injection protocol. Mice
received six weekly IV injections of 4 mg/kg of Annamycin or
vehicle. Bioluminescent imaging (BLI), Magnetic Resonance Imaging
(MRI) or Computer Tomography (CT) were used to track tumor
progression.
Annamycin exhibited robust antitumor activity in both models. In
the lung metastasis model, a dose-dependent delay in the tumor
progression was visualized by both BLI and CT scan in the Annamycin
treated group. The delay correlated with 272% extension of survival
in the group receiving 6 mg/kg Annamycin [median survival (MS) 79d
for treated vs 29d vehicle, p<0.0001] and 234% for the animals
dosed with Annamycin at 4 mg/kg [MS 68d, p=0.0012]. In the liver
metastasis model, all vehicle-treated mice showed massive tumors in
the liver and peritoneal cavity as monitored by BLI and MRI. In the
vehicle group, 13/14 died or were euthanized by 35d (median
survival was 34.5d). Yet, no tumors were detected by BLI or MRI in
Annamycin treated mice as of 44d and 0/14 mice died (100%
survival). This indicates a highly significant (P< 0.0001)
extension of survival (ongoing experiment).
"We continue to be encouraged by the growing body of robust
preclinical and human clinical data demonstrated by Annamycin. The
positive results seen in these preclinical models provide added
confidence in the potential follow-on development opportunities we
believe Annamycin holds. While metastatic colorectal cancer is not
an immediate area of focus for us, this data set continues to
provide valuable insight as we advance its clinical development for
the treatment of highly resistant tumors," commented Walter Klemp, Chairman and CEO of Moleculin.
In summary, the strategy to develop anticancer agents that
imitate metastatic colorectal cancer organotropism appears to be
highly promising and is supported by these results. This study
demonstrating efficacy of Annamycin in colorectal cancer models
provides convincing evidence for further preclinical development
aimed at initiation of clinical studies in metastatic colorectal
cancer patients.
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. 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 (FDA) 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 press
release include, without limitation, whether the results described
in the poster will be shown in follow on preclinical and clinical
development and whether the Company will be able to develop
Annamycin to treat additional indications . 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.