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'OX40L Antibody New Drug' IMBiologics, CEO Kyung-Sik Ha Says 'Possible IPO as Early as Next Year'

[Edaily, Reporter Lim Jung-Yo] "After passing the technical evaluation in the first half of 2025, we plan to apply for a preliminary listing review and aim for an IPO by the end of 2025 or at the latest in the first quarter of 2026."IMBiologics CEO Kyung-Sik Ha made this statement on the 10th during an interview with Edaily at the "2024 National New Drug Development Program (KDDF) Outstanding Project Presentation" held at Hotel Naru Seoul M Gallery in Mapo-gu.IMBiologics, selected as one of the six outstanding projects by KDDF, has recently gained attention as a biotech company with its antibody new drug pipeline. Its key pipeline, "IMB-101," is currently in Phase 1 clinical trials. Despite not having human proof-of-concept (PoC) data, the company signed two global technology transfer agreements this year. In June, it secured a $1.3 billion technology transfer agreement with Navigator Medicine in the U.S., receiving an upfront payment of 28 billion KRW. In August, IMBiologics also signed a $430 million agreement with Hangzhou Zhongmei Huadong Pharmaceutical in China, receiving an additional upfront payment of 11 billion KRW.CEO Ha explained, "IMB-101 is a dual-antibody targeting both OX40L and TNF-a, simultaneously inhibiting inflammatory cytokines and adaptive immunity. The Phase 1A trial for rheumatoid arthritis has been completed, and we have confirmed its safety and pharmacokinetics." The company plans to expand indications for various autoimmune diseases based on future human PoC data.Ha attributed the success of the technology transfer to the growing interest from global big pharma companies such as Sanofi and Amgen in OX40L. Sanofi, in particular, is focusing on OX40L research as a next cash cow to follow its blockbuster atopic dermatitis treatment, Dupixent. To bolster this, Sanofi acquired Ablynx for 5 trillion KRW in 2018 and Kymab for 1.9 trillion KRW in 2021, securing related pipelines.Like Sanofi, IMBiologics is also pursuing a "two-track" strategy, developing both an OX40L-targeted monoclonal antibody and an OX40L-TNF-a dual-target inhibitor. However, Sanofi’s dual-target inhibitor is based on a nanobody (camel antibody) rather than a dual-antibody format, and it is currently undergoing Phase 2 trials for pyoderma gangrenosum, with data expected next year.CEO Ha noted that in terms of OX40L antibody research and development for autoimmune diseases, Sanofi is 2-3 years ahead of IMBiologics. However, he emphasized that working with Sanofi will allow IMBiologics to learn whether the drug concept works in that disease area. Ha also mentioned that developing a new drug with a new target is a risky endeavor for a Korean bio venture, and that IMBiologics is following a "fast follower" and "best-in-class" strategy, moving quickly behind global big pharma.Ha is confident in IMBiologics' ability to outperform Sanofi in terms of efficacy, as their OX40L-OX40 binding inhibition mechanism differs from Sanofi’s OX40L trimer formation inhibition. IMBiologics is also advancing other pipelines, including the non-clinical development of OX40L monoclonal antibody "IMB-102" and "IMB-104," a combination of OX40L monoclonal antibody and the ePENDY platform, which is being co-developed with Dong-A ST.IMBiologics, founded in August 2020 by CEO Kyung-Sik Ha, has raised over 200 billion KRW in Series B funding as of July last year. The company has more than 10 financial investors, with lead investors including KB Investment and Atinum Investment. Other investors include Partners Investment, CJ Investment, K2 Investment Partners, Shinhan Venture Investment, and Yuanta Securities.Regarding the IPO, CEO Ha stated, "If everything goes according to plan, we believe we can operate the business for more than five years using public offering funds without needing additional financing or deals." He also mentioned that although a pre-IPO funding round is not necessary according to their current financial plan, the possibility remains open depending on market conditions.In preparation for the IPO, IMBiologics recently completed a 1:14 stock split, increasing its issued shares to 9.21 million, a prerequisite for ensuring adequate liquidity. Korea Investment & Securities and Shinhan Investment Corp. are serving as lead underwriters.Source: Lim Jung-Yo (kaylalim@edaily.co.kr)

