Imugene Ltd (ASX:IMU) is planning to conduct two separate phase I clinical trials in 2020 to test two constructs of the CF 33 oncolytic virus (OV).
One version of the OV is “armed” with an immune checkpoint inhibitor inserted in the virus, which is known as CheckVacc.
The second is an unarmed construct, known as Vaxinia.
CheckVacc and Vaxinia to be manufactured in Californian facility
Both constructs have completed clinical-grade GMP batches at the City of Hope Center for Biomedicine and Genetics (CBG).
The CBG is a California-licensed, 20,000 square foot, multi-product biologics manufacturing facility within City of Hope.
With twelve ISO 7 production rooms in three product type zones, a dedicated aseptic fill suite and a staff with extensive biopharmaceutical experience, the CBG is capable of producing virtually any type of biologic at scales suitable for phase I through phase II clinical trials.
Imugene’s managing director and CEO Ms Leslie Chong said: “This is a significant milestone met in our preparation for commencing our planned CF33 oncolytic virus phase I clinical trials in 2020.”
CF33 OV technology recently acquired
Imugene Shareholders recently agreed to the purchase of Vaxinia Pty Ltd and City of Hope licence which results in the company completing the acquisition of the CF33 oncolytic virus technology.
Approval was granted at an extraordinary meeting of shareholders held in Melbourne last week.
The CF33 OV was developed in the lab of Professor Yuman Fong, an internationally recognised surgeon and scientist at City of Hope in California.
City of Hope is a world-renowned independent research and treatment centre for cancer, diabetes and other life-threatening diseases.