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Innovative Medicines based on
ImmunoModulatory Biologics

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IMBIO, selected as a project by the Ministry of Trade, Industry and Energy

'Glioblastoma treatment candidate'... Received 3.7 billion won in support over 30 monthsIMBIOLOGICS (CEO Ha Kyung-sik) announced on the 13th that it had been selected for a new project of the 2024 Ministry of Trade, Industry and Energy Materials and Components Technology Development Project, a heterogeneous technology convergence project, and signed a project agreement with a total project cost of KRW 3.7 billion (government subsidy of KRW 2.5 billion).The Materials and Components Technology Development Heterogeneous Technology Convergence Project is a program that selects and supports companies with global competitiveness for technological advancement and future market dominance. The project for which IMBiologics was selected this time aims to 'secure and conduct non-clinical research on a peptide-HLA multimer-based glioblastoma innovative treatment candidate (IMB-402).' The project period is from July 2024 to December 2026 (a total of 30 months).The drug development concept of the IMB-402 project is to apply a cancer peptide-HLA complex to ePENDY, a multimer platform technology based on IgM antibodies, to selectively proliferate and activate only T cells specific to glioblastoma, and to add a co-stimulatory factor to prevent the activated T cells from falling into a state of lethargy. It is currently in the candidate substance optimization research stage, and through this project, it is planned to secure candidate substances and conduct non-clinical studies.Ha Kyung-sik, CEO of iMBIOLOGICS, said, “I am very pleased that the project using our ePENDY platform technology has been selected as a national project for the first time,” and added, “I think it is very meaningful as it proves the competitiveness of our platform technology.”

2024-09-27

Huadong Medicine introduced two new autoimmune drugs

Medaverse 2024年08月15日 22:518月14日，华东医药全资子公司杭州中美华东制药有限公司（简称“中美华 东”）与韩国IMBiologics corp.（简称“IMB ”）签订了产品独家许可协议。中美华东获得IMB两款自身免疫领域的全球创新产品IMB-101及IMB-102在包含中国在内的37个亚洲国家（不含日本，韩国和朝鲜）的独家许可，包括开发、注册、生产及商业化权益。中美华东将向IMB支付600万美元首付款，200万美元技术转移里程碑付款，最高不超过3.075亿美元的开发、注册及销售里程碑付款， 以及分级最高两位数的净销售额提成费。IMB总部位于韩国的京畿道水原市，是一家成立于2020年8月的生物技术公司，利用下一代IgM平台技术ePENDY开发肿瘤免疫创新产品，致力于为自身免疫性疾病和癌症开发新的治疗方案。IMB 管理团队具有深厚的生物制药专业背景及丰富的商业化经验。创始人兼首席执行官Gyongsik Ha拥有超过20年的生物制药行业从业经验，曾负责多个IND和NDA生物药的开发，具备研发、临床和商业化的复合背景。在加入IMB之前，曾担任HK inno.N生物研究中心负责人，CJ CheilJedang高级研究员，他的大部分职业生涯都致力于生物药领域。引进的两款创新生物药IMB-101和IMB-102IMB-101是靶向OX40L和TNFα的双特异性抗体，参与调节炎症细胞因子，促进T细胞和浆细胞分化，以及自身抗体产生，维持免疫稳态平衡。IMB-101最早由HK-InnoN和Y-Biologics（2家韩国公司）共同研发，并于2020年授权给IMB全球独家许可权益。2023年，IMB向美国FDA递交IMB-101的IND申请并获得批准，临床前数据显示其在动物模型上有良好的有效性和安全性。目前IMB-101正在美国进行临床Ⅰ期研究，拟用于治疗类风湿关节炎。目前，同靶点双抗全球仅2款在研产品，另一款是赛诺菲的SAR442970，处于临床Ⅱ期，拟用于治疗化脓性汗腺炎，微小病变性肾病综合征和局灶性节段性肾小球硬化。IMB-102是靶向OX40L的单抗，目前处于临床前研究，潜在适应症为中重度特应性皮炎及其他自身免疫性疾病。据了解，目前同靶点单抗全球仅有5款在研产品，进展最快的是赛诺菲的amlitelimab，用于治疗中重度特应性皮炎，处于临床Ⅲ期研究阶段。除特应性皮炎外，赛诺菲还在探索amlitelimab治疗哮喘、化脓性汗腺炎、斑秃、系统性硬化症等适应症的潜力。

2024-08-28

Navigator Medicines Announces $100 Million Series A Financing and In-Licensing of NAV-240, a Potential Best-in-Class Anti-OX40L and Anti-TNFα Bispecific Antibody Therapeutic for Autoimmune Diseases

