Cross-Agency Discussion Highlights Interest in Oral Formulation as Field-Deployable Medical Countermeasure

跨机构讨论凸显对口服制剂作为现场部署医疗对策的兴趣

SAN ANTONIO

圣安东尼奥

,

，

May 19, 2026

2026年5月19日

/PRNewswire/ -- Valion Bio, Inc. (Nasdaq:

/PRNewswire/ -- Valion Bio, Inc. (纳斯达克:

VBIO

VBIO

), a late-stage innate immunotherapeutics company, today announced that it presented Entolimod for acute radiation syndrome (ARS) to senior officials from the U.S. Department of War and the Biomedical Advanced Research and Development Authority (BARDA) in a joint briefing held on May 14, 2026. The session was Valion Bio's second engagement with senior Department of War officials, following the Company's April 28, 2026, Pentagon briefing on Entolimod..

），一家处于后期阶段的先天免疫治疗公司，今天宣布在2026年5月14日举行的联合简报会上，向美国国防部和生物医学高级研究与发展管理局（BARDA）的高级官员介绍了用于急性辐射综合症（ARS）的Entolimod。此次会议是Valion Bio与国防部高级官员的第二次接触，此前公司曾于2026年4月28日在五角大楼就Entolimod进行过简报。

We believe the cross-agency engagement reflects continued U.S. government interest in Entolimod as a differentiated medical countermeasure for radiological threats. Agency discussion included a specific interest in an oral formulation of the Company's lead candidate, which would offer operational advantages over injectable agents in mass-casualty scenarios and support broader field deployment for the warfighter.

我们相信，跨机构的参与反映了美国政府对Entolimod作为针对放射性威胁的差异化医疗对策的持续兴趣。机构讨论中特别提到对公司主要候选药物的口服制剂感兴趣，这在大规模伤亡情况下相比注射剂具有操作优势，并支持更广泛的战士现场部署。

and national stockpile integration..

以及国家储备整合。

'This second engagement, requested by the DoW, at senior levels of the Department of War, conducted jointly with BARDA, reflects the increasing interest of Entolimod within the national radiological preparedness conversation,' said

“这次由国防部请求的第二次合作，在战争部高级别官员与BARDA共同进行，反映了Entolimod在全国辐射应急准备讨论中日益增长的兴趣，”

Michael K. Handley

迈克尔·K·汉德利

, Chief Executive Officer of Valion Bio. 'Cross-agency interest at this level signals that policymakers recognize the strategic importance of a differentiated, dual-tissue radiation countermeasure, and the specific focus on a potential oral formulation underscores the operational realities of field deployment and stockpile readiness that our platform is positioned to address.'.

瓦利昂生物公司首席执行官表示：“跨机构在这一层面的兴趣表明，政策制定者认识到一种差异化、双组织辐射对抗措施的战略重要性，而特别关注潜在的口服制剂则凸显了现场部署和储备准备的操作现实，我们的平台正是为了应对这些需求而定位的。”

Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling to stimulate bone marrow and protect gastrointestinal tissues following ionizing radiation exposure — a dual-tissue mechanism not available in currently stockpiled countermeasures. Unlike Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which target hematopoietic recovery alone, Entolimod addresses the gastrointestinal damage that is often the limiting factor for survival at higher radiation doses.

Entolimod 是一种新型的 Toll 样受体 5 (TLR5) 激动剂，可激活 NF-κB 信号传导，在暴露于电离辐射后刺激骨髓并保护胃肠道组织——这是一种目前储备的应对措施中尚未具备的双重组织机制。与仅针对造血恢复的 Neupogen®（非格司亭）、Neulasta®（培非格司亭）和 Leukine®（沙格司亭）不同，Entolimod 能够解决胃肠道损伤问题，而这种损伤往往是高剂量辐射下生存率的关键限制因素。

Valion Bio is working to advance both injectable and oral transmucosal formulations of Entolimod to support a broad range of deployment scenarios..

