ISA106’s promising results in preclinical tests warrant fast entry into human studies to address the need for effective COVID-19 therapy

March 3rd, 2021 – ISA announces that it has completed pre-clinical work for ISA106, a novel COVID-19 immunotherapy and is planning clinical trials. A phase 1 dose finding study in healthy volunteers will start in the next few months.

ISA106 is an immunotherapy agent that is intended to treat patients with SARS-CoV2 infections, and prevent progressive pneumonia and further complications – thereby avoiding admission to hospital and ICU. It is designed to elicit a robust T cell immune response specifically against SARS-CoV2, the virus that causes COVID-19. T cells are very effective at eradicating virusses. The mechanism of action of ISA106 is different from prophylactic vaccines, as the latter are designed to prevent infection but can not be used to treat individuals with established infections. Boosting the T cell response against SARS-CoV2 in an infected individual at the right time is expected to shorten the infection period, and prevent serious disease. T cells generated by ISA106 target multiple viral proteins that include the currently known new variants.

Safe, specific and effective therapies to treat COVID-19 are desperately needed, in addition to the current preventive vaccination efforts. The emergence of more infectious variant strains of the virus, ‘’vaccination hesitancy’’ in the population, and the variable duration of protection of current vaccines create a distinct need for a therapy to serve as a safety net for infected individuals. New virus variants that escape current prophylactic vaccines are likely to emerge in response to pressure from these vaccines. Research also shows that traditional prophylactic vaccines are not as effective in individuals with a less competent immune system such as the elderly, patients with cancer and auto-immune diseases, organ transplant recipients, and other immune-compromised patients.

Prof. Dr. Melief, Chief Scientific Officer at ISA Pharmaceuticals, commented: “Preclinical testing of ISA106 has shown clear signals of potential efficacy in humans. It is capable of inducing killer T cells in mice, and re-activates T cell responses of patients that have successfully cleared the virus. A robust T cell response is essential to remove infected cells and prevent disease progression. Strong T cell memory responses may also prevent re-infection.”

Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: “There is a desperate need for effective therapeutics to fight diseases that are caused by pandemic viruses like SARS-Cov2, particularly in individuals with a compromised immune system. Our promising preclinical results with ISA106 highlight the potential of anti-viral T cell therapy against SARS-CoV2, and against future pandemic viruses, to provide society with an additional line of defense and help control pandemics.”

ISA106 uses ISA’s Synthetic Long Peptide (SLP®) platform technology. The same technology is used for ISA’s lead asset ISA101b, which is currently in late stage clinical development for the treatment of human papilloma virus type 16 (HPV16) induced cancers.

Meet ISA Pharmaceuticals in March at BioCapital Europe and BIO-Europe Spring Digital, and connect with us on BD@isa-pharma.com.