BI-765063

BI 765063联合细胞程序性死亡蛋白-1（PD1）抑制剂ezabenlimab+西妥昔单抗证实，在复发/转移性（R/M）头颈部鳞状细胞癌（HNSCC）患者的二线治疗中表现出耐受性良好的安全性特征和潜在显著的有效性信号。在晚期实体瘤患者中开展的剂量递增试验显示，新一代SIRPα抑制剂BI 770371在单药治疗和与PD1抑制剂ezabenlimab联合使用中均表现出良好的耐受性。目前在一项针对R/M HNSCC一线患者的1b期研究中，BI 770371正在被进一步深入研究。近日，勃林格殷格翰宣布，靶向信号调节蛋白α（SIRPα）先天性免疫检查点的两项早期试验的最新临床数据将于2025年5月30日至2025年6月3日在美国芝加哥举办的2025年美国临床肿瘤学会（ASCO）年会上公布。勃林格开展的一项Ib期研究中，其潜在同类首创SIRPα单克隆抗体BI 765063联合PD-1抑制剂ezabenlimab和西妥昔单抗，在复发/转移性（R/M）头颈部鳞状细胞癌（HNSCC）患者的治疗中表现出可控的安全性，且有激活免疫并叠加抗肿瘤活性的初步迹象。1此外，勃林格开展的一项开放性、I期试验显示，其新一代SIRPα单克隆抗体BI 770371在单药治疗和联合PD-1抑制剂ezabenlimab时，在晚期实体瘤患者中展现出良好的耐受性。两种治疗方式均未出现剂量限制性毒性，且均未达到最大耐受剂量。2Mike Akimov勃林格殷格翰肿瘤治疗领域医学负责人这些早期项目的初步结果令人鼓舞，并进一步加强了勃林格殷格翰稳健的免疫肿瘤产品管线。这一产品管线旨在加速开发新一代肿瘤疗法，以解决高度未满足的患者需求。勃林格正在开发各种互补的方法来激活免疫系统对抗癌细胞，SIRPα阻断联合PD-1抑制剂是一种极具潜力的策略。随着研发项目的推进，我们期待看到这种双重激活机制能否诱发更广泛、更持久的抗肿瘤效应。BI 765063和BI 770371旨在阻断癌细胞用来逃避免疫系统识别的“别吃我”信号。通过靶向SIRPα，这些抗体帮助免疫细胞（如巨噬细胞）识别并破坏肿瘤细胞，从而增强机体的自然防御能力。3这两种抗体的开发均与OSE合作进行，勃林格将全权负责未来的临床开发和商业化。勃林格将继续推进新一代SIRPα抑制剂抗体BI 770371的研发，该抗体目前正在一项Ib期研究中评估。报告详情标题：一项评估SIRPα抑制剂BI 765063联合PD-1抑制剂Ezabenlimab和西妥昔单抗治疗头颈部鳞状细胞癌患者的开放性、Ib期试验摘要编号：6019会议类型/标题：快速口头摘要-开发治疗-免疫治疗日期/时间：2025年6月1日，11:30–13:30标题：一项评估SIRPα单克隆抗体BI 770371单药治疗以及联合PD-1抑制剂Ezabenlimab治疗晚期实体瘤患者的开放性、I期试验摘要编号：2515会议类型/标题：快速口头摘要-开发治疗-免疫治疗日期/时间： 2025年6月1日，11:15 –12:45向右滑动查看更多关于OSE Immunotherapeutics作为一家专注于肿瘤免疫（IO）与免疫炎症（I&I）领域首创疗法开发的生物技术公司，OSE Immunotherapeutics致力于解决当前及未来未满足的临床需求。我们与顶尖学术机构及生物制药企业合作，共同开发并上市针对重大疾病的变革性疗法。公司总部位于南特和巴黎之间，并在泛欧洲交易所上市。有关OSE Immunotherapeutics产品的更多信息，请访问公司网站：www.ose-immuno.com。点击并在LinkedIn关注我们。参考文献[1] An open-label, phase Ib trial of the SIRPα inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma. - ASCO[2] An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors. - ASCO[3] Lopez-Yrigoyen, M., et al.(2017).Anti-SIRPα antibody immunotherapy enhances neutrophil and macrophage antitumor activity.Proceedings of the National Academy of Sciences, 114(33), 201710877. https://doi.org/10.1073/pnas.1710877114*:contentReference[oaicite:2]{index=2}医学审批号：MPR-CN-101980

· BI 765063 in combination with programmed cell death-1 (PD1) inhibitor antibody ezabenlimab + cetuximab demonstrated a well-tolerated safety profile and potentially promising efficacy signals as second-line treatment in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). · Next generation SIRP α inhibitor BI 770371 was shown to be well tolerated alone and in combination with PD1 inhibitor ezabenlimab in a dose escalation trial in patients with advanced solid tumors. BI 770371 is currently being further investigated in a Phase 1b study in first-line patients with R/M HNSCC. Ingelheim, Germany, 22 May 2025 – Boehringer Ingelheim today announced that new clinical data from two early-stage trials targeting the signal regulatory protein α (SIRP α ) innate immune checkpoint will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 - June 3, 2025, in Chicago, IL, USA. In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRP α monoclonal antibody, BI 765063, demonstrated a manageable safety profile as well as preliminary signs of immune activation and additive antitumor activity when combined with PD-1 inhibitor ezabenlimab and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). [1] Additionally, in an open-label, Phase I trial conducted by Boehringer, its next-generation SIRP α monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab, was shown to be well tolerated in patients