If we can confirm the expected level of treatment efficacy and dosing intervals in next year’s clinical trials, we believe we’ll be well-positioned to compete in the global market.
These results could mark a pivotal turning point for our company’s growth.
Ha Kyung-sik, Chief Executive Officer (CEO) of IMBiologics, recently sat down with News1 to discuss the clinical development strategy for their key drug candidate, IMB-101.
IMBiologics is a biotech firm specializing in antibody drugs for autoimmune diseases. Founded in 2020, the company went public on the KOSDAQ market this March. In 2024, it made headlines by licensing IMB-101 to Navigator Medicine in the U.S. for a deal worth approximately 1.8 trillion KRW (about 1.35 billion USD).
Currently, Ha is focusing his efforts on developing a treatment for hidradenitis suppurativa, a chronic skin condition that causes recurrent inflammation and abscesses in areas where skin folds, such as the armpits and groin. There’s a significant unmet need for new treatments, as some patients don’t respond adequately to existing medications.
According to the company, the global market for hidradenitis suppurativa treatments is currently valued at around 24 trillion KRW (about 18 billion USD) and is projected to grow to about 105 trillion KRW (about 78.8 billion USD) by 2034.
Middle-Distance Speed, Long-Distance Stamina: Betting on Bispecific Antibodies
IMBiologics is developing IMB-101, a dual antibody that simultaneously inhibits tumor necrosis factor (TNF), which triggers inflammation, and OX40 ligand (OX40L), which regulates immune response. The goal is to enhance treatment efficacy and durability by blocking both direct inflammatory signals and higher-level signals that modulate immune responses.
Ha likened this approach to that of a runner. He explained that drugs that inhibit direct inflammatory signals like TNF are similar to middle-distance runners. They show quick effects, but inflammation can return once the medication is stopped.
He continued that on the other hand, drugs that regulate higher-level signals like OX40L are more like long-distance runners. They may take longer to show effects, but they offer the advantage of prolonged efficacy.
Ha emphasized that they’re aiming to combine both into a single antibody to develop a treatment that has the speed of a middle-distance runner and the endurance of a long-distance runner.
Currently, IMB-101’s main competitor is Sanofi’s Brivekimig. According to IMBiologics’ investor materials, Brivekimig achieved a HiSCR75 response rate of 54% in a Phase 2a clinical trial for hidradenitis suppurativa patients, where inflammatory nodules and abscesses decreased by over 75%.
Ha stated that their goal is to achieve a treatment response rate of over 50% in next year’s clinical trials. The strategy is to match the efficacy of competing candidates while demonstrating advantages in dosing intervals and safety.
IMBiologics plans to use technology that extends the half-life of antibodies, aiming to increase dosing intervals for subcutaneous injections compared to existing treatments. Recent early clinical cohorts have shown promising results in this direction. The goal is to reduce injection frequency compared to current competitors, improving patient convenience.
Currently, IMB-101 is undergoing global Phase 2 clinical trials for intravenous formulations in the U.S., while separate clinical development for subcutaneous formulations is also in progress. Previous Phase 1 trials confirmed safety and pharmacokinetic properties in healthy adults.
2027 Clinical Results: A Watershed Moment For Future Success
Ha believes that next year’s clinical trial results will significantly impact IMBiologics’ future valuation and global commercialization strategy.
In 2024, IMBiologics licensed IMB-101 to Navigator Medicine in the U.S. The total deal value is approximately 1.8 trillion KRW (about 1.35 billion USD), with the company having received about 50 billion KRW (about 37.5 million USD) so far, including upfront payments and subsequent royalties.
Navigator Medicine employs a NewCo business model, which aims to enhance the value of acquired drug candidates for potential deals with global pharmaceutical companies.
Ha expects that demonstrating clinical proof of concept (POC) for efficacy in actual patients during next year’s trials will significantly increase interest from global pharmaceutical companies. He noted the current trend of major pharma firms actively pursuing mergers and acquisitions (M&A) with promising biotech companies to secure treatments for autoimmune diseases.
Key results from the Phase 2 clinical trial of IMB-101’s intravenous formulation are expected in the second half of 2027, while results from the Phase 1 trial of the subcutaneous formulation are targeted for the same year. Based on these outcomes, the company plans to generate additional commercialization success after 2028 and pursue global approvals by 2032.
Aiming For In-House Drug Development By 2036: Targeting The Global Autoimmune Disease Market
IMBiologics plans to expand its pipeline, focusing on autoimmune disease treatments beyond IMB-101.
Key follow-up projects include IMB-105 and IMB-106. IMB-105 aims to improve efficacy and safety based on technologies developed during IMB-101’s creation. It’s being developed as an upgraded version of IMB-101, with plans for early commercialization. IMB-106 is in development as a dual-mechanism treatment to reduce pathogenic autoantibodies.
The company is also developing its proprietary platform technology, SeliCon, which improves antibody half-life and immune cell regulation. This technology will be applied to subsequent pipelines to continually secure new antibody drug candidates.
IMBiologics has established a solid financial foundation. As of the second quarter of this year, the company reported cash and cash equivalents of about 123.6 billion KRW (about 92.7 million USD). This, combined with government grants, is estimated to fund over five years of research and development.
Ha’s long-term vision is to grow the company beyond merely discovering drug candidates for out-licensing, to developing and obtaining approvals for its own global drugs.
He stated that once it demonstrates solid business results, it aims to develop several projects to completion, leveraging the accumulated capabilities and experience. The ultimate goal is to establish the capability and infrastructure to develop the own drugs in the autoimmune disease field.
Ha set 2036 as the target year for achieving this goal. Over the next decade, the plan is to accumulate research, development, and commercialization experience to grow to a level capable of advancing its own pipeline to Phase 3 clinical trials.
Ha expressed optimism, saying that it expects to see results related to global drug approvals around 2032. By then, it hopes IMBiologics will be recognized as a prominent player in the global autoimmune disease market.
He added that in the future, it wants IMBiologics to be the first name that comes to mind when people think of autoimmune diseases in Korea. Globally, it aspires for the company to be recognized as a leader in autoimmune disease treatments.
◇Profile of Hakyung-sik Ha, CEO of IMBiologics
△B.S. in Genetic Engineering, Korea University △M.S. in Biotechnology, Korea University Graduate School △Ph.D. in Biotechnology, Korea University Graduate School △Clinical team and marketing PM for cancer drugs, CJ CheilJedang △Head of Bio Business Development, CJ Healthcare △Director of Bio Research Center, HK Inno.N △Founded IMBiologics in 2020, serving as CEO △Advisory Committee Member, Ministry of SMEs and Startups’ Pharmaceutical Bio Ventures △Member, Investment Review Committee of the National New Drug Development Project (KDDF) △Recipient, Minister of Health and Welfare’s commendation (2024) △Recipient, Minister of Trade, Industry and Energy’s commendation (2024)
