WyBioLogics Reveals First Domestic PD-1 Antibody 'YBL-006' Phase 1 Clinical Trial Results at US ASCO

[Asia Economy Reporter Lee Gwan-joo] Y-Biologics announced on the 27th that it has disclosed the Phase 1 clinical trial results of the immuno-oncology drug 'YBL-006' through an abstract at the American Society of Clinical Oncology (ASCO).

This announcement comes about eight months after presenting the interim Phase 1 results at ESMO, Europe's largest oncology conference, in September last year.

Among a total of 67 patients with various solid tumors, efficacy was evaluated in 52 patients, showing an objective response rate (ORR) of 15.4%, including one complete response (CR) and seven partial responses (PR). Even after 12 months, sustained responses were observed in two patients who showed complete and partial responses, with a median duration of response of 4.9 weeks.

In the patient group with special interest tumor types for efficacy confirmation, excluding those enrolled for pharmacokinetic studies, the ORR was 19.4%. Among the participating patients, 32 were available for biomarker analysis, and the ORR in the biomarker-positive group was 62.5%, significantly higher compared to 8.3% in the biomarker-negative group.

YBL-006 is the first domestic PD-1 antibody immuno-oncology drug. PD-1, whose mechanism was discovered in 1992, is credited with transforming the paradigm of cancer treatment following the launch of Merck (MSD)'s 'Keytruda' in 2015. However, only 10 products have been globally approved to date.

A Y-Biologics official stated, “We are pleased to share the Phase 1 clinical trial results of the first domestic PD-1 targeting immuno-oncology drug candidate at ASCO, a major international cancer conference,” adding, “We will do our best to deliver good results in the remaining clinical trials.”

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