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A novel injectable immunotherapy, BO-112, hit its primary endpoint in a Phase 2b trial for basal cell carcinoma (BCC), the world's most common cancer. Over 61% of patients achieved a visual and pathological response, with more than half of high-risk head and neck cases reaching complete remission — all without serious side effects. This could offer a much-needed non-surgical alternative for patients where surgery risks scarring or functional damage.
Highlight Therapeutics just released encouraging Phase 2b data for BO-112, an intralesional immunotherapy for basal cell carcinoma (BCC) — the most common human malignancy. Presented at the EADV Congress in Vienna, the SPOTLIGHT-204 trial showed that the drug, a double-stranded RNA nanoparticle, activates the immune system to attack tumors from within, successfully meeting its primary endpoint of visual and pathological response at week 24.
The results are particularly notable for high-risk head and neck BCC patients — a group where surgery, while effective, can leave lasting scars and functional impairment. In this population, BO-112 achieved complete responses in over half of cases, and nearly two-thirds of patients with facial lesions responded. Safety was also a bright spot: no serious adverse events, no Grade ≥3 treatment-related events, and the vast majority of side effects were mild and short-lived.
By the Numbers:
Why it matters: BCC is incredibly common and rising globally, yet non-surgical options — especially for sensitive facial and neck areas — remain scarce. BO-112 could fill a critical gap, sparing patients from disfiguring surgery while delivering meaningful tumor clearance.