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Sanofi's Phase 2 Success with 'Brivekimig' Targeting TNFα and OX40L Brings a Smile to IMBiologics

By Yongjun Ji │ Published: April 28, 2025 06:10 │ Updated: April 28, 2025 17:05     -Sanofi shifts HS strategy priority from Amlitelimab to Brivekimig      -TNF and OX40L emerge as key targets for immune modulation as Brivekimig proves PoC      -IMBiologics' dual-antibody candidate 'IMB-101' gains renewed attention Sanofi, the multinational pharmaceutical company, has signaled a reprioritization of its next-generation autoimmune disease asset to potentially succeed its global top-4 drug by sales, Dupixent (dupilumab). Amlitelimab, a monoclonal antibody targeting OX40L once considered a leading candidate, fell short of expectations. In contrast, Brivekimig—a nanobody-based investigational treatment for hidradenitis suppurativa (HS) that targets both TNF-α and OX40L—met its primary endpoint in a Phase 2 trial and is now emerging as Sanofi’s new strategic asset. This outcome is particularly noteworthy for Korean biotech IMBiologics, which has licensed out its TNF-α/OX40L bispecific antibody candidate 'IMB-101' to U.S.-based Navigator Medicines in a deal valued at approximately 1.3 trillion KRW. With Sanofi’s positive clinical data, attention is turning toward the potential of this shared target mechanism. Sanofi Prioritizes Brivekimig Over Amlitelimab in HS Development On April 24 (local time), Sanofi announced during its Q1 earnings call that Brivekimig had successfully met its primary endpoint in a Phase 2 clinical trial for HS. The candidate demonstrated clinically meaningful improvements in HiSCR50 and other metrics. The safety profile after 28 weeks of treatment aligned with expectations, with no new adverse events observed. Sanofi confirmed it would prioritize Brivekimig over Amlitelimab for HS development going forward. After the blockbuster success of Dupixent, which generated roughly 21 trillion KRW in revenue last year, Sanofi has aggressively expanded its immunology pipeline to maintain its lead in autoimmune disease treatments. In 2021, it acquired UK-based biotech Kymab for $1.4 billion, securing the rights to Amlitelimab, which targets OX40L. However, in April this year, Amlitelimab failed to meet its primary endpoint in a Phase 2 trial for moderate asthma, falling short of expectations. Role of TNF-α and OX40L in the Body: A Complex Immune Pathway Beyond Single-Target Modulation TNF-α (tumor necrosis factor alpha) is a major cytokine involved in inflammatory responses, and its inhibition is a key strategy in treating autoimmune diseases. Globally successful drugs like Humira, Remicade, and Enbrel are TNF-α inhibitors. OX40L is a co-stimulatory molecule that binds to the OX40 receptor on T cells. It is expressed on the surface of antigen-presenting cells (APCs), while OX40 appears on T cells. Their interaction boosts immune responses in healthy individuals, but in autoimmune patients, it leads to T cell hyperactivation and excessive cytokine release, triggering autoimmune conditions. Targeting both TNF-α and OX40L seeks to modulate complex immune responses that single-target therapies struggle to control. IMBiologics Also Sees a Positive Signal for Its Dual-Antibody Program Sanofi’s positive clinical data is considered a meaningful signal for IMBiologics, which is developing the bispecific antibody IMB-101 targeting both TNF-α and OX40L. Brivekimig’s success serves as a proof of concept (PoC) for this dual-target approach and may enhance the commercial value of similar pipelines. IMBiologics had previously licensed out IMB-101 to Navigator Medicines in June 2024 in a 1.3 trillion KRW deal covering global rights excluding China. Navigator has since received approval to begin a Phase 1b global trial for HS using IMB-101. In parallel, Huadong Medicine, the company's Chinese partner, also received approval for a Phase 1b trial in China and is preparing to begin patient enrollment across over ten institutions. A company representative from IMBiologics commented, “Sanofi’s Brivekimig showing positive Phase 2 indicators in HS gives us reason to expect favorable outcomes from IMB-101, which targets the same molecules. Moreover, as a bispecific antibody, IMB-101 may have advantages in safety and efficacy over Brivekimig, which is a nanobody.”

