BIONEER CORPORATION

Bioneer's subsidiary, siRNAgen Therapeutics, files IND with MDFS for Phase 1b Trial of SRN-001 for IPF

Bioneer’s subsidiary, siRNAgen Therapeutics (hereafter “siRNAgen”), announced on the 1st that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a phase 1b clinical trial of its idiopathic pulmonary fibrosis (IPF) candidate, SRN-001.

This phase 1b trial will be based on the successful completion of a phase 1a study in Australia and will evaluate the safety and target engagement of SRN-001 in healthy adults through multiple dosing. siRNAgen plans to obtain IND approval from the MFDS and IRB approval from clinical sites by the end of September, begin screening participants in October, and conduct the trial at major institutions in Korea through August next year.

SRN-001 is a proprietary siRNA drug developed using Bioneer’s SAMiRNA® platform, specifically targeting Amphiregulin (AREG), a key factor in fibrosis. Inhibiting AREG is closely associated not only with pulmonary fibrosis but also with kidney, liver, and metabolic disorders such as NASH, enabling broad indication expansion. Recent publications in journals like Nature have highlighted AREG’s role not only in inflammation and fibrosis but also in cancer, drawing significant scientific attention. In particular, a May study by Dr. Ralph R. Weichselbaum’s group at the University of Chicago Cancer Center, published in Nature, demonstrated that radiation-induced cancer metastasis is driven by AREG—the target of SRN-001. This provides scientific and objective evidence of AREG as a novel target in oncology, suggesting that SRN-001 may be developed as a first-in-class anti-cancer therapy acting on a previously unaddressed mechanism.

This phase 1b trial is expected to confirm the strengths of SRN-001 and further validate the potential of SAMiRNA® as a versatile RNAi drug development platform. The results could open up new opportunities for collaborative research and licensing agreements with domestic and international companies developing RNAi therapies. Upon completion of the study, siRNAgen plans to leverage patient efficacy data to accelerate technology transfer and joint development negotiations with global pharmaceutical companies. The company aims to step up global partnering efforts from the first half of 2026, building on the scientific basis, indication expansion potential, and marketability of SRN-001.

A siRNAgen representative stated, “SRN-001 is a next-generation siRNA drug targeting AREG, with potential not only in pulmonary fibrosis but also in other fibrotic and oncology indications. We will demonstrate its efficacy and safety in Korean clinical trials and move toward global market entry and strategic partnerships.”###