Brightline-3: A Phase III, Randomized, Open-label, Multi-center Trial of Brigimadlin + Ezabenlimab Compared to Gemcitabine + Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma Subtypes

This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.
Participants are put into 3 groups by chance:
* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks
* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.
There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.
Participants can continue treatment in the study as long as they benefit from it and can tolerate it.
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing.

开始日期2024-06-27

申办/合作机构

Boehringer Ingelheim GmbH

NCT06091930

/ Recruiting临床1期

Phase I, Non-randomised, Open-label, Multi-centre Dose Escalation and Expansion Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Repeated Intravenous Infusion in Asian Patients With Malignant Solid Tumours Expressing B7-H6

This is a study in adults from Asia with different types of advanced cancer (solid tumours). People can join the study if they have cancer of the stomach, large bowel and rectum, pancreas, liver, head and neck or non-small cell lung cancer. This is a study for people for whom previous treatment was not successful or no treatment exists. People can participate if their tumour has the B7-H6 marker.
The purpose of this study is to find the highest dose of BI 765049 that people with advanced cancer can tolerate when taken (alone and) together with ezabenlimab. Another purpose is to check whether BI 765049 taken (alone and) together with ezabenlimab can make tumours shrink. Both medicines may help the immune system fight cancer.
Participants can stay in the study up to 3 years, as long as they can tolerate it and can benefit from it. During this time, they visit the study site about every 3 weeks. At the study site they get BI 765049 alone or in combination with ezabenlimab as an infusion into a vein. BI 765049 is given in 3-week cycles, ezabenlimab is given once every 3 weeks.
The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body.

开始日期2024-02-16

申办/合作机构

Boehringer Ingelheim GmbH

NCT06084689

/ Not yet recruiting临床2期IIT

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

开始日期2024-01-01

申办/合作机构

Institut Bergonié

[+1]

100 项与 Ezabenlimab 相关的临床结果

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100 项与 Ezabenlimab 相关的转化医学

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100 项与 Ezabenlimab 相关的专利（医药）

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项与 Ezabenlimab 相关的文献（医药）

2025-01-14·Future Oncology

Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors

Article

作者: Gutierrez, Martin E. ; Schmohl, Michael ; Harrington, Kevin ; Barrueco, José ; Fernandez, Natalia ; Berz, David ; LoRusso, Patricia ; Kitano, Shigehisa ; Doi, Toshihiko ; Moreno, Irene ; Gambardella, Valentina ; Alonso, Guzman ; Parkes, Eileen E.

BI 1703880, a novel STimulator of INterferon Genes (STING) agonist, has demonstrated preclinical antitumor activity. As STING activation can upregulate programmed death ligand 1 and human leukocyte antigen in tumor cells, a combination of BI 1703880 and an anti-programmed cell death protein 1-antibody, such as ezabenlimab, may improve efficacy. This first-in-human phase Ia study (NCT05471856) is evaluating BI 1703880 plus ezabenlimab in patients with advanced solid tumors. The study utilizes an innovative lead-in design; all patients receive BI 1703880 monotherapy in Cycle 1 and combination therapy from Cycle 2. The primary endpoint is dose-limiting toxicities during the maximum tolerated dose evaluation period. Results will inform the future development of BI 1703880 for treatment of metastatic or recurrent malignancies.Clinical Trial number: NCT05471856.

2024-07-01·Ophthalmology and therapy

RETRACTED ARTICLE: Cystoid Macular Oedema in a Patient Treated with STING Agonist and Ezabenlimab for Disseminated Melanoma

Article

作者: Kiraly, Peter ; Fischer, M Dominik

INTRODUCTION:

We describe a case of cystoid macular oedema associated with combination treatment using a STING agonist and ezabenlimab for disseminated melanoma.

CASE REPORT:

A 66-year-old male patient presented with worsening vision and cystoid macular oedema in the right eye, along with a small accumulation of subretinal fluid in the left eye. The patient has been undergoing treatment for melanoma since 2014. Five months prior to the ocular presentation, the patient was enrolled in a first-in-human trial with a STING agonist and ezabenlimab. Topical treatment with dexamethasone 0.1% drops and ketorolac 0.5% drops was prescribed, and he continued with systemic immunotherapy. After 6 weeks, morphological and functional improvement was noted; however, cystoid macular oedema persisted. Consequently, systemic immunotherapy was temporarily suspended. After an additional 4 weeks, cystoid macular oedema regressed in the right eye and subretinal fluid completely resolved in the left eye.

