The Cuban vaccine against lung cancer, CIMAvax-EGF®, developed by the Centre for Molecular Immunology (CIM), continues to broaden its horizons both in therapeutic indications and in scientific collaboration, while remaining the core of joint research between the CIM and the Roswell Park Institute in New York, in the United States.

This was confirmed to Cubadebate by Doctor of Science Ernesto Chico Véliz, general director of the joint venture between the two institutions, Innovative Immunotherapy Alliance (IIA), whose main activity today, he said, is the clinical trials being carried out with the Cuban vaccine CIMAvax-EGF® for the prevention of lung cancer.

This drug, an immunotherapy that drastically reduces the levels of epidermal growth factor (EGF) in the blood, has demonstrated its efficacy in the treatment of advanced lung cancer.

The sessions dedicated to cancer immunotherapy at the BioHabana 2022 congress, said Chico, will be the setting for a teleconference presentation by the study’s principal investigator at the Roswell Park Institute, Grace Dy, of the advances in the results of the phase I/II clinical trial in advanced lung cancer, “which has been running for years and has several patients who have had a longer than expected survival”.

“In principle, what we hope is that this will determine which group of patients can benefit most from the vaccine, in combination with advanced therapies available in the United States, which are not available here in Cuba due to the blockade,” he explained.

CIMAvax-EGF® has been used a lot as monotherapy, but there are other drugs in the world that it is advisable to combine them with our vaccine and that is what we are testing in the United States: whether the combination of the most advanced drugs for lung cancer therapy in the United States offers good results and for which group of patients it would be, Chico explained.

This has to do, he said, with the trend towards precision medicine, in which the patient is deeply characterised from an immunological and genetic point of view, and the tumour is genetically characterised so that we can see for which tumours and for which patients the vaccine is most likely to be successful.

For example, in Cuba, studies have shown long life expectancy among a quarter to a fifth of the patients studied. “But we haven’t fully understood why this group of people benefit and another group of patients. That is the importance of what we are doing in the United States, because with other diagnostic and genetic characterisation techniques that are not available in Cuba, we can go much deeper into patient characterisation and therefore have a better idea of which patients can benefit most from the product and how the treatment should be done,” he explained.

How the clinical trial is progressing in the preventive setting is another of the novelties that CIMAvax-EGF® is bringing to the congress. The research aims to show whether the therapeutic vaccine can be used for patients at high risk of lung cancer, whether they are chronic smokers or suffer from inflammatory lung disease.

“We want to know if these patients who are treated with CIMAvax-EGF® have a lower risk of developing lung cancer, and also to see if the vaccine can delay the relapse in those patients whose cancer was detected at a very early stage, who underwent surgery and are at risk of relapse,” Chico said.

As a novel element, Chico pointed out that they are locating patients who have had a long survival in Cuba and extracting samples to send to the United States. “Using the most advanced techniques available in that country, we could have a better characterisation of these patients, also seeking a comparison between what is being obtained in the United States and the scientific evidence that we have accumulated.

He said that also with CIMAvax-EGF®, scientists at the Roswell Park Institute intend to explore the use of the vaccine in colon cancer, a line of research that is currently being discussed with the CIM for the design of a future trial.

In addition to the Cuban therapeutic lung cancer vaccine, another product that is now part of the scientific collaboration portfolio between the two institutions is Interleukin-2 (IL-2) muteins. “As we always do, our products are first tested on Cuban patients and there is a clinical trial underway for the first time in humans, once that research progresses then we are planning to start a trial in the United States which could be at the end of this year or early 2023,” he said.

In the meantime, he said, basic research is being conducted with these muteins in the United States, in vitro experiments, and the evidence that the MIC has had is being consolidated.

Another line of joint research they are currently consolidating is related to VSSP, an immunomodulator for which they have already obtained basic, preclinical, joint scientific research.

“What is new this year is that we have been sending certain samples of Cuban patients who have been treated at the Institute of Oncology and Radiobiology or at the Hermanos Ameijeiras Hospital with VSSP to the United States to carry out other types of research with these samples. In principle, what we are generating is evidence of the basic mechanism of action of this product with the intention of also moving towards a clinical study in the United States,” he said.

“The scientific collaboration between Roswell Park Cancer Institute and the Center for Molecular Immunology began based on science, with no business or political interests. We simply believed from the beginning that CIMAvax-EGF® could have an impact on the prevention of lung cancer, one of the most serious health problems affecting the United States, as well as Cuba,” Dr. Mary Reid told the press.

The director of Collaborative Research and associate professor of Oncology at Roswell Park, who is also a research associate in the Department of Social and Preventive Medicine at the SUNY School of Public Health in Buffalo, presented the results of one of the studies being carried out with the Cuban drug at the New York institution.

According to the scientist, Roswell Park is the only place in the United States that is currently using the CIMAvax-EGF® vaccine in two clinical trials.

She explained that this is a trial in advanced lung cancer where CIMAvax-EGF® is combined with standard therapies approved for the treatment of advanced lung cancer in the United States, and another study in a preventive setting, for patients at high risk of lung cancer due to certain characteristics and for another group of subjects whose disease was detected in early stages and who are free of the tumour at the moment.

“We started visiting Cuba and the CIM in 2013 and established a close scientific collaboration. The first two years we were doing exchanges around science and we found an association and alliance between the cancer treatment that was being done in Cuba with CIMAvax-EGF® and cancer prevention,” said Reid.

For the American researcher, important elements in the consolidation of this collaborative relationship were “the determination and persistence of the CIM scientists, their knowledge and confidence in CIMAvax-EGF®, which convinced us to test it in the United States”.

“The evidence in Cuba using the CIMAvax-EGF® vaccine alone for the treatment of lung cancer is good, but our work at Roswell Park is to use technology that Cuba does not have access to and demonstrate that the effect of this vaccine on lung tissue has a positive impact at the cellular level. That information is very important for us,” he explained.