AFFIRMA BIOTECH

Affirma Biotech was created in 2020 with the objective of developing new drugs for the treatment of infectious diseases that uses the innovative strategy of stimulating the immune system of the patient (Host Directed Therapy).

Long-lasting infectious diseases cause exhaustion of the T cells, key cells of the immune system, leading to a deficient immune response, and consequently, the persistence of the illness. Similar strategies in the last decade have revolutionised the treatment of cancer, but there has been little development in the area of sever infections. The development of the Affirma Biotech’s new compounds is therefore an excellent opportunity to achieve significant improvements in the approach to these indications.

There is a long list of illnesses that lead to T cell exhaustion, including a range of different viral infections, such as chronic hepatitis B, cytomegaloviruses and influenza viruses; persistent bacterial infections, like the colonisation of Pseudomonas aureginosa in patients with cystic fibrosis, some fungal infections and various types of tumours. Thus, the development of new drugs to reverse this mechanism of action allows us to treat a wide range of diseases.

Among all of these indications, Affirma Biotech has strategically selected the treatment of chronic hepatitis B as lead indication. We are dealing here with a disease that currently has no functional cure, and that causes approximately 900.000 deaths per year, since 20% of the 290M people that suffer from this disease on a global level run the risk of developing life-threatening complications like cirrhosis or hepatocellular carcinoma, which is the third most common cause of death by cancer.

The chronic hepatitis B market, valued at an estimated 5,2B$ in 2029 in the 9 major markets, in which China clearly dominates with 65% of the market. In addition, it is a market in which existing patents will expire within the next two years and which will enter a phase of predominately generic products. Pharmaceutical companies will therefore be looking for synergies and compounds to start new periods of treatment protection.

To develop PD-1/PD-L1 inhibitors that restore the activity of the T cells, Affirma Biotech has carried out an extensive program of medicinal chemistry to design new drugs, that are taken orally and are protected by a broad patent of recent priority. Our compounds have been confirmed to stimulate the immune system when faced with an infectious stimulus in cellular models form healthy donors, to levels similar to those seen in treatments for cancer.

The objective of the present round is to optimise the pharmacological properties of the company’s products and to confirm efficacy in in vivo models for the selected indications. Subsequently, we will look for additional investors for the regulatory development of our drugs.

Affirma has an entrepreneurial team lead by Maribel Berges, who has more than 25 years of experience in the Biotech sector, in which she has validated the business model that Affirma will be following, having obtained licenses on an international level for a number of the compounds developed in previous companies. What is more, she has organised significant funding rounds, managing to raise more than 25 million euros in the course of her career.   A number of well-known investors in the biotechnology sector are participating in Affirma, such as Alfons Hidalgo, Luis Ruiz, Antonio Parente and Reig Investments.