Peregrine Pharmaceuticals, Inc. provided a clinical development update for bavituximab, the company's investigational phosphatidylserine (PS)-targeting immunotherapy. In the first quarter of 2016, the company plans to initiate two new Phase II clinical trials in breast and lung cancer in combination with current standard of care treatments including both chemotherapy and immuno-oncology agents. In addition, the company has entered into a collaboration with the National Comprehensive Cancer Network (NCCN) to evaluate bavituximab in other tumor types and combinations.

Additionally, the company is nearing completion of enrollment of an ongoing Phase III trial in non-small cell lung cancer (NSCLC) named SUNRISE. The planned trials include a Phase II NSCLC trial in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), and a Phase II trial in early stage triple negative breast cancer (TNBC). These are in addition to the recently initiated Phase II/III study in combination with chemotherapy in human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC).

The company expects that initial data from these trials may be available in late 2016 or early 2017. Additionally, the company looks forward to the initiation of additional trials of bavituximab combinations through its ongoing collaborations with AstraZeneca and NCCN. Peregrine's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial is evaluating the use of bavituximab and docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC.

Peregrine expects that the first interim analysis (33% of targeted number of deaths) will be conducted in early 2016 and the second interim analysis (50% of targeted number of deaths) in mid-2016. Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca's durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC during the first quarter of 2016. In December 2015, Peregrine initiated an open-label, randomized Phase II/III study comparing the efficacy and safety outcomes for taxane monotherapy (paclitaxel or docetaxel at investigator discretion) versus taxane therapy in combination with bavituximab in HER2-negative MBC patients.

The goal of the Phase II portion of this study is to generate mature data on the combination of bavituximab and chemotherapy in MBC to guide the design and execution of the trial's Phase III component.