Company Presented Entolimod™ from its TLR5 Platform to the Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs

公司向国防部负责核、化学和生物防御计划的副助理部长介绍了其TLR5平台的Entolimod™。

SAN ANTONIO

圣安东尼奥

,

，

April 28, 2026

2026年4月28日

/PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq:

/PRNewswire/ -- Valion Bio, Inc.（前身为Tivic Health Systems, Inc.）（纳斯达克：

VBIO

VBIO

), a late-stage immunotherapeutics company, today announced that it briefed senior officials at the U.S. Department of War on Entolimod™ for acute radiation syndrome. The briefing, facilitated by American Defense International (ADI), was presented to the Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs and his team at the Pentagon..

），一家处于晚期阶段的免疫治疗公司，今天宣布它向美国国防部高级官员介绍了用于急性辐射综合症的Entolimod™。此次介绍由美国国防国际（ADI）促成，在五角大楼向国防部负责核、化学和生物防御计划的副助理部长及其团队进行了展示。

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VALION BIO

瓦利昂生物

The briefing reflects growing U.S. government interest in Entolimod™ as a next-generation medical countermeasure for radiological threats. Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that provides dual-tissue protection against ionizing radiation-induced damage, addressing both hematopoietic and gastrointestinal acute radiation syndrome — a differentiated mechanism not available in currently stockpiled countermeasures..

简报反映了美国政府对Entolimod™作为下一代应对放射性威胁的医疗对策的兴趣日益增加。Entolimod™是一种新型的Toll样受体5（TLR5）激动剂，能够提供针对电离辐射损伤的双重组织保护，同时应对造血和胃肠急性辐射综合症——这是一种当前储备的应对措施中所不具备的独特机制。

'Engaging directly with senior leadership at the Pentagon marks a significant milestone in our work with the Department of War,' said Michael K. Handley, Chief Executive Officer of Valion Bio. 'The Deputy Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs oversees critical national preparedness capabilities, and the opportunity to present Entolimod™ at this level validates our strategic positioning at the intersection of biodefense and medical countermeasures.

“直接与五角大楼的高级领导层接触标志着我们与国防部合作的一个重要里程碑，”Valion Bio首席执行官迈克尔·K·汉德利表示。“国防部负责核、化学和生物防御计划的副助理部长监督着国家关键的备战能力，在这一层面展示Entolimod™验证了我们在生物防御和医疗对策交叉领域的战略定位。”

We were able to demonstrate the strength of our data package and how Entolimod™ addresses current gaps in the Strategic National Stockpile.'.

我们能够证明我们的数据包的实力，以及Entolimod™如何解决国家战略储备中的当前缺口。

Entolimod™ is being developed under the FDA's Animal Rule pathway for acute radiation syndrome, with over $140 million invested in the program to date, including approximately $35.6 million in non-dilutive U.S. 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..

Entolimod™ 正在 FDA 的动物规则途径下开发，用于急性辐射综合症，截至目前该项目已投入超过 1.4 亿美元，其中包括约 3560 万美元的非稀释性美国政府资金。该化合物已在 42 项非人类灵长类动物研究中进行评估，并给予约 300 名人类受试者使用，展示了明确的安全性和有效性特征。

Unlike currently stockpiled agents such as Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which target hematopoietic recovery alone, Entolimod™ activates NF-κB signaling pathways to protect both bone marrow and gastrointestinal tissues simultaneously. This dual-organ mechanism addresses a critical unmet need, as gastrointestinal damage is often the limiting factor for survival at higher radiation doses..

与目前储备的药物如Neupogen®（非格司亭）、Neulasta®（培非格司亭）和Leukine®（沙格司亭）不同，这些药物仅针对造血恢复，而Entolimod™激活NF-κB信号通路，同时保护骨髓和胃肠道组织。这种双器官机制满足了一个关键的未满足需求，因为在较高辐射剂量下，胃肠道损伤往往是生存的限制因素。

'The current geopolitical environment has elevated radiological preparedness to a national security priority,' Handley continued. 'Our engagements with BARDA, DTRA, NIAID, and now direct Pentagon leadership demonstrate that Entolimod™ is being recognized at the highest levels of the U.S. defense establishment as a differentiated solution to protect both military personnel and civilian populations.

