Highlight Therapeutics reports positive Phase 2b results for intralesional BO-112 in localized basal cell carcinoma, with 61% achieving the primary endpoint.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Highlight Therapeutics announced topline results from the SPOTLIGHT-204 trial (NCT06422936) on September 30, 2026, presented during a late-breaking session at the 35th European Academy of Dermatology and Venereology (EADV) Congress in Vienna. The multicenter, single-arm Phase 2b trial evaluated intralesional BO-112 in patients with resectable primary low- and high-risk basal cell carcinoma (BCC).
Basal cell carcinoma is the most common human malignancy. Treatment remains particularly challenging for high-risk lesions located in anatomically sensitive areas such as the head and neck.
The study met its primary endpoint of visual and pathological response at Week 24, along with key secondary endpoints including safety and tolerability. The modified intention-to-treat (mITT) population comprised 46 patients with 54 evaluable lesions assessed by a central review committee.
Among the mITT population, 28 of 46 patients (61%) achieved the primary composite endpoint of visual and pathological response (defined as Grade 3 or better across all treated lesions). Highlight Therapeutics also reported high concordance between visual and histological assessments.
Responses reported across risk groups
Composite visual and pathological responses were observed across both risk categories. Among patients in the high-risk BCC cohort, 21 of 36 (58%) achieved the composite endpoint. In the low-risk cohort, 7 of 10 evaluable patients (70%) achieved the same response benchmark.
Additional findings were reported for high-risk head and neck disease. Complete visual and complete pathological responses classified specifically as Grade 1 (Complete Response) in the trial’s central review grading scale were achieved in 18 of 32 evaluable head and neck patients (56%). Among patients with facial lesions, 16 of 26 (62%) achieved complete visual and complete pathological responses.
These efficacy results reflect the company’s topline analysis of SPOTLIGHT-204. The complete response rates (Grade 1) should be distinguished from the broader composite response endpoint (Grade 3 or better) utilized for the primary analysis.
BO-112 administered before surgical excision
SPOTLIGHT-204 enrolled 50 total patients (comprising 40 high-risk BCC patients and 10 low-risk BCC patients, with 46 qualifying for the mITT analysis). Within the high-risk cohort, 36 patients presented with head and neck lesions. The overall median patient age was 75 years (ranging from 34 to 90 years), and 48% were female.
Participants received three once-weekly intralesional injections of BO-112, followed by complete surgical excision at Week 24. The primary endpoint was visual and pathological response at Week 24, as determined by the central review committee. Secondary endpoints included investigator-assessed visual and pathological responses, as well as overall safety and tolerability.
Safety findings
BO-112 was well tolerated in SPOTLIGHT-204. No serious adverse events, Grade 3 or higher treatment-related adverse events (TRAEs), or treatment discontinuations due to adverse events were reported.
The majority of TRAEs were mild, with 91% classified as Grade 1 adverse events. Highlight Therapeutics reported that 88% of these events resolved within three days.
Investigational treatment advances in development
BO-112 is a double-stranded RNA nanoparticle formulated for intralesional administration. According to Highlight Therapeutics, its immunotherapeutic mechanism involves activating innate antiviral sensing pathways, inducing immunogenic tumor cell death, and triggering tumor-specific adaptive immunity.
The company characterizes BO-112 as an immune activator designed to engage both innate and adaptive immune responses. BO-112 remains an investigational agent and has not been approved by any regulatory authority.
Based on these Phase 2b findings, Highlight Therapeutics plans to advance BO-112 into late-stage development for localized primary BCC. The company noted that the SPOTLIGHT-204 results provide the first clinical validation for BO-112 in basal cell carcinoma.
Reference
Highlight Therapeutics Presents Positive Phase 2b Topline Results of Intralesional BO-112 in Localized Basal Cell Carcinoma as a Late-Breaker at EADV, Highlight Therapeutics via GlobeNewswire, 30 September 2026
Clinical Trial to Evaluate BO-112 in Patients with Basal Cell Carcinoma (BCC) (SPOTLIGHT204), ClinicalTrials.gov ID NCT06422936
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.