TapImmune to start phase 2 ovarian cancer trial with AstraZeneca’s durvalumab

The study will start in the second quarter of this year at Memorial Sloan Kettering Cancer Center in New York.

Clinical costs will be shared by the companies. The US Food and Drug Administration recently granted orphan drug designation for TPIV 200 in ovarian cancer.

This single arm phase 2 trial will feature 40 women with high-grade ovarian, tubal, or primary peritoneal carcinomas, who have progressed within six months of their most recent platinum chemotherapy.

The study’s primary objective is to identify the effectiveness of the combination by measuring overall response rate and progression free survival rate at six months.

Safety and immune and correlation of folate receptor-specific immune responses with clinical efficacy are the secondary endpoints.

TapImmune chairman and CEO Glynn Wilson said: "This collaboration is a significant event for TapImmune.

"We are delighted to bring a leading T-cell vaccine platform into this combination study and to work with AstraZeneca/Medimmune and Sloan Kettering in a patient population that is in dire need of an effective treatment."

TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha, which is overexpressed in several cancers including more than 90% of ovarian cancer cells.

In phase I clinical trials, the vaccine was demonstrated to be safe and well tolerated and to give cellular immune responses in 20 out of 21 evaluable patients.