CONCLUSIONS:

In the first-in-human trial with a STING agonist and ezabenlimab for melanoma, cystoid macular oedema emerged as a notable ocular side effect with vision worsening. This case highlights the importance of careful ocular monitoring in patients receiving this combination therapy. The cGAS-STING pathway is an important target for future research in treating ocular inflammatory conditions.

2023-06-01·Cancer chemotherapy and pharmacology

Phase I study of the VEGF/Ang-2 inhibitor BI 836880 alone or combined with the anti-programmed cell death protein-1 antibody ezabenlimab in Japanese patients with advanced solid tumors.

Article

作者: Sarashina, Akiko ; Kawakami, Takeshi ; Koyama, Takafumi ; Shimizu, Toshio ; Hou, Jianrui ; Erzen, Damijan ; Yamamoto, Noboru ; Yamazaki, Kentaro ; Li, Bin ; Todaka, Akiko

PURPOSE:

This two-part, open-label, non-randomized dose-escalation study aimed to define the maximum tolerated dose (MTD) of BI 836880 (humanized bispecific nanobody® targeting vascular endothelial growth factor and angiopoietin-2) as monotherapy and in combination with ezabenlimab (programmed death protein-1 inhibitor) in Japanese patients with advanced and/or metastatic solid tumors.

METHODS:

In part 1, patients received an intravenous infusion of BI 836880 at 360 or 720 mg every 3 weeks (Q3W). In part 2, patients received BI 836880 at doses of 120, 360, or 720 mg in combination with ezabenlimab 240 mg Q3W. The primary endpoints were the MTD and the recommended phase II dose (RP2D) of BI 836880 as monotherapy and in combination with ezabenlimab, based on dose-limiting toxicities (DLTs) during the first cycle.

RESULTS:

Twenty-one patients were treated; nine in part 1 and 12 in part 2. No DLTs were reported in either part and the MTD was not reached. The RP2Ds were BI 836880 720 mg Q3W as monotherapy and BI 836880 720 mg plus ezabenlimab 240 mg Q3W. The most common adverse events were hypertension and proteinuria (33.3%) with BI 836880 monotherapy and diarrhea (41.7%) with the combination. Four patients (44.4%) in part 1 had stable disease as best overall tumor response. In part 2, two patients (16.7%) had confirmed partial responses and five had stable disease (41.7%).

CONCLUSION:

MTD was not reached. BI 836880 alone and in combination with ezabenlimab had a manageable safety profile with preliminary clinical activity in Japanese patients with advanced solid tumors.

TRIAL REGISTRATION AND DATE:

NCT03972150, registered on June 3, 2019.

