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A Phase 2b trial of BO-112, an injectable immunotherapy for basal cell carcinoma (BCC), hit its primary endpoint — with over half of high-risk patients achieving complete response. The results, presented at the EADV Congress in Vienna, could offer a non-surgical alternative for patients with BCC on the face and neck, where surgery often leaves lasting scars. No serious adverse events were reported.
Basal cell carcinoma (BCC) is the world's most common cancer, and while surgery works well, it can leave significant scarring — especially when tumors sit on the face or neck. Highlight Therapeutics has shared Phase 2b results for BO-112, a double-stranded RNA nanoparticle injected directly into tumors to activate the immune system, with encouraging findings presented at the EADV Congress in Vienna.
The SPOTLIGHT-204 trial enrolled 50 patients (40 high-risk, 10 low-risk) who received three weekly injections of BO-112 before surgical excision at week 24. The trial met its primary endpoint, with 61% of patients achieving a composite visual and pathological response. Notably, 56% of high-risk head & neck patients achieved complete response — rising to 62% for those with facial lesions. The safety profile was clean: no serious adverse events, no Grade ≥3 treatment-related events, and 91% of side effects were mild.
By the Numbers:
Why it matters: For patients with BCC in cosmetically sensitive areas, surgery can be disfiguring. BO-112 could offer a well-tolerated, point-of-care alternative — particularly for elderly patients or those where surgical risk is high. These results support advancing into late-stage development.