Innovative Medicines based on ImmunoModulatory Biologics
About IMBiologics
Research and Development of Antibody Therapeutics
We focus on protecting human health by bringing back homeostasis, a physiological balance of a healthy person, through developing novel innovative immunomodulatory antibody drugs.
We are accelerating the development of innovative immunomodulatory antibody therapeutics to treat autoimmune diseases and cancer with our own platform technology and in-licensed drug candidates.
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.”
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
“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.
- 사노피, HS 전략 우선순위 ‘암리텔리맙→브리베키믹’으로 전환 - TNF·OX40L, 면역 조절 핵심 타깃 등극할까…브리베키믹 PoC 입증 - 아이엠바이오 TNF·OX40L 이중항체 ‘IMB-101’ 가치도 재조명
출처 : 사노피
[더바이오 지용준 기자] 다국적 제약사 사노피(Sanofi)가 전 세계 의약품 매출 4위 제품인 ‘듀피젠트(Dupixent, 성분 듀필루맙)’를 잇는 차세대 자가면역질환 애셋(Asset)의 우선 순위 조정을 시사했다. 앞서 선도물질로 평가된 ‘OX40L’을 타깃하는 단일항체인 ‘암리텔리맙(Amlitelimab)’이 기대에 못미치는 성적을 내놓았다. 반면, TNF-α·OX40L을 타깃하는 나노바디 기반의 화농성 한선염(HS) 치료제 후보물질인 ‘브리베키믹(Brivekimig)’이 임상2상에서 1차 평가변수를 충족하며 사노피의 전략적 자산으로 부상했다.
특히 국내 바이오텍인 아이엠바이오로직스는 TNF-α·OX40L 이중항체인 ‘IMB-101(개발코드명)’을 미국 네비게이터메디신(Navigator Medicines)에 약 1조3000억원 규모로 기술수출해 개발이 진행 중이어서, 최근 사노피의 이같은 긍정적인 임상 결과 발표에 주목하고 있다.
◇사노피, ‘암리텔리맙→브리베키믹’…HS 치료제 개발 우선 순위 조정
28일 업계에 따르면 사노피는 지난 24일(현지시간) 1분기 콘퍼런스콜을 통해 브리베키믹이 HS 임상2상에서 1차 평가변수를 충족했다고 발표했다. 브리베키믹은 해당 임상에서 프라이머리 엔드포인트(주요 평가지표)를 충족했고, HiSCR50 및 기타 평가지표들에서도 임상적으로 의미 있는 개선 효과를 나타냈다. 또 28주간의 치료 기간 안전성 프로파일이 예상과 일치했으며, 새로운 이상반응은 나타나지 않았다. 사노피는 “기존 암리텔리맙보다 브리베키믹을 HS 치료제로 우선 개발하기로 결정했다”고 밝혔다.
사노피는 지난해 매출 규모 약 21조원에 달하는 듀피젠트의 성공 이후 자가면역질환 치료제 분야에서 주도권을 놓지 않기 위해 ‘면역학’ 파이프라인을 확장해왔다. 지난 2021년 14억달러(약 2조원)에 달하는 규모로 영국 바이오텍인 ‘키맵’을 인수하며 OX40L을 타깃하는 암리텔리맙도 확보했다. 하지만 기대와 달리 암리텔리맙은 올해 4월 중등도 천식 환자를 대상으로 진행한 임상2상 결과에서 주요 평가지표를 충족하지 못했다.
◇TNF-α·OX40L 체내 역할은…기존 단일 타깃 전략으로 조절하기 어려운 복합 면역반응 제어
‘TNF-α(종양괴사인자 알파)’는 체내 염증반응을 유발하는 주요 사이토카인으로, 이를 억제하는 것은 자가면역질환 치료의 핵심 전략 중 하나다. 글로벌 블록버스터 의약품인 ‘휴미라’와 ‘레미케이드’, ‘엔브렐’ 등이 TNF-α 억제제다.
‘OX40L’은 ‘OX40’에 결합하는 ‘T세포 자극인자’다. OX40L은 ‘항원제시세포(APCs)’의 표면에 발현하고, OX40은 ‘T세포’의 표면에 있다. 두 세포의 상호반응은 정상인에게서는 면역반응을 활성화하는데 도움을 주지만, 자가면역질환 환자의 경우는 ‘반대’다. OX40L과 OX40의 상호작용으로 T세포의 ‘과활성’ 상태를 유도하면서 과도하게 사이토카인을 분비시켜 자가면역질환을 발생시킨다. ‘TNF-α·OX40L’ 억제제는 기존 단일 타깃 전략으로는 조절하기 어려운 복합 면역반응을 제어하는 시도인 셈이다.
하경식 아이엠바이오로직스 대표 (출처 : 아이엠바이오로직스 홈페이지 캡처)
◇TNF-α·OX40L 이중항체 개발사 아이엠바이오로직스도 ‘긍정 신호탄’
이번 사노피의 긍정적인 임상 결과 발표는 TNF-α·OX40L 이중항체인 ‘IMB-101’을 개발 중인 아이엠바이오로직스에도 의미 있는 신호로 분석된다. 브리베키믹 덕분에 TNF-α·OX40L 억제제의 ‘개념증명(Proof of Concept)’에 도달했고, 파이프라인의 상업적 가치가 재조명될 수 있기 때문이다.
앞서 아이엠바이오로직스는 지난해 6월 미국 네비게이터메디신에 IMB-101을 1조3000억원 규모로 글로벌(중국 제외) 기술수출했다. 네비게이터메디신은 HS를 적응증으로 IMB-101의 글로벌 임상1b상을 승인받은 상태다. IMB-101의 중국 파트너사인 화동제약은 최근 중국 임상1b상을 승인받아 10여개 기관에서 환자 투여를 앞뒀다.
아이엠바이오로직스 관계자는 “사노피의 브리베키믹이 HS 임상2상에서 긍정적인 지표를 확인한 만큼, 타깃이 똑같은 IMB-101도 긍정적인 결과 도출을 기대할 수 있다”며 “특히 IMB-101은 이중항체인 만큼 나노바디인 브리베키믹 대비 안전성과 효과 부문에서 이익이 있을 수 있다”고 말했다.
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