Set to evaluate the drug safety, efficacy, optimal dose, etc. with 70 solid cancer patients​​

Y-Biologics, a biotech company specializing in the development of antibody drugs, has started administering YBL-006, a PD-1 immunotherapy candidate, in the Phase 1 dose expansion cohort in Australia. As was the case with the dose escalation study, the expansion cohort study will also first begin at Macquarie University Hospital.

 

 

Y-Biologics received approval for Phase 1 clinical trials on YBL-006 in Korea and Australia in May last year and has since conducted a dose escalation study. The company announced the results of the phase 1, first-in-human clinical trial of solid cancer at the American Society of Clinical Oncology (ASCO) held this past June. The interim results confirmed drug safety and tolerability and demonstrated the clinical benefits of the drug, with one patient showing a complete response (CR).

 

 

The dose expansion study, which recently commenced in Australia, is being conducted as part of a global clinical trial being carried out in Korea and Thailand among others. The objective is to evaluate the safety and efficacy of YBL-006 and the recommended Phase 2 dose (R2PD) of the drug for various types of solid cancer. This dose expansion study will proceed with around 70 solid cancer patients.

 

 

Y-Biologics is aiming to market the first domestically licensed PD-1 antibody targeting rare types of cancer Korea and is developing PD-1 antibody in consideration of pursuing combination therapy with an immuno-oncology drug.

 

 

Meanwhile, Y-Biologics is getting ready for its IPO in the second half of this year. The company selected Korea Investment & Securities as the underwriter and applied for a preliminary review in May.

By Sung Min Kim, sungmin.kim@bios.co.kr