The Phase 2 trial evaluating the combination of the TPIV 200 cancer vaccine with the immune checkpoint inhibitor Imfinzi (durvalumab) in ovarian cancer patients who progressed after receiving platinum-based chemotherapy has enrolled more than half of study participants, TPIV 200 developer TapImmune announced.
The company also provided updates on the Phase 2 trial evaluating TPIV 200, which received fast–track status from the U.S. Food and Drug Administration, as a maintenance therapy in ovarian cancer patients who responded to platinum-based chemotherapy.
Results of the trials are expected by the second quarter of 2017 and the second half of 2018, respectively.
TPIV 200 is a multi–epitope peptide vaccine targeting the folate receptor alpha, known to be over-expressed in over 90% of ovarian cancer cells. According to TapImmune, Phase 1 studies in patients with breast and ovarian cancer showed the vaccine to be safe and well–tolerated, resulting in immune responses in 20 out of 21 evaluable patients.
The single-arm clinical trial is evaluating the effectiveness and safety of the combination therapy in 40 ovarian cancer patients whose cancer progressed within six months of their most recent platinum-based chemotherapy. To date, the study has enrolled 27 women.
The clinical trial is sponsored by the Memorial Sloan Kettering Cancer Center. According to TapImmune, interim results from this study are expected in coming months. If the safety profile of TPIV 200 remains favorable and sufficient signs of tumor response exist, patient enrollment will resume, the company says.
TPIV 200 is also being evaluated as a maintenance therapy in a multicenter, blinded, randomized, placebo-controlled Phase 2 trial, (NCT02978222), in platinum-sensitive ovarian cancer. This study is currently enrolling 120 women with ovarian cancer who responded to standard platinum-based therapy.
The two-arm study will evaluate TPIV 200 as a maintenance therapy to potentially prolong the time to cancer recurrence, compared to GM-CSF alone. GM-CSF, or granulocyte–macrophage colony–stimulating factor, is a protein that enhances immune system activation.
The trial’s primary measures are progression–free survival after two years of treatment and time to disease progression or recurrence. Secondary endpoints include a two-year post–treatment assessment of overall survival, best overall response, including complete responses and partial responses, disease control rate, and cancer antigen–125 response. An interim analysis is expected when 50% of patients are enrolled in the study, likely by mid-2018.
“TapImmune is entering a period where we expect to reach several substantive clinical milestones over the next 18 months,” Glynn Wilson, TapImmune chairman and CEO, said in a press release. “By the end of 2017, we expect to have four active Phase 2 studies ongoing in multiple high-need cancers, including clinical studies sponsored by our top–tier partners, the Mayo Clinic and Memorial Sloan Kettering Cancer Center.”
The U.S. Food and Drug Administration granted TPIV 200 orphan drug designation for the treatment of ovarian cancer in 2015. This designation provides TapImmune’s TPIV 200 ovarian cancer clinical program with certain benefits, including tax credits on clinical research and seven–year market exclusivity upon receiving marketing approval. The FDA also granted TPIV 200 fast–track designation for the treatment of ovarian cancer in 2016.
TPIV 200 is also being evaluated in several clinical trials for the treatment of patients with breast cancer. More information on TapImmune’s TPIV 200 breast cancer clinical development program can be found here.