Highlight Therapeutics touted positive topline results in patients with localized high-risk head and neck basal cell carcinoma (BCC).
The phase 2b study met its primary endpoint of visual and pathological response at week 24, as well as safety and tolerability, with no serious adverse events.
These results, presented today during the European Academy of Dermatology and Venereology (EADV) congress in Vienna, support the advancement of Highlight’s BO-112 to late-stage development for localized primary BCC.
"Today marks an important milestone for Highlight Therapeutics as these results represent the first clinical validation of BO-112 in BCC and give us strong conviction to advance into late-stage development,” Mercedes Diz, CEO of Highlight Therapeutics, said in the release. “We are excited to bring this potential non-surgical option a step closer to patients, particularly those with high-risk BCC in the head and neck, where the need is greatest.”
Basal cell carcinoma is the most common type of skin cancer, and it appears most frequently on the face, head, neck and arms. This cancer begins in the basal cells that live on the outer layers of the skin. When these cells are exposed to damaging rays from the sun or other UV light, the cells can begin to mutate and multiply, leading to a lesion on the surface of the skin.
The phase 2 trial, called Spotlight-204, is a multicenter, single-arm study evaluating the safety and efficacy of intralesional BO-112 in 46 patients with resectable primary low- and high-risk BCC.
Out of the 46 patients who received BO-112, 61% achieved visual and pathological response. Stratifying these patients further, 58% of high-risk and 70% of low-risk patients achieved visual and pathological response.
In the high-risk head and neck group, 56% reached complete pathological response, and in those with lesions in the face, 62% achieved complete pathological response.
BO-112 was well tolerated across all patients, as no serious adverse events or grade 3 or higher treatment-related adverse events were reported. Grade 1 adverse events were noted in 91% of patients and resolved in 88% of patients within three days.
BO-112 is a double-stranded RNA nanoparticle designed to convert immunological cold tumors to hot tumors so that the immune system can recognize them. It works by activating the innate antiviral sensing pathways, inducing immunogenic tumor cell death, leading to the development of tumor-specific adaptive immunity, according to the company.
The Spanish biotech was founded in 2010 under the original name of Bioncotech Therapeutics. Back in 2019, Bioncotech entered a phase 2 clinical trial collaboration with MSD, a subsidiary of Merck, to try BO-112 with Keytruda in patients with advanced stage solid tumors with liver metastases.
Highlight has multiple phase 1 and 2 trials running in advanced and resistant melanoma as well as sarcoma and hepatocellular carcinoma.
In the field of BCC immunotherapy, there is Sanofi and Regeneron’s PD-1 targeted antibody, Libtayo, which was approved by the FDA in 2021 for advanced BCC, Novartis’ Odomzo and Genentech’s oral Erivedge.