TapImmune (TPI
V), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers has announced that it has amended the patient inclusion criteria for its Phase 2 clinical trial of their 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 increases 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 the majority of those suffering from ovarian cancer, and the vaccine has showed durable immune responses in a completed Phase 1 study. Patients in their first remission following platinum therapy currently have no approved therapeutic option to prevent the high occurrences of disease recurrence. TapImmune decided to amend the clinical protocol after extensive discussions with their clinical advisors regarding the unmet need in this patient population. Regarding this trial, Dr. Richard Kenney, Head of Clinical Development at TapImmune, stated: “Our investigators, as well as their ovarian cancer patients, are enthusiastic about this trial, which is intended to demonstrate enhanced progression-free survival for women prior to their first recurrence. Shifting our focus to earlier in the treatment cycle enables TapImmune to showcase the potential of our novel T cell vaccine in a much larger patient population. Furthermore, should TPIV 200 demonstrate a significant benefit for these women in prolonging the time to disease recurrence, the Company will be well positioned within the current treatment paradigm for ovarian cancer, which now includes the PARP inhibitor niraparib for treating patients with recurrent disease.”
The Phase 2 ovarian cancer trial is a double-blind controlled study designed to examine the potential benefits of using TapImmune’s lead product candidate TPIV200 following standard of care platinum-based chemotherapy. TPIV200 has Fast Track designation from the FDA and Orphan Drug status for ovarian cancer. Study size was increased to 120 patients to better evaluate the effect of the immunotherapy and to achieve statistical significance of efficacy data.
TapImmune, Inc. is advancing multiple Phase 2 and Phase 1b/2 clinical studies for the treatment of ovarian and breast cancer. Their peptide- or nucleic acid-based immunotherapeutic products comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient’s killer T cells and helper T cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. These technologies may be used as stand-alone medications or in combination with current treatments.
For more information about TapImmune, please visit their website.