Moleculin Receives Notice of Intent to Grant New European Patent for Annamycin
Moleculin Biotech (Nasdaq: MBRX) has received a Notice of Intent to Grant for a European patent application for its drug candidate Annamycin (naxtarubicin). The patent, extending until 2040, covers methods of making preliposomal Annamycin lyophilizate with improved stability and high purity.
Annamycin is positioned to become 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, utilizing a unique lipid-based delivery technology with potential applications across various cancer types.
Moleculin Biotech (Nasdaq: MBRX) ha ricevuto un Avviso di Intenzione di Concessione per una domanda di brevetto europea relativa al suo candidato farmaco Annamycin (naxtarubicina). Il brevetto, che sar脿 valido fino al 2040, riguarda i metodi di produzione del liofilizzato pre-liposomiale di Annamycin con stabilit脿 migliorata e alta purezza.
Annamycin 猫 destinato a diventare 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 Fast Track e la Designazione di Farmaco Orfano sia dalla FDA che dall'EMA, sfruttando una tecnologia unica di somministrazione basata su lipidi, con potenziali applicazioni in diversi tipi di tumore.
Moleculin Biotech (Nasdaq: MBRX) ha recibido un Aviso de Intenci贸n de Concesi贸n para una solicitud de patente europea de su candidato a medicamento Annamycin (naxtarubicina). La patente, que se extender谩 hasta 2040, cubre m茅todos para fabricar liofilizado pre-liposomal de Annamycin con mayor estabilidad y alta pureza.
Annamycin est谩 destinado a convertirse en la primera antraciclina no cardiot贸xica para el tratamiento de la leucemia mieloide aguda (LMA) y las met谩stasis pulmonares de sarcoma de tejidos blandos. El medicamento ha recibido estatus de v铆a r谩pida y designaci贸n de medicamento hu茅rfano tanto de la FDA como de la EMA, utilizando una tecnolog铆a 煤nica de administraci贸n basada en l铆pidos con aplicaciones potenciales en varios tipos de c谩ncer.
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Annamycin鞚� 旮夓劚 瓿垬靹� 氚表槇氤�(AML)瓿� 鞐半秬 臁办 鞙§ 韽� 鞝勳澊毳� 旃橂頃橁赴 鞙勴暅 觳� 氩堨Ц 牍勳嫭鞛ル弲靹� 鞎堩姼霛检偓鞚错伌毽�鞙茧 鞛愲Μ毵り箑頃� 鞓堨爼鞛呺媹雼�. 鞚� 鞎诫鞚� FDA鞕� EMA 氇憪搿滊秬韯� 韺姢韸� 韸鸽灆 歆�鞙� 氚� 頋穩 鞚橃暯頀� 歆�鞝�鞚� 氚涭晿鞙茧┌, 霃呿姽頃� 歆�歆� 旮半皹 鞝勲嫭 旮办垹鞚� 頇滌毄頃橃棳 雼れ枒頃� 鞎� 鞙犿槙鞐� 鞝侅毄霅� 臧�電レ劚鞚� 鞛堨姷雼堧嫟.
Moleculin Biotech (Nasdaq : MBRX) a re莽u un avis d'intention d'octroi pour une demande de brevet europ茅enne concernant son candidat m茅dicament Annamycin (naxtarubicine). Le brevet, valable jusqu'en 2040, couvre les m茅thodes de fabrication du lyophilisat pr茅-liposomal d'Annamycin avec une stabilit茅 am茅lior茅e et une haute puret茅.
Annamycin est destin茅 脿 devenir le premier anthracycline non cardiotoxique pour le traitement de la leuc茅mie my茅lo茂de aigu毛 (LMA) et des m茅tastases pulmonaires de sarcome des tissus mous. Le m茅dicament a obtenu le statut de proc茅dure acc茅l茅r茅e et la d茅signation de m茅dicament orphelin aupr猫s de la FDA et de l'EMA, utilisant une technologie unique de d茅livrance lipidique avec des applications potentielles dans divers types de cancers.
Moleculin Biotech (Nasdaq: MBRX) hat eine Absichtserkl盲rung zur Erteilung eines europ盲ischen Patents f眉r seinen Arzneimittelkandidaten Annamycin (Naxtarubicin) erhalten. Das Patent, das bis 2040 gilt, umfasst Verfahren zur Herstellung von pre-liposomalen Annamycin-Lyophilisaten mit verbesserter Stabilit盲t und hoher Reinheit.
Annamycin soll der erste nicht-kardiotoxische Anthrazyklin zur Behandlung von akuter myeloischer Leuk盲mie (AML) und Lungenmetastasen von Weichteilsarkomen werden. Das Medikament hat sowohl von der FDA als auch von der EMA den Fast Track-Status und die Orphan-Drug-Zulassung erhalten und nutzt eine einzigartige lipidbasierte Verabreichungstechnologie mit potenziellen Anwendungen bei verschiedenen Krebsarten.
- Patent protection in Europe extends until 2040, strengthening market exclusivity
- Drug candidate positioned to be first-ever non-cardiotoxic anthracycline
- Fast Track Status and Orphan Drug Designation from both FDA and EMA
- Novel lipid-based delivery technology with potential for multiple cancer applications
- Patent grant still subject to final fees and amendments
- Drug not yet approved by regulatory authorities
Insights
Moleculin secures European patent protection for Annamycin until 2040, strengthening its position in cancer therapeutics with potentially first non-cardiotoxic anthracycline.
