February 26, 2016
By Alex Keown, BioSpace.com Breaking News Staff
TUSTIN, Calif. – Peregrine Pharmaceuticals stock is down more than 60 percent following the company announcing it was discontinuing the company’s Phase III trial of bavituximab in patients previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
The company 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, the company said. Peregrine’s stock is currently trading at 40 cents per share, down from $1.06 per share.
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.
Not only is Peregrine ceasing its Phase III trial for bavituximab, Steven King, president and chief executive officer of Peregrine, said the company was also suspending 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. The planned trials included 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.
“While this is an unexpected and disappointing setback for the bavituximab chemotherapy combination clinical program, we have not seen anything in this trial result that diminishes our enthusiasm for advancing our immuno-oncology (I-O) combination trials,” King said in a statement. “The I-O combination studies are based on different mechanistic synergies that are clearly separate from the chemotherapy combination being evaluated in the SUNRISE study.”
Peregrine said it planned to hold a conference call with investors at 4:30 p.m. eastern time today to discuss the decision and how the company will move forward.
King said it was also important to note that although the company faced a setback due to terminating the Phase III trial, it did not have any negative impact on the company’s contract manufacturing business conducted by its subsidiary, Avid BioServices.
“This business has shown consistent revenue growth and has been instrumental in maintaining a strong cash position and our plan is to continue growing this business,” King said.
As of Feb. 1, Avid BioServices had a revenue backlog in excess of $58 million under committed contracts from existing clients. In addition, Peregrine had $67.5 million in cash and equivalents as of Jan. 31, King said.
