Balstilimab

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced five presentations featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody) at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium. The conference will take place on January 23-25, 2025, in San Francisco, California. The presentations will showcase BOT/BAL's activity across three distinct colorectal cancer settings—late-line metastatic, first-line, and neoadjuvant treatment. The studies demonstrate BOT/BAL’s consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer. “These presentations will highlight BOT/BAL’s potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings,” said Dr. Garo Armen, Chairman and CEO of Agenus. “We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide.” Presentation Details Abstract Title: Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal cancer with no liver metastases (MSS mCRC NLM)* Abstract Number: 23 Presenting Author: Dr. Marwan Fakih Session: Rapid Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: 1/25/2025, 9:15 AM-10:00 AM PST Abstract Title: Preoperative botensilimab (BOT) with or without balstilimab (BAL) for patients with resectable locally advanced pMMR or dMMR colon cancer: Results from the UNICORN trial by GONO Abstract Number: 158 Presenting Author: Dr. Filippo Ghelardi Session: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST Abstract Title: A phase II study of agenT-797 (invariant natural killer T-cells), botensilimab (Fc-enhanced CTLA-4 inhibitor) and balstilimab (anti-PD-1) in patients with advanced, refractory gastroesophageal adenocarcinoma Abstract Number: TPS515 Presenting Author: Dr. Samuel Cytryn Session: Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers Session Date and Time: 1/23/2025, 11:30 AM-1:00 PM PST Abstract Title: Neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable mismatch repair proficient (pMMR) and deficient (dMMR) colorectal cancer (CRC): NEST clinical trial update Abstract Number: 207 Presenting Author: Dr. Erika Hissong Session: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST Abstract Title: A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer. Abstract Number: 180 Presenting Author: Dr. Marwan Fakih Session: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST Complete abstracts will be released at 5:00 PM ET on January 21 st , 2025. Data presented at the conference will be available to view in the publications section of the Agenus website ( https://agenusbio.com/publications ) following the ASCO GI Meeting. *Agenus Sponsored Study About 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 (through SaponiQx). 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 www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking 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 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. Approximately 1,100 patients have been treated with botensilimab and/or balstilimab 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. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, 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. 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 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. 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. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

欧洲肿瘤内科学会亚洲年会（ESMO ASIA）是专门关注亚洲地区多学科肿瘤学的年度盛会，旨在为参会者提供一个平台，以分享和讨论该领域的最新研究结果、临床试验和治疗策略。2024年欧洲肿瘤内科学会亚洲年会（ESMO Asia）大会上，贝达药业BPI-371153等研究以优选口头报告形式公布了最新进展。 中国医学科学院肿瘤医院杨建良教授口头报告BPI-371153进展 BPI-371153是一种口服小分子PD-L1抑制剂，可诱导PD-L1的二聚化和内吞，从而降低细胞膜上的PD-L1水平，有效地破坏PD-1/PD-L1的相互作用。研究共纳入20例患者，包括16例实体瘤患者（11例NSCLC）和4例淋巴瘤患者，其中70%的患者既往接受过≥2线系统性抗肿瘤治疗，包括抗PD-(L)1治疗。剂量递增范围为100-1600 mg，每天一次（QD）给药，主要终点是安全性、耐受性和药代动力学。截止到2024年4月26日，本研究中未发生剂量限制毒性，未达到最大耐受剂量。BPI-371153安全性良好，≥3级的TRAE发生率仅15%。常见的药物相关不良事件包括腹泻、呕吐、腹痛和ALT升高，大多数为1-2级，安全性可控。未观察到导致降低剂量、永久停药或死亡的TRAE发生。在≥600mg剂量组中观察到初步的抗肿瘤活性，4例患者达到肿瘤缓解，其中肺腺癌1例CR，非小细胞肺癌或霍奇金淋巴瘤3例PR。BPI-371153特别是在PD-L1高表达或TMB-H患者中观察到更显著的疗效，且既往接受过免疫检查点抑制剂治疗的患者接受BPI-371153仍可获益。综上，BPI-371153在晚期实体瘤或r/r淋巴瘤中表现出可控的安全性、良好的药代动力学特征和有前景的抗肿瘤活性。 中国医学科学院肿瘤医院安菊生教授口头报告Balstilimab单药或与zalifrelimab联合治疗宫颈癌进展 大会还报告了Balstilimab单药治疗和Balstilimab联合Zalifrelimab在PD-L1阳性、复发或转移性宫颈癌症临床研究情况，显示出良好的临床疗效和可控的安全性。 关于项目研究团队 BPI-371153项目主要研究者：中国医学科学院肿瘤医院石远凯教授；助理研究者：杨建良教授。 Balstilimab单药或与zalifrelimab联合治疗宫颈癌项目主要研究者：中国医学科学院肿瘤医院吴令英教授；助理研究者：安菊生教授。