Hanmi Pharmaceutical announces Clinical Trial Collaboration with MSD to evaluate 'BH3120' in combination with KEYTRUDA in phase 1 clinical trial in patients with progressive or metastatic solid tumors

Hanmi Pharmaceutical宣布与MSD合作进行临床试验，以评估“BH3120”与KEYTRUDA联合用于进行性或转移性实体瘤患者的1期临床试验

SEOUL, South Korea, April 23, 2024 /PRNewswire/ -- Hanmi Pharmaceutical (KOSPI: 128940, CEO: Jae-Hyun Park), a leading biopharma company in Korea that focuses on research areas such as oncology, obesity/metabolism, and rare diseases, announced it has entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA)..

韩国首尔，2024年4月23日/PRNewswire/--韩国领先的生物制药公司Hanmi Pharmaceutical（KOSPI:128940，CEO:Jae Hyun Park）宣布，已与MSD（美国新泽西州拉韦市默克公司的商标名）签订临床试验合作与供应协议（CTCSA）。。

Upon the execution of the agreement, Hanmi Pharmaceutical will conduct a phase 1 clinical trial to evaluate the safety and efficacy of its immuno-oncology drug, 'BH3120', in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with progressive or metastatic solid tumors. Hanmi Pharmaceutical will sponsor the clinical trial, and MSD will supply KEYTRUDA..

协议签署后，Hanmi Pharmaceutical将进行一期临床试验，以评估其免疫肿瘤药物“BH3120”与MSD的抗PD-1疗法KEYTRUDA®（pembrolizumab）联合用于进行性或转移性实体瘤患者的安全性和有效性。汉米制药将赞助该临床试验，MSD将提供KEYTRUDA。。

'BH3120' is a next-generation immunotherapy drug that applies 'Pentambody', a bispecific antibody platform technology, currently under joint development by Hanmi Pharmaceutical and its Chinese subsidiary, BJHM (Beijing Hanmi Pharmaceutical).

“BH3120”是一种应用双特异性抗体平台技术“Pentambody”的下一代免疫治疗药物，目前由汉米制药及其中国子公司BJHM（北京汉米制药）联合开发。

Pentambody is a technology that combines one antibody to two different targets simultaneously, facilitating both immuno-oncology therapy and targeted therapy.

Pentambody是一种同时将一种抗体与两种不同靶标结合的技术，可促进免疫肿瘤学治疗和靶向治疗。

More specifically, BH3120 is an lgG-like bivalent bispecific antibody targeting PD-L1 and 4-1BB with biased binding affinities towards PD-L1.

更具体地说，BH3120是靶向PD-L1和4-1BB的lgG样二价双特异性抗体，对PD-L1具有偏向的结合亲和力。

This design aims to induce strong anti-tumor activities, particularly in PD-L1 overexpressed tumor tissues within the tumor microenvironment (TME), while minimizing undue immune activation in normal tissues.

该设计旨在诱导强烈的抗肿瘤活性，特别是在肿瘤微环境（TME）内PD-L1过表达的肿瘤组织中，同时最小化正常组织中过度的免疫激活。

Most of the existing antibody candidates targeting 4-1BB have limitations in terms of safety. However, BH3120 has been shown through various non-clinical studies to exhibit a clear decoupling of immune activity between TME and normal tissue, confirming its potential as an effective and safe anticancer agent..

大多数针对4-1BB的现有抗体候选物在安全性方面都有局限性。然而，通过各种非临床研究表明，BH3120在TME和正常组织之间表现出明显的免疫活性解耦，证实了其作为有效且安全的抗癌剂的潜力。。

Dr. Kim Dong-wan, the director of the Seoul National University Hospital Clinical Trials Center (Hemato-Oncology Department), is the Principal Investigator of the phase 1 clinical trial of BH3120 in Korea and the US. He said, 'Through the collaboration with MSD, we expect BH3120 in combination with KEYTRUDA could improve outcomes for patients with relapsed or refractory disease.'.

首尔国立大学医院临床试验中心（血液肿瘤科）主任金东万博士是韩国和美国BH3120第一阶段临床试验的主要研究者。他说，“通过与MSD的合作，我们预计BH3120联合KEYTRUDA可以改善复发或难治性疾病患者的预后。”。

A Hanmi representative stated, 'BH3120 is our first global clinical research project using the next-generation bispecific antibody platform technology 'Pentambody' in the field of immuno-oncology therapy, potentially changing the paradigm of anticancer treatment,' and added, 'We are dedicated to surpassing the constraints of current therapies and innovatively boosting therapeutic efficacy through our next-generation immune-oncology therapy.'.

