Clinical Trials

Date: 2017-08-07

Type of information: Amendment to the study protocol

phase: 2

Announcement: amendment to the study protocol

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.
• TPIV 200 has orphan drug status for ovarian cancer.

Disease: platinum sensitive ovarian cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

• This is a blinded, randomized, parallel groups Phase II trial. Patients with platinum sensitive ovarian cancer (defined as time to progression > 6 months in the penultimate platinum containing regimen) and who had either a tumor response or a stable disease upon completing their last platinum containing regimen will be randomized to either vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within 8 weeks of last platinum administration. The vaccination phase will include 6 administrations of the study drug at 4-week intervals. After vaccination, patients will be monitored for tumor response (if measurable tumor was present at baseline) and for relapse or progression during an 18-month follow-up after completion of vaccine treatment. The total duration of the study will be 2 years. Assessment for tumor response, disease progression and recurrence will be conducted every 12 weeks from the end of treatment until documented disease progression. (NCT02978222)

Latest news:

• • On August 7, 2017, TapImmune announced that, in coordination with the FDA, it has amended the patient inclusion criteria for its Phase 2 clinical trial of T-cell therapeutic peptide vaccine TPIV200 to focus on women with Stage III and IV ovarian cancer who are in remission following their first round of successful platinum-based chemotherapy. TapImmune has enrolled the first women under this amended study protocol, which significantly expands the population of patients that can be addressed with TPIV 200 as a potential maintenance therapy designed to prevent disease recurrence.
• TPIV200 targets the folate receptor alpha protein, which is overexpressed by most patients with ovarian cancer, and the vaccine has generated durable immune responses in a completed Phase 1 study. TapImmune sought to amend the clinical protocol following extensive discussion with its clinical advisors regarding the unmet need in this patient population and in anticipation of FDA approval of niraparib for women with recurrent disease. Patients in their first remission following platinum therapy currently have no approved therapeutic option to prevent disease recurrence, which occurs at a high rate. Therefore, these patients are in the best position to benefit from TPIV 200 maintenance therapy.
• • 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 10, 2017, TapImmune announced the opening of its Phase 2 company-sponsored ovarian cancer study in platinum-sensitive ovarian cancer patients. The company’s first three clinical sites have received regulatory and Investigational Review Board (IRB) approval to begin enrollment. The study will utilize TPIV 200, a T-cell therapy targeting the folate receptor alpha protein.
• This ovarian cancer study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company’s lead product candidate TPIV 200 in combination with standard of care chemotherapy. The study has Fast Track designation from the FDA.

Is general: Yes