peregrine pharmaceuticals (PPHM) Key Developments
AstraZeneca and Peregrine Pharmaceuticals to Collaborate on Solid Tumor Trial
Aug 31 15
AstraZeneca and Peregrine Pharmaceuticals are collaborating on an early-phase clinical trial to evaluate the safety and efficacy of two novel investigational drugs in patients with a range of solid tumor types. The Phase 1/1b trial, slated to start in 2016, will combine it's durvalumab, an anti-PDL1 immune checkpoint inhibitor, with Peregrine's bavituximab, a phosphatidylserine-signaling pathway inhibitor. Preclinical data show that tumor-specific T-cells have a prolonged ability to continue attacking a tumor when the antitumor activity of bavituximab is combined with checkpoint inhibitors such as PDL1 antibodies, the companies say. The nonexclusive collaboration is the latest indication of significant interest in Peregrine's bavituximab as a potential key component in immuno-oncology combos, says company spokesman Tim Brons.
Peregrine Pharmaceuticals, Inc. Proposes Amendment to Certificate of Incorporation
Aug 28 15
Peregrine Pharmaceuticals, Inc. announced that an annual meeting of stockholders will be held on October 15, 2015, to approve an amendment to certificate of incorporation, as amended, to increase the number of shares of common stock authorized for issuance thereunder from 325 million to 500 million shares.
Peregrine Pharmaceuticals, Inc Presents Data at Annual Immunotherapy and Vaccine Summit Supporting Ability of Bavituximab to Mediate Anti-Tumor T Cell Responses Across Multiple Tumor Types
Aug 26 15
Peregrine Pharmaceuticals, Inc. announced the presentation of a range of clinical, translational and pre-clinical study results of bavituximab, Peregrine’s investigational phosphatidylserine (PS)-signaling pathway inhibitor, to promote anti-tumor T cell mediated activity in several tumor types. Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine’s PS signaling pathway inhibitor candidates, including bavituximab, reverse the immunosuppressive environment that many tumors establish in order to proliferate and fight cancer by activating macrophages and cytotoxic T cells in tumors. Preclinical data demonstrate that combining the enhanced T cell anti-tumor activity of bavituximab-like antibodies with checkpoint inhibitors, such as anti-PD-1 antibodies, results in significantly improved tumor control in multiple models of cancer. The potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor. Presented findings demonstrate that bavituximab-like antibodies significantly increase the prevalence of tumor infiltrating CD8+ T-cells and immune-activating cytokines, while decreasing macrophages and myeloid cells that allow the tumor to evade immune detection. This elucidation and confirmation of bavituximab’s mechanism of action highlights the potential of bavituximab to enhance the anti-tumor effects of both chemotherapy and immune checkpoint inhibitors. Bavituximab increases the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, thereby upregulating the target for checkpoint inhibitors such as anti-PD-1 and anti-PD-L1. Results from several clinical and preclinical studies in a range of tumor types show that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated estimated survival curves that plateau.
AstraZeneca PLC and Peregrine Pharmaceuticals, Inc. to Collaborate on Immuno-Oncology Combination Clinical Trial
Aug 24 15
AstraZeneca PLC and Peregrine Pharmaceuticals, Inc. announced that they have entered into a cancer immunotherapy clinical trial collaboration. The collaboration will evaluate Peregrine’s investigational phosphatidylserine (PS)-signaling pathway inhibitor, bavituximab, in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumors. Peregrine and AstraZeneca will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumors. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination and the Phase Ib part of the trial will assess the safety and efficacy of the investigational combination. Under the terms of the agreement, the initial trial will be conducted by Peregrine. Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. The treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. MEDI4736 is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor.
Peregrine Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Twelve Months Ended April 30, 2015; Expects Contract Manufacturing Revenue for Fiscal 2016
Jul 14 15
Peregrine Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the fourth quarter and twelve months ended April 30, 2015. Total revenues for the fourth quarter of 2015 were $9,308,000, compared to $6,474,000 for the same quarter of the prior fiscal year. The company’s consolidated net loss attributable to common stockholders was $13,513,000 or $0.07 per basic and diluted share, for the fourth quarter of 2015, compared to a net loss attributable to common stockholders of $10,649,000, or $0.06 per basic and diluted share, for the same prior year quarter. Loss from operations was $12,169,000 compared to $10,529,000 a year ago.
For fiscal 2015, total revenues were $26,781,000, compared to $22,401,000 for the prior fiscal year. The fourth quarter and full year of 2015 increases were attributed to an increase in contract manufacturing revenue. For fiscal 2015, net loss attributable to common stockholders was $54,054,000, or $0.30 per basic and diluted share, compared to $35,763,000, or $0.22 per basic and diluted share, for fiscal 2014. Loss from operations was $50,499,000 compared to $35,706,000 a year ago.
The company expects contract manufacturing revenue for fiscal 2016 to be between $30 and $35 million. In addition to providing biomanufacturing services to its third-party customers, Avid will continue to prepare for the potential commercialization of bavituximab.