Clinical Trials

Date: 2017-01-24

Type of information: update on patient enrollment

phase: 2

Announcement: update on patient enrollment

Company: Memorial Sloan Kettering Cancer Center (USA - NY) AstraZeneca (UK) Tapimmune (USA - Fl)

Product: TPIV 200 (multi-epitope folate receptor alpha peptide vaccine with GM-CSF adjuvant) and durvalumab

Action mechanism:

• immunotherapy product/therapeutic vaccine/monoclonal antibody/immune checkpoint inhibitor.  TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha which is overexpressed in multiple cancers including over 90% of ovarian cancer cells.
• Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics.

Disease: ovarian cancer

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

• This Phase 2 clinical trial tests two investigational drugs: TPIV200/huFR-1 (also called TPIV200), which is a vaccine consisting of proteins from the folate receptor alpha mixed with GM-CSF, and durvalumab (MEDI4736) , which is an antibody drug that help un-block parts of the immune system. The aim of this study is to find out whether these drugs, when given together are safe, and whether they are effective in treating cancer. (NCT02764333)

Latest news:

• • On February 2, 2017,  TapImmune announced it has successfully completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, its multi-epitope T-cell vaccine targeting folate receptor alpha. The manufactured vaccine product will be used to supply an ongoing Phase 2 study of TPIV 200 for the treatment of platinum-sensitive ovarian cancer, as well as a planned Phase 2 study sponsored by the Mayo Clinic for treating triple-negative breast cancer. “Our first TPIV 200 lot was manufactured in early 2016 to fully supply a TapImmune-sponsored Phase 2 trial evaluating the vaccine for the treatment of triple-negative breast cancer as well as a Phase 2 trial evaluating the vaccine in combination with a checkpoint inhibitor for platinum-resistant ovarian cancer, both of which are currently enrolling patients,” said Dr. John Bonfiglio, President and COO of TapImmune. “The current, larger clinical batch of TPIV 200 will fully supply the first TapImmune-sponsored Phase 2 trial in platinum-sensitive ovarian cancer, for which a number of clinical sites are currently being screened and initiated. The batch will also supply a planned Mayo Clinic-sponsored Phase 2 trial for triple-negative breast cancer, which is fully funded by a grant from the Department of Defense.”
• • On January 24, 2017, TapImmune announced that Memorial Sloan Kettering Cancer Center (MSKCC) successfully completed the first safety cohort in its Phase 2 ovarian cancer study. The study is designed to examine the efficacy of its lead investigational product candidate, TPIV 200, in combination with AstraZeneca’s investigational checkpoint inhibitor, durvalumab.
• The Phase 2 ovarian cancer study is sponsored by MKSCC under the leadership of Dr. Jason Konner. This clinical milestone allows MSKCC to increase the number of patients that can be enrolled and will subsequently increase the study’s enrollment rate. Patients in this study are resistant to platinum chemotherapy and have few treatment options. Since TPIV 200 and durvalumab have not been used before in combination, the protocol required the start of the study to proceed cautiously for the first four patients. There have been no safety issues to date, and the enrollment is now allowed to proceed at a faster rate.

Is general: Yes