Clinical Trials

Date: 2017-11-14

Type of information: Completion of patient enrollment

phase: 2

Announcement: DSMB assessment

Company: Tapimmune (USA - FL)

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

Action mechanism:

• immunotherapy product/therapeutic vaccine.  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.

Disease: triple-negative breast cancer (TNBC)

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

• This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FR?) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC). (NCT02593227)

Latest news:

• • On November 14, 2017, TapImmune announced that it has enrolled the final patient in a randomized Phase 2 clinical study of  the T-cell vaccine candidate TPIV200 for treating triple-negative breast cancer (TNBC). The comprehensive four-arm study is designed to help determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine’s molecular target, folate receptor-alpha (FRa), a cancer cell biomarker that is highly correlated with disease recurrence.
• TapImmune and its clinical partners are evaluating TPIV200 in multiple ongoing Phase 2 trials for treating ovarian and breast cancers, including a 280-patient efficacy trial sponsored by the Mayo Clinic that is randomized, double-blind, and placebo-controlled to evaluate disease-free survival in women with advanced TNBC. This larger clinical study to evaluate efficacy is fully funded by a $13.3 million grant from the U.S. Department of Defense and patient dosing is expected to begin by year end 2017 • On June 27, 2017, TapImmune announced that it has enrolled 50% (40/80) of the patients in its randomized Phase 2 clinical study of  TPIV 200 for treating triple-negative breast cancer. The four-arm study is designed to determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine’s molecular target, folate receptor-alpha (FRa).
• The multi-center Phase 2 study continues to enroll women with stage I(T1c)-III TNBC who have completed initial surgery and radiation/chemotherapy, and who have not yet had a cancer recurrence. It is during this window of opportunity that TPIV 200 is used to vaccinate patients in an effort to delay or prevent cancer recurrence by stimulating the immune system to produce T-cell immunity specific for tumor antigens.
• • On February 15, 2017, TapImmune announced its lead cancer vaccine candidate, TPIV 200, received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue dosing triple-negative breast cancer (TNBC) patients in an ongoing Phase 2 clinical trial. The planned safety review was performed when enrollment had reached 25 percent benchmark (20/80 patients). The four-arm trial is designed to test the safety, dosing level and optimal treatment regimen of TPIV 200, the company's novel five-peptide vaccine designed to elicit a long-lasting adaptive immune response against TNBC cells, involving both "helper" and "killer" T-cells. The study tests two vaccine dose levels with and without cyclophosphamide priming of the immune system and will monitor for sustained immune response and relapse-free survival for three years. TapImmune will be enrolling the remaining patients at 12 clinical centers in the U.S. with enrollment completion targeted for the end of 2017.

 

Is general: Yes