Cuban vaccine against lung cancer centers scientific collaboration between the CIM and the Roswell Park Institute, New York

The Cuban vaccine against lung cancer, CIMAvax-EGF®, developed by the Center for Molecular Immunology (CIM), continues to expand 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, New York, in the United States.

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

Said 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—Chico commented— will serve as the stage for the presentation via teleconference, by the principal investigator of the study at the Roswell Park Institute, Grace Dy, of the advances in 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 survival than expected.”

“In principle, what we hope is that from there it will come out which group of patients is the one that can benefit the most from the vaccine, in combination with advanced therapies that exist in the United States and that are not available here in Cuba for reasons of the blockade,” explained the interviewee.

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

This has to do, he said, with the trend towards precision medicine, with which the patient is deeply characterized from the immunological and genetic point of view, and the tumor is genetically characterized so that it is possible to see for which tumors and for which which patients the vaccine is most likely to be successful.

For example, in Cuba, studies have shown a long survival between a quarter and a fifth of the patients studied. “But we haven’t fully understood why this group of people benefits and another group of patients. That is the importance of what the United States is doing, since there are other genetic diagnosis and characterization techniques that are not available in Cuba, we can go much deeper into the characterization of the patient and therefore we can have a better idea of ​​which patients can benefit more from the product and how the treatment should be done,” he explained.

How the clinical trial is progressing in the preventive scenario is another of the novelties that CIMAvax-EGF® brings to the congress. This is an investigation that seeks to demonstrate whether the therapeutic vaccine can be used for those patients at high risk of having lung cancer, whether they are chronic smokers, or who suffer from an inflammatory lung disease.

“We want to know if those patients who are treated with CIMAvax-EGF® manage to have a lower risk of suffering from lung cancer, and also to observe if in those patients whose cancer was detected at a very early stage, they underwent surgery and have a risk of coming back. to relapse, the vaccine can delay that relapse,” Chico pointed out.

He added that this study began very recently in the United States, so a very small group of patients are still included in it. “What its principal investigator, Dr. Mary Reid, will show us is why they think scientifically that our therapeutic vaccine could give hope to patients to prevent lung cancer, what are the scientific bases that justify that, the rationale, the design of the trial and what they expect from the study”, he specified.

“It must be said that here in Cuba this clinical stage is also being carried out by the Hermanos Ameijeiras hospital. There is a group of patients who have been treated in this scenario and these results will also be commented on by Dr. Tania Crombet, director of Clinical Research at the CIM, who will also address the efficacy of the drug in its phases II/III in our country”, he pointed.

As a novel element, Chico pointed out that patients who have had a long survival in Cuba are being located and samples are being taken from them to be sent to the United States. “Using the most advanced techniques available in that country, we could have a better characterization of these patients, also looking for there to be some comparison between what is being obtained in the United States and the scientific evidence that we have accumulated.”

He commented that also with CIMAvax-EGF®, scientists from 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 therapeutic Cuban vaccine against lung cancer, another product that today forms part of the scientific collaboration portfolio between both institutions is Interleukin 2 (IL-2) muteins. “As we always do, our products are tested first in Cuban patients and there is a clinical trial underway for the first time in humans, once that research progresses, then we plan to start a trial in the United States that could be at the end of this year or early 2023,” he said.

Meanwhile, he highlighted, basic research is being carried out with these muteins in the United States, in vitro experiments, and the evidence that the CIM has had is being consolidated.

Likewise, another of the lines of joint research that they are consolidating today is related to VSSP, an immunomodulator for which basic, preclinical, joint scientific research has already been obtained.

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

According to Chico, the CIM’s relations with the Roswell Park Institute continue to be very good “precisely because they are based on good science.”

“We have managed to overcome all the political and legal obstacles that exist because in this collaboration there is a scientific vocation and a vocation to improve patients on both sides of the Florida Straits. The doctors there, the doctors here, our scientists, are very committed and continue to trust in the good science that the CIM does. There is still a good atmosphere of collaboration, there is a mutual exchange of ideas and already this year we presented the first joint patent between the CIM, the Roswell Park Institute and the joint venture based on the results of CIMAvax-EGF®. The pandemic did not manage to cool the relationship and stop scientific collaboration. We are waiting for visa issues to open up again, so that we can once again have a significant presence of Cuban scientists in Roswell Park. Our collaboration continues and we are confident that it will continue to develop in the future because the results are being obtained and the benefits will be for everyone”, he considered.

More than 10,000 Cuban patients have benefited from CIMAvax-EGF®

One of the most important advantages of the Cuban therapeutic vaccine against lung cancer is its use in primary health care, highlighted Dr. Tania Crombet, director of Clinical Research at the Center for Molecular Immunology (CIM).

“This is an opportunity because it is not essential that the patient has to go to secondary care, that is, to a hospital to receive the vaccine. We have shown that it is sufficiently safe and that its use in primary care guarantees better adherence to treatment”, said the researcher.

More than 10,000 Cuban patients have benefited from this vaccine in the different medical care scenarios (primary care, hospitals and institutes) of the national health system.

He noted that real-world data on the use of CIMAvax-EGF®—as clinical research is called once product registration is complete—confirms the safety and effectiveness data that had been generated in previous research. Similarly, data obtained by the Roswell Park Institute, stated.

He explained that in the scientific institution based in New York, an investigation is underway in the most advanced stage of patients in the second line of non-small cell lung cancer.

“In this study, the vaccine is not used alone, but rather it is a combination of CIMAvax-EGF® with Nivolumab, an immunomodulatory drug. In this case we also showed that the combination was very safe and increased immunogenicity. At the same time we have a group of patients who are obtaining a very long survival. This gives us the possibility of identifying new biomarkers that allow us to anticipate populations that receive a benefit from the combination of both drugs”, explained the scientist.

Cancer, he said, is a major health problem in Cuba. “Having a drug that improves lung cancer survival is an opportunity, and above all a very safe drug. Unlike other more aggressive treatments, with immunotherapy it is possible to carry out a long-term treatment without affecting the patient’s quality of life. We demonstrated this when a trial such as phase IV was carried out, which does not have such restrictive criteria and where all patients with a lung tumor could be included”, he referred.

Now, he insisted, in the United States we have the possibility of combining our vaccine with a drug that we do not have in Cuba as a result of the blockade, and therefore it allows us to insert our vaccine in the scenario that is used in the first world at this time.

Demonstrating that the combination is very safe, which is very important for advanced cancer, and that the immune response is strengthened when an immunomodulatory molecule is used in combination with the Cuban vaccine, is significant, he specified.

Roswell Park expert: From the beginning we believed in CIMAvax-EGF® for cancer prevention

“The scientific collaboration between the Roswell Park Cancer Institute and the Center for Molecular Immunology began based on science, without business or political interest. 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 that affects the United States, and also Cuba”, Dr. Reid.

The director of Collaborative Research and associate professor of Oncology at Roswell Park, also an associate researcher at 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 in 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.

It is -he specified- a trial in advanced lung cancer where CIMAvax-EGF® is combined with standard therapies approved for the treatment of advanced lung cancer in the northern nation, and another study in a preventive scenario, for patients with high risk of lung cancer due to certain characteristics and for another group of subjects who had the disease detected in early stages and are free of the tumor at this time.

“We began to visit Cuba and the CIM in 2013 and we 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 done in Cuba with CIMAvax-EGF® and cancer prevention”, said Reid.

For the North 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 try 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 in Roswell Park is to use technology that Cuba does not have access to and demonstrate that the effect of this vaccine on the tissue lung has a positive impact at the cellular level. That information is very important to us,” he explained.