Neoleish, developed by CSIC in collaboration with the Zendal group, prevents one of the most devastating infections in dogs and reduces by up to 92% the presence of the parasite that causes the disease.

It is the first vaccine in the world aimed at combating one of the most devastating and deadly infections in dogs: canine leishmaniasis. A serious zoonosis that can also be transmitted from animals to humans. It has been created and developed in a public research laboratory of the CSIC, in collaboration with the Zendal group, based in O Porriño, and will be produced and marketed in Galicia by Petia Vet Health, a subsidiary of the Pontevedra-based group.

The vaccine, called Neoleish, was presented this Wednesday afternoon at the congress of the Madrid Association of Veterinarians, after it received a favorable opinion from the European Medicines Agency at the end of 2022, which recognized it at that time as one of the three most innovative biotechnological drugs of that year. And now it is beginning to be marketed worldwide from Galicia.

It is also the third recombinant DNA vaccine created so far in the world. The first was for the trout hemorrhagic virus and the second, developed in India, to prevent covid in humans. It is, in any case, an innovative and efficient technology that also opens the way for its application to other infections, both human and animal.

“This vaccine stands out for being very effective, since it reduces by 92% the number of parasites in vaccinated dogs in a parallel study carried out in our laboratory,” explains CSIC researcher Vicente Larraga, from the Molecular Parasitology group of the Margarita Salas Biological Research Center and director of a development on which they have been working for many years. “We are very proud,” he says, “that it has reached the market from the laboratory, because in the end we have a product that is useful for both dogs and people, because if we reduce the disease in dogs there will also be fewer people who become infected. Leishmaniasis kills between 40,000 and 50,000 people worldwide each year.

Canine leishmaniasis, a parasite that causes everything from skin ulcers to severe inflammation of the liver and spleen, is unique. The parasite gets into the cells of the immune system of the animal it infects and thus protects itself from the antibodies it generates to eliminate it. This is its survival strategy, which it also uses to avoid the effect of the two vaccines that were approved up to now to combat it, although one of them has been withdrawn.

DNA is the third. It also promises to be the most effective. First, because the antigen is manufactured by the genetic material itself, thus presenting itself in a more natural way to the immune system. And, secondly and more importantly, because the antigens have the ability to penetrate the cells where the pathogens are hiding. And this is how up to 92 % of the parasites causing the infection are reduced. Those that remain have no capacity to develop the infection. “The disease does not manifest itself”, says Vicente Larraga, who assures that “we have presented a different mechanism of action to attack the infection that we believe is the best”.

What has been done is the activation of the so-called cellular pathway to attack and eliminate the parasites in their cellular refuge. Thus, the vaccine activates both the T cells, the soldiers of the immune system, and the Natural Killers, or natural killer cells, making it more effective.

It also allows active immunization of Leishmania-negative dogs from six months of age to reduce the risk of developing an active infection.

“This is an important milestone for the company, given the importance of this vaccine in the pet health environment, to which it will bring greater health and safety. This step places Petia in a major player in this animal health segment, which is in continuous growth,” underlines Ricardo Troncoso, CEO of Petia, a company specialized in pets.

“Once again the union of public-private synergies gives a good result in the biopharmaceutical field. The Zendal-CSIC alliance has achieved a milestone in animal vaccinology. After a long time of research, today we are launching a safe vaccine on the market, belonging to the most innovative group, the so-called third generation vaccines”, said Andrés Fernández, CEO of the Zendal group.

Leishmaniasis is a disease caused by the Leishmania parasite, of the trypanosomatid family, which is carried by the phlebotomine sandfly. It is a severe zoonosis (meaning that it is transmitted from animals to humans), present in the Mediterranean basin, Asia and America, which can cause death without treatment and whose main reservoir is the dog. The clinical manifestations of the disease range from spontaneously healing skin ulcers to fatal forms in which severe inflammation of the liver and spleen occurs. Each year there are between 500,000 and one million new cases and, in Spain, it is estimated that almost 30% of dogs have had contact with the parasite.

Original article: Galicia comercializará la primera vacuna de ADN del mundo contra la leishmaniasis canina (lavozdegalicia.es), 13/03/2024.

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