Atossa Therapeutics Announces Issuance of U.S. Patent No. 12,275,684, Further Strengthening (Z)-endoxifen Portfolio
Atossa Therapeutics (NASDAQ: ATOS) has been granted a new U.S. Patent (No. 12,275,684) by the USPTO for enteric oral formulations of (Z)-endoxifen and related treatment methods. The patent specifically covers formulations and their use in treating hormone-dependent breast and reproductive tract disorders.
This development strengthens Atossa's intellectual property portfolio for its proprietary (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM). The company's patent estate now includes multiple U.S. patents with over 100 claims related to (Z)-endoxifen formulations and clinical applications, reinforcing their position in developing targeted therapies for hormone receptor-positive breast cancer.
Atossa Therapeutics (NASDAQ: ATOS) ha ottenuto un nuovo brevetto statunitense (n. 12.275.684) dall’USPTO per formulazioni orali enteriche di (Z)-endoxifen e i relativi metodi di trattamento. Il brevetto copre specificamente le formulazioni e il loro utilizzo nel trattamento di disturbi ormono-dipendenti del seno e dell’apparato riproduttivo.
Questo sviluppo rafforza il portafoglio di proprietà intellettuale di Atossa per il suo (Z)-endoxifen proprietario, un potente modulatore selettivo del recettore degli estrogeni (SERM). L’azienda ora detiene diversi brevetti statunitensi con oltre 100 rivendicazioni relative alle formulazioni di (Z)-endoxifen e alle applicazioni cliniche, consolidando la sua posizione nello sviluppo di terapie mirate per il cancro al seno con recettori ormonali positivi.
Atossa Therapeutics (NASDAQ: ATOS) ha recibido una nueva patente estadounidense (N.º 12,275,684) otorgada por la USPTO para formulaciones orales entéricas de (Z)-endoxifeno y métodos de tratamiento relacionados. La patente cubre específicamente las formulaciones y su uso en el tratamiento de trastornos hormonodependientes de mama y del tracto reproductivo.
Este avance fortalece la cartera de propiedad intelectual de Atossa para su (Z)-endoxifeno patentado, un potente modulador selectivo del receptor de estrógenos (SERM). La empresa ahora cuenta con múltiples patentes en EE.UU. con más de 100 reivindicaciones relacionadas con formulaciones de (Z)-endoxifeno y aplicaciones clínicas, reforzando su posición en el desarrollo de terapias dirigidas para el cáncer de mama con receptores hormonales positivos.
Atossa Therapeutics (NASDAQ: ATOS)는 USPTO로부터 (Z)-엔도키센 및 관련 치료 방법의 장용성 경구 제형에 대한 새로운 미국 특허(번호 12,275,684)를 받았습니다. 이 특허는 호르몬 의존성 유방 및 생식기 질환 치료에 사용되는 제형과 그 활용을 구체적으로 포함합니다.
이번 특허 획득은 강력한 선택적 에스트로겐 수용체 조절제(SERM)인 Atossa의 독점 (Z)-엔도키센 지적 재산권 포트폴리오를 강화합니다. 회사의 특허 자산에는 (Z)-엔도키센 제형 및 임상 적용과 관련된 100개 이상의 청구항을 포함한 여러 미국 특허가 포함되어 있어, 호르몬 수용체 양성 유방암을 위한 표적 치료제 개발에서 입지를 굳건히 하고 있습니다.
Atossa Therapeutics (NASDAQ : ATOS) s’est vu attribuer un nouveau brevet américain (n° 12 275 684) par l’USPTO pour des formulations orales entériques de (Z)-endoxifène et des méthodes de traitement associées. Le brevet couvre spécifiquement les formulations et leur utilisation dans le traitement des troubles hormonodépendants du sein et des voies reproductives.
Ce développement renforce le portefeuille de propriété intellectuelle d’Atossa pour son (Z)-endoxifène propriétaire, un modulateur sélectif des récepteurs aux œstrogènes (SERM) puissant. Le portefeuille de brevets de l’entreprise comprend désormais plusieurs brevets américains avec plus de 100 revendications liées aux formulations de (Z)-endoxifène et à leurs applications cliniques, consolidant ainsi leur position dans le développement de thérapies ciblées contre le cancer du sein hormono-dépendant.
Atossa Therapeutics (NASDAQ: ATOS) wurde von der USPTO ein neues US-Patent (Nr. 12.275.684) für enterische orale Formulierungen von (Z)-Endoxifen und zugehörige Behandlungsmethoden erteilt. Das Patent deckt speziell Formulierungen und deren Anwendung bei der Behandlung hormonabhängiger Brust- und Fortpflanzungsorganderkrankungen ab.
