Translational Research Underway to Expand Indications for PHI-101 and PHI-501

Pharos iBio, an AI-driven drug development company led by CEO Jeong-Hyuk Yoon, announced on September 12th that it has signed a Material Transfer Agreement (MTA) with Dr. David Zigler, a specialist in brain tumors at the Children’s Cancer Institute Australia, to advance the clinical potential of its key drugs, PHI-101 and PHI-501. This collaboration will focus on expanding indications and conducting translational research in pediatric brain tumors, specifically Diffuse Intrinsic Pontine Glioma (DIPG) and high-grade gliomas (HGGs).

The agreement aims to verify the efficacy of PHI-101, a radiosensitizer (PHI-101-RS), and PHI-501, a Pan-RAF inhibitor, using patient samples derived from rare pediatric brain tumors. PHI-101 is currently undergoing multinational Phase 1 clinical trials in South Korea and Australia for relapsed and refractory acute myeloid leukemia (AML), and it has recently been approved for a global investigator-initiated trial targeting minimal residual disease (MRD).

Additionally, PHI-101 is being developed as a CHK2 inhibitor radiosensitizer for radiation therapy, with plans to test its efficacy in clinical trials for treating DIPG, an aggressive pediatric brainstem tumor. DIPG primarily affects children aged 5 to 10, leading to severe symptoms such as balance issues, headaches, and paralysis. It remains one of the most challenging brain tumors to treat.

The partnership will also investigate PHI-501 in treating pediatric high-grade gliomas (HGGs) with the BRAF V600E mutation. PHI-501 is currently in preclinical development, with plans to submit an Investigational New Drug (IND) application for Phase 1 clinical trials by the end of the year.

Professor David Zigler expressed his enthusiasm for the collaboration, noting, "We are excited to work with Pharos iBio to explore these promising therapies for pediatric brain tumors. PHI-101 and PHI-501 offer hope in treating rare brain tumors, and we are eager to move forward with cellular and preclinical evaluations, with the goal of advancing to clinical development."

Gyu-Tae Kim, Chief Business Officer of Pharos iBio, added, "This MTA represents a significant step in expanding the indications for our key pipeline drugs. By entering new markets and optimizing our R&D efforts, we remain committed to delivering medical solutions with high clinical value."

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