LEXINGTON, Mass.--(BUSINESS WIRE)--

马萨诸塞州列克星敦--(BUSINESS WIRE)--

Agenus Inc

安吉纳斯公司

. (

。(

Nasdaq: AGEN

纳斯达克：AGEN

), a leader in immuno-oncology innovation, today announced the closing of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The agreement is designed to accelerate global development and potential commercialization of Agenus’ botensilimab and balstilimab (BOT+BAL) immunotherapy combination program..

），作为免疫肿瘤学创新领域的领导者，今天宣布了与Zydus生命科学有限公司先前披露的战略合作正式达成。该协议旨在加速Agenus公司的博替尼单抗和巴利单抗（BOT+BAL）免疫治疗联合项目的全球开发及潜在商业化进程。

The collaboration provides Agenus with strategic capital and committed, long-term biologics manufacturing capacity in the United States to support BOT+BAL clinical development, authorized early access pathways, and commercial supply preparation.

该合作为Agenus提供了战略资本，并确保了其在美国的长期生物制品生产能力，以支持BOT+BAL的临床开发、授权早期获取途径以及商业供应准备。

As part of the collaboration, Agenus has granted Zydus exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories.

作为合作的一部分，Agenus已授予Zydus在印度和斯里兰卡独家开发和商业化BOT和BAL的权利，Agenus有资格在这些地区获得净销售额的特许权使用费。

The collaboration, first

合作，首先

announced on June 3, 2025

2025年6月3日宣布

, included the following key financial terms:

，包含以下关键财务条款：

Upfront Consideration:

预先考虑：

$75 million cash payment to Agenus for transfer of biologics manufacturing facilities in Emeryville and Berkeley, California

7500万美元现金支付给Agenus，用于转让位于加利福尼亚州埃默里维尔和伯克利的生物制品生产设施。

Equity Investment:

股权投资：

$16 million purchase by Zydus of Agenus (AGEN) common stock (~2.1 million shares at $7.50 per share)

Zydus以1600万美元购买Agenus（AGEN）普通股（约210万股，每股7.50美元）

Contingent Milestone Payments:

或有里程碑付款：

Up to $50 million payable to Agenus, triggered by BOT+BAL production orders

高达5000万美元可支付给Agenus，由BOT+BAL生产订单触发。

Exclusive License:

独家许可：

Zydus obtains exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive a 5% royalty on net sales in those territories

Zydus获得在印度和斯里兰卡开发和商业化BOT及BAL的独家权利，Agenus有资格在这些地区获得净销售额5%的特许权使用费。

“Closing this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated U.S. manufacturing capacity at a pivotal moment for Agenus,” said

“与Zydus的这次合作加强了我们的资产负债表，更重要的是，在Agenus的关键时刻确保了专用的美国制造能力，”

Dr. Garo Armen Ph.D., Chairman and Chief Executive Officer of Agenus.

Garo Armen博士，Agenus公司董事长兼首席执行官。

“With these foundations in place, our focus in 2026 is disciplined execution—advancing our Phase 3 program, broadening paid patient access through authorized pathways, and progressing toward regulatory submission supported by one of the most substantial clinical datasets generated in MSS colorectal cancer.”.

“在这些基础到位的情况下，我们2026年的重点是严格执行——推进我们的第三阶段计划，通过授权途径扩大付费患者准入，并在监管提交方面取得进展，该提交得到了在MSS结直肠癌中生成的最庞大的临床数据集之一的支持。”

In 2025, the BOT+BAL combination demonstrated a two-year overall survival rate of 42% and a now-mature median overall survival of 21 months in an expanded cohort of 123 patients with third-line or later microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. Building on these results, Agenus, in collaboration with Canadian Cancer Trials Group (CCTG) has initiated the global BATTMAN Phase 3 trial, with sites activated and prepared to enroll patients..

2025年，BOT+BAL联合疗法在123名无活动性肝转移的三线或更晚微卫星稳定（MSS）型转移性结直肠癌（mCRC）患者的扩展队列中，显示出42%的两年总生存率和现已成熟的21个月中位总生存期。基于这些结果，Agenus与加拿大癌症试验组（CCTG）合作，启动了全球BATTMAN三期试验，各试验点已准备就绪并开始招募患者。

Following the closing, the Emeryville and Berkeley, California biologics manufacturing facilities will be transferred to Zydus and housed under a newly formed subsidiary named Zylidac Bio LLC. Agenus has secured committed manufacturing capacity at these U.S. sites to support BOT+BAL supply needs for their clinical trials, global access programs and future commercialization..

