New patents will extend coverage to major
markets outside the U.S., expanding upon existing U.S.
claims
Affirms expectations for an initial data
readout of the phase 3 MIRACLE trial for the second half of
2025
HOUSTON, March 6,
2025 /PRNewswire/ -- Moleculin Biotech,
Inc., (Nasdaq: MBRX) (Moleculin or the Company), a
late-stage pharmaceutical company with a broad portfolio of drug
candidates targeting hard-to-treat tumors and viruses, today
announced it has received a Notice of Intent to Grant for the
European patent application titled, "Method of Reconstituting
Liposomal Annamycin". The grant is subject to payment of fees
and completion of final amendments and formalities. Such grant will
enhance the global exclusivity of Annamycin with the potential to
be a next generation, non-cardiotoxic treatment for certain
cancers.
When issued, the patent claims will cover methods of making
liposomal Annamycin suspension as well as the resulting
compositions for use in the treatment of cancers, with a base
patent term currently extending until June
2040, subject to extension to account for time required to
fulfill requirements for regulatory approval. Moleculin's novel
drug candidate is being positioned to become the first ever
non-cardiotoxic anthracycline to be approved and is currently being
developed for the treatment of acute myeloid leukemia (AML) and
soft tissue sarcoma lung metastases (STS lung mets). Additional
preclinical studies performed at a world-renowned cancer center
indicate Annamycin may be a potential treatment for many more other
types of cancers. The new chemical entity uses a unique lipid-based
delivery technology and has shown the potential to be used in a
wide range of cancers. In addition to the expected European patent
and previously issued U.S. patents, Moleculin has additional patent
applications related to Annamycin pending in the U.S., Europe and in major jurisdictions
worldwide.
Wally Klemp, Chairman and CEO of
Moleculin, said "Acknowledgment by the European Patent Office of
the innovation underlying Annamycin is an important milestone for
Moleculin, underscoring the importance and proprietary nature of
the innovation that makes this next generation anthracycline
possible. We expect Europe
to be an important market for Annamycin and look forward to making
an important new treatment available to patients in this region.
This enhancing of our exclusivity for Annamycin is exciting when
coupled with our continued expectation for an initial data readout
for the MIRACLE trial in the second half of 2025."
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, the timing of the achievements
of each of the milestones in this press release. Moleculin will
require significant additional financing, for which the Company has
no commitments, in order to conduct its clinical trials as
described in this press release, and the milestones described in
this press release assume the Company's ability to secure such
financing 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
(908) 824-0775
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.
