RNA interference (RNAi) corporations OliX Pharmaceuticals(226950) is bringing on a global new drug development expert to strengthen capabilities in clinical development and regulatory approval.
OliX Pharmaceuticals said on the 10th that it hired Dr. Min Ji-young as executive vice president (EEVP) and chief development officer (CDO).
Executive Vice President Min has spent about 20 years at the National Institutes of Health (NIH), Institut Pasteur Korea, and global drugmaker GSK leading RNAi and nucleic acid therapy development.
At GSK, Min oversaw global development and clinical research and development and led new drug discovery projects. Leading a global development team comprising nonclinical and chemistry, manufacturing and controls (CMC), clinical, regulatory, and external partners, Min handled stage-by-stage decision-making from candidate discovery to clinical entry, subsequent clinical trials, and regulatory responses.
In addition to GalNAc-based delivery technology targeting the liver, Min also has experience delivering to extrahepatic tissues using lipid conjugates, and developing nucleic acid therapies for the central nervous system (CNS) and skin.
OliX Pharmaceuticals said it is expanding its RNAi platform beyond the liver to adipose tissue, skin, the eye, and the central nervous system (CNS), and that this experience aligns with the company's pipeline development strategy.
Executive Vice President Min will oversee global development strategies for key pipelines going forward. Min will lead overall development from securing nonclinical data for investigational new drug (IND) submissions to building CMC and manufacturing systems, clinical design and operations, biomarker and dose selection, and engagement with global regulators.
Min will also coordinate development strategies between the Korea and U.S. organizations and further advance collaboration among research, nonclinical, CMC, clinical, and regulatory functions. The company plans to establish development strategies that consider data needed from early research through subsequent clinical trials and approval, and to build a data package robust enough for a global pharmaceutical company to continue development after a technology transfer.
OliX Pharmaceuticals' key pipelines are successively entering clinical stages.
The MASH (metabolic dysfunction–associated steatohepatitis) and obesity therapy "OLX702A" has completed a phase 1 trial in Australia and is set to receive the clinical study report in the second half of this year. The hair loss therapy "OLX104C" is in the final stage of completing a phase 1b trial in Australia.
The macular degeneration therapy "OLX301A" is preparing to enter a multinational, multicenter phase 2a trial in the second half of this year for patients with geographic atrophy (GA). The ALK7-targeting obesity therapy "OLX501A" is preparing nonclinical and clinical entry with a goal of submitting a phase 1 IND in the first half of next year.
Lee Dong-gi, CEO of OliX Pharmaceuticals, said, "Executive Vice President Min Ji-young can determine what needs to be prepared in the early development stage to raise the chances of success in subsequent development and the value of technology transfer."
Lee added, "We will reflect global pharmaceutical companies' development standards and requirements from early research to raise the completeness of the OASIS platform and key pipelines, and expand opportunities for technology transfer and global partnerships."