News & Activities » GenScript ProBio Congratulates IMBiologics on FDA Clearance of IND Application for Innovative Bispecific Antibody Drug Project (IMB-101)

GenScript ProBio Congratulates IMBiologics on FDA Clearance of IND Application for Innovative Bispecific Antibody Drug Project (IMB-101)

Recently, IMBiologics, a partner of GenScript ProBio, announced FDA clearance of its IND application for an innovative bispecific antibody drug project (IMB-101). GenScript ProBio, the main partner in CMC development and supporting IND filing of IMB-101, warmly extends congratulations on this major milestone achievement.

IMB-101 is a bispecific antibody that targets OX40L and TNF to regulate immune cells involved in inflammatory cytokines and adaptive immunity, which is being developed as a therapeutic agent for autoimmune diseases. GenScript ProBio has successfully navigated technology transfer challenges and established a robust cell culture and purification process. This process has been effectively scaled up to 200L and 500L scales in a single attempt, demonstrating its reliability. Furthermore, the achieved titer is notably 33% higher than the original process. In an in vivo monkey model, IMB-101 demonstrated equivalent or superior efficacy in arthritis inhibition at lower doses than "Humira," its safety was confirmed in a 13-week repeated dosing toxicity test in monkeys. IMB-101 can be an effective novel treatment option for patients unresponsive to anti-TNF agents.

With this approval, IMBiologics will be able to conduct phase 1 clinical trials of the lead project IMB-101 in the United States starting in the second half of 2023. The approved phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of IMB-101 in healthy subjects and rheumatoid arthritis patients compared with placebo.

Park Chi-hye, Head of Development at IMBiologics, explained, "This immuno-modulatory antibody drug candidate can overcome the low response rate of existing treatments, a major unmet medical need for rheumatoid arthritis patients. We have secured a wide margin of safety for IMB-101 due to its excellent efficacy and safety in preclinical studies." She added, "With this IND approval and through collaboration with the professional team at GenScript ProBio, we are confident in expediting the global clinical development of IMB-101."

Dr. Patrick Liu, Chairman and Acting CEO of GenScript ProBio, "We are thrilled with the FDA's clearance of IMBiologics' IND application for IMB-101, an innovative bispecific antibody drug project. The approval of this project demonstrates our superior process development capabilities. I believe this product will benefit patients with rheumatoid arthritis in the future. We will obviously continue to our close collaboration with the IMBiologics team to advance their clinical trials."

About IMBiologics

IMBiologics is a biotechnology company established in August 2020 with the slogan ‘Innovative Medicines based on Immuno-modulatory Biologics'.

IMBiologics have initiated the journey with a 4 Billion KRW seed fund in January 2021 and 13 Billion KRW in Series A financing in August 2021. IMBiologics successfully raised 20 Billion KRW in Series B financing in July 2023. The Series B investment will secure global clinical results, additional indication expansions for IMB-101, and develop immune oncology pipelines using ePENDY, a next-generation IgM platform technology. The OX40/OX40L inhibitory signal targeted by IMB-101 has recently been attracting new attention in autoimmune disease, and ePENDY has higher avidity and target protein clustering effect than IgG antibodies. IMBiologics explained that it is currently looking for potential partners to IMB-101 and is making efforts to make partnerships through business meetings with several global pharmaceutical companies.

GenScript ProBio – a global CDMO

GenScript ProBio, a subsidiary of GenScript Biotech Corporation, offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in CGT, vaccine, antibody and recombinant protein drug, aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 60 IND approvals since October 2017.