TapImmune has initiated a Phase 2 clinical trial to evaluate the T-cell therapy TPIV 200 in platinum-sensitive ovarian cancer patients. Following regulatory and Investigational Review Board (IRB) approval, the first three clinical sites were allowed to begin enrolling patients.
The multicenter, randomized Phase 2 clinical trial (NCT02978222) will evaluate the activity of TPIV 200, a T-cell therapy that targets the folate receptor alpha protein, as a consolidation treatment following completion of at least four cycles of a platinum-containing regimen.
The study will enroll 80 patients with recurrent platinum-sensitive, non-mucinous ovarian, fallopian tube, or primary peritoneal cancer.
The trial’s primary endpoints include the assessment of progression-free survival following two years of treatment and time to disease progression or recurrence of ovarian cancer.
Secondary endpoints include a two-year post-treatment assessment of overall survival (OS), best overall response, including complete responses and partial responses, disease control rate, response rate, and cancer antigen (CA)-125 response.
The clinical trial has Fast Track designation from the U.S. Food and Drug Administration (FDA), which also granted TPIV 200 Orphan Drug status for ovarian cancer.
“The opening of this study represents the fulfillment of a major 2016 milestone,” Dr. John Bonfiglio, president and CEO of TapImmune, said in a press release. “We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients.”
He said a fourth study in triple-negative breast cancer sponsored by the Mayo Clinic with a $13.3 million grant from the U.S. Department of Defense is scheduled to begin shortly.
“We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers,” Bonfiglio said.
TPIV 200 is also being evaluated in a Phase 2 clinical trial (NCT02764333) in combination with AstraZeneca’s investigational therapy durvalumab, an anti-PD-L1 antibody, in patients with platinum-resistant ovarian cancer. The single-arm study will evaluate the effectiveness and safety of the combination therapy in 40 women with high-grade ovarian, tubal, or primary peritoneal carcinomas whose cancer progressed within six months of their most recent platinum chemotherapy.
TPIV 200 is a multi-epitope peptide vaccine targeting the folate receptor alpha, known to be over-expressed in over 90 percent of ovarian cancer cells. In Phase 1 studies, conducted in patients with breast and ovarian cancer, the vaccine was safe and well tolerated and resulted in cellular immune responses in 20 out of 21 evaluable patients.