Sanofi has pulled out of a pediatric pentavalent vaccine collaboration with Daiichi Sankyo in Japan. The action, which Sanofi disclosed (PDF) alongside other pipeline updates, follows a multiyear effort to get phase 3 data on the vaccine candidate.
Japan has lagged other parts of the world in adopting pentavalent vaccines that prevent pertussis, diphtheria, tetanus, poliomyelitis and Hib, choosing instead to give tetravalent and single antigen shots concomitantly. Sanofi was working with Daiichi to change that, but disclosed in its second-quarter results that it has “decided not to pursue the collaboration.”
The action follows years in which the targeted filing date for the vaccine has slipped steadily. A phase 3 study got underway in Japan in 2014. By 2017, Sanofi was planning to file for approval in 2020. The target slipped to 2021 the following year. Earlier this year, Sanofi moved the vaccine into its “2023 and beyond” group of planned filings. Now, Sanofi has dropped the filing plan altogether.
Sanofi also used the pipeline update to confirm a change in its collaboration with Denali. As Denali disclosed last month, the partners have dropped their phase 1 RIPK1 inhibitor SAR 443060 in favor of a backup compound.
Denali said the decision reflected “emerging evidence that higher levels of target inhibition may be required for maximizing efficacy, and challenges to achieving higher doses imposed by molecule-specific toxicity findings." The now-dropped drug went through two phase 1b studies in Alzheimer’s disease and amyotrophic lateral sclerosis, plus chronic toxicity studies in cynomolgus monkeys.
Elsewhere, the combination of Sarclisa and Libtayo was the only phase 2 removal disclosed by Sanofi in the update. Sanofi decided not to pursue the combination in multiple myeloma after finding that adding PD-1 inhibitor Libtayo to anti-CD38 antibody Sarclisa yielded “insufficient additional efficacy” over the latter drug as a monotherapy.