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Locally developed vaccine against cancer is tested

After more than 13 years of research, a multidisciplinary team formed by researches from the universities of Buenos Aires and Quilmes, Instituto Roffo, Garrahan hospital, the Academy of Medicine, and researchers from Argentine company Elea is at the forefront of the most innovative cancer research: within the next months, an international clinical trial will be launched to study the effects of a vaccine developed in the country against lung tumor cells

This is a Phase III clinical trial, the last stage testing required by the health authorities before a company can request approval to market a new drug to the public. 760 patients from Argentina, Brazil, Cuba, India, Malaysia and Singapore will participate in this trial. European subjects may possibly be included during a later stage.

Details of this project are evidence of the way a private company and public administration can collaborate in a research. Elea Laboratory bet on the Argentine researchers’ know-how and not only did they greatly contribute to the project financing, but also engineered the drug and its clinical implementation. The research is included with the Strategic Area Program of the National Agency for Science and Technology Promotion (Agencia Nacional de Promoción Científica y Tecnológica).

"In a Latin American country, this is something peculiar. A discovery", highlights Daniel Alonso, MD, director of the Molecular Oncology Laboratory of Universidad de Quilmes and a Conicet researcher.

The team group carries out several lines of research that intend to attack the residual disease of cancer. Among said research lines, the most advanced development is this vaccine called “therapeutic”, that is, although it stimulates the immune system, it is designed to complement the conventional medical treatments and not prevent the disease.

As it may often occur, the idea of designing a vaccine that may stimulate the immune response against the tumor cells raised from a conversation. “It is known that there is an immune response in every type of cancer disease, but this is not enough”, tells doctor Hugo Sigman, director of Elea Laboratory. “Once, during a visit to two centers in La Habana, -Inmunología Molecular and Ingeniería Genética centers, which are our partners- we asked the way in which we could make the body’s immune system efficiently attack a tumor. And that is when we thought of a molecular target, an antigen which only in few cases is found in cancer cells. With hindsight, this project was a utopia.

Immunological Privilege

The process that led us here improved step by step and included the obstacles inherent to every ambitious research..

"In the first publication, we showed that the compound was not toxic –explains Leonardo Fainboim, MD, a Conicet chief researcher from the Immunogenetic Center at Hospital de Clínicas-. Then, we initiated a phase II trial in women with breast cancer, and we described for the first time how the vaccine triggered an anti-tumor cell response. This fact allowed us to continue”.

As the researcher explained, it was very difficult to attack the tumor because it mutates itself in an immune privileged site. "In this sense, I believe that one of the most important things is to be able to modify the local immune response to break that privilege”, he adds.

The product selected for this large-scale trial is a monoclonal antibody (the result of the fusion of a mouse B lymphocyte with a human tumor cell which allowed to obtain identical antibodies due to the fact that they are produced by a single type of cell of the immune system) that acts as a vaccine: it stimulates the immune system against a specific molecular target (ganglioside), which in this case appears on the cell surface of lung cancers.

The results of preliminary clinical trials conducted in the country, during which 15 doses of this compound–the scientific name of which is 1E10, an anti-idiotypic vaccine- were injected to several patients at 15-week intervals, are encouraging according to the researchers..

"Essays on patients with a high level of relapse after receiving a standard treatment, such as melanoma surgery, or surgery, chemotherapy, and hormone therapy in patients with breast cancer have been published-explains Gabriela Cinat, MD, director of the melanoma and sarcoma area of the Clinical Oncology Service Unit at Instituto Angel Roffo. After these patients received a conventional medical treatment, we know at some point that the disease will progress. Our intention is to stop the disease progress, which is no small thing considering the prognosis. In a study to be released soon by the American Society of Clinical Oncology, 40 patients with melanoma, 20 patients with breast cancer and a similar number with advanced melanoma participated in a trial, which although it was initially planned to last six months, they vaccinated for two years. In spite of the fact that this is not a homogenous group, we may say that the results are very encouraging and the average life expectancy is higher than expected. Now, we need controlled studies”.

A chronic disease

The vaccine, which has no important adverse effects, is designed for a specific molecular target. The expression of this molecular target is higher in metastases than in primary tumors, which makes it far more convenient if we consider that the vaccine will be used as a complementary therapy to conventional medical treatment.

"We aim at reducing the tumor load before commencing with the immunological treatment –explains Cinat. It should be clarified that this approach to cancer treatment is not infallible, but we hope it can help to improve the patients’ life expectancy. We have previous examples of non-relapsing patients who had all signs to relapse. But we do not consider them as cured; we call them “long survivors”.

"One of the hopes we have is to turn cancer into a chronic disease –concludes Sigman-. Let’s think about hypertension: the patients suffering this disease cannot find a cure, but can keep it under control. I don’t think that any of the therapies we are testing will eliminate the disease. The patient will still have cancer, but our intention is to improve his or her life expectancy and quality of life."

By Nora Bär

http://www.lanacion.com.ar/988554