Highlight Therapeutics reported positive topline phase 2b trial results for its intralesional treatment BO-112 in patients with localized primary basal cell carcinoma. The data, presented at the European Academy of Dermatology and Venereology congress in Vienna, show the study met its primary endpoint of visual and pathological response at week 24, alongside favorable safety and tolerability profiles.
Phase 2b Spotlight-204 Trial Results in Basal Cell Carcinoma
The multicenter, single-arm Spotlight-204 trial evaluated BO-112 in 46 patients diagnosed with resectable primary low- and high-risk basal cell carcinoma. Out of the total participant group, 61% achieved the combined visual and pathological response. When stratified by risk level, 58% of high-risk patients and 70% of low-risk patients reached the endpoint.
For patients with lesions specifically located in the head and neck region, 56% achieved a complete pathological response. Among patients with lesions on the face, that figure reached 62%. Basal cell carcinoma is the most common form of skin cancer, typically developing on sun-exposed areas such as the face, head, neck, and arms when UV rays mutate basal cells in the outer layers of the skin.
Safety and Tolerability Data for BO-112
The trial recorded no serious adverse events or treatment-related adverse events of grade 3 or higher. Investigators noted grade 1 adverse events in 91% of patients, with 88% of those events resolving within three days. Mercedes Diz, CEO of Highlight Therapeutics, stated in the release that the findings provide the first clinical validation of BO-112 in basal cell carcinoma and support advancement into late-stage development.
BO-112 functions as a double-stranded RNA nanoparticle engineered to convert immunologically cold tumors into hot tumors. This mechanism activates innate antiviral sensing pathways to induce immunogenic tumor cell death, which triggers tumor-specific adaptive immunity.
Development History and Competitive Landscape in Skin Cancer Immunotherapy
Originally founded in Spain in 2010 as Bioncotech Therapeutics, Highlight Therapeutics entered a clinical trial collaboration with MSD in 2019 to evaluate BO-112 alongside Keytruda in advanced solid tumors. The company maintains ongoing phase 1 and 2 trials in resistant melanoma, sarcoma, and hepatocellular carcinoma.
In the market for basal cell carcinoma immunotherapies and targeted treatments, BO-112 faces established therapies. These include Sanofi and Regeneron’s PD-1 targeted antibody Libtayo, approved by the U.S. Food and Drug Administration in 2021 for advanced basal cell carcinoma, alongside Novartis’ Odomzo and Genentech’s Erivedge.
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