Diese Entwicklung stärkt Atossas geistiges Eigentumsportfolio für sein proprietäres (Z)-Endoxifen, einen potenten selektiven Estrogenrezeptor-Modulator (SERM). Das Patentportfolio des Unternehmens umfasst nun mehrere US-Patente mit über 100 Ansprüchen zu (Z)-Endoxifen-Formulierungen und klinischen Anwendungen, was ihre Position bei der Entwicklung zielgerichteter Therapien für hormonrezeptorpositiven Brustkrebs festigt.
- Secured new U.S. patent protection for (Z)-endoxifen formulations
- Patent portfolio expanded to over 100 claims related to (Z)-endoxifen
- Strengthened intellectual property protection for core breast cancer therapy
- None.
Insights
Patent strengthens Atossa's (Z)-endoxifen IP portfolio, potentially extending market exclusivity for their breast cancer treatment candidate.
The issuance of U.S. Patent No. 12,275,684 represents a strategic expansion of Atossa's intellectual property portfolio for (Z)-endoxifen, a Selective Estrogen Receptor Modulator (SERM). This patent specifically covers enteric oral formulations of (Z)-endoxifen and methods for treating hormone-dependent breast and reproductive tract disorders with these formulations.
The scope of this patent is particularly notable as it protects both the composition of matter (the enteric formulation itself) and the method of use (treatment applications). This dual protection approach is a common strategy in pharmaceutical patent portfolios to create multiple barriers around key assets.
As stated in the article, this patent joins Atossa's existing collection of "multiple U.S. patents, collectively encompassing over 100 claims related to (Z)-endoxifen formulations and their clinical applications." This layered approach to IP protection is standard practice for companies developing novel therapeutics.
In the pharmaceutical industry, formulation patents can extend market exclusivity beyond the original compound patents, potentially adding years of protection. For clinical-stage biopharmaceutical companies like Atossa, building a robust patent estate around lead candidates is essential for preserving future market opportunities if clinical development is successful.
New patent adds value to Atossa's intellectual property estate without changing near-term clinical timelines for their breast cancer program.
This patent issuance represents an incremental strengthening of Atossa's position in the (Z)-endoxifen development landscape. For a
The patent specifically covers enteric oral formulations and treatment methods for hormone-dependent breast and reproductive tract disorders. This aligns with Atossa's stated mission of "developing innovative medicines for breast cancer" as mentioned in the article.
CEO Steven Quay frames this development as "a significant milestone" that "reinforces our commitment to protecting our intellectual property." This language suggests the company views this patent as an important component of their overall strategy to address "persisting unmet medical needs in breast cancer treatment and prevention."
It's worth noting that while patent protection is valuable, Atossa remains a clinical-stage company, meaning commercial products and revenue are still contingent on successful clinical trials and regulatory approvals. The expanded patent portfolio does not accelerate this timeline but may enhance the commercial potential if development is successful.
This patent adds to what the company describes as a "robust patent estate" with "multiple U.S. patents" covering (Z)-endoxifen formulations and applications, suggesting a systematic approach to building comprehensive intellectual property protection around their lead candidate.
SEATTLE, April 22, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (U.S. Patent No. 12,275,684) directed to enteric oral formulations comprising (Z)-endoxifen as well as methods of treating subjects with those oral formulations.
This newly granted patent further fortifies Atossa’s intellectual property portfolio surrounding its proprietary (Z)-endoxifen formulations, encompassing novel compositions and methods related to (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM). Specifically, the patent covers enteric oral formulations of (Z)-endoxifen and salts thereof as well as their use in treating hormone-dependent breast and reproductive tract disorders.
“The issuance of U.S. Patent No. 12,275,684 marks a significant milestone in our mission to advance innovative treatments for breast cancer. This patent not only reinforces our commitment to protecting our intellectual property but also underscores our dedication to delivering effective therapeutic options to patients,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “We remain steadfast in our pursuit of scientific excellence and patient-centered solutions to address the persisting unmet medical needs in breast cancer treatment and prevention.”
Atossa's robust patent estate now includes multiple U.S. patents, collectively encompassing over 100 claims related to (Z)-endoxifen formulations and their clinical applications. This comprehensive and ongoing protection strategy bolsters the company's continued leadership in developing targeted therapies for hormone receptor-positive breast cancer.
About (Z)-Endoxifen
(Z)-endoxifen is one of the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and may cause estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.
Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in clinical studies of women with and without breast cancer. (Z)-endoxifen is currently being studied both for the treatment and prevention of breast cancer, including a program in metastatic breast cancer that was announced earlier this year.
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company’s lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit atossatherapeutics.com.
FORWARD LOOKING STATEMENTS
This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “design,” “predict,” “future,” or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company’s strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
Contact:
Michael Parks
VP, Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
FAQ
What is the significance of Atossa's new patent for (Z)-endoxifen?
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What type of drug is (Z)-endoxifen and how does it work?
