Pharos iBio will collaborate with the team of Professor Shin Sang-joon of the Department of Medical Oncology at Yonsei Cancer Center to conduct the translational study of PHI-501 under development for treating solid tumors.
PHI-501 is a pipeline of solid tumor therapeutics in preclinical development. Pharos iBio and Professor Shin's research team will test PHI-501 in solid tumors, including malignant melanoma and refractory colorectal cancer, to validate the modulation of immune signaling. They will also evaluate the anti-cancer efficacy of PHI-501 in combination with immunotherapy in animal models, the company said on Monday.
Translational research is conducted to develop basic research findings into novel therapies for clinical application or to lay the foundation for basic research based on new observations from clinical studies. Through this translational study, Pharos iBio will test the differential efficacy of PHI-501 in various ways and study new therapeutic regimens.
Pharos iBio expects to complete preclinical studies of PHI-501 in the third quarter of this year.
Upon completion of preclinical studies, the company will begin preparations for a phase 1 IND (investigational new drug) submission. PHI-501 has been undergoing toxicology testing at Charles River Laboratories, a U.S. Good Laboratory Practice (GLP) facility since last year. After completing preclinical studies, the company plans to file a phase 1 IND in the latter half of this year.
Pharos iBio is actively conducting open innovation with external experts and organizations to develop new drugs successfully. Since August, it has been conducting translational research with the research team of Donald Small, professor of oncology at Johns Hopkins University School of Medicine, to expand the combination therapy of PHI-101, a treatment for acute myeloid leukemia.
PHI-101, the most advanced drug in Paros iBio's pipeline, is in the final stages of a phase 1b clinical trial. In addition, Pharos iBio has research collaborations with the University of Sydney, Australia.
"We are conducting multidisciplinary R&D to discover the potential of PHI-501 and increase its added value," said Nam Ki-yeop, president and chief technology officer of new drug development at Pharos iBio. "We aim to become a global biotech through the successful development of PHI-501, which is targeted as a 'first-in-class' therapy.”
Professor Shin said, "Rare diseases are where patients have limited treatment options and large unmet needs. We hope that the development of innovative therapies by Korean companies will accelerate and improve the treatment environment for urgent rare and incurable diseases."