Hanmi Enters Into Clinical Trial Collaboration and Supply Agreement With MSD to Evaluate BH3120 in Combination With KEYTRUDA (Pembrolizumab)
Hanmi Enters Into Clinical Trial Collaboration and Supply Agreement With MSD to Evaluate BH3120 in Combination With KEYTRUDA (Pembrolizumab)
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
韓美製藥宣佈與默沙東合作進行臨床試驗，在針對進行性或轉移性實體瘤患者的1期臨床試驗中評估與KEYTRUDA聯合使用的 “BH3120”
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).
韓國首爾，2024 年 4 月 23 日 /PRNewswire/ — 專注於腫瘤、肥胖/代謝和罕見疾病等研究領域的韓國領先生物製藥公司韓美製藥（KOSPI：128940，首席執行官：樸載賢）宣佈已與 MSD（默沙東的商品名）簽訂臨床試驗合作與供應協議（CTCSA）Co.，Inc.，美國新澤西州拉威）。
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.
協議執行後，韓美製藥將進行1期臨床試驗，以評估其免疫腫瘤藥物 “BH3120” 與默沙東的抗PD-1療法KEYTRUDA聯合使用的安全性和有效性 （pembrolizumab），用於進行性或轉移性實體瘤患者。韓美製藥將贊助該臨床試驗，默沙東將提供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'是應用'Pentambody'的下一代免疫治療藥物，這是一種雙特異性抗體平台技術，目前由韓美製藥及其中國子公司BJHM（北京漢美製藥）聯合開發。
Pentambody is a technology that combines one antibody to two different targets simultaneously, facilitating both immuno-oncology therapy and targeted therapy.
Pentambody 是一項將一種抗體同時組合到兩個不同靶標的技術，可促進免疫腫瘤學治療和靶向治療。
More specifically, BH3120 is an lgG-like bivalent bispecific antibody targeting PD-L1 and 4-1BB with biased binding affinities towards PD-L1.
更具體地說，BH3120 是一種類似 LGG 的雙價雙特異性抗體，靶向 PD-L1 和 4-1BB，對 PD-L1 具有偏向的結合親和力。
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.
該設計旨在誘導強大的抗腫瘤活性，特別是在腫瘤微環境 (TME) 內的 PD-L1 過度表達的腫瘤組織中，同時最大限度地減少正常組織中過度的免疫激活。
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.
大多數靶向4-1BB的現有候選抗體在安全性方面存在侷限性。但是，通過各種非臨床研究，BH3120 表現出TME和正常組織之間的免疫活性明顯脫鉤，這證實了其作爲有效和安全的抗癌藥物的潛力。
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."
首爾國立大學醫院臨床試驗中心（血液腫瘤學部）主任金東萬博士是韓國和美國的 BH3120 一期臨床試驗的首席研究員。他說：“通過與默沙東的合作，我們預計 BH3120 與 KEYTRUDA 聯合使用可以改善復發或難治性疾病患者的預後。”
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."
韓美的一位代表表示：“BH3120 是我們在免疫腫瘤學治療領域使用下一代雙特異抗體平台技術'Pentambody'的第一個全球臨床研究項目，有可能改變抗癌治療的模式”，並補充說：“我們致力於通過下一代免疫腫瘤療法突破當前療法的限制，創新地提高治療療效。”
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
KYTRUDA 是默沙東夏普和多姆有限責任公司的註冊商標，默沙東公司是位於美國新澤西州拉威的默沙東公司的子公司。
Contact info:
聯繫信息：
Official Websites:
[email protected], +08-2-410-0467
官方網站：
[電子郵件保護]，+08-2-410-0467
Introducing Hanmi Pharmaceutical
介紹韓美製藥
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. 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. For more information, please refer to our website
韓美製藥成立於1973年，是一家以研發爲中心的製藥公司，致力於通過行業領先的研發投資創造全球一流的藥物。韓美製藥已戰略性地建立了30多條產品線，涵蓋代謝性疾病（糖尿病、肥胖）、炎症纖維化（MASH）治療、抗癌藥物和罕見病治療，其中中性粒細胞減少症治療藥物 “Rolontis” 已於2022年獲得美國食品藥品管理局的上市許可。該公司基於專有技術，例如 “LAPSCOVERY”（一種延長生物製劑作用時間的平台技術）和雙特異性抗體平台技術 “PENTAMBODY” 等專有技術，與全球領先的製藥公司保持着牢固的合作伙伴關係。韓美製藥正在通過 “開放創新” 戰略，增強人工智能新藥開發和免疫抗癌藥物開發等各種研發活動的協同效應，該戰略爲卓越的外部研發能力打開了大門。欲了解更多信息，請參閱我們的網站
About BH3120
關於 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. 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.
BH3120 是一種異二聚體雙特異性抗體 (PENTAMBODY)，旨在同時靶向 4-1BB 和 PD-L1，通過抑制免疫檢查點機制和激活腫瘤微環境 (TME) 中的共刺激信號，刺激抗腫瘤免疫反應。BH3120 的非臨床觀察，無論是單一療法還是聯合療法，都能以腫瘤組織特異性的方式解釋強大的抗腫瘤 T 細胞活性，明顯的劑量依賴性，而全身免疫反應的調節微乎其微。這些特性支持對免疫調節雙特異性抗體的進一步評估，BH3120 將作爲多種類型實體瘤的候選治療藥物進行研究。
SOURCE Hanmi Pharmaceutical
來源 Hanmi 製藥
譯文內容由第三人軟體翻譯。