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July 29, 2025

2025年7月29日

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Atossa Therapeutics, Inc.

阿托萨治疗公司

(NASDAQ:

（纳斯达克：

ATOS

阿托斯

), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, today announced positive written feedback from the U.S. Food and Drug Administration (FDA) regarding the company's proposed dose optimization trial of (Z)-endoxifen for the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer..

），一家处于临床阶段的生物制药公司，专注于开发肿瘤学领域的创新药物，今日宣布已收到来自美国食品药品监督管理局（FDA）的积极书面反馈，内容涉及公司提出的关于使用(Z)-endoxifen治疗雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）的转移性乳腺癌的剂量优化试验。

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The FDA has provided highly constructive responses ahead of the scheduled pre-Investigational New Drug (IND) meeting, affirming key elements of Atossa's clinical development plan, negating the need for a virtual meeting, and paving the way for a potential IND submission targeted for the fourth quarter of 2025..

美国食品药品监督管理局（FDA）在计划召开的临床试验新药（IND）前会议之前提供了极具建设性的反馈，确认了Atossa临床开发计划中的关键要素，无需召开虚拟会议，为预计在2025年第四季度提交的IND申请铺平了道路。

With the FDA's feedback, Atossa is energized and moving quickly to advance (Z)-endoxifen in metastatic breast cancer.

在FDA的反馈下，Atossa备受鼓舞，正迅速推进(Z)-endoxifen在转移性乳腺癌中的应用。

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'These FDA responses mark a significant milestone for the Company and are supportive of our comprehensive approach to developing (Z)-endoxifen for metastatic breast cancer,' stated Dr.

“这些FDA的回应标志着公司的一个重要里程碑，并且支持我们开发（Z）-恩多昔芬用于转移性乳腺癌的全面方法，”博士表示。

Steven Quay

史蒂文·奎

, Atossa's Chief Executive Officer and Chairman of the Board. 'The detailed feedback received significantly advances our goal of submitting an IND by year-end. Importantly, the FDA's support of our dose optimization strategy and general agreement with our nonclinical data package leave us confident in our scientific rationale and overall regulatory approach.'.

，阿托萨的首席执行官兼董事会主席。“收到的详细反馈大大推进了我们年底前提交新药临床试验申请的目标。重要的是，FDA对我们剂量优化策略的支持以及对我们非临床数据包的总体认同，使我们对我们的科学依据和整体监管方法充满信心。”

Key Highlights:

关键亮点：

Dose Optimization Strategy Affirmed:

剂量优化策略确认：

FDA agreed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the proposed dose optimization study and provided clear guidance on randomization cohort sizes and study design enhancements.

FDA同意现有的临床和非临床数据足以启动拟议剂量优化研究的A部分（单药治疗），并就随机化队列规模和研究设计改进提供了明确指导。

Combination Study Support:

组合研究支持：

The Agency agreed with the scientific rationale for combining (Z)-endoxifen with approved breast cancer standard-of-care therapies, such as some CDK4/6 inhibitors, PI3K inhibitors, mTOR inhibitors, and capecitabine. While not all combinations will be investigated in this study, FDA guidance on the matter is helpful in narrowing the strategic approach for the potential IND..

该机构同意将 (Z)-endoxifen 与已批准的乳腺癌标准治疗方案（如某些 CDK4/6 抑制剂、PI3K 抑制剂、mTOR 抑制剂和卡培他滨）结合使用的科学依据。尽管并非所有组合都会在本研究中进行调查，但 FDA 对此问题的指导有助于缩小潜在 IND 的战略方法范围。

Nonclinical Data Package Deemed Adequate:

非临床数据包被认为足够：

FDA indicated the existing nonclinical safety data package is adequate to proceed without additional general toxicity or neurotoxicity studies.

FDA表示，现有的非临床安全性数据包足以继续进行，无需额外的一般毒性或神经毒性研究。

Agreement on Cardiac Safety Assessments for Monotherapy:

关于单药治疗心脏安全性评估的协议：

FDA confirmed Atossa's cardiac safety assessment plan, including serial electrocardiograms (ECGs) and QT interval monitoring, is sufficient for the monotherapy portion of the trial.

FDA确认，Atossa的心脏安全性评估计划（包括连续心电图（ECGs）和QT间期监测）对于试验的单药治疗部分是足够的。

Next steps:

下一步：

In the coming weeks, Atossa will announce plans for the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study. The Agency acknowledged the Company's plan to file an IND in 2025 and encouraged Atossa to incorporate specific safety and eligibility refinements in the final protocol, which the Company has accepted..

未来数周，Atossa 将宣布计划中的目标患者群体、联合治疗基础方案以及即将开展的剂量范围研究的整体试验设计。药管局已认可该公司在 2025 年提交新药临床试验申请 (IND) 的计划，并鼓励 Atossa 在最终方案中纳入特定的安全性和资格标准改进，公司已接受此建议。

Dr. Quay continued, 'With the FDA's feedback now in hand, Atossa is energized and moving quickly. We believe the company is well positioned to maintain strategic momentum and meet regulatory milestones, bringing us closer to delivering (Z)-endoxifen to patients in need and driving shareholder value.

奎博士继续说道：“在获得FDA的反馈后，Atossa公司充满活力并迅速行动。我们相信公司有能力保持战略势头并达成监管里程碑，这将使我们更接近于向有需要的患者提供（Z）-恩多西芬，并提升股东价值。”

Further updates will be provided as the trial design is finalized, and next steps are implemented.'.