2025-05-08

IMBiologics Writes 1.7 Trillion KRW Tech Export Success Story — IMB-101's Straightforward Strategy Pays Off

Robust safety and efficacy data transparently presented at international conferences proves decisive Signed licensing-out deals worth 1.3 trillion KRW with Navigator Medicines and 438 billion KRW with Huadong Medicine Secured upfront payments totaling 39 billion KRW, validating commercial viability By Hyukjin Kwon │ hjkwon@yakup.com Published: April 23, 2025 06:00 │ Updated: April 23, 2025 16:17Jung In-soo, Head of Business Operations at IMBiologics, gives a presentation at “ICPI WEEK 2025” held at KINTEX in Goyang, Gyeonggi Province, on April 23. ©Yakup News “Many people think there’s some special secret to licensing-out success. But in truth, there isn’t. Just one thing: solid data backed by science that proves superior safety and efficacy, and transparent sharing of this data at global conferences to build trust. That was the key driver behind our successful technology transfer.” Jung In-soo, Head of Business Operations at IMBiologics, shared the background behind the licensing-out success of IMBiologics' bispecific antibody-based autoimmune disease candidate, ‘IMB-101’, during the “1st Pharma/Bio Business Development Strategy Forum 2025,” a side event at “ICPI WEEK 2025,” held at KINTEX, Goyang on April 23. The forum was hosted by the Pharma/Bio Business Development Society under the Korea Drug Development Research Association (Chairman: Kim Jeong-jin). It served as a platform to discuss strategies for commercializing technology and advancing Korea’s bio-health industry into the global market. IMBiologics’ ‘IMB-101’ has gained attention as a rare case of a domestic biotech firm achieving back-to-back large-scale licensing deals. The success is attributed to a unique mechanism targeting both immune cell regulator OX40L and inflammatory cytokine TNF, clinically proven safety and efficacy, and a well-structured business development (BD) strategy. IMB-101 is being developed as a treatment for a range of immune diseases including rheumatoid arthritis, atopic dermatitis, and inflammatory bowel disease. Jung stated, “Publishing IMB-101’s data transparently at major international conferences like the American College of Rheumatology (ACR) laid the groundwork for technology export.” He added, “Navigator Medicines first encountered IMB-101 at the ACR conference in November 2023 and signed the deal within about seven months. Similarly, Huadong Medicine saw the data at BioChina in September 2023 and concluded a deal about 11 months later.” Such swift technology transfers were made possible by a strategic approach aligned with global standards from the earliest negotiation stages. IMBiologics began by signing Confidential Disclosure Agreements (CDA) to establish information-sharing frameworks. This was followed by preliminary due diligence (DD), exchange of Term Sheets outlining deal terms and rights, and then thorough Index DD to solidify trust necessary for contract finalization. Jung emphasized, “These deals went beyond mere contracts — they included upfront payments totaling 39 billion KRW, proving real commercial potential. Especially notable, Navigator Medicines began recruiting top talent from global pharma giants like Amgen and GSK to lead IMB-101’s clinical development after the deal was signed.” The first licensing-out deal for IMB-101 was signed in June 2024 with U.S.-based Navigator Medicines, covering global rights excluding Japan, valued at 1.3 trillion KRW. Of this, about 28 billion KRW was paid upfront. In August of the same year, a second deal worth about 438 billion KRW was signed with China’s Huadong Medicine, covering 40 Asian countries excluding Korea and Japan, with 11.6 billion KRW paid upfront. IMB-101’s clinical competitiveness also stands out. IMBiologics submitted its IND application to the FDA in June 2023 and received approval within just one month with no additional requests. Jung explained, “We collaborated with global CROs PPD and Syneos to design a hybrid Phase 1a/1b trial involving healthy adults and patients. In Phase 1a, IMB-101 demonstrated excellent safety and tolerability across 0.1–10mg/kg doses.” He added, “Only one drug-related adverse event (Grade 1) was observed, and pharmacokinetic analysis confirmed dose proportionality.” IMB-101 is currently preparing for Phase 1b clinical trials in both the U.S. and China. In preclinical studies, the drug demonstrated meaningful efficacy at one-quarter the dose of AbbVie’s Humira, showing not only anti-inflammatory effects but also suppression of autoantibody production — enhancing its potential as a broad-spectrum immune disease treatment. Jung added, “IMBiologics is now actively expanding its pipeline beyond autoimmune diseases into immuno-oncology. We are already executing strategies for our second and third licensing deals, aiming to secure global clinical data within 2–3 years and create new business opportunities through collaborations with global pharmaceutical companies.” IMBiologics currently holds a pipeline of eight follow-up candidates: three IgG-based modalities and five based on IgM and IgA. Notably, IMB-201 has been selected for the national “Scale-Up Teams” program and has received 1.2 billion KRW in research funding. IMB-401, a bispecific antibody with a cancer vaccine concept, has secured 2.5 billion KRW in government support. Meanwhile, “ICPI WEEK 2025,” Korea’s largest integrated industry exhibition — now in its 20th year — runs through April 25 at KINTEX Halls 1 and 2 in Goyang. The event showcases the latest technologies and trends across the entire value chain of the pharmaceutical, biotech, and cosmetics industries — from R&D to production, processing, packaging, and logistics. It is co-hosted by Kyungyeon Exhibition and KY Expo, with Yakup News serving as the official media partner.아이엠바이오로직스 IMB-101 임상 1a상 결과.©약업신문, 아이엠바이오로직스아이엠바이오로직스 후속 파이프라인 연구개발 현황.©약업신문, 아이엠바이오로직스