with advanced solid tumors. There were no dose-limiting toxicities in either treatment arm, and the maximum tolerated dose was not reached in either group. [2] “The preliminary results from these early-stage programs are encouraging and further strengthen Boehringer’s robust immuno-oncology pipeline aimed at accelerating next-generation cancer therapies to address high unmet patient needs,” said Mike Akimov, Head of Medicine, Therapy Area Oncology at Boehringer Ingelheim. “Boehringer is developing various complementary approaches to activate the immune system against cancer cells and SIRP α blockade paired with a PD-1 inhibitor is a promising strategy. We look forward to seeing if this dual activation may lead to a broader and more sustained anti-tumor response as the programs progress. ” BI 765063 and BI 770371 are designed to block the “don’t eat me” signal that cancer cells use to hide from the immune system. By targeting SIRP α , these antibodies help immune cells like macrophages recognize and destroy tumor cells, bolstering the body’s natural defenses. [3] Both antibodies have been developed in partnership with OSE, with Boehringer solely responsible for future clinical development and commercialization. Boehringer will move forward with the improved next generation SIRP α inhibitor antibody BI 770371, which will now be tested in a Phase 1b study. Presentation Details: Title: An Open-Label, Phase Ib Trial of the SIRP α Inhibitor BI 765063 in Combination with the PD-1 Inhibitor Ezabenlimab and Cetuximab in Patients (pts) with Head and Neck Squamous Cell Carcinoma ​ Abstract Number: 6019 Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – Immunotherapy Date/Time: 01 June 2025 – 11:30am – 1:30pm CDT Title: An Open-label, Phase I Trial of the SIRP α Monoclonal Antibody, BI 770371, Alone and in Combination with the PD-1 Inhibitor Ezabenlimab in Patients with Advanced Solid Tumors Abstract Number: 2515 Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – Immunotherapy Date/Time: 01 June 2025 – 11:15am – 12:45pm CDT Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer Ingelheim takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,500 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com (Global). OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com . Click and follow us on LinkedIn. Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Contacts Boehringer Ingelheim Linda Ruckel +1 203-791-6672 linda.ruckel@boehringer-ingelheim.com Reinhard Malin +49 (6132) 77-90815 reinhard.malin@boehringer-ingelheim.com OSE Immunotherapeutics Fiona Olivier fiona.olivier@ose-immuno.com Sylvie Détry sylvie.detry@ose-immuno.com French Media Contact FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 U.S. Media Contact Rooney Partners LLC Kate Barrette kbarrette@rooneypartners.com +1 212 223 0561 [1] An open-label, phase Ib trial of the SIRP α inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma. - ASCO [1] An open-label, phase I trial of the SIRP α monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors. - ASCO [3] Lopez-Yrigoyen, M., et al. (2017). Anti-SIRP α antibody immunotherapy enhances neutrophil and macrophage antitumor activity. Proceedings of the National Academy of Sciences, 114(33), 201710877. https://doi.org/10.1073/pnas.1710877114*:contentReference[oaicite:2]{index=2} Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.