项与 Ezabenlimab 相关的新闻（医药）

2024-07-03

·Pharmaceutical Technology

AbbVie licenses OSE’s chronic inflammation therapy for $48m upfront

OSE-230 is a ChemR23, a G-Protein coupled receptor (GPCR) targeting monoclonal antibody. Image Credit: Poetra.RH / Shutterstock. AbbVie has signed a partnership and licensing agreement with OSE Immunotherapeutics for the latter’s monoclonal antibody OSE-230 in a deal worth up to $713m. OSE-230 is a monoclonal antibody that targets ChemR23, a G-Protein coupled receptor (GPCR). The therapy can potentially resolve chronic inflammation and modulate the function of macrophages and neutrophils. It is currently in preclinical development. Following the news, OSE’s stock was up by more than 55% in trading today. The French pharmaceutical company’s market cap stands at $111.2m. Under the collaboration agreement, AbbVie will pay $48m in upfront payment for the exclusive global licence of the therapy. OSE will also be in line to receive up to $665m in milestone-based payments along with tiered royalties on net sales. OSE has a pipeline of multiple monoclonal antibody candidates that it is developing in collaboration with other pharmaceutical companies. The company is developing two signal regulatory protein α (SIRPα) targeting monoclonal antibodies—BI 765063/ OSE-172 and BI 770371—in collaboration with Boehringer Ingelheim. BI 765063 is being evaluated as a combination therapy with different cancer therapies such as Boehringer’s ezabenlimab, BI 836880, chemotherapy, and Eli Lilly’s Erbitux (cetuximab) in a Phase I trial (NCT05249426). BI 770371 is being evaluated as a monotherapy and in combination with a PD1 inhibitor, BI 754091, in an international Phase I dose escalation and expansion trial (NCT05327946) in patients with solid tumours. OSE is also developing an anti-CD28 selective monoclonal antibody FR104/VEL-101 in partnership with Denmark-based Veloxis Pharmaceuticals. It is being researched as a treatment to help prevent organ rejection in people who have had a kidney transplant. In February 2022, the therapy received a fast track designation by the FDA for prophylaxis against transplant rejection. Veloxis is planning Phase II trials for the subcutaneous therapy. AbbVie has also made recent investments related to antibody therapies. In December 2023, it partnered with BigHat Biosciences to identify and develop antibody therapies in oncology and neuroscience indications. On a larger scale, in November 2023, AbbVie announced a $10.1bn ImmunoGen acquisition deal. The antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) was a central part of the deal. The therapy was granted priority review by the US Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024.