2025-05-08

What is the Background of IMBiologics' 1 Trillion Won 'Big Deal' with J&J?

■ J-Labs Focuses on BioTech <1> IMBiologicsRapid growth with technology exports in just 4 years since its establishmentReinforcing its operations this year with a "Second Founding Spirit"IMB-106 candidate drug under full-scale developmentIPO push expected by the end of this year or Q1 next yearHigh expectations from J-Labs’ 'global mentoring' [Seoul Economy]J-Labs is a biotech accelerator program run by global pharmaceutical giant Johnson & Johnson (J&J). Since its founding in 2012, it has supported over 1,000 biotech and medical technology ventures worldwide, raising $109.4 billion (approximately 145 trillion KRW) in investment and helping 57 companies go public. Companies passing J-Labs' rigorous selection process receive services like laboratory rentals and preclinical/clinical research consulting.Ha Kyung-sik, CEO of IM Biologics, posed for a photo at the entrance of the company headquarters in Gwanggyo, Suwon, on January 22. (Photo by Seong Hyeong-ju, Seoul Economy)A biotech company has recently stunned the pharmaceutical and biotech industries by achieving a 1 trillion KRW “big deal” just four years after its establishment. The company is IMBiologics, which is developing antibody drugs using its bispecific antibody technology. In June of last year, IMBiologics licensed its autoimmune disease treatment drug 'IMB-101' to the US-based Navigator Medicine for 1.3 trillion KRW, the largest domestic deal of the first half of the year. Two months later, it also licensed its technology to China's Huadong Pharmaceutical for 4.309 trillion KRW.Ha Kyung-sik, CEO of IMBiologics, refers to IMB-101 as his “child.” IMB-101 is a drug candidate co-developed with HK inno.N and Y BioLogics. Ha, who was the head of the bio division at CJ Healthcare (HK inno.N) during the process of reducing its antibody pipeline, founded IMBiologics and acquired the technology.IMB-101 is a bispecific antibody that simultaneously activates OX40L, which activates immune cells, and inhibits TNF-α, which triggers inflammatory responses in the body. It is currently undergoing Phase 1 clinical trials in the US. Competing French pharmaceutical company Sanofi is developing a "nanobody" based on camel antibodies rather than bispecific antibodies, which experts say gives IM Biologics an edge in terms of efficacy and safety.Ha defines this year as the “second founding year” of the company. He stated, “Having already licensed out IMB-101, the project that led to the founding of the company, I’m now aiming to secure future growth drivers by generating meaningful data from new projects as if this is my second startup.” He added, “The goal is to complete one technology export every year.” Ha is particularly hopeful about an unpublished substance, “IMB-106,” as the next big candidate for licensing out. He stated, “I expect it to become the best-in-class drug for autoimmune diseases. We plan to secure the substance by the first half of the year and conduct evaluations in the second half, with full development expected to begin next year.” Since it is a substance that could attract interest from global partners, licensing out is also a possibility.The success of IMBiologics’ big deal is the result of Ha’s strategic decision-making. He explained, “Global big pharma was interested in our substances, but they wanted later-stage clinical trials. However, we faced practical limitations in terms of finances, making it difficult to carry out clinical trials on our own.” Realizing that achieving visible results with independent development was not feasible, Ha chose to license out