交易完成后，位于加利福尼亚州埃默里维尔和伯克利的生物制品制造设施将转移至Zydus，并归于新成立的子公司Zylidac Bio LLC名下。Agenus已确保这些美国基地的承诺生产能力，以支持其临床试验、全球准入计划以及未来商业化的BOT+BAL供应需求。

This transaction further positions Agenus to execute on its near- and long-term strategy as interest in BOT+BAL continues to grow globally.

这笔交易进一步使Agenus能够执行其短期和长期战略，因为全球对BOT+BAL的兴趣持续增长。

Commenting on the finalization of the deal,

就这笔交易的最终达成发表评论，

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited.

锐尔生命科学有限公司董事总经理夏维尔·P·帕特尔博士。

, stated, 'With this deal, Zylidac Bio LLC will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the U.S., which prioritizes secure, domestic, and high-quality supply chains for advanced therapies.

，他表示：“通过此次交易，Zylidac Bio LLC 将为全球生物制药公司提供提供 CDMO 服务的生物制品生产场地。这支持了美国生物制品制造不断发展的格局，优先考虑为先进疗法打造安全、国内且高质量的供应链。

Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localized supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation.'.

Zylidac Bio LLC 为全球创新者提供了一个关键且合规的解决方案，并实现了本地化的供应链。这增强了我们以可靠性和创新性服务国际生物制药行业的能力。

Advisors

顾问

As part of this effort, Agenus was advised by Porrima Ltd and Biotech Value Advisors (BVA), who provided guidance on partner selection, transaction structure, and negotiations.

作为这项工作的一部分，Agenus 得到了 Porrima Ltd 和 Biotech Value Advisors (BVA) 的建议，他们就合作伙伴选择、交易结构和谈判提供了指导。

About Agenus

关于Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants.

Agenus是一家领先的免疫肿瘤学公司，拥有针对癌症的全面免疫药物管道。该公司成立于1994年，其使命是通过组合方法扩大受益于癌症免疫疗法的患者群体，利用广泛的抗体治疗剂、过继细胞疗法（通过MiNK Therapeutics）和佐剂。

Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit .

Agenus具备强大的端到端开发能力，涵盖商业和临床cGMP生产设施、研发与发现，以及全球临床运营布局。Agenus总部位于马萨诸塞州列克星敦。欲了解更多信息，请访问。

www.agenusbio.com

www.agenusbio.com

or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

或@agenus_bio。可能对投资者重要的信息将定期发布在我们的网站和社交媒体渠道上。

Agenus is committed to responsible patient access to investigational medicines through clinical trials and regulatory-authorized early-access mechanisms. In France, BOT+BAL is available only through the ANSM-authorized AAC framework under a nationally validated protocol, with full government reimbursement for eligible patients treated in hospital..

Agenus 致力于通过临床试验和监管机构授权的早期获取机制，为患者提供负责任的试验药物使用途径。在法国，BOT+BAL 仅可通过 ANSM 授权的 AAC 框架获取，并遵循全国验证的方案，符合条件的住院患者可享受政府全额报销。

About Global Access Pathways

关于全球访问路径

Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the planned Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework.

在获得上市许可之前，BOT+BAL仅能通过临床试验获取，包括计划中的针对难治性MSS结直肠癌的III期BATTMAN试验，以及在各国监管框架下允许并可用的授权早期获取机制。

For eligible French patients treated in hospitals under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system (Assurance Maladie). Reimbursement is structured as a single, upfront, course-based reimbursement per patient that covers the patient’s full course of therapy according to the national AAC protocol, rather than on a per-dose basis.

对于在符合预先定义标准的AAC协议下于医院接受治疗的法国适用患者，BOT+BAL可获得法国国家健康系统（Assurance Maladie）的全额报销。报销结构为每位患者一次性、基于疗程的整体报销，覆盖根据国家AAC协议的整个治疗过程，而非按每次剂量进行报销。

Once a patient is authorized and treatment is initiated under the protocol, full course of treatment and all subsequent administrations are supplied without additional product charges. In line with AAC requirements, the maximum indemnity applicable to BOT+BAL is declared to the relevant French authorities..

一旦患者获得授权并根据协议开始治疗，整个疗程及所有后续给药均免费提供，不收取额外的产品费用。根据AAC的要求，适用于BOT+BAL的最高赔偿已向相关法国当局申报。

Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions.