临床1期引进/卖出优先审批快速通道抗体药物偶联物

2024-06-04

·美通社

勃林格殷格翰与OSE Immunotherapeutics扩大合作，开发肿瘤和心肾代谢疾病同类首创疗法

2024年5月31日 -- 近日，勃林格殷格翰和临床阶段生物技术公司OSE Immunotherapeutics SA (OSE)（ISIN：FR0012127173；Mnemo：OSE）宣布扩大合作。两个开发同类首创疗法的新项目将被添加到正在进行的抗 SIRPα肿瘤免疫项目中。第一个项目涉及扩大对已合作资产的治疗评估以覆盖更多患者，另一个涉及新资产收购：对抗SIRPα肿瘤免疫化合物BI 765063和BI 770371现有合作和许可协议进行了修订，这些化合物正在开展针对晚期实体瘤的I期临床研究，现在还将被用于在心肾代谢疾病中（CRM）进行开发研究。将通过资产收购启动基于OSE的cis靶向抗PD1/细胞因子平台的免疫细胞激活疗法的临床前项目。全球超过10亿人的生命受到CRM疾病影响，每年导致 2000 万人死亡。CRM疾病相互关联、共存，并且可以相互放大，给患者的生活造成重大负担。肿瘤导致近 1000 万人死亡，对于许多肿瘤患者来说，没有或只有有限的治疗选择。新的开发项目加强了勃林格殷格翰的产品管线，并体现了公司坚定不移的承诺，致力于探索和开发新疗法以满足患者的未尽需求，包括 CRM 疾病和肿瘤。cis靶向抗PD1/细胞因子平台资产将进一步丰富勃林格殷格翰一系列新型潜在免疫调节肿瘤疗法。正在进行的抗SIRPα化合物的新适应症开发加强了公司全面的CRM产品管线，并计划在今年晚些时候启动2期临床研究。勃林格殷格翰高级副总裁、全球发现研究负责人 Clive R. Wood 表示："我们非常高兴能够扩大我们潜在的同类首创 CRM 疾病产品管线，以及我们同类首创的基于 T 细胞的抗肿瘤疗法产品管线。与 OSE 扩大合作体现了我们的共同使命，那就是改善受到全球两大最威胁健康疾病患者的预后。" OSE Immunotherapeutics首席执行官 Nicolas Poirier 表示："我们对于将两个高度创新的新开发项目添加到我们与勃林格殷格翰已有的、富有成果的合作中感到兴奋。我们期待与勃林格殷格翰的科学家合作开展新的开发项目，这些项目有可能为 CRM 疾病和肿瘤患者带来新的突破性治疗选择。" OSE Immunotherapeutics将收到 1350万欧元的预付款，以及潜在的1750 万欧元近期里程碑付款，用于购买处于临床前阶段的新型cis靶向抗 PD-1/细胞因子资产。关于两项正在进行的抗 SIRPα项目BI 765063 和 BI 770371，双方达成部分特许权买断协议，勃林格殷格翰同意一次性支付 2530 万欧元。此外，勃林格殷格翰还将获得在进一步开发过程中进行额外收购的选择权，触发一次性付款并增加销售里程碑付款。所有其他约定的开发、监管和销售里程碑支付，最高可达11亿欧元，仍按照双方在初始协议下达成的协议保持不变。勃林格殷格翰是全球领先的生物制药企业，布局人用药品、动物保健两大业务领域。公司研发投入位居行业前列，致力于研究突破性疗法，解决巨大未满足的医疗需求，从而帮助改善或延长生命。自1885年成立以来，勃林格殷格翰一直是独立的家族企业，始终着眼长远发展，将可持续发展理念贯穿全价值链。公司在全球有超过5.35万名员工，服务逾130个市场，致力于打造一个更健康、更可持续、更公平的未来。更多详情，请访问：www.boehringer-ingelheim.com OSE Immunotherapeutics 是一家生物技术公司，致力于开发免疫肿瘤 (IO) 和免疫炎症 (I&I) 领域的同类首创资产。公司当前均衡的同类首创临床管线包括： Tedopi®（激活肿瘤特异性 T 细胞的免疫疗法，即用型，基于新表位）：这种肿瘤疫苗是该公司最先进的产品；在检查点抑制剂治疗失效后出现继发性耐药的非小细胞肺癌患者中开展的 3 期临床试验（Atalante 1）取得了积极结果。由临床肿瘤团队赞助的 Tedopi® 2 期临床试验联合治疗实体瘤正在进行中。 OSE-279（抗PD-1）：正在开展的针对实体瘤的1\/2 期临床试验已取得积极结果。 OSE-127 - lusvertikimab（IL-7 受体的人源化单克隆抗体拮抗剂）；正在开展针对溃疡性结肠炎 2 期临床试验（ OSE Immunotherapeutics赞助）；正在开展针对白血病临床前研究（OSE Immunotherapeutics）。 FR-104\/VEL-101（抗CD28单克隆抗体）：与Veloxis Pharmaceuticals, Inc.合作开发移植治疗；正在开展针对肾移植的1\/2 期临床试验（南特大学医院赞助）；在美国成功完成1期临床试验（ Veloxis Pharmaceuticals, Inc.赞助）。与勃林格殷格翰合作开发 BI 765063 和 BI 770371（CD47\/SIRPα 通路上的抗 SIRPα 单克隆抗体）用于治疗晚期实体瘤；在单药疗法和联合疗法中，特别是与抗PD-1抗体ezabenlimab一起，呈现出积极的第一阶段剂量递增结果。现在正在开展国际 1b 期临床试验，单独连用ezabenlimab 或与其他药物联用治疗复发\/转移性头颈鳞状细胞癌 (HNSCC) 和肝细胞癌 (HCC) 患者。 OSE-230（ChemR23 激动剂单克隆抗体）与 AbbVie 合作开发，用于治疗慢性炎症。 OSE Immunotherapeutics 期望进一步发掘其三个专有药物发现平台的重大价值，这些平台是公司实现提供下一代同类首创免疫疗法宏伟目标的核心： Pro-resolutive mAb平台专注于靶向和促进炎症消退，以及优化 I&I 中靶向中性粒细胞和巨噬细胞的治疗潜力。OSE-230（已授权给 AbbVie）是该平台生成的第一个候选药物，新的pro-resolutive GPCRs发现项目正在进行中。 Myeloid Checkpoint平台专注于通过靶向巨噬细胞和树突状细胞表达的免疫调节受体来优化 IO 中髓系细胞的治疗潜力。BI 765063 和 BI 770371（已授权给勃林格殷格翰）是该平台生成的最先进的候选药物。正在进行的其它研发项目，特别是在新的抗 CLEC-1 mAb 单药疗法中获得了积极的临床前结果。双功能检查点抑制剂\/细胞因子平台专注于利用I-O 和I&I 中细胞因子的顺式传递递送。BiCKI®是一个双功能融合蛋白平台，建立在抗PD1的关键骨架成分上，与新的免疫治疗靶点相结合，以提高抗肿瘤功效。内容来源于网络，如有侵权，请联系删除。

