Peregrine Reports Bavituximab Preclinical Results, Manufacturing In-House
By Cyndi Root
Peregrine Pharmaceuticals announced in a press release that its bavituximab antibody treatment met with success in preclinical trials. The company also announced in a conference call that it seeks to expand in-house manufacturing of the agent, rather than outsource it to a contract and development manufacturing organization (CDMO). Bavituximab is already in Phase 3 development for non-small lung cancer (NSCLC) and is being investigated in other oncology indications. Bruce Freimark, Ph.D., director of preclinical research at Peregrine commented on the new findings, "These data supplement previous findings, that the combination of a PS-targeting antibody and an anti-PD-1 antibody demonstrated statistically significant tumor growth inhibition in preclinical breast tumor models compared to anti-PD-1 alone.”
Bavituximab
Bavituximab is an antibody that targets the phosphatidylserine (PS) signaling pathway. The agent suppresses tumor growth and supports the immune system. In the new findings from the preclinical study, Peregrine found that the preclinical equivalent to bavituximab, ch1N11, showed statistically significant tumor growth inhibition in EMT-6 breast tumor mice compared to a control antibody. Additionally, ch1N11 increased CD4 and CD8 tumor infiltrating lymphocytes.
In November 2014, Peregrine announced progress for bavituximab in patients with advanced hepatocellular carcinoma (HCC). The trial of the agent administered with Sorafenib showed that bavituximab regulates immune cells in tumors and may have a positive effect on the tumor microenvironment. In April 2014, the company reported that it was conducting a trial of bavituximab in combination with Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of advanced melanoma.
Peregrine Manufacturing
Peregrine has cGMP manufacturing capabilities through its subsidiary Avid Bioservices, which also provides manufacturing services for other companies. Peregrine announced a facility expansion in a conference call, and Avid reported its upcoming activities in a press release. Peregrine and Avid intend to double manufacturing capacity at the Tustin, CA site due to increased demand for mammalian cell culture services and due to the anticipated demand for bavituximab upon regulatory approval.
The companies join other biotech companies who are ramping up biologics manufacturing. Steven King, president at Avid, said that his company was an early adopter of single-use technology, which is now a mainstream practice for biologics production. The facility expansion is a repurposing of the 40,000 sq. ft. facility to accommodate single-use bioreactors.