Astellas and Vical begin CMV vaccine trial

Astellas and Vical have announced the commencement of a multinational phase III registration trial of ASP0113, a groundbreaking new vaccine for cytomegalovirus (CMV).

The study will involve approximately 500 haematopoietic cell transplant (HCT) recipients and will utilise an adaptive design, with the primary goal of the first half being overall survival, while the second part will focus on either survival or a composite endpoint including other variables.

ASP0113 is the first therapeutic CMV vaccine to ever reach phase III testing, with the companies hoping to jointly commercialise the therapy under the name TransVax.

Astellas will take responsibility for conducting the new phase III trial, with Vical providing development, regulatory and manufacturing support.

Yoshihiko Hatanaka, president and chief executive officer of Astellas, said: "There still remains high unmet medical needs to control CMV in transplant recipients. We are pleased to advance the ASP0113 programme in a highly challenging HCT recipient population."

This comes after the firm announced a new alliance with Cytokinetics focusing on the research, development and commercialisation of skeletal muscle activators earlier this week.