Precision Biologics Selected to Present Encouraging Clinical Results
from Phase 1-2 Study of NPC-1C at the Annual Meeting of the American
Society of Clinical Oncology
Precision Biologics, in collaboration with investigators from Duke University, Johns Hopkins, and the University of Texas Southwestern, has been selected to present an abstract of findings from its Phase 1-2 clinical trial at the Annual Meeting of the American Society of Clinical Oncology. The meeting will be held May 30 – June 3, 2014 at the McCormick Place Convention Center in Chicago, Illinois.
This first in-man study tested NEO-102, the newly glycoengineered reformulation of NPC-1C, which is a novel monoclonal antibody derived from glycoproteins expressed on colorectal cancer and found to be a variant of MUC5ac. This target is expressed on approximately 65-70% of human colorectal and pancreatic cancers but is rarely found to be expressed in healthy tissue. NEO-102 has been administered to 17 patients evaluable for toxicity. Maximum Tolerated Dose (MTD) was established at 3.0 mg/kg IV every 2 weeks. Relative to NEO-101 (the original formulation of NPC-1C), patients receiving NEO-102 have tolerated a higher dose level (3.0 mg/kg vs. 1.5 mg/kg) as well as a higher number of doses (maximum of 11 vs. 4), indicative of an improved safety profile. In addition, despite the advanced disease in this patient population which progressed on standard chemotherapy, preliminary signs of activity were observed based on stabilization in 5/9 (55%) of patients evaluable for response on CT scans. The full detailed presentation will be available on Precision Biologics’ website following the poster session on Monday June 2, 2014.
Based on the encouraging results, there is an ongoing expansion cohort of 73 patients in the ongoing Phase 2 component of this study (pancreatic n=30, colorectal cancer n=43). In addition, there is an ongoing, open label, randomized phase IIb study utilizing gemcitabine and nab-paclitaxel with or without NEO-102 in patients with refractory advanced pancreatic cancer. Detailed descriptions of these studies can be found at the following link from Clinical Trials.gov. http://www.clinicaltrials.gov/ct2/results?term=NPC-1C&Search=Search 
Presentation information is as follows:
Abstract Title: A Phase I/II Study of NEO-102: A Therapeutic Antibody for the Treatment of Pancreatic and Colorectal Cancers
Permanent Abstract ID: 3072
Session Title: Developmental Therapeutics - Immunotherapy
Session Type: General Poster Session
Date: Sunday, June 01, 2014
Time: 8:00AM - 11:45AM
Location: S Hall A2
Poster Board #: 139
Founded in February 2012 and commencing business in late September 2012, Precision Biologics, Inc. is a clinical stage biotechnology corporation focused on developing therapeutic and diagnostic products for the early detection and treatment of cancer. Precision Biologics is uniquely positioned to create innovative therapeutics through the use of proprietary cancer vaccines, several of which have demonstrated success in human trials. For more information visit www.precision-biologics.com