Korea-based biopharma company Hanmi Pharmaceutical announced on Monday, at the Society for Immunotherapy of Cancer (SITC) conference, recently held in Houston, USA, the latest progress in the clinical trial of BH3120, an innovative immunotherapy jointly developed with Beijing Hanmi Pharmaceutical

BH3120 is a novel anticancer drug based on Hanmi's proprietary dual antibody platform, 'Pentambody.' This technology enables a single antibody to simultaneously bind to two distinct targets, allowing for a targeted anticancer action by specifically attacking cancer cells while activating immune cells to enhance immunotherapy effects. BH3120 is designed to target PD-L1 on cancer cells and 4-1BB on immune cells, thereby acting as a 'bridge' that facilitates immune cells' recognition and killing of tumour cells.

The Phase 1 clinical trial has progressed smoothly through cohort 3 (1 mg/kg) of the dose escalation phase, with no dose-limiting toxicities (DLT) or grade 3 or higher adverse drug reactions observed to date.

Hanmi is also conducting a Phase 1 trial to assess the safety and efficacy of BH3120 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced or metastatic solid tumours.

In September, Hanmi obtained approval from both the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) to modify the Phase 1 trial plan to evaluate BH3120 in combination with KEYTRUDA. Full-scale clinical development is expected to commence early next year. Hanmi will serve as the lead sponsor and conduct the clinical trial, while MSD will supply KEYTRUDA for the trial.