Boehringer Ingelheim and OSE Immunotherapeutics advance clinical development of first-in-class SIRP cancer immunology treatment BI 770371

勃林格殷格翰和OSE免疫疗法促进一流SIRP癌症免疫治疗BI 770371的临床开发

Ingelheim, Germany and Nantes, France, 3 July 2024 – Today Boehringer Ingelheim and OSE Immunotherapeutics SA (OSE), a clinical stage biotech company (ISIN: FR0012127173; Mnemo: OSE), announced that Boehringer will be progressing their first-in-class SIRPα immuno-oncology program into the next phase in clinical development.

德国英格翰和法国南特，2024年7月3日——今天，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，勃林格殷格翰将把他们的第一个一流SIRPα免疫肿瘤学计划推进临床开发的下一阶段。

As part of the program, Boehringer will move forward with an improved next generation SIRPα inhibitor antibody, which will now be tested in a Phase 1b study..

作为该计划的一部分，勃林格将推出改进的下一代SIRPα抑制剂抗体，该抗体现在将在1b期研究中进行测试。。

Immuno-oncological therapies achieve sustained remission only in 15-20% of all cases of cancer. Boehringer Ingelheim is on a mission to significantly increase this share. With its immuno-oncology research, Boehringer is developing various complementary approaches to activate the immune system against cancer cells.

免疫肿瘤疗法仅在所有癌症病例的15-20%中实现持续缓解。勃林格殷格翰的使命是大幅提高这一份额。通过其免疫肿瘤学研究，勃林格正在开发各种互补方法来激活针对癌细胞的免疫系统。

Blocking the SIRPα immune checkpoint is one of these approaches..

阻断SIRPα免疫检查点是这些方法之一。。

“We are very excited about progressing the SIRPα program which was initiated by OSE.” said Vittoria Zinzalla, Global Head of Translational Medicine and Clinical Pharmacology at Boehringer Ingelheim. “With the positive data from our first clinical studies and the switch to an improved antibody we hope to achieve our aim of accelerating and expanding our pipeline of first-in-class cancer therapies to transform the lives of patients affected by cancer.”.

勃林格殷格翰转化医学和临床药理学全球负责人维托里亚·津扎拉（Vittoria Zinzalla）表示：“我们对OSE发起的SIRPα计划取得进展感到非常兴奋。”。。

Nicolas Poirier, CEO of OSE Immunotherapeutics, commented: “We are thrilled to see the SIRPα project moving forward in clinical development in immuno-oncology and the expansion in CRM diseases. This brings us one step closer to achieving our aim of providing this selective SIRPα innovation for the benefit of more patients.”.

OSE Immunotherapeutics首席执行官尼古拉斯·波里耶（Nicolas Poirier）评论道：“我们很高兴看到SIRPα项目在免疫肿瘤学的临床开发和CRM疾病的扩展方面取得进展。这使我们离实现提供这种选择性SIRPα创新以造福更多患者的目标又近了一步。”。

SIRPα is a receptor expressed on macrophages, which can recognize, engulf, and destroy cancer cells. The binding of this receptor to its binding partner, cluster of differentiation 47 (CD47), stops this immune activity. This is why many cancer cells display CD47 on their surface to escape detection and destruction by the immune system.

SIRPα是巨噬细胞上表达的受体，可以识别，吞噬和破坏癌细胞。该受体与其结合伴侣分化簇47（CD47）的结合阻止了这种免疫活性。这就是为什么许多癌细胞在其表面显示CD47以逃避免疫系统的检测和破坏。

Blocking SIRPα enables macrophages to enhance their immune activity and destroy cancer cells..

。。

Boehringer Ingelheim is further strengthening its comprehensive immuno-oncology pipeline with the progression of this program to accelerate next-generation cancer therapies to address high unmet patient needs. Boehringer will be solely responsible for all further development and potential future commercialization..

勃林格殷格翰正在进一步加强其全面的免疫肿瘤学管道，该计划的进展将加速下一代癌症治疗，以满足高度未满足的患者需求。勃林格将全权负责所有进一步的开发和未来潜在的商业化。。

About Boehringer Ingelheim

关于勃林格殷格翰

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.

勃林格殷格翰（BoehringerIngelheim）正在研究突破性疗法，以改变当今和子孙后代的生活。作为一家领先的研究驱动型生物制药公司，该公司通过在高度未满足医疗需求领域的创新创造价值。勃林格殷格翰公司成立于1885年，自成立以来一直为家族所有，从长远和可持续的角度出发。

More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more www.boehringer-ingelheim.com.

超过53000名员工服务于人类制药和动物健康两个业务部门的130多个市场。了解更多信息www.boehringer-ingelheim.com。

About OSE Immunotherapeutics

关于OSE免疫疗法

OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I).

OSE Immunotherapeutics是一家生物技术公司，致力于开发免疫肿瘤学（IO）和免疫炎症（I＆I）领域的一流资产。

The Company’s current well-balanced first-in-class clinical pipeline includes:

该公司目前平衡良好的一流临床渠道包括：

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.

Tedopi®（免疫疗法激活肿瘤特异性T细胞，现成，基于新表位）：这种癌症疫苗是该公司最先进的产品；检查点抑制剂失败后继发耐药的非小细胞肺癌患者的3期临床试验（Atalante 1）的阳性结果。

Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors..

由临床肿瘤学小组赞助的Tedopi®联合其他2期临床试验正在实体瘤中进行。。

OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors.

OSE-279（抗PD1）：实体瘤正在进行的1/2期的首次阳性结果。

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).

OSE-127-lusvertikimab（IL-7受体的人源化单克隆抗体拮抗剂）；正在进行的溃疡性结肠炎第二阶段（赞助商OSE免疫治疗）；正在进行的白血病临床前研究（OSE免疫治疗）。

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.).

