Updated clinical data from phase I study of Ensituximab presented at AACR meeting

Precision Biologics announced today that in conjunction with researchers from Precsion Biologics , Johns Hopkins Medical Center and Duke University Medical Center presented updated clinical data from the phase I study of Ensituximab, a novel therapeutic antibody to treat pancreas and colorectal cancers. Ensituximab is the first development stage antibody therapeutic discovered by Precision Biologics and part of a pipeline of antibodies that target specific cancers. The NPC-1C epitope appears to be a variant of MUC5AC that is expressed specifically by human colon and pancreatic tumor tissues and cell lines with minimal cross reactivity to certain gastrointestinal tract tissues. The poster presentation was delivered at the American Association of Cancer Research (AACR) 2013 Annual Meeting on April 9th at the Washington DC Convention Center.

“This marks yet another important milestone in our efforts to discover and develop novel new antibodies for the diagnosis and treatment of a range of cancers.”

In this study, fifteen individuals with advanced pancreatic and colorectal cancer who progressed on standard therapy were enrolled on study. The drug was well tolerated with a favorable safety profile at the 1.5mg/kg dose given intravenously every 2 weeks. Despite the advanced disease of the patients enrolled on this study, results were encouraging in that disease stabilization was observed in some patients as defined by RECIST criteria during the 8 weeks of treatment with NPC-1C. In addition, extensive sampling was performed to allow for the terminal pharmacokinetics of NPC-1C. A greater than dose proportional increase in exposure was observed with increasing dose. However, with a 14 day dosing interval, no significant accumulation of NPC-1C was observed in trough samples collected prior to subsequent infusion. This data supports additional dose escalation of NPC-1C which is being performed in an ongoing Phase 2a study. In addition, laboratory studies evaluating the effects of the drug on patients' immune system are being performed at Duke University.

"It is exciting to work on the development of novel, well tolerated therapies such as NPC-1C for our pancreatic and colorectal cancer patients. Presentation of this promising therapy at AACR is a reminder of how far we have come in cancer research with hope of great successes for our patients in the future", said Dr. Sandip Patel of Duke University Cancer Center.

Dr. Philip Arlen, President and CEO of Precision Biologics said, "This marks yet another important milestone in our efforts to discover and develop novel new antibodies for the diagnosis and treatment of a range of cancers."