并购免疫疗法

2024-05-22

·BioSpace

OSE Immunotherapeutics and Boehringer Ingelheim expand collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases

OSE Immunotherapeuticsand Boehringer Ingelheim expand collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases Nantes, France - Ingelheim, Germany - 22 May 2024, 7:30am CET - Today OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and Boehringer Ingelheim announced a major expansion of their partnership. Two new projects to develop first-in-class treatments will be added to the ongoing anti-SIRPα immuno-oncology programs. The first involves broadening the therapeutic evaluation of an already partnered asset to reach more patients and the other a new asset acquisition: Reflecting an amendment of the existing collaboration and license agreement for the anti-SIRPα immuno-oncology compounds BI 765063 and BI 770371, which are being investigated in Phase I clinical studies in advanced solid tumors, development will now also be pursued in cardiovascular-renal-metabolic (CRM) diseases. A new preclinical program will be launched to develop immune-cell activating treatments based on OSE’s cis-targeting1 anti-PD1/cytokine platform via an asset acquisition. Affecting over one billion lives globally2, CRM diseases cause 20 million deaths annually. They are interconnected, co-exist, and can amplify one another, resulting in a significant burden on patients’ lives. Cancer accounts for nearly 10 million deaths and for many cancer patients there are no or only limited treatment options. The new development programs bolster Boehringer Ingelheim’s pipeline and reflects the company’s unwavering commitment to explore and progress new therapies to address unmet patient needs, including in CRM diseases and cancer. The cis-targeting anti-PD1/cytokine platform asset will further enrich Boehringer Ingelheim’s array of novel potential immune-modulatory cancer treatments. The development of the ongoing anti-SIRPα compounds for a new indication adds to the company’s comprehensive CRM pipeline with the initiation of a Phase 2 clinical study planned for later this year. “We are very pleased to expand our pipeline of potential first-in-class CRM disease therapies, as well as our pipeline of first-in-class T-cell based anti-cancer therapies,” said Clive R. Wood, Corporate Senior Vice President and Global Head of Discovery Research at Boehringer Ingelheim. “The expansion of our partnership with OSE reflects our joint mission to improving patient outcomes in two of the biggest threats to global health.” Nicolas Poirier, CEO of OSE Immunotherapeutics, commented: “We are excited about adding two highly innovative new development programs to our fruitful collaboration with Boehringer Ingelheim. We look forward to working with the scientists at Boehringer Ingelheim on the new development programs that have the potential to bring new breakthrough therapy options to patients with CRM diseases and cancer.” OSE Immunotherapeutics will receive EUR 13.5. million in upfront payment and a potential near-term milestone of EUR 17.5 million for the purchase of a novel, cis-targeting anti-PD-1/cytokine asset in preclinical stage. Regarding the two ongoing anti-SIRPα programs BI 765063 and BI 770371 the parties agreed on partial royalty buy-out monetizing with a one-time payment of EUR 25.3 million. Furthermore, Boehringer is granted an option for an additional buy-out during further development triggering a one-time payment plus the increase of one sales milestone. All other agreed development, regulatory and sales milestone payments of up to €1.1 billion remain as agreed between the parties under the initial agreement. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at . About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.). BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). OSE-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs. Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs. Cytokine platform focused on leveraging the Cis-Delivery of cytokine in IO and I&I. BiCKI® is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI®-IL-7v is the most advanced BiCKI® candidate targeting anti-PD1xIL-7. Ongoing additional discovery programs on Cis-Demasking technologies. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: . Follow us on X and LinkedIn Contacts Boehringer Ingelheim T +49 (6132) 77-90815 reinhard.malin@boehringer-ingelheim.com Boehringer Ingelheim Binger Str. 173 55218 Ingelheim am Rhein More information boehringer-ingelheim.com OSE Immunotherapeutics Sylvie Détry sylvie.detry@ose-immuno.com Nicolas Poirier Chief Executive Officer nicolas.poirier@ose-immuno.com French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 U.S. Media Contact RooneyPartners LLC Kate Barrette kbarrette@rooneypartners.com +1 212 223 0561 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 in light of 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. 1 Cis-targeting: Bispecific antibodies have the capability to target cells either in a cis- or in a trans-binding orientation. During trans-binding, the antibody recognizes two different antigens, each expressed on a different cell population, and can link two different cell populations with each other (e.g. T-cell engagers). Cis-binding bispecific antibody targets two antigens expressed on the very same cell enabling preferential activation of the desired immune cell types while minimizing the activation of others (Segués A. et al. International Review of Cell and Molecular Biology 2022). 2 Schechter M, Melzer Cohen C, Yanuv I, et al. Epidemiology of the diabetes-cardio-renal spectrum: a cross-sectional report of 1.4 million adults. Cardiovascular Diabetology. 2022;21(1):104. doi:10.1186/s12933-022-01521-9 Attachment EN_240522_OSE BI_agreement