2024-12-19

KDDF Selects 6 Outstanding Projects from 391 in 2024

IMBiologics, Nexi, Xymedi, AimedBio, Ezcuris, and Sungkyunkwan University Selected for 6 ProjectsOn the 10th, the Korea Drug Development Fund (KDDF) revealed the results of its "2024 National New Drug Development Program Outstanding Project Presentation" held at Hotel Naroo Seoul M Gallery. A total of 391 projects were evaluated, and six were selected as outstanding.The six outstanding projects selected by the KDDF include:IMBiologics: Development of an autoimmune disease treatment with multi-immunomodulatory functionsNex-I: Research on lead antibodies targeting immune checkpoint inhibitor resistance factorsAimedbio: Non-clinical development of FGFR3 ADC for bladder cancer and brain tumor treatmentSungkyunkwan University: Development of a treatment for EYS-related retinal pigment epithelium disease using prime editorZymedi: Phase 1 clinical trial of a pulmonary arterial hypertension treatment that inhibits immune cell migrationAzcuris: Discovery of novel small-molecule inhibitors targeting IL-33 cytokinesSimilar to last year, the KDDF categorized the six projects into three areas:High Performance: IMBiologics, Nex-I, AimedbioTechnology Breakthrough: Zymedi, Sungkyunkwan UniversityNew Insight: Zymedi (overlap), AzcurisSource: Shin Changmin, Reporter (changmin.shin@bios.co.kr)

2024-12-19

IMBiologics Receives Minister of Industry Award as 'Outstanding Biohealth R&D Company'

Minister of Health and Welfare Award for Contributions to Health and Medical Technology Promotion, Jang Yeong-sil Technology Innovation AwardIMBiologics (CEO: Kyung-Sik Ha) announced on the 4th that it was awarded the Minister of Trade, Industry, and Energy Award as an 'Outstanding Biohealth R&D Company' at the 2024 Bioindustry Day event held on the 28th of last month at the Westin Chosun Hotel in Seoul.This award recognizes outstanding research and development (R&D) companies that have contributed to the advancement of the biohealth sector and the growth of K-Bio. The selection process evaluates companies based on their major achievements throughout the year to motivate and promote further development in the industry.A company representative stated, "The IMB-101 pipeline, a dual antibody for the treatment of autoimmune diseases, is the first of its kind in South Korea to undergo clinical trials in the U.S. and has been selected as an outstanding project in the National New Drug Development Program." They also mentioned that the company had successfully signed two global technology transfer agreements with Navigator Medicines in the U.S. in June and with Hangzhou Zhongmei Huadong Pharmaceutical in China in August.On the same day, IMBiologics was also honored at the 2024 Health Industry Performance Exchange Conference held at the Four Seasons Hotel in Seoul. CEO Kyung-Sik Ha was recognized for his contributions to the development of the health industry and received the Minister of Health and Welfare Award for Contributions to Health and Medical Technology Promotion (R&D). Additionally, the company was awarded the Minister’s Award for Technological Innovation at the 105th IR52 Jang Yeong-sil Award ceremony, organized by the Ministry of Science and ICT.CEO Kyung-Sik Ha expressed his delight, stating, “As we approach the end of the year, I am pleased to have our R&D achievements recognized by various government departments. We will continue to focus on advancing research and development to contribute to the growth of the bio industry.”"Reporter Dae-Yeol Nam (dynam@hitnews.co.kr)"

2024-12-19

IMBiologics Selected for J&J JLABS Korea

"Networking, mentorship, business model, and strategy support expected."IMBiologics has been officially selected for Johnson & Johnson Innovation's JLABS Korea, as announced on the 29th. JLABS, operated by Johnson & Johnson Innovation, supports member companies in the healthcare sector by providing resources such as development experience, mentorship, partnerships, and venture introductions to accelerate scientific progress.IMBiologics met all the selection criteria for JLABS Korea, including technological innovation, scientific and technological capabilities, addressing unmet needs, transparency, and ethics. As a result, the company was chosen as an innovative firm for the program.In June, IMBiologics signed a global technology transfer agreement for the clinical-stage OX40LxTNF bispecific antibody ‘IMB-101’, developed as a treatment for autoimmune diseases, with Navigator Medicines in the U.S. In August, the company also entered into a similar agreement with Hangzhou Zhongmei Huadong Pharmaceutical in China.IMBiologics is developing autoimmune disease therapeutics and immuno-oncology agents based on its multivalent antibody backbone technology, 'ePENDY' (enhanced/engineered PENtamer boDY) platform, which involves 10 different conjugates.Jinsoo Jeong, Executive Director of IMBiologics, expressed gratitude for being selected to join the JLABS network, stating, “We are very grateful for this opportunity provided by Johnson & Johnson Innovation. We will focus all our business development efforts to achieve joint research with global pharmaceutical companies and additional technology exports through our JLABS membership.”"Reporter Sungmin Kim (sungmin.kim@bios.co.kr)"

2024-12-19

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

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