在法国以外的地区，可以通过付费的指定患者计划在部分国家获得使用资格，这可能涉及自费支付和/或特殊的保险安排，具体取决于当地的法规和个体的保险覆盖决策。

About BATTMAN CO.33 Phase 3 Trial

关于BATTMAN公司33期3阶段试验

Agenus, in collaboration with the Canadian Cancer Trials Group (CCTG), is initiating a global Phase 3 registrational trial evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care (BSC) in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer.

Agenus与加拿大癌症试验组（CCTG）合作，正在启动一项全球III期注册试验，评估botensilimab（BOT）联合balstilimab（BAL）对比最佳支持治疗（BSC）在难治性、不可切除的微卫星稳定（MSS）/错配修复完整（pMMR）结直肠癌患者中的效果。

The study will be conducted as an international cooperative group trial, led by CCTG and supported by academic networks including AGITG (Australasian Gastro-Intestinal Trials Group) and PRODIGE (France), which comprises Unicancer, GERCOR, and FFCD. The trial will enroll approximately 800 patients across more than 100 sites in Canada, France, Australia, and New Zealand..

该研究将作为一项国际协作组试验进行，由CCTG领导，并得到包括AGITG（澳大拉西亚胃肠道试验组）和PRODIGE（法国）在内的学术网络支持，后者由Unicancer、GERCOR和FFCD组成。试验将在加拿大、法国、澳大利亚和新西兰的100多个地点招募约800名患者。

About Botensilimab (BOT)

关于博特尼利单抗（BOT）

Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies.

Botensilimab（BOT）是一种增强人类Fc的多功能抗CTLA-4抗体，旨在提升先天性和适应性抗肿瘤免疫反应。其创新设计利用作用机制，将免疫治疗的优势扩展到通常对标准治疗反应不佳或对传统PD-1/CTLA-4疗法及试验性疗法产生耐药性的“冷”肿瘤。

Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses..

Botensilimab通过启动和激活T细胞、下调肿瘤内调节性T细胞、激活髓系细胞以及诱导长期记忆反应，增强了多种肿瘤类型的免疫反应。

Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. In France, botensilimab is accessible only through the ANSM-authorized AAC framework when used as BOT+BAL under the national protocol described above.

大约有1200名患者在一期和二期临床试验中接受了博特尼利单抗和/或巴尔替利单抗的治疗。在法国，博特尼利单抗仅可通过ANSM授权的AAC框架获取，当其作为上述国家协议中描述的BOT+BAL组合使用时。

About Balstilimab (BAL)

关于Balstilimab（BAL）

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

Balstilimab 是一种新型的全人源单克隆免疫球蛋白 G4 (IgG4)，旨在阻止 PD-1（程序性细胞死亡蛋白 1）与其配体 PD-L1 和 PD-L2 相互作用。迄今为止，它已在 900 多名患者中进行了评估，并在多种肿瘤类型中显示出临床活性和良好的耐受性。

In France, balstilimab is accessible only through the ANSM-authorized AAC framework when used as BOT+BAL under the national protocol described above..

在法国，只有通过ANSM授权的AAC框架，在上述国家协议中作为BOT+BAL使用时，才能获取balstilimab。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding botensilimab and balstilimab, early access pathways, clinical development plans (including BATTMAN), and expected regulatory and clinical timelines, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” and similar expressions intended to identify forward-looking statements.

本新闻稿包含根据联邦证券法的安全港条款作出的前瞻性声明，包括关于 botensilimab 和 balstilimab、早期获取途径、临床开发计划（包括 BATTMAN）、预期的监管和临床时间表，以及任何其他包含“可能”、“相信”、“预期”、“希望”、“打算”、“计划”、“预测”、“估计”、“将”等词语及类似表达旨在识别前瞻性声明的内容。

These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

这些前瞻性陈述受到可能导致实际结果存在重大差异的风险和不确定性的影响。这些风险和不确定性包括但不限于我们在最近的截至2024年的年度报告表格10-K中的“风险因素”部分所描述的因素，以及随后向证券交易委员会提交的季度报告表格10-Q中所述的因素。

Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law.

Agenus告诫投资者不要过分依赖本新闻稿中包含的前瞻性陈述。这些陈述仅截至本新闻稿发布之日，除非法律要求，Agenus没有义务更新或修改这些陈述。

All forward-looking statements are expressly qualified in their entirety by this cautionary statement..

所有前瞻性声明均以本警示声明为准，完全符合其规定。

Agenus Investors: 917-362-1370 |

安捷伦投资者：917-362-1370 |

investor@agenusbio.com

投资者@agenusbio.com

Agenus Media: 781-674-4422 |

Agenus 媒体：781-674-4422 |

communications@agenusbio.com

communications@agenusbio.com

Source: Agenus Inc.

来源：Agenus公司