The first immunotherapy against cancer developed entirely in Spain has shown, in a clinical trial with melanoma patients, lung and kidney tumor, that in addition to "not causing serious side effects is able to control the disease in 58% of cases and to reduce the tumor size by 17%. "
According to the Gregorio Marañón Hospital in Madrid and the University Clinic of Navarra, therapy with BO-112 has concluded the first clinical trial of safety in patients and "it can be said that this Spanish drug is safe and, in addition, in preliminary data, it shows effectiveness against certain types of cancer ".
"It is a great leap for this research promoted and developed by researchers in our country and that opens new possibilities for treatment," both centers point out in a joint statement.
Immunotherapy based on anti PD-1 / PD-L1 antibodies has revolutionized the prognosis of patients, although not all benefit from these treatments. Hence "the combination strategies of several drugs," explains the note.
In the trial with the molecule BO-112, "an intratumoral therapy with immunomodulatory effect developed entirely in Spain", 28 patients with solid tumors were treated in which "an objective reduction of the tumor size" was observed, although these results, presented at the last European Congress of Oncology held in Munich, should still be considered as "very preliminary", according to the oncologist of Gregorio Marañón, Iván Márquez Rodas.
A third hospital, the Ramón y Cajal in Madrid, has participated in the clinical study, to which seven hospitals that are recruiting patients have been incorporated.
"Our intention is to continue advancing in the knowledge of the safety profile, mechanisms of action of BO-112, as well as to find out if there is more efficacy and how long lasting it is in patients who have not had a previous therapy with anti PD -1 ", adds Márquez.
"It is a pioneering work that combines local and systemic immunotherapy," whose philosophy is "to try to convert some of the tumor lesions into an immunogenic tissue that awakens an immune response, helping the immune response in the rest of the body," Ignacio explains. Melero, from the Clínica de Navarra.
"In the animal models we have verified that the treatment with this double approach is synergistic and the preliminary data of the trial indicate that a similar situation can occur in the patients. There are several drugs that use this vaccination strategy 'in situ', but BO-112 can be the most powerful, "he says.
Researchers will continue the study, promoted by Spanish biotechnology company Bioncotech Therapeutics, until at least 30 patients treated with the combination of BO-112 and anti-PD-1 antibodies (nivolumab or pembrolizumab), adding other Spanish centers for this phase.