Navigator Medicines Announces $100 Million Series A Financing and In-Licensing of NAV-240, a Potential Best-in-Class Anti-OX40L and Anti-TNFα Bispecific Antibody Therapeutic for Autoimmune DiseasesNAV-240 is a potential best-in-class bispecific antibody targeting OX40L and TNFα currently in Phase 1 development for complex autoimmune diseasesIn connection with the transaction, Navigator Medicines has closed a $100M Series A financing, co-led by RA Capital Management and Forbion, to support the development of NAV-240 as well as a pipeline of OX40L-targeted mono- and bispecific antibodiesDana McClintock, MD, joins the Company as Chief Medical OfficerAugust 27, 2024 07:00 AM Eastern Daylight TimeSCOTCH PLAINS, N.J.--(BUSINESS WIRE)--Navigator Medicines, Inc., a privately-held biotech company leading the advancement of biologics for targeted immune regulation and restoration, today announced a Series A financing alongside the in-licensing of NAV-240 and an OX40L-targeted portfolio from IMBiologics Corp.NAV-240, formerly known as IMB101, is a clinical-stage bispecific antibody against OX40L and TNFα, two clinically-validated targets that are critical in the pathogenesis of several inflammatory diseases. Dual targeting of both OX40L- and TNFα-driven signaling pathways may improve upon the efficacy of either monotherapy alone as a potential treatment option for complex, heterogenous diseases with unmet medical needs. In connection with the transaction, Navigator has closed a $100M Series A financing, co-led by RA Capital Management and Forbion.“I am thrilled to join Navigator at this exciting time to advance NAV-240 through the clinic and we are deeply grateful for the support of our partner, IMBiologics, and our investors,” said Dr. Dana McClintock, CMO of Navigator Medicines. “NAV-240 has the potential to make an impact on patients living with autoimmune diseases, and our Series A funding will be pivotal in accelerating its development alongside other exciting programs within our pipeline. We look forward to initiating additional clinical studies with NAV-240 in the coming months and delivering on our commitment to innovation that enhances patient care.”Wouter Joustra, General Partner at Forbion, added, “Given Forbion’s experience in building and guiding life sciences companies, partnering with Navigator allows NAV-240 to reach its full potential. We are confident that Navigator has the right expertise and is now well resourced for the development of this promising therapy and pipeline to benefit patients in need.”In conjunction with the financing, Mr. Joustra and Dr. Andrew Levin, Partner and Managing Director at RA Capital Management, will join the Board of Directors at Navigator. “This is an exciting opportunity to take a big step forward in therapeutic standards and transform patient care,” said Dr. Levin.About Navigator MedicinesNavigator Medicines is a biotech company leading the advancement of biologics for targeted immune regulation & restoration. Founded in 2024 as a subsidiary of Sera Medicines, the Company is committed to developing new therapies for patients living with complex, heterogeneous autoimmune diseases. For more information, visit navigatormedicines.comAbout ForbionForbion is a leading global venture capital firm with deep expertise in Europe and offices in Naarden, The Netherlands, Munich, Germany and Boston, USA. Forbion invests in innovative biotech companies, managing €3.2 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. In addition, Forbion leverages its extensive biotech expertise in human health to also address ‘planetary health’ challenges through its BioEconomy fund strategy, which invests in companies using biotechnologies for sustainable solutions in areas like environmental tech, AgTech and food tech. Forbion’s team consists of over 30 investment professionals that have built an impressive performance track record since the late nineties with investments in over 110 companies across 9 funds. Forbion’s record of sourcing, building and guiding life sciences companies has resulted in many approved breakthrough therapies and valuable exits. Forbion typically selects impactful investments that will positively affect the health and well-being of patients, as well as meet its financial return objectives. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.About RA Capital ManagementRA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital Management forms and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital Management's knowledge engine is guided by our Tech Atlas internal research division, and our company creation team, RA Ventures (RAVen), offers experienced entrepreneurs a collaborative and comprehensive platform to explore the novel and the re-imagined.ContactsFor Media, Business or Investor Inquiries, please contact: info@navigatormedicines.com

2024-08-28

IMBiologics Corp. announced a License Agreement with Huadong Medicines

2024-08-16

IMBiologics Corp. announced a License Agreement with Navigator Medicines

2024-06-17

Signing a joint research agreement with Dong-A ST using ePENDY platform technology

For more information, please visit : IMBiologics  News (full article available in Korean)