瓦利昂生物公司正在推进Entolimod的注射和口服跨粘膜制剂，以支持广泛的部署场景。

The May 14 briefing follows prior Valion Bio engagements with BARDA, the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Company's selection for the Department of War's Tech Watch program. To date, over $140 million has been invested in the Entolimod program, including approximately $35.6 million in non-dilutive U.S.

5月14日的简报是在瓦利昂生物公司之前与BARDA、美国国家过敏和传染病研究所（NIAID）、国防威胁减少局（DTRA）的合作基础上进行的，并且该公司入选了国防部的Tech Watch计划。迄今为止，Entolimod项目已投入超过1.4亿美元，其中包括约3560万美元的非稀释性美国资金。

government funding. The compound has been evaluated in 42 non-human primate studies and administered to approximately 300 human subjects, demonstrating a well-characterized safety and efficacy profile..

政府资助。该化合物已在42项非人灵长类动物研究中进行评估，并施用于约300名人类受试者，展示了良好特征的安全性和有效性。

'The current geopolitical environment continues to elevate radiological preparedness on the national security agenda, and we are seeing that reflected in the depth and frequency of our engagement with U.S. government stakeholders,' Mr. Handley continued. 'Our objective is straightforward: to ensure that Entolimod — and an oral formulation positioned for mass casualty and warfighter applications — is recognized and supported at the levels required to translate its differentiated profile into deployed national capability.'.

“当前的地缘政治环境继续提升辐射防护在国家安全议程中的重要性，我们看到这反映在我们与美国政府利益相关者互动的深度和频率上，”汉德利先生继续说道。“我们的目标很简单：确保Entolimod——以及针对大规模伤亡和作战人员应用的口服制剂——能够在其所需的支持和认可下，将其独特的特性转化为实际部署的国家能力。”

The Company has received FDA Fast Track and Orphan Drug designations for Entolimod in acute radiation syndrome and is advancing the program toward a Biologics License Application under the FDA's Animal Rule.

公司已获得FDA快速通道和孤儿药资格认定，用于急性辐射综合症的Entolimod，并正在根据FDA的动物规则推进该计划，以提交生物制品许可申请。

Strategic and Competitive Positioning

战略与竞争定位

Cross-agency convergence:

跨机构融合：

Joint Department of War and BARDA engagement signals coordinated interest across biodefense and biomedical preparedness functions.

战争与BARDA联合部门的参与表明了在生物防御和生物医学准备功能方面的协调兴趣。

Oral formulation focus:

口服制剂焦点：

An oral medical countermeasure for ARS would expand operational deployment options for stockpiling, field use, and mass casualty response.

一种针对ARS的口服医疗对策将扩大用于储备、现场使用和大规模伤亡响应的操作部署选项。

Differentiated mechanism:

差异化机制：

TLR5 agonist provides dual-tissue cytoprotection versus single-target G-CSF therapies.

TLR5激动剂提供双组织细胞保护，而单靶点G-CSF疗法则不能。

Regulatory pathway:

监管途径:

Animal Rule framework supports development for biodefense applications.

动物规则框架支持生物防御应用的开发。

Government validation:

政府验证：

Approximately $35.6 million in prior federal funding and ongoing multi-agency engagement.

大约 3560 万美元的先前联邦资金和持续的多机构参与。

About Entolimod for Acute Radiation Syndrome

关于Entolimod用于急性辐射综合症

Entolimod (CBLB502) is a recombinant deletion variant of Salmonella FliC flagellin engineered to activate TLR5 selectively. Upon engagement, Entolimod likely triggers NF-κB-dependent signaling to stimulate G-CSF, PI3K, and IL-6 production, among others, to promote multi-tissue cytoprotection, and inhibit apoptosis in radiosensitive hematopoietic and gastrointestinal tissues.

Entolimod（CBLB502）是一种经过基因工程改造的沙门氏菌FliC鞭毛蛋白的重组缺失变体，设计用于选择性激活TLR5。在结合后，Entolimod可能触发NF-κB依赖性信号传导，刺激G-CSF、PI3K和IL-6等的产生，以促进多组织细胞保护，并抑制放射敏感性造血组织和胃肠道组织中的细胞凋亡。

The compound has demonstrated survival benefit as both a radioprotectant and a radiomitigant in controlled non-human primate studies under the FDA's Animal Rule..

