Abl Bio announced on the 7th that it has confirmed positive anti-cancer efficacy in the dose expansion cohort of the Phase 1b clinical trial for its new drug candidate 'ABL111', which is being co-developed with the U.S. biotech company Novabridge Biosciences.
This clinical trial was conducted on HER2-negative, Claudin 18.2-positive, first-line metastatic gastric cancer patients.
ABL111 is a dual antibody that targets both Claudin 18.2 and 4-1BB (a protein on the surface of immune cells) simultaneously. It is currently undergoing a Phase 1b clinical trial in the U.S. in combination with the PD-1 inhibitor Nivolumab and the chemotherapy drug (mFOLFOX6).
mFOLFOX6 is a combination chemotherapy that administers three drugs together. PD-L1 is a receptor that attaches to T cells and stops excessive activity of immune cells, while cancer cells produce a lot of PD-L1 to neutralize T cell attacks. PD-L1 inhibitors are designed to suppress this immune evasion function of cancer.
Analysis of patients receiving ABL111 at doses of 8 mg/kg or 12 mg/kg showed an objective response rate (the percentage of patients whose tumors shrank beyond a certain threshold after treatment) of 77% at 8 mg/kg and 73% at 12 mg/kg.
The ABL111 combination therapy showed consistent responses regardless of the patients' PD-L1 and Claudin 18.2 expression levels, and the safety profile was similar to the current standard first-line therapy, demonstrating overall good tolerability.
The median progression-free survival (PFS), which is the period from the start of treatment until cancer worsens (progresses) or death occurs, was confirmed to be 16.9 months for the 8 mg/kg dose. The 12 mg/kg dose group will be disclosed later due to a relatively shorter follow-up period.
Lee Sang-hoon, CEO of Abl Bio, stated, "The data announced this time confirms that ABL111 has the potential to become a 'best in class' as a potential first-line standard treatment. Since gastric cancer represents a market opportunity of about $12 billion globally, both companies will continue to collaborate to accelerate the clinical development of ABL111."
The full data from the Phase 1b trial of ABL111 is scheduled to be presented at a global academic conference in 2026. Abl Bio and Novabridge plan to initiate a global randomized Phase 2 trial comparing ABL111 at doses of 8 mg/kg and 12 mg/kg against existing standard therapies in the first quarter of this year.
