Moleculin Bolsters Annamycin Intellectual Property Portfolio with Granting of Two New U.S. Patents
Moleculin Biotech (NASDAQ: MBRX) has secured two new U.S. patents for its novel drug candidate Annamycin, extending patent protection until June 2040. The patents cover methods of making liposomal Annamycin and its suspension. Annamycin is being developed as the first non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.
The drug has received Fast Track Status and Orphan Drug Designation from both FDA and EMA. The company is currently conducting its pivotal Phase 3 MIRACLE trial, with initial data expected in H2 2025. These new patents bring Moleculin's total to four U.S. patents for Annamycin, complementing its existing European patents.
Moleculin Biotech (NASDAQ: MBRX) ha ottenuto due nuovi brevetti statunitensi per il suo innovativo candidato farmaco Annamycin, estendendo la protezione brevettuale fino a giugno 2040. I brevetti riguardano i metodi di produzione dell'Annamycin liposomiale e della sua sospensione. Annamycin è sviluppato come il primo antraciclina non cardiotossica per il trattamento della leucemia mieloide acuta (AML) e delle metastasi polmonari da sarcoma dei tessuti molli.
Il farmaco ha ottenuto lo status di Fast Track e la designazione di farmaco orfano sia dalla FDA che dall'EMA. L'azienda sta attualmente conducendo il suo cruciale studio di Fase 3 MIRACLE, con i primi dati previsti nella seconda metà del 2025. Questi nuovi brevetti portano a quattro il totale dei brevetti statunitensi di Moleculin per Annamycin, in aggiunta ai brevetti europei già esistenti.
Moleculin Biotech (NASDAQ: MBRX) ha obtenido dos nuevas patentes en EE.UU. para su innovador candidato a fármaco Annamycin, extendiendo la protección hasta junio de 2040. Las patentes cubren métodos para fabricar Annamycin liposomal y su suspensión. Annamycin se está desarrollando como la primera antraciclina no cardiotóxica para tratar la leucemia mieloide aguda (LMA) y las metástasis pulmonares de sarcoma de tejidos blandos.
El medicamento ha recibido la designación Fast Track y de Medicamento Huérfano tanto de la FDA como de la EMA. La compañía está llevando a cabo actualmente su ensayo pivotal de Fase 3 MIRACLE, con datos iniciales esperados para la segunda mitad de 2025. Estas nuevas patentes elevan a cuatro el total de patentes estadounidenses para Annamycin de Moleculin, complementando sus patentes europeas existentes.
Moleculin Biotech (NASDAQ: MBRX)는 혁신적인 신약 후보물질 Annamycin에 대해 미국 특허 2건을 추가로 확보하여 특허 보호 기간을 2040년 6월까지 연장했습니다. 이번 특허는 리포좀 형태의 Annamycin 및 그 현탁액 제조 방법을 포함합니다. Annamycin은 급성 골수성 백혈병(AML) 및 연부 조직 육종 폐 전이 치료를 위한 최초의 비심장독성 안트라사이클린으로 개발 중입니다.
이 약물은 FDA와 EMA 양측에서 패스트 트랙 지위 및 희귀 의약품 지정을 받았습니다. 회사는 현재 중대한 3상 임상 시험인 MIRACLE을 진행 중이며, 초기 데이터는 2025년 하반기에 발표될 예정입니다. 이번 신규 특허로 Moleculin의 Annamycin 미국 특허 총수는 4건이 되었으며 기존의 유럽 특허도 보완합니다.
Moleculin Biotech (NASDAQ : MBRX) a obtenu deux nouveaux brevets américains pour son candidat-médicament innovant Annamycin, prolongeant la protection par brevet jusqu'en juin 2040. Les brevets couvrent les méthodes de fabrication de l'Annamycin liposomal et de sa suspension. Annamycin est développé comme la première anthracycline non cardiotoxique pour traiter la leucémie myéloïde aiguë (LMA) et les métastases pulmonaires des sarcomes des tissus mous.
Le médicament a reçu le statut Fast Track et la désignation de médicament orphelin de la part de la FDA et de l'EMA. La société mène actuellement son essai pivot de phase 3 MIRACLE, avec des données initiales attendues au second semestre 2025. Ces nouveaux brevets portent à quatre le nombre total de brevets américains pour Annamycin chez Moleculin, complétant ses brevets européens existants.
Moleculin Biotech (NASDAQ: MBRX) hat zwei neue US-Patente für seinen neuartigen Wirkstoffkandidaten Annamycin erhalten, wodurch der Patentschutz bis Juni 2040 verlängert wird. Die Patente umfassen Herstellungsverfahren für liposomales Annamycin und dessen Suspension. Annamycin wird als erstes nicht-kardiotoxisches Anthrazyklin zur Behandlung von akuter myeloischer Leukämie (AML) und Lungenmetastasen von Weichteilsarkomen entwickelt.
