REYON Pharmaceutical (co-CEOs Jeong Soon-ok and Yoo Yong-hwan) announced on April 12 that it had concluded an agreement with NeoGene Pharm (CEO Kim Hyo-soo), a gene therapy company with which it signed an MOU last August, to produce and supply samples to evaluate the efficacy of gene therapy in liver fibrosis patients. 

Based on the recent agreement, REYON Pharmaceutial will supply samples to NeoGene Pharm after developing the process for sample production for efficacy evaluation of TIF, a gene therapy agent for liver fibrosis, and establishing the quality analysis method. NeoGene Pharm will conduct the efficacy evaluation after receiving the samples. 

Afterwards, the two companies plan on performing animal testing on TIF based on the results of the efficacy evaluation and file an Investigational New Drug (IND) Application in the first half of 2022. The production of the clinical samples, ingredients, and drug product will take place at REYON Pharmaceutical’s plant in Chungju.

The TIF gene therapy agent has been developed using TIF1γ, a liver fibrosis inhibitor gene discovered for the first time in the world by NeoGene Pharm, a biotech startup. It is a plasmid DNA-based gene therapy agent developed to prevent progression of hepatitis or fatty liver to cirrhosis, and related patent has been registered in Korea and filed in the United States. 

Liver fibrosis is an intractable disease that leads to loss of the liver function, as the hepatic stellate cells (HSCs) become degenerated due to cytokines secreted as a result of damage to the liver cells and fibrosis progresses causing the soft liver tissue to change into hard fibrous tissue. Although major pharmaceutical firms around the world are conducting research in a heated race to develop an effective therapeutic agent for liver fibrosis, there is yet to be a therapeutic agent on the market. 

An official from REYON Pharmaceutical said, “Through the process development and establishment of a quality analysis method, we will supply the plasmid DNA-based samples for clinical trials and make every effort to develop a treatment for liver fibrosis, for which there is no therapeutic agent anywhere in the world to prevent or block it, together with Neogene Pharm, which has excellent R&D capabilities.” 

Meanwhile, according to Deutsche Bank and ALPCO, the global liver fibrosis treatment market is projected to grow from KRW 360 billion in 2019 to about KRW 17 trillion in 2026, based on a CAGR of 74%.