Highlight Therapeutics’ skin cancer injections show promise in Phase 2b
Spain’s Highlight Therapeutics reported that its lead candidate, BO-112, met its Phase 2b endpoint in localized basal cell carcinoma, with 61% of evaluable patients achieving a response.
Why it matters: Highlight is developing the injected immunotherapy as a potential alternative to surgery, particularly for tumors on the face and neck. Surgery remains the most common treatment, but removing tumors in these sensitive areas can leave scars and require reconstruction.
Zoom in: The single-arm SPOTLIGHT-204 trial enrolled 50 patients, who received three weekly injections directly into their tumors, followed by surgical removal at week 24. Results presented yesterday at the European Academy of Dermatology and Venereology congress in Vienna showed:
- Overall response: 28 of 46 (61%) evaluable patients met the combined visual and pathological response endpoint across all treated lesions.
- Complete response: Both assessments showed complete responses in 56% of high-risk head and neck patients and 62% of patients with facial lesions.
- Safety: No serious adverse events, treatment-related events of Grade 3 or higher, or treatment discontinuations were reported.
How it works: BO-112 uses double-stranded RNA to mimic a viral infection, activating immune defenses against tumor cells. Its scientific roots lie in research led by Marisol Soengas at Spain’s National Cancer Research Centre.
Backstory: The company was previously called Bioncotech Therapeutics, and rebranded as Horizon Therapeutics in April 2020. As European Biotechnology reported in 2019, it partnered with MSD to test BO-112 alongside pembrolizumab in advanced cancers with liver metastases. A subsequent melanoma study conducted with MSD met its Phase 2 response endpoint, with results published in the Journal of Clinical Oncology in 2025. While the two programs are still active on Hoizon’s pipeline page, their strategy is different from the basal cell carcinoma study and focused on making tumors more responsive to checkpoint inhibitors.
- More recently, Highlight raised €15 million in a Buenavista Equity Partners-led round in 2025 to advance its skin cancer program.
Yes, but: With no control group and tumors subsequently removed, this trial does not establish that BO-112 can replace surgery or provide lasting cancer control.
What’s next: Highlight says the findings support late-stage development, but has not disclosed a pivotal trial design or start date.
