At Highlight Therapeutics, we continue advancing the development of BO-112, our RNA-based immune-activating drug, with a clear goal: finding new treatment approaches for patients who currently lack effective options.

In this context, we have reached an important new milestone with the administration of the first dose to a patient in our phase IIa clinical study, evaluating the combination of BO-112 and KEYTRUDA® (pembrolizumab)—the anti-PD-1 therapy developed by MSD—in patients with advanced solid tumors with liver metastases.

A study focused on one of oncology’s greatest challenges

The phase IIa trial is an open-label, multicenter, non-comparative study conducted in four European countries and includes two patient cohorts: one with colorectal cancer and another with gastric cancer or gastroesophageal junction cancer.

The objective is to evaluate the safety, tolerability, and antitumor activity of intratumoral administration of BO-112 into a metastatic liver lesion, combined with intravenous pembrolizumab.

Liver metastases represent one of the greatest clinical challenges in oncology. The liver is the most common site of metastatic disease: tumors that spread there are up to 20 times more frequent than primary liver tumors.

Between 25% and 50% of patients with colorectal cancer, and 30% to 50% of those with gastric cancer, develop liver metastases at some point during the course of their disease.

However, a major challenge lies in the fact that the liver is an immune-tolerant environment, meaning that many of these tumors do not respond to current immunotherapy treatments.

BO-112: a therapy designed to awaken the immune system

BO-112 is a compound that mimics a viral infection, activating the body’s natural defenses so they recognize and attack tumor cells.

In previous studies, it has already demonstrated its ability to modify the tumor microenvironment and convert so-called “cold tumors”—those not detected by the immune system—into “hot tumors”, which are visible and responsive to immunotherapy.

As our CEO Marisol Quintero explains:

“The initiation of this phase IIa study evaluating the combination of BO-112 and KEYTRUDA® represents an important step in our strategy to develop effective cancer therapies that can be used in combination with checkpoint inhibitors.”

“Current treatments do not work for many cancer patients. However, BO-112 has demonstrated immunological changes in the tumor microenvironment that have the potential to play a key role in converting cold tumors into hot tumors, making them visible to the immune system,” she added.

An international collaboration

The study involves leading oncology centers across Europe, including Institut Jules Bordet and UCL St. Luc (Belgium), Vall d’Hebron University Hospital and Clínica Universidad de Navarra (Spain), Universitätsklinikum Leipzig and Charité – Universitätsmedizin Berlin (Germany), and Ospedale Niguarda Ca’ Granda (Italy), among others.

Collaboration with leading clinical research institutions reflects the ambition of the project and the importance of combining efforts to address complex diseases such as liver metastases.

Continuing to transform immuno-oncology

This phase IIa trial represents another step in our strategy of combining BO-112 with anti-PD-1 therapies, with the aim of improving outcomes for patients with tumors that currently do not respond to available treatments.

Ultimately, we continue working with the same conviction that has guided us from the beginning: turning science into real solutions for patients.

Every new trial, collaboration, and dose administered brings us one step closer to that goal.