Development History
The development of the Sm14 vaccine began at the Fiocruz Experimental Schistosomiasis Laboratory (LEE) in Rio de Janeiro when Dr. Miriam Tendler identified an extract of Schistosoma mansoni capable of generating strong protection against worms in rabbits and mice vaccinated with it. From the serum of those animals and using molecular biology techniques, a protein with a molecular mass of 14 kDa was identified as an antigen, named Sm14. It is a protein of the FABP family (“Fatty Acid Binding Proteins“), essential for the parasites to access the lipids of their hosts as they cannot synthesize them by themselves.
In the following years, researchers inside and outside Dr. Tendler’s lab studied Sm14 as the molecular basis for vaccination against human schistosomiasis and fasciolosis in sheep, goats, and cattle. It was then clear that Sm14 could be developed as a vaccine against the chief parasitic disease affecting animal production.
Robust studies have estimated the annual economic loss due to fasciolosis at well over 3 billion dollars. In Europe alone, more than $470 million is spent annually on anthelmintic drugs. Considering that Sm14 in its veterinary formulation is a vaccine with a cost per dose below 0.08 USD and that its use allows for a growing reduction of the dependence by the animal industry on anthelmintic drugs, Fiocruz began its institutional relationships with stakeholders in the veterinary market.
In 2005, under the coordination of Dr. Tendler, Fiocruz established a partnership with Alvos Biotecnologia, an initiative of Biominas Brasil with Fir Capital, conceived within the scope of an association between Biominas and the Inter-American Development Bank (IDB) to invest in biotechnology companies.
With the input of resources from Alvos, funding from FINEP, and support from the WHO, Dr. Tendler’s team produced a batch of Sm14 in GMP conditions at Cornell University.
The batch was submitted to Quality Control by PPD Biopharmaceutical. Scientists at the PPD labs attested to the quality and stability of the protein, an achievement of Dr. Celso Ramos, now a scientist at FABP Biotech. After the PPD studies, a formulation of the vaccine with Sm14 and an adjuvant from IDRI (Infectious Disease Research Institute, Seattle, USA) was tested in animals and two Phase I clinical trials in humans. These studies demonstrated the safety and the immunogenic capacity (serum conversion) of Sm14.
In 2008, Dr. Tendler filed patents describing a protein production process using Pichia pastoris in offices in Brazil and abroad. Protein expression in Pichia permitted stabler strains; ease of scaling; absence of endotoxins; and improved safety for human health.
The accumulation of good results in the development of the veterinary vaccine, associated with the development of the human vaccine, brought a new partner to the project. Brazilian veterinary company Ourofino Saúde Animal, strengthened by an injection of 100 million reais by BNDESpar, acquired Alvos Biotecnologia and thus assumed its participation in the project.
In partnership with Ourofino, the team of scientists that today makes up FABP Biotech’s technical staff tested the current formulation of the vaccine in experiments with cattle and sheep. This formulation with a new adjuvant, significantly less expensive than the previous one, generated a high and long-lasting immune response.
In the following years, Ourofino entered a restructuring process and withdrew from the Sm14 vaccine initiative. In this scenario, Fiocruz offered Dr. Tendler the possibility of setting up a startup, FABP Biotech, to receive the license for the final development and commercial exploitation of the veterinary vaccine. In 2020, FABP and Fiocruz signed the agreement through which the company gained control of patents related to the veterinary vaccine.
In 2021, Criabiz, a group of investors working in tech, promoted two rounds of investments in the company. These initial investments allowed FABP to recruit the scientific team responsible for the entire development of the technology and to produce a regulatory dossier for the vaccine. As of 2023, this same group of scientists is working on the development of an Sm14-based vaccine against heartworm in dogs.
development: verty↗