[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 27th that it has signed an efficacy evaluation test contract with Southern Research, a specialized Contract Research Organization (CRO) that possesses a non-human primate animal model for COVID-19.
The cytokine storm suppressing new drug for severe sepsis, iCP-NI, will begin efficacy verification to determine whether it can treat acute pneumonia and severe sepsis caused by COVID-19.
Southern Research, which has signed the efficacy verification contract with Cellivery for COVID-19, is a CRO that conducts all non-clinical and clinical trials from the new drug discovery stage to the development stage. For about 80 years, it has conducted new drug development research evaluating bio-sample analysis and pharmacological efficacy for various new drug substances including chemical drugs, vaccines, and protein therapeutics. It possesses animal models for highly infectious viruses such as COVID-19, Zika virus, and Dengue virus.
Song Seungwoo, CEO of Jinapass, Southern Research’s Korean partner, said, “Southern Research is currently conducting efficacy tests for COVID-19 therapeutics upon requests from many research institutes and global pharmaceutical companies worldwide. We are doing our best to end the COVID-19 pandemic as soon as possible, and we feel a heavy responsibility in co-developing the COVID-19 therapeutic iCP-NI with Cellivery.”
This efficacy evaluation test will be conducted on 34 non-human primates (monkeys) infected with COVID-19. iCP-NI, Cellivery’s cytokine storm suppressor, will be administered to an acute pneumonia model where inflammatory cytokines rapidly increase in the lung mucosa and blood due to direct infection by COVID-19, causing lung tissue damage.
iCP-NI is an immune regulatory therapeutic designed to modulate the human genome. In rodent models, it has already demonstrated a reduction in inflammatory cytokines, lung tissue protection effects, and a 100% survival rate compared to improved survival rates. The company expects it to show excellent efficacy in primate experiments, which have genomes more similar to humans. Cho Daewoong, CEO of Cellivery, emphasized, “Currently, efforts are underway to develop preventive vaccines and antiviral antibodies for COVID-19, but even if successful, they may be ineffective against new viruses caused by various mutations. There is a need for a fundamental anti-inflammatory therapeutic that has strong treatment effects regardless of which virus invades.”
Based on the cytokine storm control ability and severe sepsis treatment efficacy results of iCP-NI, Cellivery is pursuing simultaneous clinical trials with the U.S. Food and Drug Administration (FDA) and the Korean Food and Drug Administration (KFDA) for rapid fast-track clinical development and commercialization. The goal is to develop it as the ultimate therapeutic effective not only for the current COVID-19 pandemic but also for infectious contagious diseases that will continue to occur periodically in the future. The company also emphasized that unlike vaccines and antibody therapies that must be newly developed each time a new virus pandemic occurs, iCP-NI’s strength lies in its applicability to all pathogenic virus infections regardless of viral mutations, new strains, or variants.
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