随着试验设计的最终确定和下一步的实施，将会提供进一步的更新。

Atossa's progress reflects the strong strategic momentum promised in the

阿托萨的进步反映了其承诺的强大战略动力

March 11, 2025

2025年3月11日

announcement of a metastatic focus; momentum that aligns well with FDA expectations and regulatory standards, including fulfilling Project Optimus requirements, a crucial next step in advancing (Z)-endoxifen toward potential approval.

转移性病灶的公告；与FDA期望和监管标准非常一致的势头，包括满足Project Optimus要求，这是推进(Z)-endoxifen走向潜在批准的关键下一步。

The FDA's Project Optimus initiative emphasizes data-driven dose exploration to maximize benefit and minimize toxicity. In line with this guidance, Atossa will explore multiple dose levels in its upcoming clinical study to define the optimal dose for combination therapy, while seeking to maintain a balance between efficacy and patient safety..

FDA的Project Optimus计划强调以数据驱动的剂量探索，以最大化效益并最小化毒性。根据这一指导，Atossa将在其即将进行的临床研究中探索多种剂量水平，以确定组合疗法的最佳剂量，同时力求在疗效和患者安全之间保持平衡。

About (Z)-Endoxifen

关于(Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels.

(Z)-endoxifen 是一种高效的选择性雌激素受体调节剂 (SERM)，具有抑制甚至可能降解雌激素受体的能力。即使在对其他内分泌治疗产生耐药性的肿瘤中，它也显示出活性。除了其抗雌激素特性外，(Z)-endoxifen 还能在临床可达到的血药浓度下靶向致癌信号蛋白蛋白激酶 C β1 (PKCβ1)。

Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen..

重要的是，（Z）-endoxifen似乎相对于他莫昔芬具有相当或更优的骨保护效果。

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. This innovation ensures optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer.

阿托萨正在开发一种专有的（Z）-恩多昔芬口服制剂，该制剂采用肠溶包衣以避开胃酸，否则胃酸会将活性的（Z）-异构体转化为其非活性的（E）-形式。这一创新确保了最佳的生物利用度和治疗完整性。临床研究表明，阿托萨的（Z）-恩多昔芬在健康女性和乳腺癌患者中均具有良好的耐受性。

In over 700 subjects (healthy volunteers and breast cancer patients), doses up to 360 mg/day have been administered with no maximum tolerated dose (MTD) identified, supporting continued dose-ranging exploration..

在超过700名受试者（健康志愿者和乳腺癌患者）中，已给予高达360毫克/天的剂量，未确定最大耐受剂量 (MTD)，支持继续进行剂量范围探索。

Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer.

阿托萨公司优先开发（Z）-恩多昔芬用于治疗转移性乳腺癌，该领域急需新的治疗选择。该化合物目前正在进行三项二期试验：一项针对导管原位癌（DCIS）的女性患者，另外两项针对雌激素受体阳性/人表皮生长因子受体2阴性（ER+/HER2-）乳腺癌的女性患者。

Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide..

阿托萨的（Z）-恩多昔芬项目得到了不断增长的全球知识产权组合的支持，包括三项最近颁发的美国专利和全球众多正在申请的专利。

About Atossa Therapeutics

关于阿托萨治疗公司

Atossa Therapeutics, Inc. (Nasdaq:

阿托萨治疗公司 (纳斯达克:

ATOS

阿托斯

) 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.

）是一家临床阶段的生物制药公司，致力于通过创新科学和以患者为中心的解决方案变革乳腺癌治疗。该公司的主要候选产品（Z）-恩多昔芬是一种高效的选择性雌激素受体调节剂（SERM），旨在用于乳腺癌的各个领域，包括预防、新辅助治疗、辅助治疗和转移性治疗。

Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit .

Atossa致力于推进其强大的临床研究项目，以改善患者预后，同时为股东创造可持续的价值。欲了解更多信息，请访问。

atossatherapeutics.com

阿托萨治疗学公司

.

。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含某些可能构成1995年《私人证券诉讼改革法案》意义下的前瞻性陈述的信息。我们可能会通过使用诸如“预期”、“潜力”、“继续”、“可能”、“将”、“应该”、“可以”、“会”、“寻求”、“打算”、“计划”、“估计”、“预期”、“相信”、“设计”、“预测”、“未来”或其他类似词语来标识这些前瞻性陈述。

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, including the potential IND submission and related timing, 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.

本新闻稿中所有非历史事实的陈述，包括有关 (Z)-endoxifen 项目的数据、(Z)-endoxifen 的安全性、耐受性和有效性、(Z)-endoxifen 作为乳腺癌预防和治疗剂的潜力、公司可能针对 (Z)-endoxifen 追求的潜在适应症、(Z)-endoxifen 获得监管批准的潜力（包括潜在的 IND 提交及其相关时间）、公司追求 (Z)-endoxifen 转移性适应症策略的好处、试验的预期设计与招募及数据和相关发布的时机，以及公司的潜在市场和增长机会，均为前瞻性陈述。

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 fore.

本新闻稿中的前瞻性陈述受制于可能导致实际结果、结果的时间或实际结果或结果与预期或预计的情况产生重大差异的风险和不确定性，包括以下相关的风险和不确定性：我们为候选产品获得专利覆盖的能力；宏观经济状况及日益加剧的地缘政治不稳定；数据发布的预期时间；任何中期、初步与最终临床结果或分析之间的差异；FDA及其他监管机构的行动或不作为。

SOURCE Atossa Therapeutics Inc

来源：Atossa Therapeutics Inc

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