该化合物在FDA的动物规则下，于受控的非人类灵长类动物研究中，作为放射防护剂和放射缓解剂均显示出生存益处。

About Valion Bio, Inc.

关于瓦利昂生物公司

Valion Bio, Inc. (Nasdaq:

瓦利昂生物公司（纳斯达克：

VBIO

生物虚拟化

), the new corporate identity of Tivic Health Systems, Inc., is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The Company's lead candidate, Entolimod for acute radiation syndrome (ARS), has been extensively studied and has demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule.

），Tivic Health Systems, Inc. 的新企业标识，正在开发激活先天免疫途径以实现细胞保护并在由辐射、疾病和免疫失调引发的状况下调节免疫反应的生物制品。该公司的主要候选药物 Entolimod（用于急性放射综合症，ARS）已经过广泛研究，并在 FDA 的动物规则下，展示了在动物模型中的生存益处和组织恢复改善。

Entolimod is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Valion Bio is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care.

Entolimod是一种新型的Toll样受体5（TLR5）激动剂，可激活NF-κB信号通路以保护细胞免受损伤并刺激免疫反应。Entolimod用于急性辐射综合征（ARS）已获得美国食品药品监督管理局（FDA）的快速通道和孤儿药资格认定。Valion Bio还在推进Entolasta的研发，这是一种下一代TLR5激动剂，设计用于潜在更广泛的治疗应用，包括肿瘤支持治疗。

Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development and manufacturing organization (CDMO) that provides biomanufacturing services to third-party biotech companies. Valion Bio also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes, and supply chain security.

瓦利昂生物的全资子公司Velocity Bioworks是一家全方位服务的合同开发和制造组织（CDMO），为第三方生物技术公司提供生物制造服务。瓦利昂生物还利用Velocity Bioworks的制造能力来推进自己的药物研发管线，预计将带来降低成本、加快生产进度和保障供应链等优势。

For more information, visit .

欲了解更多信息，请访问 。

www.valionbio.com

www.valionbio.com

.

。

Forward-Looking Statements

前瞻性声明

This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim, 'should,' 'will,' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words.

本新闻稿可能包含“前瞻性声明”，这些声明受重大风险和不确定性的影响。本新闻稿中除历史事实陈述之外的所有声明均为前瞻性声明。本新闻稿中的前瞻性声明可以通过使用诸如“预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“意图”、“寻求”、“或许”、“也许”、“计划”、“潜在”、“预测”、“预计”、“目标”、“旨在”、“应该”、“将”、“会”等词语或这些词语的否定形式或其他类似表达来识别，尽管并非所有前瞻性声明都包含这些词语。

Forward-looking statements are based on Valion Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S.

前瞻性声明基于Valion Bio公司的当前预期，并受制于难以预测的固有不确定性、风险和假设。此外，某些前瞻性声明基于对未来事件的假设，这些假设可能被证明不准确，包括由于公司与FDA及其他监管机构的互动和指导；BARDA及其他美国机构的持续关注。

government agencies in Entolimod; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercial.

政府机构在Entolimod方面；公司是否能够在未来预期时间内或完全从收购开发和制造资产中获得预期收益；公司与其合作伙伴关系的变化；未能获得FDA或类似许可或批准，以及不符合FDA或类似规定，包括与动物规则相关的规定；公司未来对Entolimod或Entolasta的开发；公司业务战略的调整；临床前和临床试验的时间安排、成功与否及研究结果；监管要求和审批路径；公司成功商业化的能力。

Investor + Media Contact:

投资者 + 媒体联系：

Rich Cockrell

里奇·科克雷尔

CG Capital

CG资本

[email protected]

电子邮件地址

SOURCE Valion Bio, Inc.

来源：Valion Bio, Inc.

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