Patent, once issued, will provide composition
of matter protection through 2040, with potential for additional
term extension
Next-generation anthracycline uses unique
lipid-based delivery technology to bring hope to the estimated 58%
of AML patients for whom no approved
therapy exists
HOUSTON, March 27, 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 11,951,118 titled, "Preparation of Preliposomal
Annamycin Lyophilizate" (the '118 patent') to be issued on
April 9, 2024 to Moleculin and The
University of Texas System Board of
Regents.
When issued, the patent will provide claims to compositions that
contain Annamycin with a base patent term 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 '118 patent, Moleculin has
additional patent applications pending in the U.S. and in major
jurisdictions worldwide.
Walter Klemp, CEO and Chairman of
Moleculin, stated, "We believe this critical milestone is very well
timed, as it removes a major risk element in the overall assessment
of the potential asset value for Annamycin just in time for the
potential partnering discussions which we expect to have in the
near future. Especially in light of our recent announcement
that Annamycin has delivered a 60% CRc (complete response
composite) rate in 2nd line AML subjects, outperforming
the pivotal trial CRc rate of every other drug approved in this
2nd line space by a wide margin. Issuance of this patent
underscores the importance and proprietary nature of the innovation
that makes this next generation anthracycline possible."
Annamycin is Moleculin's next-generation anthracycline,
initially expected to fulfill a significant unmet need for the
2nd line treatment of relapsed or refractory AML
patients. For a description of the magnitude of this opportunity,
please see the Company's video at this link. As described in the
Company's latest corporate update, Annamycin's recent performance
in a Phase 1B/2 clinical trial
produced patient response data multiple times greater than the
response rates used for the approval of all existing AML drugs
approved for 2nd line treatment. Servier acquired two
2nd line AML drugs with lower pivotal clinical trial
performance data with a valuation in excess of $1.8 billion.
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, the pace of enrollment in Moleculin's
clinical trials, the timing of Moleculin's ability to report
topline data from its studies, the timing of the commencement of
investigator-sponsored and/or externally funded clinical trials
which are outside the control of Moleculin, and whether the results
of Moleculin's preclinical animal models can be replicated in human
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
(833) 475-8247
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.