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Clinical Trials

Date: 2015-09-08

Type of information: Presentation of results at a congress

phase:

Announcement: presentation of results at the International Association for the Study of Lung Cancer's (IASLC's) World Conference on Lung Cancer (WCLC), being held in Denver, Colorado

Company: Peregrine Pharmaceuticals (USA - CA)

Product: bavituximab

Action mechanism:

monoclonal antibody. Bavituximab is a chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab blocks PS to alter this immunosuppressive signal and send an immune activating signal. Targeting PS with bavituximab has been shown to shift the functions of immune cells in tumors, resulting in anti-tumor immune responses. 

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

 

Latest news:

* On September 8, 2015, Peregrine Pharmaceuticals, a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, announced positive new data from a translational study of bavituximab, the company's investigational phosphatidylserine (PS)-signaling pathway inhibitor. Findings demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway. Results from the study are being presented as part of a mini-oral presentation at the International Association for the Study of Lung Cancer's (IASLC's) World Conference on Lung Cancer (WCLC), being held this week in Denver, Colorado .

For the study presented at the WCLC, researchers from Nilogen Oncosystems and the H. Lee Moffitt Cancer Center , in collaboration with Peregrine, evaluated immune changes in 3D tumor microspheres generated from human NSCLC fresh tumors extracted at the time of surgery. These were tumor microspheres were treated with bavituximab alone, docetaxel alone, a combination of bavituximab and docetaxel, and a control. Bavituximab, alone and in combination with docetaxel, induced activation of tumor infiltrating lymphocytes as demonstrated by a statistically significant increase in key immune-stimulating cytokines such as IFN-?, TNF-?, and GM-CSF with a corresponding decrease in secretion of the immunosuppressive cytokine IL-10. Importantly, the bavituximab-affected immune response activity appeared to correlate with low PD-L1 expression on the tumor samples.  "These new translational data suggest that bavituximab has the potential to activate a tumor specific immune response in patients with PD-L1 negative tumors that generally do not respond as well to immune checkpoint inhibitors. By doing so, it is believed that bavituximab may hold potential to increase the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies," said Jeff Hutchins, vice president preclinical development of Peregrine. "These findings continue to expand our collection of translational data supporting the mechanism of action for bavituximab and corroborate our wide range of previously published preclinical study results. Taken together, these data provide us with growing confidence for our bavituximab development programs, including the ongoing Phase III SUNRISE clinical trial in NSCLC which is evaluating the same treatment combination used in these studies." In addition, Peregrine is presenting a poster providing a general overview of the company's ongoing SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial at the conference. 

Peregrine Pharmaceuticals is currently investigating bavituximab in combination with other immuno-oncology agents through ongoing collaborations with AstraZeneca, the Memorial Sloan Kettering Cancer Center and UT Southwestern. 

Is general: Yes