At Highlight Therapeutics, we continue to move forward in the clinical development of BO-112. In collaboration with the CRO Pivotal, we have launched a phase IIa trial to evaluate the combination of BO-112 with an anti–PD-1 therapy in patients with unresectable or metastatic melanoma.

The study has already begun recruiting patients across 19 leading centers in Spain and France, marking an important milestone in our clinical development program.

A new step in the development of BO-112

Metastatic melanoma remains one of the greatest challenges in oncology. Although immune checkpoint inhibitors such as anti–PD-1 therapies have significantly improved patient survival, many individuals develop either primary or acquired resistance, which limits long-term treatment efficacy.

BO-112 aims to address this challenge through a complementary approach: it is administered directly into the tumor to activate the innate immune system and enhance the effectiveness of anti–PD-1 treatments, even in patients who have previously developed resistance.

“This phase IIa study represents a step forward in our strategy to develop effective cancer therapies that can be used in combination with checkpoint inhibitors,” explained Marisol Quintero, Chief Executive Officer of Highlight Therapeutics. “We are encouraged by the efficacy already observed in melanoma patients previously treated in the phase I study with BO-112, and we are pleased to collaborate once again with the Pivotal team.”

A collaborative trial across centers in Spain and France

This open-label, non-comparative study will enroll at least 40 patients with unresectable melanoma. It will evaluate both the antitumor activity and systemic exposure of repeated intratumoral injections of BO-112 combined with intravenous administration of an anti–PD-1 therapy.

The collaboration with Pivotal, which brings extensive experience in early-phase clinical trials, will allow the study to advance efficiently and rigorously in evaluating this therapeutic combination.

“The excellence of the clinical teams, together with Pivotal’s infrastructure and experience, has enabled us to activate recruitment and move forward rapidly with the study,” said Lourdes Huarte, Senior Vice President of Regulatory and Clinical Operations at Pivotal.

A continued commitment to immunotherapy

This is the third clinical trial involving BO-112, following the launch of the phase I study in 2016 and a trial in gastrointestinal tumors initiated in 2020. With this study, we continue to expand the scientific evidence supporting our RNA-based therapy, designed to transform “cold” tumors into “hot” tumors and make them more visible to the immune system.

Our objective remains clear: to turn scientific innovation into real therapeutic options for patients with advanced melanoma.