The patent, together with others Neovacs has obtained, give the company global protection for the vaccine until at least 2032.
Neovacs’ technology targets diseases associated with an overproduction of endogenous cytokines. Cytokines are small mediators released by specific immune cell subsets that play key roles in moderating both innate — or built-in — and adaptive immune responses.
Too little or too much cytokine production, as well as abnormal immune-cell response to the presence of cytokines, can lead to immune-mediated diseases. An immune-mediated disease is one in which the immune system attacks the central nervous system.
Injecting IFNα Kinoid in muscle induces an immune response. It also stimulates the production of polyclonal antibodies that block the overproduction of a cytokine — and the effects of that overproduction.
Lupus is characterized by dysregulation of the immune system — that is, the system not working properly. Lupus is a multi-systemic autoimmune disease, which means that many immune cell subsets affect the course of the disease. Scientists believe cytokines contribute to the immune dysregulation and subsequent immune abnormalities.
Trials in mice and humans have found cytokines to be associated with the disease’s development.
“Based on our innovative technology, Neovacs has a unique position globally in the field of autoimmune disease treatment. The issuance of this patent, and subsequent further expansion of our IP portfolio, represents further progress in the pursuit of our global development strategy for IFNα Kinoid. Moreover, this method of use patent will benefit our partnership discussions in China, where the prevalence of Lupus and Type 1 Diabetes is high,” Miguel Sieler, Neovacs’ chief executive officer, said in a press release.
A Phase 2b clinical trial (NCT02665364) evaluating IFNα Kinoid in patients with moderate-to-severe lupus recently received a positive interim review from the Independent Data and Safety Monitoring Board (IDSMB), which oversaw the study. The trial is expected to enroll 178 patients in the United States and 20 countries in Latin America, Asia, and Europe.