Das Medikament hat von FDA und EMA den Fast Track Status und die Orphan Drug Designation erhalten. Das Unternehmen führt derzeit die entscheidende Phase-3-Studie MIRACLE durch, wobei erste Daten für die zweite Hälfte des Jahres 2025 erwartet werden. Mit diesen neuen Patenten erhöht sich die Gesamtzahl der US-Patente für Annamycin bei Moleculin auf vier, zusätzlich zu den bereits bestehenden europäischen Patenten.
- Two new U.S. patents granted, extending protection until June 2040
- Drug has both FDA Fast Track Status and Orphan Drug Designation
- Phase 3 MIRACLE trial progressing with data expected in H2 2025
- Potential for broader application in various cancer types based on preclinical studies
- None.
Insights
Moleculin's two new patents strengthen Annamycin's market exclusivity through 2040, creating valuable IP protection for their novel cancer drug candidate.
The granting of two new U.S. patents (12,257,261 and 12,257,262) for Annamycin represents a significant strengthening of Moleculin's intellectual property position. These patents specifically cover manufacturing methods - one for preparing preliposomal Annamycin lyophilizate and another for reconstituting liposomal Annamycin suspension. With protection extending until June 2040, Moleculin has secured nearly 15 years of additional exclusivity for these production methods.
The company now holds four U.S. patents related to Annamycin, in addition to European patents, creating a robust global IP portfolio. For pharmaceutical companies, method-of-manufacturing patents are strategically valuable as they prevent competitors from using protected processes even after compound patents expire, effectively extending market exclusivity.
This patent timing aligns perfectly with Moleculin's clinical development timeline, as they're conducting their Phase 3 MIRACLE trial. The multi-layered patent strategy creates significant barriers to entry for potential competitors and maximizes the potential commercial runway if Annamycin receives regulatory approval. This IP expansion demonstrates proper foresight in protecting their novel lipid-based delivery technology, which is central to Annamycin's potential advantages.
Moleculin strengthens Annamycin's patent position through 2040 while advancing Phase 3 trials for a potentially cardiotoxicity-free cancer treatment.
Moleculin's Annamycin is being positioned as potentially the first anthracycline without cardiotoxicity - addressing a critical limitation of current anthracycline therapies that often cause dose-limiting heart damage. The company is currently conducting a pivotal Phase 3 MIRACLE trial with initial data expected in H2 2025, marking the final stage of clinical development before potential regulatory submission.
The drug candidate has accumulated significant regulatory advantages, including FDA Fast Track Status and Orphan Drug Designation for relapsed/refractory AML, additional Orphan designation for STS lung metastases, and European Orphan Drug Designation. These designations typically provide benefits including expedited review processes, reduced regulatory fees, and extended market exclusivity periods if approved.
Moleculin's novel approach uses a unique lipid-based delivery technology, which may contribute to its differentiated safety profile. The press release indicates preclinical studies at a world-renowned cancer center suggest potential applications beyond current indications, pointing toward pipeline expansion possibilities.
With these patent extensions securing protection through 2040 and a Phase 3 trial underway, Moleculin appears to be executing a comprehensive development strategy for Annamycin, though clinical trial success remains the critical upcoming milestone for the company.
Company continues to expand global IP coverage and claims to major markets, now extending to June 2040
HOUSTON, May 05, 2025 (GLOBE NEWSWIRE) -- 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 cancers and viruses, today announced the U.S. Patent and Trademark Office (USPTO) has granted two additional U.S. patents with claims covering Annamycin. U.S. patent number 12,257,261 titled, “Preparation of Preliposomal Annamycin Lyophilizate”, has claims covering methods of making liposomal Annamycin and U.S. patent 12,257,262 titled “Method of Reconstituting Liposomal Annamycin“, has claims covering methods of making liposomal Annamycin suspension. Both patents have a base patent term currently extending until June 2040, subject to adjustment for delays in prosecution and extension to account for time required to fulfill requirements for regulatory approval. Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.
Annamycin, Moleculin’s novel drug candidate, is being positioned to become the first anthracycline demonstrating a lack of cardiotoxicity 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 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.
Wally Klemp, Chairman and CEO of Moleculin, said, “We remain focused on expanding our intellectual property portfolio for Annamycin. Following the issuance of two U.S. patents in 2024, these new patents enhance the exclusivity of Annamycin, bringing to four the total number of U.S. patents related to Annamycin, in addition to the European patents granted. Based on the data seen to date and feedback we continue to receive from clinicians and patients, we are dedicated to advancing this important and much needed treatment option forward. We continue to make solid progress in our ongoing pivotal, adaptive Phase 3 MIRACLE trial and remain on track to report initial data in the second half of 2025.”
Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Discussions surrounding Annamycin’s lack of cardiotoxicity are based on the intent of its design, preclinical studies demonstrating a lack of cardiotoxicity as compared to currently prescribed anthracyclines and reports from clinical trial cardiac data as reviewed by an independent expert showing a lack of cardiotoxicity to date. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
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 release of the initial data in the MIRACLE trial. 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
FAQ
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