TapImmune Amends Phase 2 Clinical Trial to Focus on Larger Population of Women with Platinum-Sensitive Ovarian Cancer with Greatest Unmet Need for New Treatments

TapImmune, Inc. today announced that, in coordination with the U.S. Food and Drug Administration (FDA), it has amended the patient inclusion criteria for its Phase 2 clinical trial of the Company’s 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 significantly expands the population of patients that can be addressed with TPIV 200 as a potential maintenance therapy designed to prevent disease recurrence.

IMFINZI™ (Durvalumab) Granted Breakthrough Therapy Designation by US FDA for Patients with Locally Advanced Unresectable Non-Small Cell Lung Cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for IMFINZI™ (durvalumab), an anti-PD-L1 monoclonal antibody, being investigated for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.