PharosEye Shows 2.8x Increased Anticancer Efficacy Compared to Pfizer Combination Therapy... AI New Drug Platform Achievement

BRAF and KRAS Mutations Inhibit Colorectal Cancer Tumor Growth by 96% and 83.3% Respectively
Presented at the European Society for Medical Oncology Targeted Therapy Conference
"Demonstrates Efficacy in Inhibiting Cancer Cell-Inducing Mutations and Growth"

Pharos iBio, an AI-based rare and intractable disease new drug development specialist company, announced on the 27th that it presented preclinical research results of PHI-501 for the treatment of intractable colorectal cancer at the European Society for Medical Oncology Targeted Anticancer Therapy Conference (ESMO TAT 2024) held in Paris, France, starting on the 26th (local time).

PHI-501 is a targeted anticancer drug candidate for mutations such as BRAF, KRAS, and NRAS that cause intractable solid tumors. Pharos iBio will present interim preclinical trial results related to the treatment of intractable colorectal cancer with PHI-501 at the conference.

The preclinical study of PHI-501 is being jointly conducted as part of open innovation by Pharos iBio and the oncology team led by Professor Shin Sang-jun of Yonsei Cancer Hospital. According to the research results presented as a poster by Pharos iBio at the conference, PHI-501 showed anticancer efficacy against colorectal cancer with BRAF and KRAS mutations. KRAS mutations occur in about 20% of colorectal cancer patients, and BRAF mutations are observed in about 10%.

BRAF mutations are known to cause intractable colorectal cancer and are associated with poorer prognosis compared to cases without such mutations. They are also identified as causative factors for various rare cancers such as malignant melanoma. When PHI-501 was administered alone to colorectal cancer xenograft models with BRAF and KRAS mutations, tumor growth was inhibited by 96% and 83.3%, respectively. Compared to the combination therapy of Vitrakvi (active ingredient: encorafenib) and Erbitux (active ingredient: cetuximab), which are existing treatments approved by the U.S. Food and Drug Administration (FDA), the anticancer efficacy was approximately 2.8 times higher. PHI-501 also inhibited tumor growth by 76.1% in colorectal cancer models that showed drug resistance after treatment with Pfizer’s BRAF inhibitor Vitrakvi.

Pharos iBio is developing PHI-501 as a pan-RAF and DDR dual inhibitor that simultaneously acts on two signaling pathways involved in cancer tumor survival and growth. As a pan-RAF inhibitor, it suppresses cancer cell growth signals through pan-RAF inhibition while also acting on DDR1 and DDR2 to interfere with cancer cell survival signal transmission.

Pharos iBio has expanded the disease indications of PHI-501 beyond intractable colorectal cancer to include malignant melanoma and triple-negative breast cancer by utilizing the disease target prediction module ‘DeepRECOM’ of its proprietary AI drug development platform ‘Chemiverse®’.

Pharos iBio is preparing to submit an Investigational New Drug (IND) application for the Phase 1 clinical trial of PHI-501. GLP toxicity testing of PHI-501 is currently underway at Charles River, a U.S.-based preclinical testing specialist company. Last month, Pharos iBio signed a contract with IntroBioPharma for the production of finished drugs for Phase 1 clinical trials (CDMO).

Pharos iBio plans to complete the preclinical study of PHI-501 by the third quarter of this year and submit the IND for global Phase 1 clinical trials within the year. Hye-jung Han, CEO of Pharos iBio’s U.S. branch, introduced PHI-501 as a candidate drug under research and development aiming to be a ‘first-in-class’ drug that achieves both mutation inhibition and overcoming resistance to existing drugs. She added, “We are fully committed to successful development by leveraging Pharos iBio’s excellent new drug development capabilities, advanced AI platform utilization, and promoting open innovation with outstanding researchers.”

Pharos iBio is a KOSDAQ-listed company developing treatments for rare and intractable diseases using the AI drug development platform Chemiverse. Its main pipelines include ‘PHI-101,’ an acute myeloid leukemia treatment currently in global Phase 1 clinical trials, and ‘PHI-201,’ a KRAS anticancer drug licensed out to Yuhan Corporation.

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