Sum­it­o­mo and Japan Na­tion­al In­sti­tute's uni­ver­sal in­fluen­za vac­cine en­ters clin­i­cal tri­als

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.