Hanmi的一位代表表示，“BH3120是我们在免疫肿瘤学治疗领域使用下一代双特异性抗体平台技术‘Pentambody’的第一个全球临床研究项目，可能会改变抗癌治疗的范式”，并补充说，“我们致力于超越当前疗法的限制，并通过我们的下一代免疫肿瘤学疗法创新性地提高治疗效果。”。

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

KEYTRUDA® 是美国新泽西州拉威市默克公司股份有限公司子公司默克夏普多姆有限责任公司的注册商标。

Contact info:

联系方式：

Official Websites: www.hanmipharm.cominnovation@hanmi.co.kr, +08-2-410-0467

Official Websites: www.hanmipharm.cominnovation@hanmi.co.kr, +08-2-410-0467

Introducing Hanmi Pharmaceutical

汉米制药简介

Established in 1973, Hanmi Pharmaceutical is an R&D-centric pharmaceutical company that strives to create global first-in-class drugs through industry-leading R&D investments. Hanmi Pharmaceutical has strategically established more than 30 pipelines covering metabolic diseases(diabetes, obesity), inflammation-fibrosis(MASH) treatment, anticancer drugs, and rare disease treatments, among which 'Rolontis', a neutropenia treatment, has received marketing authorization from the FDA in 2022.

汉米制药成立于1973年，是一家以研发为中心的制药公司，致力于通过业界领先的研发投资创造全球一流的药物。Hanmi Pharmaceutical已战略性地建立了30多条管道，涵盖代谢疾病（糖尿病，肥胖症），炎症纤维化（MASH）治疗，抗癌药物和罕见疾病治疗，其中中性粒细胞减少症治疗药物“Rolontis”已于2022年获得FDA的上市授权。

The company retains solid partnerships with leading global pharmaceutical companies based on proprietary technologies such as 'LAPSCOVERY', a platform technology that prolongs the duration of action of biologics, and 'PENTAMBODY', a bispecific antibody platform technology. Hanmi Pharmaceutical is enhancing the synergy of various R&D activities, such as AI new drug development and immuno-anticancer drug development, through the 'Open Innovation' strategy that opens the door to excellent external R&D capabilities.

该公司基于专有技术与领先的全球制药公司保持着牢固的合作伙伴关系，例如延长生物制剂作用持续时间的平台技术“LAPSCOVERY”和双特异性抗体平台技术“PENTAMBODY”。汉米制药通过“开放式创新”战略，为优秀的外部研发能力打开了大门，正在增强各种研发活动的协同作用，例如AI新药开发和免疫抗癌药物开发。

For more information, please refer to our website https://www.hanmipharm.com.

有关更多信息，请访问我们的网站https://www.hanmipharm.com.

About BH3120

关于BH3120

BH3120 is a heterodimeric bispecific antibody (PENTAMBODY) designed to target 4-1BB and PD-L1 simultaneously to stimulate anti-tumor immune response either by inhibition of an immune checkpoint mechanism and by activation of a co-stimulatory signal in tumor microenvironment (TME) focused manner. Non-clinical observations with BH3120, either as a monotherapy or in combination settings, consistently explain strong anti-tumor T cell activities in a tumor tissue-specific manner with clear dose dependency, while systemic immune response is minimally modulated.

BH3120是一种异二聚体双特异性抗体（PENTAMBODY），设计用于同时靶向4-1BB和PD-L1，通过抑制免疫检查点机制和激活肿瘤微环境中的共刺激信号来刺激抗肿瘤免疫应答（TME）聚焦方式。BH3120作为单一疗法或联合治疗的非临床观察结果一致地解释了以肿瘤组织特异性方式具有明显剂量依赖性的强抗肿瘤T细胞活性，而全身免疫应答的调节最小。

These properties support further evaluation of the immune-modulating bispecific antibody, and BH3120 will be studied as a therapeutic candidate with multiple types of solid tumors..

这些特性支持对免疫调节双特异性抗体的进一步评估，BH3120将作为多种类型实体瘤的治疗候选物进行研究。。

SOURCE Hanmi Pharmaceutical

来源Hanmi Pharmaceutical