Patent, once issued, will provide composition
protection through 2040, with potential for additional
term extension
Annamycin is advancing towards pivotal AML
study in 2024 and may qualify for an accelerated approval
pathway
HOUSTON, May 9, 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 it has received
an Issue Notification from the United States Patent and Trademark
Office (USPTO) for U.S. Patent number 11,980,634 titled, "Method
of Reconstituting Liposomal Annamycin" (the '634 patent') to be
issued on May 14, 2024 to Moleculin
and The University of Texas System
Board of Regents.
When issued, the patent will provide claims to liposomal
Annamycin suspension compositions with a base patent term currently
extending until June 2040, subject to
extension to account for time required to fulfill regulatory
requirements for FDA approval. Moleculin's novel candidate for the
treatment of acute myeloid leukemia (AML) and soft tissue sarcoma
lung metastases (STS lung mets) uses a unique lipid-based delivery
technology. In addition to the expected '634 patent and recently
issued '118 patent, Moleculin has additional patent applications
related to Annamycin pending in the U.S. and in major jurisdictions
worldwide.
Walter Klemp, CEO and Chairman of
Moleculin, stated, "We remain committed to establishing a robust
patent estate for Annamycin and driving its development forward. In
addition to our recently announced composition of matter patent for
Annamycin, we believe we are well positioned for the potential
partnering discussions which we expect to have in the near future.
The issuance of this patent further underscores the importance and
proprietary nature of the innovation that makes this next
generation anthracycline possible and bolsters our confidence in
its potential to address a number of high-value indications where
there remains unmet medical need."
Annamycin is the Company's next-generation anthracycline that
has been designed to be non-cardiotoxic (unlike currently
prescribed anthracyclines) and has shown to be non-cardiotoxic in
the 82 subjects treated in multiple studies in the U.S. and in
Europe. Furthermore, Annamycin has
recently shown in Moleculin's European clinical study for the
treatment of AML using Annamycin in combination with Cytarabine
(MB-106) a preliminary 60% composite complete response (CRc) rate
in 2nd line subjects (N=10) and an overall interim CRc of 39% in
all subjects (N=18), regardless of the prior number of therapies,
in the European trial. Durability of the CRc's is developing. One
subject has surpassed the one-year mark with a durable complete
response. Recruitment in MB-106 has ended for 2nd line subjects
while recruitment for 1st line and 3rd line subjects continue.
Annamycin is currently in development for the treatment for AML and
STS lung mets, and the Company believes the drug may have the
potential to treat additional indications.
Disclosure
MD Anderson has an institutional conflict
of interest with Moleculin, and this relationship is managed
according to an MD Anderson Institutional Conflict of Interest
Management and Monitoring Plan.
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 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, the expected issuance of the
patent discussed above. 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.