2024-02-19

Patent registration of ePENDY platform technology in Korea

IMBiologics  News

2024-02-19

IMB-101, Selection of the top 10 excellent projects for KDDF 2023

IMBiologics  News

2024-02-19

汉腾生物与韩国IMBiologics达成战略合作

汉腾生物与韩国IMBiologics达成战略合作中国融媒产业网2023年10月25日 16:09:00 来自北京市0人参与0评论2023 年 10 月 23 日,汉腾生物宣布与韩国IMBiologics签署战略合作协议。双方将在lgM分子开发与表达平台方面展开战略合作,包括但不限于联合营销/联合业务开发、CDMO项目、Licenses in/out等。本次合作基于汉腾生物高产量、高纯度和高效价的lgMax®平台技术与IMBiologics的ePENDY®平台技术。汉腾生物将与IMBiologics携手,共同为推动中韩两国及全球生物医药的高质量发展贡献力量。IMBiologics 创始人/CEO Dr. HA GYONGSIK(左)与 汉腾生物创始人/CEO沈潇博士(右)作为双方代表签订合作协议汉腾生物CEO 沈潇 博士“很高兴能有机会与IMBiologics合作。‘ePENDY’是一项创新的技术,在免疫调节的创新药物开发上有着独到的优势。汉腾将利用自身的lgMax®平台技术协助‘ePENDY’平台分子的CMC开发,实现规模化生产,同时,期待双方能在IgM领域共同协作,在不久的将来利用新型抗体平台技术造福全球患者。”IMBiologics CEODr. HA GYONGSIK“我们很高兴能与汉腾生物合作。这次合作是我们公司‘ePENDY’平台技术的首次全球合作,也代表着市场对‘ePENDY’平台技术卓越性的认可。通过这一合作,许多中国的公司将能够使用IMBiologics的‘ePENDY’开发新的药物。我们将这次合作视为进入中国和全球市场的第一步,期待未来能与更多公司建立合作关系。”关于lgMax®平台lgMax®平台是汉腾生物自主研发的IgM相关表达及开发平台,其具备了高产量、高纯度和高效价的特点,技术转移路线清晰,可满足大规模生产的需求。该平台已成功助力客户lgM抗体开发项目获批IND。高表达lgM载体通过特殊设计的载体系统,细胞株产量可达8 g/L ,并且lgM构型均一,五聚体比例接近100%,无六聚体产生,从源头避免后续六聚体难去除风险lgM工艺开发能力下游纯化包含亲和层析和非亲和层析两种纯化路线,均可达到97%以上纯度,回收率达到>55%,让工艺成本及效益达到较理想的状态lgM理化分析能力汉腾生物已完成了五聚体和六聚体超大型蛋白分子的全面质量分析和表征工作。成功完成lgM聚集体构型、轻链重链J链完整性、98对二硫键、2个游离巯基,51个N-糖位点和各N-糖位点优势糖型等全面属性揭示,大大加快了lgM在生物制药领域的应用进度lgM生化分析能力汉腾生物可通过ELISA结合、假病毒体外中和试验和SPR技术等方法评估lgM活性及综合效力lgM制剂开发能力汉腾生物的制剂平台可以为IgM抗体提供稳定的可长期保存的液体或冻干制剂开发关于ePENDY®平台IMBiologics作为韩国唯一的IgM抗体研发公司,开发了下一代的IgM分子构型(已获专利授权):ePENDY®平台与全球领先的IGM bioscience的IgM平台对比,具有 :-更高的生物活性-更长的半衰期-更简单的下游工艺-显著改善的疗效-更小的副作用适应症可扩展范围广-扩展了开发免疫疗法各种激动剂和拮抗剂候选药物的可能性-适应症可以扩展到眼科疾病、传染病和粘膜免疫相关疾病市场价值-全球大型制药公司高度感兴趣:赛诺菲和IGM Bioscience签订了价值60亿美元的合同(2022.03)关于韩国IMBiologicsIMBiologics 是一家成立于2020年8月的生物技术公司,致力于研究基于免疫调节的创新药物。IMBiologics在2021年1月以4亿韩元的种子基金启动了研发旅程,并于2021年8月进行了13亿韩元的A轮融资,及在2023年7月成功进行了20亿韩元的B轮融资。B轮融资将用于确保IMB-101的全球临床试验结果,扩展其他适应症,并利用下一代IgM平台技术ePENDY开发肿瘤免疫产品线。IMB-101所靶向的OX40/OX40L抑制信号最近在自身免疫性疾病中引起了新的关注,而ePENDY的亲和力和靶蛋白聚集效应比IgG抗体更高。IMBiologics解释说,他们目前正在寻找潜在的合作伙伴来推广IMB-101,并通过与多家全球制药公司进行商务会议来努力建立合作关系。关于汉腾生物广州汉腾生物科技有限公司(简称“汉腾生物”)自2016年成立以来,专注于大分子生物药CDMSO领域,包括抗体优化、细胞株构建及开发、上下游工艺开发、分析方法开发、制剂工艺开发、技术及质检方法转移、中试及商业化生产、临床生物分析,临床供应服务,以及国际一流的质量保障体系等,面向全球生物医药企业提供符合国际监管标准、覆盖从早期发现到商业化的一站式服务。创新是企业发展的核心竞争力。注重研发投入,提升自主研发的能力是汉腾生物多年来坚持的目标。汉腾生物擅长于研究难以表达的蛋白质,包括双抗特异性抗体(BsAb)和重组蛋白;在细胞系的驯化,优化和开发方面,拥有行业领先的知识、专利技术储备以及丰富的项目技术经验,尤其是自主开发的高表达CHO细胞株构建平台,抗体表达滴度高,工艺稳定,包括了CHOzen®细胞系平台和GLYCOEXPRESS® (GEX®)细胞系平台等。经过多年科研技术的转化,汉腾生物发展欣欣向荣,规模已从广州总部扩大至全球六大研发及生产基地,科学家团队约300余人,研发人员中硕博士占比达60%以上;技术服务方面,目前拥有符合中、美、欧GMP标准的12+4条独立生产线,具备50-2500L(批次、流加、灌流、环轨)的原液及商业化制剂灌装生产能力。

2023-10-31

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  • President(CEO) : Gyongsik Ha
  • 260, Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea