Kolon Pharma said it has signed a joint development agreement with GBiologics to develop a new drug for systemic lupus erythematosus that seeks to suppress B cells and plasmacytoid dendritic cells (pDC) simultaneously.
Under the accord, both companies plan to conduct joint research and development for GB930, GBiologics' lupus treatment candidate.
Each company will utilize its expertise to advance the development of GB903, with Kolon Pharma overseeing clinical and business development based on its extensive clinical experience and network with major pharmaceutical companies abroad, while GBiologics handling processes from sample production to preclinical stages by leveraging its experience and know-how in biopharmaceutical development.
Lupus is a chronic inflammatory autoimmune disease caused by excessive activation of immune cells, causing inflammation, fever, and pain in various organs as a systemic condition.
Conventional long-term treatments included systemic steroids and immunosuppressants, but side effects and low efficacy of existing treatments have been hurdles in lupus treatment.
The two companies expect that GB903 will show superior therapeutic effect compared to existing lupus treatments as it is a novel recombinant protein that is less susceptible to enzymatic degradation by removing the linker that connects two carbohydrate recognition domains (CRDs) in the recombinant stabilized Galectin-9.
GB930 also regulates Toll-Like receptor (TLR) 7/9 signaling by binding to CD44 expressed on the surface of pDC and B cells.
Its dual-action effect of simultaneously suppressing the activity of B cells and pDC, which are major causes of lupus, has been proven in preliminary research and development at relevant institutes in the U.S., as well as in-house research.
The company stressed that this represents a differentiated efficacy from existing treatments like GSK's Benlysta, which suppresses the generation of autoantibodies through B cell inhibition, and AstraZeneca's Saphnelo, which inhibits Type-1 IFN, which targets only one lupus pathogenic factor.
Kolon Pharma and GBiologics aim to submit an investigational new drug (IND) application to the U.S. FDA by the second half of 2024. They are also discussing potential technology transfers with global pharmaceutical companies during the development stage and are actively seeking collaborative methods.
"The joint development agreement will allow both companies to create synergy by collaborating organically from specialized business competencies to the clinical trial stage," a company official said. "This collaboration is expected to significantly reduce the time required for new drug development and increase the success rate."