Breast Cancer Vaccine Candidate Launches Phase 2 Clinical Study

A leading clinical-stage immuno-oncology company has enrolled the final patient need to launch a randomized Phase 2 clinical study of a 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.

As an off-the-shelf vaccine consisting of several carefully chosen FRa peptides, TPIV200 is uniquely able to stimulate both “helper” T cells and “killer” T cells to target tumor cells.

Additionally, this vaccine peptides are predicted to cover greater than 85% of human genotypes worldwide.

“The current recommended treatment plan for many women after receiving chemotherapy and/or surgery for triple-negative breast cancer or ovarian cancer is to wait,” says Peter Hoang, president, and CEO of TapImmune.

“While that patient is in remission and is stabilized, that’s when we give them the cancer vaccine. The goal is to drive the immune response to help fight relapse when it occurs and attack the tumor, thereby extending the life of the patient,” said Hoang.

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.

Triple-negative breast cancer means that the three most common types of receptors known to fuel most breast cancer growth, which is the estrogen, progesterone, and HER-2/neu receptors, but are not present on the tumor cells.

This makes therapies targeting these molecules ineffective. Estrogen and progesterone are hormones and HER-2 a protein.

TPIV 200 is composed of five peptide antigens or molecules that can trigger an immune response. It is derived from a cell surface molecule called folate receptor alpha, or FRa, that is found in high levels on tumor cells.

Ninety percent of ovarian cancer cells and 80 percent of triple-negative breast cancer cells produce too much FRa, whose overproduction is associated with cancer recurrence.

Dr. Richard Kenney, Head of Clinical Development for TapImmune, stated, “Our Phase 2 trial focuses on women who have completed initial surgery and radiation/chemotherapy for TNBC at least 60 days prior to randomization.”

“Evaluating multiple vaccine dosing strategies in this Phase 2 trial may enhance our ability to generate optimal immune responses and prevent disease recurrence in future pivotal clinical studies.”

The primary endpoint of this Phase 2 study is the immune response against the vaccine target, folate receptor-alpha (FRa), as measured by the presence of anti-FRa T cells.

TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer.