CAJICA, Colombia – Privately held Inosan Biopharma SA De Cv, of Mexico City, is racing to develop a biological treatment to cure COVID-19 patients. Inosan has mastered the technique of using horses to produce antibodies to heal patients bitten by poisonous creatures, such as snakes, spiders and scorpions.
“We have shown that the antibody platform works very well with antitoxins, and about three or four years ago, the FDA invited us to participate in a project for the Ebola outbreak,” Juan Silanes, CEO at Inosan Biopharma, told BioWorld.
Despite the Ebola outbreak being contained shortly after it arrived in the U.S., meaning further development of the platform was not required, the project triggered the Mexican company to use its established infrastructure and biotech platform to develop antibodies to neutralize viruses.
“When the COVID-19 pandemic began, we started to study and see what that was needed to be able to create an antibody that would neutralize the virus, and we found a couple of different lines of antibody production where the horses expressed a sufficient immune response to be able to use it in humans, while using the same platform that we already have,” said Silanes.
The company is joining forces with the Monterrey Institute of Technology and Higher Education (ITESM, but widely known in Latin America as the TEC), which is collaborating on preclinical trials for the FDA and Cofepris, the Mexican health care surveillance agency.
“We are close to the clinical phase,” Silanes said. “The authorities are asking us for a preclinical complement that is being done together, so that the two models clearly express safety and efficacy. Then we will do the secondary section of the preclinical tests that are required. We already have an initial preclinical part, with which safety and efficacy have been demonstrated, and which is mainly done in mice,” he explained.
Since the company is developing the treatment on an existing platform, its executives expect to hit the clinical phase in the upcoming weeks.
“We could see that we were ready for the clinical phase since the platform is for the same antibody. In fact, the only thing that changes are the epitopes of our antivenoms, which have been used in over 300,000 patients, and generally quite successfully,” said Silanes.
Inosan´s platform is based on F(ab')2 fragment antibodies.
“The antibody is actually the same one; what changes is the epitope, which is used to locate the virus. It is going to stick to it and it is going to neutralize it,” he explained.
The company expects to start the clinical phase in October, but at the same time it will add information to the preclinical phase, as required by the regulators.
Under emergency conditions, such as the outbreak that the world is facing, health care surveillance agencies are relaxing some procedures to allow researchers to move faster, with the hope of having real solutions available as rapidly as possible.
Inosan Biopharma has about 180 horses producing antibodies to fight various venoms. One of the main markets for the company is the African continent. Now some of the horses are exclusively being used for the SARS-CoV-2 project.
The plasma of a horse, according to Inosan Biopharma, can produce enough antibodies against SARS-CoV-2 to treat up to 150 patients each month.
The company is confident of its treatment, as well as about scaling up the production of antibodies to be injected into infected patients. Plasma from previously infected humans has already been used to treat new patients during the pandemic. However, this is at a 1-to-1 ratio. Horse plasma could supply effective antibodies to dozens of patients at once from one animal.
“We believe that, ideally, it should be administered in the earlier stages to avoid triggering the cytokine storms that come later, and then generate a severe respiratory syndrome,” Silanes said. “In general, the later stages are when the virus gets worse and when it causes hospitalization, or in the most serious cases, even death.”
However, the treatment developed by Inosan can be used at any stage of infection. The sooner it is administered, the better, to avoid secondary syndromes such as the inflammatory ones deriving from the infection.
“It could also be used in a patient who is seriously ill and on a ventilator, but actually there you will also have to deal with other complications due to cytokines that generate inflammation and that is something that is complex,” he explained.
Inosan Biopharma is wholly Mexican owned. It has filed for several patent protections in different jurisdictions for “polyvalent immunotherapeutics of high specificity based on modified antibodies and a highly safe and effective lyophilized injectable formulation.”
Despite not being a public company, its directors are considering raising capital to accelerate the scaling up of production and distribution of its treatment to help in the fight against the pandemic.
"We have been looking at the possibility of future growth and investment, believing that this is a treatment that has worldwide potential, and which we want to take as quickly as possible to different parts of the world," said Silanes.