At Bioncotech, we have initiated a collaboration with MSD (Merck & Co., Inc.) to launch a phase II clinical trial in patients with solid tumors presenting liver metastases.
The study will evaluate the combination of BO-112, our investigational drug, with pembrolizumab, one of the most widely used anti–PD-1 treatments in immuno-oncology. The objective is to determine whether intralesional administration of BO-112, directly into liver lesions, can activate the local immune response and improve the effectiveness of systemic immunotherapy.
A major clinical challenge
Liver metastases represent one of the most complex scenarios in oncology. The liver is an organ with a naturally immune-tolerant environment, which means that tumors that spread there often resist conventional treatments.
In this context, the trial is based on an ambitious hypothesis: that BO-112 may “awaken” the body’s natural defenses and transform this hostile microenvironment into one where immunotherapy can work more effectively.
BO-112 and pembrolizumab: a promising combination
BO-112 is a synthetic double-stranded RNA molecule designed to act as a powerful activator of the innate immune system. In early studies, it has been shown to induce immunogenic cell death and promote T-cell infiltration into tumors.
Pembrolizumab (anti–PD-1), in turn, has demonstrated proven efficacy across multiple types of cancer. The combination of both treatments could open a new therapeutic pathway for patients with very limited treatment options.
An alliance with potential impact
“This collaboration represents a key step in the development of BO-112 and in the potential of the innate immune system to deliver better outcomes for patients with cancer,” explained Marisol Quintero, Chief Executive Officer of Bioncotech.
The launch of this trial therefore marks an important milestone: combining the innovation developed in our laboratories with MSD’s global expertise in immunotherapy strengthens the possibility of advancing toward solutions that may ultimately reach patients.