LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in developing immunological cancer treatments, today announced results from the NEST-1 study, an investigator-sponsored trial (IST) evaluating the combination of botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting for colorectal cancer (CRC), both those with Microsatellite Stable (MSS) CRC and Microsatellite Instability High (MSI-H) CRC.

马萨诸塞州列克星敦市。-（商业新闻短讯）--开发免疫癌症治疗的领导者Agenus Inc.（纳斯达克：AGEN）今天宣布了NEST-1研究的结果，该研究是一项研究者赞助的试验（IST），评估了botensilimab和balstilimab（BOT/BAL）在结直肠癌新辅助治疗（CRC）中的组合，具有微卫星稳定（MSS）CRC和微卫星不稳定性高（MSI-H）CRC的那些。

Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference..

威尔·康奈尔医学院结肠癌研究主任Pashtoon Kasi博士在ASCO-GI会议上介绍了这些发现。。

'BOT/BAL's potential impact on colorectal cancer is groundbreaking. The study's findings, particularly the significant tumor regression after only a single dose of BOT and two doses of BAL, and the complete elimination of ctDNA in 100% of patients tested, offer a potentially transformative treatment approach for CRC patients diagnosed with early stage and locally advanced colon and rectal cancers.

“BOT/BAL对结直肠癌的潜在影响是开创性的。该研究的发现，特别是仅单剂量BOT和两剂BAL后显着的肿瘤消退，以及100%测试患者中ctDNA的完全消除，为诊断为早期和局部晚期结肠癌和直肠癌的CRC患者提供了潜在的变革性治疗方法。

These results hold great promise for patients and providers as a framework for reduced reliance on chemotherapy and/or surgical resection,' said Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine and lead investigator of the NICHE-1 study..

威尔·康奈尔医学院结肠癌研究主任、利基-1研究首席研究员普什图·卡西（PashtoonKasi）博士说，这些结果为患者和提供者提供了减少对化疗和/或手术切除的依赖的框架。。

Study Highlights:

研究重点：

Treatment Protocol: Patients received a single dose of BOT and two doses of BAL between diagnosis and surgery, which was approximately a four-week period.

治疗方案：患者在诊断和手术之间接受了单剂量的BOT和两剂BAL，大约为期四周。

Impressive Pathologic Response: Tumor shrinkage of ≥50% was observed in 67.5% of patients in the Microsatellite Stable (MSS) CRC cohort and 100% in the Microsatellite Instability-High (MSI-High) CRC cohort.

令人印象深刻的病理反应：在微卫星稳定（MSS）CRC队列中，67.5%的患者观察到肿瘤缩小≥50%，在微卫星不稳定性高（MSI高）CRC队列中观察到100%。

Surgery Without Delays: Treatment with BOT/BAL did not cause any postponements in surgical procedures, with only two instances of Grade 3 Treatment-Related Adverse Events (TRAEs) observed.

无延迟手术：用BOT/BAL治疗不会导致手术程序的任何延迟，仅观察到两例3级治疗相关不良事件（TRAEs）。

BOT/BAL Eliminates Circulating Tumor DNA (ctDNA): patients in the NICHE-1 study were tested for ctDNA, a biomarker closely associated with long-term Disease-Free Survival (DFS).

BOT/BAL消除了循环肿瘤DNA（ctDNA）：对利基-1研究中的患者进行了ctDNA测试，ctDNA是一种与长期无病生存（DFS）密切相关的生物标志物。

In a separate, independent observational study of 1,792 patients (NCT04264702; https://meetings.asco.org/abstracts-presentations/228848), also led by Dr. Kasi and presented at the ASCO-GI meeting on January 20th, showed a correlation between ctDNA clearance and improved disease-free survival (DFS) rates.

在一项针对1792名患者的独立观察性研究中（NCT04264702；https://meetings.asco.org/abstracts-presentations/228848)同样由Kasi博士领导并于1月20日在ASCO-GI会议上发表的研究表明，ctDNA清除率与无病生存率（DFS）提高之间存在相关性。

Patients who remained ctDNA negative post-treatment exhibited better 2-year DFS as compared to ctDNA-positive patients..

