Pharos iBio Signs Clinical Raw Material Production Contract for PHI-501 with Daewoong Bio

Pharos iBio, an AI-based new drug development company, announced on the 31st that it has signed a contract with Daewoong Bio, a subsidiary of Daewoong Group, for the development of clinical trial raw materials and contract manufacturing (CDMO) of the solid cancer treatment drug ‘PHI-501’.

Pharos iBio Logo [Photo by Pharos iBio]

Based on this contract, Pharos iBio plans to proceed with the procedures for entering clinical trials of PHI-501. Daewoong Bio will optimize the new drug synthesis process, complete GMP production facilities required for Investigational New Drug (IND) approval, and prepare Chemistry, Manufacturing, and Controls (CMC) documentation.

PHI-501 is a preclinical stage targeted anticancer agent, and Pharos iBio expanded its indications using its proprietary AI platform ‘Chemiverse’. The target indications are malignant melanoma, refractory colorectal cancer, and triple-negative breast cancer. It is explained that PHI-501 shows differentiated effects in inhibiting cancer cell growth and metastasis by dual inhibition of pan-RAF, a component of mitogen-activated protein kinase (MAPK) that regulates cell proliferation and survival, and discoidin domain receptor (DDR) 1.

Pharos iBio is conducting translational research on PHI-501 in collaboration with Professor Shin Sang-jun of the Department of Oncology at Yonsei Cancer Center, Severance Hospital, Sinchon. Research data on malignant melanoma treatment was also presented at the American Association for Cancer Research (AACR) in April. After completing preclinical studies and GMP production of PHI-501, an IND approval application is planned for the second half of next year.

Yoon Jung-hyuk, CEO of Pharos iBio, said, “Based on the funds secured through listing, we pursued this agreement to concretize the entry into Phase 1 clinical trials of PHI-501,” adding, “We will advance key pipelines such as ‘PHI-101’ and ‘PHI-201’ to achieve concrete results, including early commercialization of treatments for rare and intractable diseases.” Kim Young-min, head of research at Daewoong Bio, said, “We hope that this CDMO contract will contribute to the successful entry of PHI-501 into Phase 1 clinical trials through Daewoong Bio’s optimized research technology and stable GMP production,” and added, “We will continue to support Pharos iBio’s new drug development through close cooperation between the two companies.”

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