FR-104/VEL-101（抗CD28单克隆抗体）：与Veloxis Pharmaceuticals，Inc.在移植中合作开发；正在进行的肾移植1/2期（赞助南特大学医院）；美国成功的第一阶段（赞助商Veloxis Pharmaceuticals，Inc.）。

Anti-SIRPα monoclonal antibody developed in partnership with Boehringer Ingelheim in advanced solid tumors and cardiovascular-renal-metabolic diseases (CRM); positive Phase 1 dose escalation results in monotherapy and in combination; Phase 2 in CRM diseases planned to be initiated end of 2024.

与勃林格殷格翰合作开发的抗SIRPα单克隆抗体用于晚期实体瘤和心血管肾代谢疾病（CRM）；阳性1期剂量递增导致单药治疗和联合治疗；CRM疾病的第二阶段计划于2024年底启动。

ABBV-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation.

ABBV-230（ChemR23激动剂mAb）与AbbVie在慢性炎症中合作开发。

OSE Immunotherapeutics expects to generate further significant value from its four proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies:

OSE Immunotherapeutics预计将从其四个专有药物发现平台中产生更大的价值，这是其提供下一代一流免疫疗法的宏伟目标的核心：

Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. ABBV-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs..

ProResolution mAb平台专注于靶向和推进炎症消退，并优化I＆I中靶向中性粒细胞和巨噬细胞的治疗潜力。ABBV-230（授权给AbbVie）是该平台产生的第一个候选药物，新的ProResolution GPCR正在进行其他发现程序。。

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 770371 (licensed to Boehringer Ingelheim) is the most advanced candidate from this platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs. .

骨髓检查点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中骨髓细胞的治疗潜力。BI 770371（授权给勃林格殷格翰）是该平台上最先进的候选人。正在进行的其他发现计划，特别是在使用新的抗CLEC-1单克隆抗体的单一疗法中获得了积极的临床前结果。。。

BiCKI® Platform is a bifunctional fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy by “cis-potentiating” tumor-specific T cells. A first program has been acquired by Boehringer Ingelheim.

BiCKI®平台是一种双功能融合蛋白平台，构建在抗PD1的关键骨架成分上，结合新的免疫治疗靶标，通过“顺式增强”肿瘤特异性T细胞来提高抗肿瘤功效。勃林格殷格翰（BoehringerIngelheim）收购了第一个项目。

mRNA Therapeutic platform allows local delivery into the inflammatory site of innovative immunotherapies encoded by RNA to locally controls and/or suppress immune responses and inflammation.

mRNA治疗平台允许局部递送到由RNA编码的创新免疫疗法的炎症部位，以局部控制和/或抑制免疫应答和炎症。

Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn

Contacts

联系人

Boehringer Ingelheim

勃林格殷格翰

T

T

+49 (6132) 77-90815

+49 (6132) 77-90815

reinhard.malin@boehringer-ingelheim.com

reinhard.malin@boehringer-ingelheim.com

Boehringer Ingelheim

勃林格殷格翰

Binger Str. 173

Binger街173号

55218 Ingelheim am Rhein

55218 Ingelheim am Rhein

More information

更多信息

boehringer-ingelheim.com

勃林格英格海姆网站

OSE Immunotherapeutics

OSE免疫疗法

Sylvie Détry

西尔维·德特里

sylvie.detry@ose-immuno.com

sylvie.detry@ose-immuno.com

Nicolas Poirier

尼古拉斯·波里耶

Chief Executive Officer nicolas.poirier@ose-immuno.com

首席执行官nicolas.poirier@ose-immuno.com

French Media: FP2COM

法国媒体：FP2COM

Florence Portejoie

佛罗伦萨Portejoie

fportejoie@fp2com.fr

fportejoie@fp2com.fr

+33 6 07 768 283

+33 6 07 768 283

U.S. Media Contact

U、 美国媒体联系人

RooneyPartners LLC

RooneyPartners有限责任公司

Kate Barrette

凯特·巴雷特

kbarrette@rooneypartners.com>

kbarrette@rooneypartners.com>

+1 212 223 0561

+1 212 223 0561

Forward-looking statements

前瞻性声明

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. .

本新闻稿包含明确或暗示的信息和声明，这些信息和声明可能被视为OSE免疫治疗方面的前瞻性信息和声明。它们不构成历史事实。。。。

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.

这些前瞻性陈述包括通常使用条件句的陈述，其中包含动词，如“expect”、“prespect”、“believe”、“target”、“plan”或“estimate”，它们的词尾和词缀以及类似含义的单词。尽管OSE Immunotherapeutics管理层认为前瞻性声明和信息是合理的，但OSE Immunotherapeutics的股东和其他投资者应注意，此类预期的完成本质上受到各种风险的影响，无论是否已知，以及难以预测且通常超出OSE Immunotherapeutics控制的不确定性。

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.

这些风险可能导致实际结果和发展与前瞻性声明中表达、暗示或预测的结果和发展存在重大差异。这些风险包括OSE Immunotherapeutics向AMF提交的公开文件中讨论或确定的风险。这种前瞻性陈述并不能保证未来的表现。

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..

本新闻稿仅包含摘要信息，应与2024年4月30日向AMF提交的OSE Immunotherapeutics通用注册文件一起阅读，包括OSE Immunotherapeutics网站上提供的2023财年年度财务报告。除适用法律要求外，OSE Immunotherapeutics于本新闻稿发布之日发布本新闻稿，不承担更新或修订前瞻性信息或声明的任何义务。。

Attachment

附件

EN_240703_OSE-BI SIRPa

EN_240703_OSE-BI SIRPa