Therapeutic Vaccine for Ovarian Cancer Receives Fast Track Designation

Therapeutic Vaccine for Ovarian Cancer Receives Fast Track Designation

February 10, 2016

An experimental therapeutic vaccine for the treatment of ovarian cancer is now showing promise and on February 3, 2016, was granted Fast Track Designation by the US Food and Drug Administration.

An experimental therapeutic vaccine for the treatment of ovarian cancer is now showing promise and on February 3, 2016, was granted Fast Track Designation by the US Food and Drug Administration (FDA). For now, the vaccine is being referred to as TPIV 200 and it is being developed by TapImmune, Inc. for a specific group of ovarian cancer patients.

TPIV 200 is a multiple-epitope Folate Receptor Alpha Peptide Vaccine with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer who achieved stable disease or partial response following completion of standard-of-care chemotherapy. Folate Receptor Alpha is overexpressed in multiple cancers, including over 90% of ovarian cancer cells.

“We believe that the FDA’s decision to grant Fast Track designation to TPIV 200 for the treatment [of] ovarian cancer significantly expedites our clinical development program. We look forward to starting phase II trials in the near future to address this highly aggressive cancer,” said Glynn Wilson, PhD, Chairman and CEO of TapImmune, in a press release. “We believe that TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis.”

The vaccine was shown to be safe, well-tolerated, and effective in phase I clinical studies conducted at the Mayo Clinic in patients with breast and ovarian cancer--cellular immune responses occurred in 20 out of 21 evaluable patients. The data showed that 16 out of 16 patients in the observation stage still showed immune responses.

Data from the phase I studies were presented at 2015 ASCO Annual Meeting Society in Chicago. Multiple phase II studies will examine the efficacy of this vaccine in ovarian and in triple-negative breast cancer.

Researchers also presented vaccine data at the 2015 San Antonio Breast Cancer Symposium, December 10, 2015, on a second vaccine called TPIV 100 for treating HER2/neu-positive breast cancer. In a phase I trial, researchers found that the percentage of patients who responded with augmented T-cell immunity to the four peptide antigens contained in the vaccine was high for each peptide and ranged from 68% to 88%.

Approximately 21,290 women were diagnosed with ovarian cancer in 2015 and an estimated 14,180 will die from the disease, according to the National Cancer Institute. Because ovarian cancer tends to be detected at a later stage, the five-year survival rate for ovarian cancer is 45%.