Pharos iBio's 'PHI-101' Advances Research to Expand First-Line Combination Therapy

Pharos iBio, an AI-based innovative new drug development company, announced on the 28th that it is conducting translational research to expand combination therapy of the acute myeloid leukemia (AML) drug candidate ‘PHI-101’ with Donald Small, MD, PhD, Professor of Oncology at Johns Hopkins University School of Medicine and Chair of Pediatric Oncology at Johns Hopkins Kimmel Cancer Center. The plan is to enable PHI-101 to enter the AML first-line treatment market through translational research on combination therapies with existing approved first-line treatments.

Pharos iBio logo
Photo by Pharos iBio

Professor Donald Small is recognized as a world authority in the field of acute myeloid leukemia. He has conducted research related to the target protein of PHI-101, the tyrosine kinase (FLT3), for over 30 years and has led numerous clinical studies on FLT3 inhibitors. He is also providing clinical consultation for the global Phase 2 design of PHI-101 and supporting the clinical hospital network in the United States where the trials will be conducted.

This study tests the efficacy of combining PHI-101 with azacitidine (brand name Vidaza) and venetoclax (Venclexta), which are used as first-line treatments for acute myeloid leukemia. The ongoing PHI-101 clinical trial targets AML patients who are refractory to existing drugs or have relapsed after treatment and is currently in the multinational Phase 1b stage. On the 2nd of this month, it also received ‘compassionate use approval’ from the Korean Ministry of Food and Drug Safety. Compassionate use approval allows applicants’ critically ill patients to use investigational drugs still under development. Through this, PHI-101 is also being used to treat relapsed and refractory AML patients at Seoul St. Mary’s Hospital of the Catholic University of Korea, which is the current applicant for compassionate use approval.

Pharos iBio is expanding the indications of PHI-101 using its AI drug development platform ‘Chemiverse.’ Currently, PHI-101 is being researched and developed to target diseases beyond acute myeloid leukemia, including recurrent ovarian cancer, triple-negative breast cancer, and as a radiosensitizer, using Chemiverse. If the indication expands to first-line treatment for relapsed and refractory AML, the target market will grow, and the probability of success as a new drug will increase, thereby enhancing the added value of the drug.

Yoon Jung-hyuk, CEO of Pharos iBio, stated, “PHI-101 is our flagship pipeline, and we are preparing for global Phase 2 clinical trials in the United States, Australia, and Korea by the first half of next year, while developing various expanded indications using Chemiverse.” He added, “The translational research on combination therapy with Johns Hopkins University School of Medicine is also part of our ‘One Source Multi-Use’ strategy.” He continued, “We will accelerate the early commercialization of PHI-101 by expanding investment and strengthening the organization of our U.S. subsidiary (100% owned) and expanding joint research and development with excellent basic research institutions and global biotech companies in the U.S., including Johns Hopkins, through global Phase 2 clinical trials. We aim to promptly launch innovative new drugs that meet the unmet needs of rare and intractable patients worldwide, led by PHI-101, and continuously generate related pipelines.”

This content was produced with the assistance of AI translation services.