Pharos iBio, a pharmaceutical company specializing in AI-driven drug development, witnessed a significant surge in its shares after announcing the therapeutic use approval of PHI-101, a revolutionary treatment for relapsed or refractory acute myeloid leukemia (AML). The approval, granted by the Ministry of Food and Drug Safety, marks a groundbreaking moment for the pharmaceutical industry as it showcases the clinical application of an AI-developed drug. With this development, the market’s anticipation for the potential of AI in drug discovery and development has reached new heights.
AI-developed PHI-101 receives therapeutic use approval for AML treatment
Pharos iBio reported that it has received approval for the therapeutic use of PHI-101, a targeted anticancer drug designed to treat patients with AML who have relapsed or are refractory to existing treatments. The Ministry of Food and Drug Safety granted the approval on an individual basis, giving the green light to a healthcare provider at the Catholic University of Korea-Seoul St. Mary’s Hospital to administer the treatment to an eligible patient.
Therapeutic use approval allows the use of investigational drugs for patient treatment in specific cases where no alternative treatments are available. It represents a significant advancement in patient care, offering hope to those suffering from rare diseases and emergencies without effective treatment options. The approval of PHI-101 stands out from conditional licenses as it focuses on enabling single treatments for individual patients.
AI-driven drug discovery and development revolutionize cancer treatment
The groundbreaking approval of PHI-101 stems from its origin in Pharos iBio’s AI drug discovery platform, Chemiverse. By harnessing the power of artificial intelligence, Pharos iBio successfully identified and developed PHI-101, a targeted anticancer drug that aims to combat the FLT3 gene mutation found in approximately 30%-35% of AML patients.
Patients with FLT3 mutations often face a lower survival rate and an increased risk of relapse compared to those without the mutation. But, clinical trials of PHI-101 have shown promising results, demonstrating its ability to reduce malignant myeloid cells in patients resistant to existing FLT3 inhibitors.
CEO Yun Jeong-hyuk expressed his satisfaction with the approval, emphasizing the company’s commitment to contributing to public health by focusing on the development of rare and incurable drugs with high unmet medical needs. Phase I clinical studies for PHI-101 are now being conducted in Korea by Pharos iBio, which is also actively broadening the drug’s indication to include the treatment of recurrent ovarian cancer.
In addition to the groundbreaking AI-developed PHI-101, Pharos iBio is also engaged in joint research and development of PHI-201, a KRAS anticancer drug, in partnership with Yuhan Corp. The company’s dedication to innovation extends beyond cancer treatment, as it recently signed a contract manufacturing organization (CDMO) agreement with Daewoong Bio to advance the development of raw materials for the solid cancer drug PHI-501 clinical trials.
The news of the therapeutic use approval for PHI-101 sparked a significant surge in Pharos iBio’s shares on the Kosdaq market, reaching its daily upper limit. As of 11 a.m. Thursday, the company’s share price soared to 18,920 won ($14.5), a remarkable 29.95% increase from the previous day’s closing price of 14,560 won.
AI-driven drug approval boosts market expectations
The approval of PHI-101 for therapeutic use highlights the enormous potential of AI-driven drug discovery and development in revolutionizing cancer treatment. Pharos iBio’s achievement sets a precedent for the pharmaceutical industry, inspiring further research and investment in AI-based approaches to tackle rare and challenging diseases. As the company continues its pursuit of innovative solutions to address unmet medical needs, it stands poised to make significant contributions to public health and patient care in the years to come.
