BO-112

Highlight Therapeutics announces completion of enrollment for Phase 2b study of BO-112 in large, underserved basal cell carcinoma population VALèNCIA, VALENCIA, SPAIN, January 28, 2026 / EINPresswire.com / -- Highlight Therapeutics (“Highlight”), a private, clinical-stage biopharmaceutical company advancing an innovative RNA-based skin cancer immunotherapy into late-stage development, announces completion of enrollment in its SPOTLIGHT-204, a phase 2b clinical evaluating BO-112, Highlight’s lead asset, in patients with basal cell carcinoma (BCC). The completion of enrollment represents a major milestone for the company and highlights the unmet medical need in patients with basal cell carcinoma. Mercedes Diz, CEO of Highlight Therapeutics, said: “The completion of enrollment in SPOTLIGHT-204 represents an important step in our strategy to develop innovative and scalable dermato-oncology therapies. BCC is a high-incidence disease in which treatment paradigms have remained largely unchanged for decades, particularly for patients with lesions in cosmetically and functionally sensitive areas. By advancing BO-112 in this Phase IIb study, we aim to help redefine the role of intratumoral immunotherapy in BCC.” About SPOTLIGHT-204 SPOTLIGHT 204 is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate efficacy and safety of intra-lesional BO-112 as monotherapy in 50 patients with resectable primary low and high-risk BCC currently ongoing in 10 clinical centers in Spain and Israel. The study evaluates BO-112 efficacy in patients with up to 8 BCC lesions, who are treated with 3 weekly intralesional injections of BO-112 followed by complete surgical excision of the injected lesions. About BCC Traditional first line treatment for BCC, the most common human skin malignancy, involves surgical excision. Although surgery remains a standard treatment for BCC, in circumstances where excisional methods are not feasible or could lead to disfigurement or poor cosmetic outcomes, non-surgical therapeutic alternatives may be considered by the treating clinician, based on individual patient circumstances and applicable clinical guidelines. There are approximately 5 million BCC lesions diagnosed yearly in the USA with approximately 70% of BCCs affecting the face, most commonly the nose and eyelid, and therefore may require particular consideration of non-surgical therapeutic approaches in certain patients. As the incidence of BCC continues to increase, there is a need for additional effective alternative treatment options, particularly as our population ages. About Highlight Therapeutics and BO-112 Highlight is a private, clinical-stage company dedicated to advancing the potential of immuno-dermato-oncology. Its proprietary dsRNA platform is supported by scientific research, and its lead drug candidate BO-112 is an investigational RNA-based in-office, intralesional immuno-therapy. BO-112 is designed to mimic the effects of a viral infection, stimulating the immune system to attack tumor cells through activation of dendritic cells, CD8 T-cell infiltration, induction of interferons (IFNs), induction of apoptosis and enhancement of immunogenic cell death. BO-112 has been investigated in a range of phase 1 and 2 clinical trials as a monotherapy and in combination with checkpoint inhibitors. BO-112, in combination with KEYTRUDA ® , has shown encouraging clinical efficacy in patients with anti-PD-(L)1 relapsed or refractory advanced and metastatic melanoma, including pathological complete responses in patients with non-visceral disease. BO-112 has an observed favorable risk-benefit profile to date in more than 170 patients with dermatology and cancer indications. BO-112 is an investigational product and has not been approved for any indication by any regulatory authority. Highlight Therapeutics Highlight Therapeutics email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.