Peregrine Nixes Planned Trials for Bavituximab, But Hints at a Future Trial with AstraZeneca PLC’s Durvalumab

Peregrine Nixes Planned Trials for Bavituximab, But Hints at a Future Trial with AstraZeneca’s Durvalumab June 2, 2016
By Alex Keown, Breaking News Staff

TUSTIN, Calif. – Shares of Peregrine Pharmaceuticals, Inc. have jumped more than 32 percent this morning after the immuno-oncology company laid out its projections for 2017—which includes a new direction for its investigational immunotherapy drug, bavituximab.

In a Thursday announcement, Peregrine said it was taking a new course with bavituximab that focuses on a development strategy conducting small, early stage studies of bavituximab in combination with other immuno-oncology agents. These trials may be conducted as part of ongoing collaborations with AstraZeneca and the National Comprehensive Cancer Network (NCCN), Peregrine said in a statement. Peregrine is currently working with AstraZeneca to evaluate data from its failed Phase III Sunrise trial for patients previously treated locally advanced or metastatic non-squamous non-small cell lung cancer. In February, Peregrine said it discontinued the trial following an independent data monitoring committee review that showed the drug did not improve overall patient survival rates. The interim analysis showed that the bavituximab combination group is performing as expected according to the original trial assumptions in terms of overall survival, while the docetaxel group is dramatically outperforming overall survival expectations based on the original trial assumptions and as compared to recently published studies. Although that trial has ceased, Peregrine said it is working with AstraZeneca to identify the optimal strategy for the companies' clinical development collaboration focused on combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. The company said a Phase I trial testing bavituximab and durvalumab will be determined by the continued collection of data from the Sunrise trial and finalization of the trial design.

Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal.

In addition to its Sunrise trial, Peregrine also suspended other chemotherapy combination studies until further analysis of the Sunrise trial could be conducted. Those trials include two recently announced Phase II clinical trials in breast and lung cancer for bavituximab in combination with current standard of care treatments including both chemotherapy and immuno-oncology agents.

While the company refocuses on bavituximab, Peregrine announced that its contract manufacturing subsidiary, Avid Bioservices, saw “significant organic growth” over the past year, generating $44 million in revenue compared to $26.7 million in contract manufacturing revenue for 2015. Peregrine said it anticipates the next year will see even greater revenues or between $50 and $55 million for Avid due to a backlog of committed contracts from clients.

Peregrine’s stock is currently trading at 57 cents per share, up from Wednesday’s close of 43 cents per share. Last year at this time the stock was trading at $1.49 per share, but the termination of the Sunrise trial caused shares to dramatically fall—a fall from which it has yet to recover. Analysts have predicted the stock could rise back to at least $1 per share in part due to the strength of its contract manufacturing subsidiary, Avid Bioservices.

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