免疫疗法临床1期临床结果引进/卖出临床3期

100 项与 Ezabenlimab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期软组织肉瘤	临床3期	-	Boehringer Ingelheim GmbH	2024-06-27
粘液样MFH	临床3期	-	Boehringer Ingelheim GmbH	2024-06-27
胆道癌	临床2期	法国	Boehringer Ingelheim GmbH	2024-01-01
错配修复缺陷或微卫星高度不稳定性结直肠癌	临床2期	法国	Boehringer Ingelheim GmbH	2024-01-01
软组织肉瘤	临床2期	法国	Boehringer Ingelheim GmbH	2024-01-01
三阴性乳腺癌	临床2期	法国	Boehringer Ingelheim GmbH	2024-01-01
大细胞神经内分泌肺癌	临床2期	日本	Boehringer Ingelheim GmbH	2023-07-28
大细胞神经内分泌肺癌	临床2期	比利时	Boehringer Ingelheim GmbH	2023-07-28
大细胞神经内分泌肺癌	临床2期	法国	Boehringer Ingelheim GmbH	2023-07-28
大细胞神经内分泌肺癌	临床2期	德国	Boehringer Ingelheim GmbH	2023-07-28

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03964233 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	26	BI 907828+ezabenlimab+BI 754111	廠觸顧淵觸願艱鹽壓廠(顧糧構鬱壓壓獵製鑰簾) = 選繭糧鏇淵顧鹹鬱範網壓觸鹹構積網鬱餘獵鹽 (廠顧顧艱築鹹餘廠鏇壓 ) 更多	积极	2022-06-02
				BI 907828+ezabenlimab	廠觸顧淵觸願艱鹽壓廠(顧糧構鬱壓壓獵製鑰簾) = 蓋蓋膚壓淵繭鑰鹽鹽鬱壓觸鹹構積網鬱餘獵鹽 (廠顧顧艱築鹹餘廠鏇壓 ) 更多
NCT03697304 (ASCO_GI2022)	临床2期	晚期结直肠腺癌	30	BI 836880 720 mg plus Ezabenlimab 240 mg	積網鏇憲淵繭構鑰壓製(築淵範齋壓膚選蓋鬱壓) = 鬱遞繭鏇憲鬱鬱簾醖願衊夢壓醖鹽壓範憲範繭 (鏇壓製鬱窪壓積顧窪觸 ) 更多	不佳	2022-01-19
NCT03468426 (ESMO2021) 人工标引	临床1期	肿瘤	215	BI 836880+ezabenlimab	襯糧淵淵餘製膚餘遞鑰(淵膚艱廠願獵襯餘壓鏇) = 糧餘鹽窪觸範衊網構膚淵獵繭憲選構衊鏇願願 (構顧鑰夢鏇築網遞憲蓋 ) 更多	积极	2021-09-16
NCT03697304 (ESMO2021) 人工标引	临床2期	晚期恶性实体瘤	60	BI 836880 720 mg+Ezabenlimab 240 mg (locally advanced/metastatic gastric/gastroesophageal adenocarcinoma with ≥1 prior treatment (anti-PD-[L]1 naïve))	繭顧鬱憲淵壓網艱築鹹(醖淵顧襯衊鑰觸齋艱齋) = 簾簾膚醖夢願遞顧簾願夢製選壓淵糧壓願簾醖 (鏇醖網繭夢遞艱窪廠壓 ) 更多	积极	2021-09-16