与ctDNA阳性患者相比，治疗后ctDNA阴性的患者表现出更好的2年DFS。。

Dr. Steven O’Day, Chief Medical Officer of Agenus, stated, “The NEST-1 trial results are remarkable. Neoadjuvant BOT/BAL in both MSS and MSI-H CRC resulted in marked tumor regression and robust immune cell infiltration in a very short interval. These results in MSS CRC (90% of all CRC) are particularly compelling and may lead to an unprecedented shift away from invasive and morbid standard treatments in the future.”.

Agenus首席医疗官Steven O'Day博士表示，“NEST-1试验结果显着。MSS和MSI-H CRC中的新辅助BOT/BAL在很短的时间内导致明显的肿瘤消退和强大的免疫细胞浸润。MSS CRC（占所有CRC的90%）的这些结果特别引人注目，并可能导致未来前所未有的从侵入性和病态标准治疗的转变。”。

NEST-1 data presented at the conference is available to view in the publications section of the Agenus website (https://agenusbio.com/publications).

会议上提供的NEST-1数据可在Agenus网站的出版物部分查看(https://agenusbio.com/publications)。

About Botensilimab

关于博滕西林单抗

Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (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是一种研究性多功能抗CTLA-4免疫激活剂（抗体），旨在增强先天性和适应性抗肿瘤免疫反应。其新颖的设计利用作用机制将免疫治疗的益处扩展到通常对标准治疗反应不佳或对常规PD-1/CTLA-4疗法和研究疗法难治的“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通过引发和激活T细胞，下调肿瘤内调节性T细胞，激活骨髓细胞和诱导长期记忆反应来增强多种肿瘤类型的免疫反应。。

Approximately 750 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316..

在1期和2期临床试验中，大约750名患者接受了botensilimab治疗。单独使用Botensilimab或与Agenus的研究性PD-1抗体balstilimab联合使用，已显示出对9种转移性晚期癌症的临床反应。有关botensilimab试验的更多信息，请访问www.clinicaltrials.gov，标识符为NCT03860272，NCT05608044，NCT05630183和NCT05529316。。

About Agenus

关于Agenus

Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is 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 (through SaponiQx).

Agenus是一家领先的免疫肿瘤学公司，针对癌症和传染病，拥有全面的免疫制剂管道。该公司的使命是通过组合方法，使用广泛的抗体疗法，过继细胞疗法（通过水貂疗法）和佐剂（通过SasioQX），扩大受益于癌症免疫疗法的患者群体。

Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels..

Agenus总部位于马萨诸塞州列克星敦。有关更多信息，请访问www.agenusbio.com或@Agenus\u bio。对投资者可能很重要的信息将定期发布在我们的网站和社交媒体渠道上。。

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 relating to the use of botensilimab and balstilimab, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action (including validation of mechanism of action), potency, durability, and safety profile (including the absence of specific toxicities) of the Company’s therapeutic candidates; and any other statements containing the words 'may,' 'believes,' 'expects,' 'anticipates,' 'hopes,' 'intends,' 'plans,' 'forecasts,' 'estimates,' 'will,' “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements.

本新闻稿包含根据《联邦证券法》的安全港条款做出的前瞻性声明，包括与使用波替尼单抗和巴尔替利单抗有关的声明，例如，关于治疗益处和疗效、作用机制（包括作用机制的验证）、效力、耐久性，公司治疗候选人的安全性（包括没有特定毒性）；以及任何其他包含“可能”、“相信”、“期望”、“期望”、“希望”、“打算”、“计划”、“预测”、“估计”、“意志”、“建立”、“潜力”、“优越性”、“同类最佳”等词语的陈述，以及类似的表达都旨在识别前瞻性陈述。

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 Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission.

这些前瞻性陈述受到可能导致实际结果产生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我们最近向证券交易委员会提交的10-Q表季度报告或10-K表年度报告中风险因素部分所述的因素。

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提醒投资者不要过分依赖本新闻稿中的前瞻性声明。这些声明仅在本新闻稿发布之日有效，除法律要求外，Agenus不承担更新或修订声明的义务。

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

本警示声明明确限定了所有前瞻性声明的全部内容。。