This European patent notice represents a significant intellectual property milestone for Moleculin's Annamycin (naxtarubicin) program. The patent specifically covers their preliposomal lyophilizate formulation technology, which solves crucial stability and purity challenges common in liposomal drug delivery systems. With protection extending into 2040 (potentially longer with regulatory extensions), this patent substantially strengthens Moleculin's market exclusivity position in Europe.
The patented formulation technology addresses two critical pharmaceutical development hurdles: stability and manufacturing scalability. The preliposomal approach allows for a shelf-stable precursor that converts to the active liposomal form when needed, overcoming the notorious stability limitations of conventional liposomal formulations. This technological advantage creates a dual commercial moat - both for Annamycin specifically and potentially as a platform technology for other lipophilic oncology drugs.
This patent complements Moleculin's regulatory advantages, including Fast Track Status and Orphan Drug Designations from both FDA and EMA. These designations provide additional market exclusivity beyond the patent life and potential accelerated approval pathways. The company's strategic patent estate now spans major pharmaceutical markets including the US, Europe, China, and India - covering both composition and manufacturing methods. This comprehensive approach to intellectual property protection maximizes the commercial potential for Annamycin in both acute myeloid leukemia and soft tissue sarcoma lung metastases indications.
Moleculin's patent strengthens its position in developing what could be the first non-cardiotoxic anthracycline, potentially transforming cancer treatment standards.
Anthracyclines represent one of the most potent classes of chemotherapy, but their clinical utility has been severely limited by cumulative, dose-dependent cardiotoxicity that can lead to heart failure. If Annamycin (naxtarubicin) successfully maintains efficacy while eliminating this cardiotoxicity, it would represent a paradigm shift in cancer treatment, particularly for acute myeloid leukemia (AML) where anthracyclines are backbone therapies.
The patented preliposomal formulation technology addresses a fundamental challenge in anthracycline development. Traditional anthracyclines like doxorubicin cause cardiotoxicity partly because they distribute broadly throughout the body, including heart tissue. Moleculin's lipid-based delivery system appears designed to alter this biodistribution profile, potentially achieving preferential tumor accumulation while sparing cardiac tissue.
Moleculin's development strategy targeting both AML and soft tissue sarcoma lung metastases is clinically sound. Both indications have significant unmet needs and represent logical applications for an anthracycline with improved safety. The dual-indication approach also diversifies clinical development risk. The company's reference to preclinical studies at a "world-renowned cancer center" suggesting broader applications implies the potential for label expansion into additional cancer types.
The regulatory designations - Fast Track and Orphan Drug status from both FDA and EMA - provide significant advantages beyond market exclusivity. These designations enable enhanced regulatory interactions, potential for accelerated approval pathways, and reduced development costs. Combined with the patent protection, Moleculin has constructed a comprehensive strategy to maximize Annamycin's potential to reach patients with difficult-to-treat cancers.
鈥� New patent enhances market position in Europe
HOUSTON, July 30, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (鈥淢oleculin鈥� or the 鈥淐ompany鈥�), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has received a Notice of Intent to Grant for the European patent application titled, 鈥�PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE.鈥� Such grant should solidify the Company鈥檚 European Union exclusivity of Annamycin, also known by its non-proprietary name of naxtarubicin, with the potential to become the first non-cardiotoxic anthracycline.
The grant is subject to payment of fees and completion of final amendments and formalities. When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending until into 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin鈥檚 novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline 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. In addition to the newly expected European patent and previously issued U.S. patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.
Walter Klemp, Chairman and CEO of Moleculin, said, 鈥淥ur preliposomal formulation for Annamycin not only improves the stability and usability of Annamycin, but also creates a scalable platform that has the potential to be a catalyst for how lipophilic oncology drugs are delivered. We are pleased to add this newly granted European patent to our global intellectual property portfolio and believe it provides further validation of Annamycin鈥檚 potential. The current patent portfolio includes patents and patent applications with claims to methods of making our preliposomal Annamycin and liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers in the US, Europe, China, and India, among others. We remain committed to fortifying our global patent protection for Annamycin and advancing the development of this potentially transformative therapeutic candidate for hard-to-treat tumors.锟斤拷
Annamycin (naxtarubicin), 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 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鈥檚 lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. 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 has begun 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 remains 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 and connect on , and .
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 on the first 45 subjects in the trial and the Company鈥檚 ability to reconcile the US and EU protocols with the FDA and EMA, respectively. 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鈥檚 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 鈥榖elieves,鈥� 鈥榚stimates,鈥� 鈥榓nticipates,鈥� 鈥榚xpects,鈥� 鈥榩lans,鈥� 鈥榩rojects,鈥� 鈥榠ntends,鈥� 鈥榩otential,鈥� 鈥榤ay,鈥� 鈥榗ould,鈥� 鈥榤ight,鈥� 鈥榳ill,鈥� 鈥榮hould,鈥� 鈥榓pproximately鈥� 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. 鈥淩isk Factors鈥� 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
FAQ
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