the technology to Navigator Medicine, which could conduct the clinical trials to the stage that big pharma desired. Navigator Medicine, which focuses solely on the IMB-101 study, recently secured $100 million in funding from global venture capitalists, enabling it to proceed with clinical trials in a stable manner. Ha explained, “By quickly generating proof-of-concept (PoC) data, we plan to increase the chances of success for the drug through larger-scale licensing or M&A.”Ha has high expectations for J-Labs’ program, particularly its global networking. He said, “Receiving mentoring from J&J, a potential demand-side company, helps us understand global trends.” He also expressed satisfaction with the practical assistance he is receiving, such as guidance on increasing the value of research projects and technology export consulting.IMBiologics is now in its fifth year of operation. The company aims for an Initial Public Offering (IPO) by the end of this year or Q1 of next year, with plans to complete a technological evaluation in the first half of the year. Ha’s vision for the company in its 10th year is to become a biotech capable of launching a global new drug. He stated, “By the 10th year, I want IMBiologics to be at the level where it can launch a global new drug.”By Lee Jung-min (mindmin@sedaily.com)Photo by Seong Hyeong-ju (foru82@sedaily.com)

2025-02-10

Y-Biologics Partners with IMBiologics on Joint Research for 'Autoimmune' Antibody

Y-Biologics and IMBiologics Collaborate on 'Autoimmune' Antibody DevelopmentY-Biologics, an antibody drug development company, announced on the 8th that it has signed a joint research and development agreement with IMBiologics to develop a new target autoimmune disease antibody drug candidate.Under the agreement, the two companies will collaborate to develop an antibody drug candidate targeting a protein (undisclosed) considered a major factor in autoimmune diseases.This approach is expected to suppress excessive T-cell activation and normalize the function of regulatory T-cells (Treg), effectively controlling autoimmune reactions. The company anticipates that this differentiated mechanism of action will provide new treatment options for patients with autoimmune diseases.Through this joint research, both companies aim to replicate the success of previous partnerships. Y-Biologics and IMBiologics, in collaboration with HK Innoen, developed the autoimmune disease candidate, OX40LxTNF bispecific antibody ‘IMB-101,’ which was licensed out in June last year to Navigator Medicines in the U.S. for up to $944.75 million, including a $20 million upfront payment.In August, the same asset was licensed out to Huadong Pharmaceutical in China (excluding Korea and Japan) for up to $315.5 million, including an upfront payment of $8 million.An IMBiologics representative stated, “Based on our experience and capabilities in developing immune disease antibody therapies, we are currently implementing various open innovation strategies. Through this collaboration with Y-Biologics, we aim to develop even more innovative antibody drugs than IMB-101 and achieve business success in a short time.”A Y-Biologics representative explained, “This agreement is significant as we are embarking on the development of innovative new drugs for global market entry with a trusted partner. By combining the expertise of both companies, we believe we can gain differentiated competitive advantages.”Kim Sung-min, Reportersungmin.kim@bios.co.kr

2025-01-15

'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

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

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