				BI 836880 720 mg+Ezabenlimab 240 mg (any advanced/metastatic solid tumours (except non-squamous NSCLC or melanoma) with prior anti-PD-(L)1 treatment, which progressed following at least stable disease (SD) for ≥4 months)	繭顧鬱憲淵壓網艱築鹹(醖淵顧襯衊鑰觸齋艱齋) = 襯顧膚蓋構夢願廠廠觸夢製選壓淵糧壓願簾醖 (鏇醖網繭夢遞艱窪廠壓 ) 更多
NCT03433898 \| NCT02952248 \| NCT03780725 (ESMO2021)	临床1期	晚期恶性实体瘤	111	Ezabenlimab 240 mg	鬱積選夢積齋構網遞齋(齋壓餘襯艱鑰築襯醖簾) = 選顧築鑰鹹衊願鹽淵鏇齋繭艱膚餘鹽夢鑰餘襯 (艱遞遞夢鹽襯網夢網遞 ) 更多	-	2021-09-16
NCT04046445 (KISIMA-01, ESMO_GI2021)	临床1期	结直肠癌 CEA \| Survivin \| Achaete-scute complex homolog 2 (ASCL2)	9	ATP128 alone	鑰顧鑰膚選醖顧蓋獵膚(繭選襯齋蓋齋醖餘餘範) = 願憲廠鹽觸衊衊糧蓋顧顧簾範憲壓選壓簾範繭 (觸網糧窪鹹鹹糧鹹蓋選, 25.3) 更多	积极	2021-07-03
				ATP128 + ezabenlimab	鑰顧鑰膚選醖顧蓋獵膚(繭選襯齋蓋齋醖餘餘範) = 鏇構糧網鑰築獵選鏇選顧簾範憲壓選壓簾範繭 (觸網糧窪鹹鹹糧鹹蓋選, 14.11) 更多
NCT03433898 (ASCO_GI 12021 \| ASCO_GI 22021) 人工标引	临床1期	食管癌 \| 胃食管交界处癌 \| 胃癌	73	BI 754091+BI 754111 (gastric/gastroesophageal junction cancer (Cohort A))	壓獵網廠鏇鹹積簾積膚(鬱壓糧襯網襯衊鏇鬱鑰) = 獵鹹鏇齋製繭繭淵選齋膚壓淵憲鏇壓壓顧顧壓 (構鏇鬱壓鏇襯鹹糧憲齋 ) 更多	积极	2021-01-20
				BI 754091+BI 754111 (esophageal cancer (Cohort B))	壓獵網廠鏇鹹積簾積膚(鬱壓糧襯網襯衊鏇鬱鑰) = 糧構製構膚壓鬱餘鹽鹽膚壓淵憲鏇壓壓顧顧壓 (構鏇鬱壓鏇襯鹹糧憲齋 ) 更多
NCT03468426 (ASCO 12020 \| ASCO 22020) 人工标引	临床1期	晚期非小细胞肺癌	12	BI 836880+BI 754091	襯構鹽鑰壓齋襯壓壓築(鏇選築夢選顧鹹醖願襯) = 1 pt (360 mg; G3 pulmonary embolism) 網積觸鹹選簾顧壓夢願 (築鏇構觸願醖鬱窪蓋選 ) 更多	积极	2020-05-29
NCT03433898 (ASCO 12020 \| ASCO 22020) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	121	BI 754091+BI 754111 (gastric/esophagogastric junction cancer)	網夢壓遞衊繭壓壓鹽窪(艱構獵範鹽積鬱觸蓋廠) = 製壓鏇蓋範鬱築構膚構積鹹遞鹹獵鹹糧蓋廠鬱 (齋構鏇壓遞鏇淵醖壓構 ) 更多	积极	2020-05-29
				BI 754091+BI 754111 (esophageal cancer)	網夢壓遞衊繭壓壓鹽窪(艱構獵範鹽積鬱觸蓋廠) = 願鏇糧衊鹹艱襯壓積憲積鹹遞鹹獵鹹糧蓋廠鬱 (齋構鏇壓遞鏇淵醖壓構 ) 更多