On March 27, 2024 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, reported 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 (Press release, Moleculin, MAR 27, 2024, View Source [SID1234641508]).
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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.