Sumitomo Pharma and Japan’s National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN) announced last week that they will begin Phase 1 clinical trials for a universal influenza vaccine under development.
The aim is to commercialize a universal flu vaccine that can respond to seasonal influenza A, even if mutations occur. The experimental vaccine, fH1/DSP-0546LP, is being developed by a research team led by Sumitomo, and NIBIOHN is participating in the development as a co-researcher.
The Phase 1 clinical trial for fH1/DSP-0546LP will be conducted in Belgium by Sumitomo, with the first doses administered in July. Later testing, including a Phase 2, will involve an exposure test in which subjects participating in the clinical trial are infected with the influenza virus.
There are a limited number of places where exposure tests are allowed, and at Sumitomo’s financial results briefing last week, the company’s Representative Director and Senior Managing Executive Officer Toru Kimura said, “Europe has the soil for conducting exposure tests, so clinical trials will be conducted in Belgium.” A Phase 2 clinical trial will also be conducted in Belgium, with plans to obtain a proof of concept by exposing vaccinated subjects to the influenza virus and assessing whether the vaccine prevents infection.
The experimental vaccine uses a modified membrane-fused hemagglutinin as the antigen. Hemagglutinin is a glycoprotein localized on the surface of cell membranes of influenza viruses and other viruses, and is used by the virus to help infect host cells. The antigen is made by changing the structure of normal hemagglutinin to expose epitopes that are common to various influenza viruses.
Furthermore, fH1/DSP-0546LP uses DSP-0546LP as an adjuvant, which contains a substance that specifically activates TLR7, which is one of the Toll-like receptors. Toll-like receptors induce immune responses in response to RNA contained in viruses. By using DSP-0546LP, the aim is to increase the immune response and its sustainability caused by the vaccine.
The trial will target subtypes of seasonal influenza A that have high antigenic similarity with the membrane-fused hemagglutinin used in the vaccine. The future goal is to be able to respond to all subtypes of seasonal influenza A.
The study will include a placebo group, a group administered with antigen alone, and a group administered with adjuvant alone, with several dozen patients in each group scheduled to be enrolled. The goal is to verify whether administration of fH1/DSP-0546LP produces antibodies against a wide range of influenza viruses as expected.