Moleculin Announces U.S. Patent Issue Notification for Lipid-Based Delivery Technology for Annamycin

Rhea-AI Summary

Moleculin Biotech, Inc. announced the receipt of a U.S. Patent for Lipid-Based Delivery Technology for Annamycin, extending through 2040 with potential for further extensions. The drug Annamycin is moving towards a pivotal AML study in 2024, possibly qualifying for accelerated approval. The Company aims to establish a strong patent estate for Annamycin and drive its development forward, with promising results in clinical trials.

Positive

• The issuance of the U.S. Patent for Lipid-Based Delivery Technology for Annamycin provides composition protection until 2040, with the potential for extension, enhancing the Company's intellectual property portfolio.

• Annamycin, the next-generation anthracycline developed by Moleculin, has demonstrated promising results in clinical studies, showing non-cardiotoxic properties and high response rates in AML patients, indicating potential for effective treatment.

• The Company's commitment to advancing the development of Annamycin and its potential for treating various indications highlights a strong focus on innovation and addressing unmet medical needs in the field of oncology.

Negative

• None.

Insights

Pharmaceutical Patent Expert

The notification of patent issuance for Moleculin's lipid-based delivery technology signifies a substantial reinforcement of the company's intellectual property portfolio. A patent term extending potentially through 2040, with room for extensions, provides a solid competitive moat, given the high barriers to entry in pharmaceuticals due to the complexity of drug development and associated regulatory hurdles. From a retail investor's perspective, extended patent protection not only secures exclusivity on the market for a longer period but also enhances the appeal of Moleculin for potential partnerships, especially those with larger firms looking to expand their oncology pipelines with innovative, non-cardiotoxic treatments. However, the true value of the patent will be realized only if Annamycin successfully advances through pivotal studies and gains FDA approval. This is a non-trivial risk, as clinical trials have inherent uncertainties and regulatory pathways can be complex and challenging.

Biotech Market Analyst

Looking at the broader implications of the announcement, the data indicating a 60% composite complete response rate in second-line subjects treated with Annamycin, in combination with Cytarabine, is noteworthy. In the highly competitive biotech industry, where many players vie for a slice of the oncology market, such promising results can be a game-changer, potentially impacting Moleculin's market capitalization and investor sentiment positively. However, the reported response rates must be viewed cautiously as they are interim and pertain to a small sample size; thus, they may not be indicative of larger population outcomes. Furthermore, it's essential to consider the operational and financial implications of ongoing clinical trials, such as the cost of R&D and the time to market, which could strain resources if prolonged. Nonetheless, Annamycin's progress and its designation as non-cardiotoxic in multiple studies underscore its differentiation in the anthracycline drug class and may drive speculative interest in Moleculin's stock.

Clinical Development Analyst

The advancement of Annamycin towards a pivotal AML study and its potential for accelerated approval could significantly shorten the time-to-market, a critical factor for biotech companies. The designation of Annamycin as non-cardiotoxic is notable, as it addresses a substantial unmet medical need in the treatment of AML and STS lung metastases. If long-term efficacy and safety are confirmed in larger clinical studies, Annamycin could be a disruptive force in the oncology space. Investors should monitor enrollment rates and the progress of ongoing studies for Annamycin, as these will provide further clues about the drug's likelihood of regulatory success and commercial viability. Tailwinds such as positive study results or favorable regulatory designations could provide momentum for the stock, while headwinds could include any clinical setbacks or regulatory challenges.

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.

FAQ

What is the title of the U.S. Patent issued to Moleculin related to Annamycin?

The U.S. Patent issued to Moleculin is titled 'Method of Reconstituting Liposomal Annamycin.'

What is the base patent term for the U.S. Patent related to Annamycin?

The base patent term for the U.S. Patent related to Annamycin currently extends until June 2040, with the potential for extension.

What are the key properties of Annamycin developed by Moleculin for AML treatment?

Annamycin has shown non-cardiotoxic properties and high response rates in AML patients, indicating its potential for effective treatment.

What are the recent clinical trial results for Annamycin in Europe for AML treatment?

Annamycin in combination with Cytarabine showed a preliminary 60% composite complete response rate in 2nd line subjects and an overall interim CRc of 39% in all subjects in the European trial, with developing durability in complete responses.

What is the current status of Annamycin's development for AML and STS lung mets?

Annamycin is currently in development for the treatment of AML and STS lung mets, with ongoing recruitment for 1st line and 3rd line subjects.