Wybiologics Begins Phase 1 Dose Expansion Trial of Immuno-Oncology Drug in Australia

Park Young-woo, CEO of Y-Biologics (Photo by Y-Biologics)

[Asia Economy Reporter Kim Ji-hee] Y-Biologics announced on the 29th that it has started the first dosing of the dose expansion cohort of the Phase 1 clinical trial for its immuno-oncology drug candidate ‘YBL-006’ in Australia. Following the dose escalation, the dose expansion cohort will also begin first at Macquarie University Hospital.

YBL-006 is an immuno-oncology drug candidate independently discovered and developed by Y-Biologics. Immuno-oncology drugs work by inducing the body's immune response to attack cancer cells. YBL-006 targets the PD-1 protein located on the surface of immune T cells. When the PD-L1 protein on the surface of cancer cells binds to PD-1 on immune T cells, the immune T cells recognize the cancer cells as normal cells and do not attack them. This drug inhibits such an ‘immune checkpoint’ to enable immune T cells to attack cancer cells.

Y-Biologics is researching and developing new drug substances based on an antibody platform. It possesses core technologies including ‘ALiCE,’ a proprietary immune T cell bispecific antibody platform, and ‘Ymax®-ABL,’ a human antibody library with over 100 billion genetic diversities. Based on these technologies, Y-Biologics discovers and develops candidate substances for antibody drug development.

In May of last year, Y-Biologics received approval for the Phase 1 clinical trial of YBL-006 in South Korea and Australia and confirmed complete remission (CR) through dose escalation trials. This dose expansion trial is a global clinical trial including South Korea and Thailand, verifying the safety and efficacy of YBL-006 in treating solid tumors across various cancer types. The trial aims to evaluate the optimal dosage of the drug and will be conducted on approximately 70 patients with solid tumors.

Y-Biologics is also planning an IPO targeting the second half of this year. It has selected Korea Investment & Securities as the lead manager and filed for preliminary review for listing in May.

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