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Antibody-Based Solutions Address Rare Health Issues

Juan Silanes - Inosan Biopharma
CEO

STORY INLINE POST

Miriam Bello By Miriam Bello | Senior Journalist and Industry Analyst - Tue, 10/27/2020 - 12:55

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Q: Why is Inosan Biopharma a unique player in the healthcare sector?

A: Inosan Biopharma has focused on developing a technological platform related to antibodies. We began developing antibodies such as antivenoms for Africa and the Middle East. To date, we export almost all our production to countries in those regions. Inosan Biopharma’s antibodies have been tested and proven to work as antivenoms, antitoxins and antivirals. This has paved the way for our R&D pipelines, especially for antiviral solutions.

The company maintains close contact with the medical professionals who use our products and it has been very gratifying to hear and see how our solutions are saving lives on a daily basis. Seeing how we have given people another chance at life is the fuel for our company and the motivation to keep innovating with unique solutions.

Q: Antivenoms are complex and costly to produce and develop. How has Inosan Biopharma tackled these challenges to offer cost-effective solutions?

A: For antivenom development, we created a technological platform that allows us to simplify the antibody. We took our original development for antivenom and we divided it into three stages: venom selection, horse immunization, purification and lyophilization. Working with each individual stage and through the use of technology, we were able to reach a purifying stage that guarantees its safe use. For Inosan Biopharma, safety was the priority because our products tend to be used in precarious healthcare systems. Alongside the purifying stage, we were able to develop complex products that are multipurpose, having the ability to neutralize the venom from multiple snakes or scorpions. This expanded the regionalization of our products in these parts of the world.

Increasing the efficiency of our products has enabled us to do more with less, despite the volume of the primary investment. Inosan Biopharma develops its products to FDA and EMA standards to guarantee the highest quality.

Q: Inosan products are sold to NATO, the US Army and other military bodies going to Asia and Africa. How have Inosan Biopharma’s products reached these entities?

A: We are very proud of this work because it is recognition of the quality and effectiveness of our products. The US Army was the first to reach out to us during its research to find the best antivenom solutions in the market. After that, we began working with the primary armed forces of the world. We take our solutions to their military bases or they receive it through their local embassy.

This is the result of years of having a quality product in the market.

Q: How does the company address the dangers in different regions of the word?

A: We work largely in the field. We try to reach the opinion leaders and regulators of the countries or regions where we are working to understand what we need to develop and distribute. Furthermore, Inosan Biopharma has coordinated its work with WHO, which has specifically addressed snake venom dangers and has catalogued it as a neglected rare disease.

Q: How complex are the regulatory processes for such innovative solutions?

A: Since the very beginnings of the company, we have tried to make our work understandable. Trying to fit our antibodies solutions into existing regulations was challenging, especially for antivirals because regulatory authorities were unsure if these belonged in vaccine or treatment categories. We built a close relationship with the regulators, which enabled us to create an explanation for products to be used in different countries that is understandable for other authorities to issue quick approvals. We have registered products simultaneously, which is a challenge. However, we focused on creating understandable science to make our solutions accessible in every region of the world.

Q: How does Inosan Biopharma uses its expertise to combat the COVID-19 pandemic?

A: Years ago, Inosan Biopharma was invited by the FDA to participate in a treatment development project for Ebola. From this work, we recognized the effectiveness of our antibodies as antivirals.

This experience gave us the background to work on a COVID-19 solution as soon as we found the right immune response to develop a treatment. Inosan Biopharma began working with horses to find this immune response. We developed two research lines and we selected the one that delivered the best antibody efficiency. We then began preclinical trials and to date, the results have been very positive. We have noticed a neutralization of the virus while keeping a safe profile in terms of other reactions. Inosan Biopharma has allied with TecSalud to scale this project and begin other trials and for this stage, CINVESTAV has recently joined us. We are already in talks with the FDA and COFEPRIS to begin human trials in the upcoming weeks.

Q: How is this product a better alternative to the treatments being developed by other pharmaceuticals?

A: The treatment we are developing uses antibodies. Therefore, it can work from the early stages of contagion to neutralize the virus. During the early stages, you are preventing the virus from developing and the treatment also stops the virus from spreading. Traditional products are focusing on advanced stages of COVID-19, when the patient is already in the hospital.

Scalability of production would be our priority after the solution is approved. We are in the early stages of the development but we are aiming for an accessible cost to make it available for the population.

Q: Besides the COVID-19 treatment, what other products will Inosan Biopharma launch in the short term?

A: Inosan Biopharma has antibody solutions for Mexico that are awaiting COFEPRIS approval. In the US, we have an antivenom for coral snake bites waiting for FDA approval and we think it will reach the market by the end of 2021. Moreover, our R&D pipeline is focusing on an antivenom for South America, one for Asia and another for Europe, which is soon to go through approval. Additionally, we are developing an anti-rabies amtitoxin.

 

Inosan Biopharma, also known as the Antivenom Company, has developed a unique and original production platform to make safe, effective antivenoms available, independent of the cold chain and at a fair price. It distributes its products in Africa and the Middle East

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