汉德利继续说道：“当前的地缘政治环境已将辐射防护提升为国家安全的优先事项。我们与BARDA、DTRA、NIAID以及现在的五角大楼高层领导的合作表明，Entolimod™正被美国国防机构最高层认可为一种独特的解决方案，以保护军人和平民。”

We are committed to moving with the urgency this threat environment demands.'.

我们承诺以应对威胁环境所需的紧迫性采取行动。

The Pentagon briefing follows Valion Bio's recent selection for the Department of War's Tech Watch program and ongoing engagements with multiple U.S. government agencies regarding the inclusion of Entolimod™ in national preparedness planning. The Company has received FDA Fast Track and Orphan Drug designations for Entolimod™ in acute radiation syndrome and is advancing toward a Biologics License Application under the Animal Rule..

五角大楼的简报紧随瓦利昂生物公司最近被国防部技术观察计划选中，并与多个美国政府机构就将Entolimod™纳入国家防范计划进行持续接触之后。该公司已获得FDA对Entolimod™在急性辐射综合症方面的快速通道和孤儿药资格，并正在根据动物规则推进生物制品许可申请。

Strategic and Competitive Positioning

战略与竞争定位

National preparedness relevance: Dual GI and bone marrow protection addresses critical gaps in current stockpiled countermeasures

国家备灾相关性：双重胃肠道和骨髓保护解决了当前储备对策中的关键缺口。

Differentiated mechanism: TLR5 agonist provides pleiotropic cytoprotection versus single-target G-CSF therapies

差异化机制：TLR5激动剂提供多效细胞保护，对比单一靶点的G-CSF疗法

Regulatory pathway: Animal Rule framework reduces clinical development risk for biodefense applications

监管途径：动物规则框架降低了生物防御应用的临床开发风险

Government validation: $35.6 million in prior federal contracts and ongoing multi-agency engagement

政府验证：3560万美元的先前联邦合同和持续的多机构参与

About Entolimod™ for Acute Radiation Syndrome

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™ triggers NF-κB-dependent signaling to stimulate G-CSF, PI3K, and IL-6 production, 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异体，能够选择性激活TLR5。在结合后，Entolimod™触发NF-κB依赖性信号传导，刺激G-CSF、PI3K和IL-6的产生，促进多组织细胞保护，并抑制对放射敏感的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，通过受控的非人类灵长类动物研究，已证明其作为放射防护剂和放射缓解剂的生存益处。

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中调节免疫反应的生物制剂。该公司的主要候选药物 Entolimod™ 用于急性放射综合症 (ARS)，已经在 FDA 的动物规则下进行了广泛研究，并在动物模型中显示出生存益处和组织恢复的改善。

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™ 用于急性辐射综合症（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™，这是一款下一代TLR5激动剂，设计用于潜在的更广泛治疗应用，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，预期将带来降低成本、加快制造成果和确保供应链安全等优势。

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诸如“预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“打算”、“寻求”、“或许”、“也许”、“计划”、“潜力”、“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.

前瞻性声明基于瓦利昂生物公司当前的预期，并受到固有的不确定性、风险和难以预测的假设的影响。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和其他监管机构的互动及指导；BARDA和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 commercia.

政府机构对Entolimod™的态度；公司能否在预期时间内或根本无法从收购开发和制造资产中获得预期收益；公司与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或类似法规，包括与动物规则相关的规定；公司未来对Entolimod或Entolasta的开发；公司业务战略的变化；临床前和临床试验的时机与成功及研究结果；监管要求和审批路径；公司成功商业化的能力。

Investor Contact:

投资者联系方式：

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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