If I say that the BO-112 can revolutionize the future of immunotherapy "made in Spain", surely understand little or nothing of what I'm talking about. However, if I explain to you that doctors from the Hospital Gregorio Marañón and from the Clínica Universidad de Navarra are getting the defenses of patients with certain tumors activated and neutralize the progress of the disease, it may be able to capture their attention. And much more if I add that this drug -the BO-112- has been born and grown in our country. It is the first immunotherapy developed entirely in Spain.
The origin of this race in the background – a drug takes, on average, ten years to go on the market – is found in one of the laboratories of the National Center for Oncological Research (CNIO) where the team of researcher Marisol Soengas discovered a molecule that I could activate the defenses of melanoma sufferers and fight against the tumor. From this important finding emerged the "spin off" BioncoTech, a new company that has opted to turn this discovery into a drug that can save cancer patients to whom current immunotherapy treatments do not work.
"We know that between 30 and 40% of patients do not respond to drugs nivolumab or pembrolizumab, those that activate anti-PD1 antibodies, which have the best effects against cancer cells", explains to LA RAZÓN one of the study directors, Iván Márquez Rodas, medical oncologist of Gregorio Marañón.
One of the main keys of this new approach is that the BO-112 is injected directly into the tumor, it is as if the patient was "vaccinated" so that his immune "army" attacks from within. Thanks to this formula, "you can concentrate a large amount of drug in a small dose," explains the expert. The success of the BO-112 is inside cancer. "Many cells of the immune system are kept inside the tumor, but it finds the formula to inhibit them so that they do not act against it. What we do is vaccination '' in situ '' and reactivate these defenses ».
What they have just demonstrated in this first phase is the most important thing in a clinical trial: its safety. "We have observed that it does not produce serious side effects," says the specialist. Thus, except for the scare that one of the patients gave them, on the first day they injected the drug, the platelets – responsible for coagulation, stopping hemorrhages – came down a lot, "from which he recovered immediately", they have detected more problems than "a little local reaction in the area of the puncture or something of a flu sensation during the first days".
In this study, 28 patients with solid tumors have been treated, initially seeking to know the safety profile and its potential as immunotherapy, since it is important to demonstrate that this new drug can effectively replace those that already exist in the market.
In the group of patients to whom the current therapies do not help them, it includes patients with lung cancer, melanoma or renal cancer to whom the BO-112 is able to control the disease in 58% of the cases, and produce an objective reduction in tumor size by 17%, although "these results should still be considered as very preliminary," according to Márquez.
Ignacio Melero, immunologist at the Clínica Universidad de Navarra and CIMA, insists that this is a pioneering work that combines local and systemic immunotherapy. "The 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." "In the animal models we have verified that the treatment with this double approach is synergistic and these preliminary data from the clinical trial indicate that a similar situation can occur in patients. There are several drugs that use this vaccination strategy '' in situ '', but BO-112 can be the most powerful, "says Melero.
Researchers will continue the study until they reach 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. "At the moment we have recruited 19 patients and will complete thirty years throughout the year," says the oncologist Gregorio Marañón. Of course, now also plays "analyze the biopsies of patients and their analytics to check their effectiveness. There is a lot of competition and we will see the effectiveness of BO-112 when we eliminate chance from the equation. "