Samsung Biologics and Ichnos Sciences Announce Agreement for Manufacture of ISB 830
Samsung Biologics announced the signing of a long-term agreement with Ichnos Sciences for manufacturing drug substance for ISB 830, an anti-OX40 monoclonal antibody in development as a potential treatment for moderate-to-severe atopic dermatitis.
Based on an entirely new mechanism of action, ISB 830 has the potential to treat a range of autoimmune diseases beyond atopic dermatitis. Enrollment in a large randomized placebo-controlled Phase 2b study in atopic dermatitis was recently completed and results are expected in the first half of 2020.
The prevalence of atopic dermatitis in the seven major markets (US, France, Germany, Italy, Spain, the UK, and Japan) currently exceeds 80 million patients and the market is expected to grow to $18.3bn by 2027 according to GlobalData, a leading data and analytics company.
Ichnos, headquartered in Paramus, N.J., is a fully integrated global biotech company that is rapidly advancing its pipeline and has five novel, first-in-class candidates in clinical stage development. Samsung Biologics and Ichnos (formerly known as Glenmark Pharmaceuticals S.A.) entered into a Master Services Agreement in 2017 for Samsung Biologics to provide Ichnos with process optimization and manufacturing services. Ichnos and Samsung Biologics have now entered into a long term agreement for Samsung Biologics to manufacture drug substance for ISB 830 Phase 3 clinical trials and for potential future global commercial supply upon regulatory approval.
"As we progress our pipeline of clinical stage assets, including our most advanced biologic ISB 830, we are pleased to continue to work with Samsung Biologics to ensure continued drug substance supply for ISB 830," said Alessandro Riva, MD, CEO of Ichnos Sciences. "We look forward to a mutually beneficial collaboration as we continue developing ISB 830 for autoimmune diseases, including atopic dermatitis."