BOGOTA, Colombia – Chilean researchers from the Instituto Milenio en Inmunología e Inmunoterapia (IMII) are developing a vaccine targeting melanoma, as well as vaccines for infectious agents of high impact on public health. IMII said the cancer vaccine will be tested in Cuba.

"Cuba has strong potential in biotech and in cancer research," IMII Director Alexis Kalergis told BioWorld Today. "They are a high-potential and strategic partner, a very important one for our institute." IMII signed a partnership with the Cuban Instituto Nacional de Oncología y Radiobiología to conduct the trials.

The development of the melanoma vaccine has been conducted by the research group under the leadership of Flavio Salazar, a professor at the Universidad de Chile and deputy director of IMII. The vaccine, known as TAPCells, has already been tested in dozens of patients in Chile.

"The results have been solid for safety and efficacy," said Kalergis. The vaccine "extends significantly the survival rates of the patients. It has been shown to be safe, without creating adverse effects."

Moving the tests to Cuba, which is a country that has established multiple agreements with different research institutes across the region, such as Argentina's National Technical and Scientific Research Council, was a natural choice for IMII. It is hoped the results will provide Latin American markets with an effective vaccine or helpful treatment, all at a reasonable cost. (See BioWorld Today, Dec. 24, 2014.)

"The clinical data drives value to the technology and eventually the idea is to bring it to a large-scale manufacturing process for its commercialization, always taking into account the public factor to secure access based on socio economical level," said Kalergis. "The idea is to bring the benefit of this technology to the society, at a cost that other Latin American countries can absorb."

Kalergis did not provide further details of the scope of the agreement with Cuba, nor the extent or nature of the trials that will be conducted on the Island.

The melanoma vaccine candidate is designed to be preventive and therapeutic. It is estimated that at least 60 percent of the melanoma patients that receive the treatment developed by the Chilean researchers have tripled their life expectancy. It has also been reported that about 33 percent of the patients have survived for at least five years after the treatment, which has been under development already for a decade.

The treatment method developed in Chile uses blood drawn from the melanoma patient, which is then centrifuged for selection of its monocytes. The monocytes are then reprogrammed and converted to dendritic cells, which are injected back to the patient, strengthening the fight against the development of new melanoma cells.

"TAPCells-based immunotherapy was tested in more than 120 stage III and IV melanoma patients and 20 castration-resistant prostate cancer patients in a series of phase I and I/II clinical trials," published in 2013 by Salazar and his colleagues in the Biological Research Journal, a publication from the Sociedad de Biología de Chile. Kalergis said that more than 300 patients have been treated during the clinical trials conducted in Chile. "TAPCells vaccines induced T cell-mediated memory immune responses that correlated with increased survival in melanoma patients and prolonged prostate-specific antigen doubling time in prostate cancer patients," the researchers said.

VACCINES FOR RSV, HUMAN METAPNEUMOVIRUS, SLAMONELLA

In addition to the melanoma vaccine, IMII is working on several others, including one for respiratory syncytial virus (RSV).

"After 10 years of research, our group developed a vaccine that showed excellent results in animal tests and which is starting its approval process for human tests, after having obtained the doses produced under U.S. FDA´s Good Manufacturing Practices standards," IMII said in a press release. The institute is partnering with Aeras TB Foundation, from Rockville, Md., to synthesize its vaccines.

"It is expected that after having [the RSV vaccine] approved, it will become very useful to prevent the winter outbreaks of the RSV that happen every year," the institute said. Kalergis did not specify the countries in which they are considering registration of the vaccine.

The institute also announced that it is currently working on the development of a human meta pneumovirus (hMPV) vaccine. It said that it expects the vaccine to hit the market in around nine years.

Their preclinical studies showed that mice that were immunized with the institute´s recombinant Bacillus Calmette-Guérin vaccine (rBCG) developed a resistance against the loss of weight, airway inflammations, and viral replication in the lungs after being infected with the hMPV.

"Data strongly support the notion that rBCG induces protective Th1 immunity and could be considered as an efficient vaccine against hMPV," Kalergis and his colleagues reported in the Journal of Immunology last year.

Another vaccine currently under development at IMII is one for salmonella, with the hope of producing more sustained efficacy than current salmonella vaccines.

"The objective is to develop a vaccine that could be applied in one single dose that brings long-lasting protection, unlike the vaccines developed up until now that grant temporary protection," said the institute on its website.

"To achieve this target it is necessary to understand the mechanisms that allow the bacteria to evade the immune response, specifically in the presentation of the antigen to the T-cell," said according to an institute's statement. "The strategy used by the vaccine would be to eliminate the bacteria´s capacity to evade the immune response of the host." It's been three years since researcher Susan Bueno at IMII started conducting studies to identify the genetic groups of salmonella. The institute is working on developing new and less aggressive strains with the hope of developing a new vaccine out of them.