TapImmune (TPIV) is planning to begin a Phase ll trial of its cancer vaccine, TPIV 200, a multi-epitope anti-folate receptor vaccine (FR), in combination with Astra Zeneca's durvalumab (MEDI4736) in patients with platinum-resistant ovarian cancer.
Scheduled to be started by the second quarter of this year, the study will be conducted at Memorial Sloan Kettering Cancer Center in New York, US, and will be led by principal investigator Jason Konner.
Clinical costs of the study will be shared by both TPIV and MedImmune, the global biologics research and development unit of AstraZeneca.
For the trials, TPIV will supply TPIV 200, which recently received orphan drug designation in ovarian cancer from the US Food and Drug Administration (FDA), and MedImmune will provide durvalumab (MED14736).
The proposed single arm Phase ll trial will include 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 main objective is to determine the effectiveness of the combination of TPIV 200 and durvalumab (MEDI4736) by measuring overall response rate (ORR) by response evaluation criteria in solid tumours (RECIST) and progression-free survival (PFS) rate at six months.
Secondary endpoints of the trial will be safety and immune and correlation of FR-specific immune responses with clinical efficacy.
TapImmune chairman and CEO Glynn Wilson said: "This study is part of a larger Phase II strategy for TPIV 200 that is designed to greatly increase our understanding of the vaccine while providing clinical evidence of efficacy."
During Phase I clinical studies of TPIV 200, conducted at the Mayo Clinic, US, in patients with breast and ovarian cancer, the vaccine was found to be safe and well-tolerated and give cellular immune responses in 20 out of 21 evaluable patients.
Developed at MedImmune, durvalumab helps blocking the signals, which come from PD-L1 that help tumours avoid detection by the immune system, and counters the tumour's immune-evading tactics.
Durvalumab is being investigated in a clinical trial programme, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, gastric, pancreatic, bladder and blood cancers.