Precision Biologics Reaches First Clinical Trial Milestone: Immunotherapy Trial Demonstrates Encouraging Survival Rates in Patients with Metastatic Colorectal Cancer Who Failed all Standard Therapy
Over 30% of patients who failed all standard chemo and antibody therapy remain alive after neo-epitope immunotherapy Ensituximab, with the longest current survivor more than two years after treatment
Results of this promising clinical trial to be presented at the ASCO 2016 Gastrointestinal Cancers Symposium on Saturday, January 23rd by lead author, Richard D. Kim, MD, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL
Rockville, MD – January 20, 2016 — Precision Biologics today announced promising data from its Phase 2 clinical trial of the first neo-epitope1 targeting antibody, Ensituximab, studied in patients with refractory metastatic colorectal cancer who failed all standards of care. Preliminary results demonstrate a 35% improvement of overall survival compared to historical controls in a similar population, and that the primary end-point of the phase 2 study was successfully achieved. Over 30% of the patients remain alive, with the longest current survivor more than two years from start of treatment. Up to 60 percent of all colorectal cancer patients screened for the study had tumor containing the neo-epitope target for Ensituximab. Forty-eight percent of patients in the trial showed stabilization of target lesions after two months of therapy.
“Ensituximab shows promise in a heavily pretreated population,” said Philip M. Arlen, M.D., President and Chief Executive Officer, Precision Biologics. “This new agent has an extremely favorable safety record compared to other drugs used for this indication. The data is very encouraging, particularly given that the patients in this study received an average of five prior therapies.
Presentation Information: A Phase 2 Therapeutic, Open Label, Multi-Center Clinical Trial of NPC-1C, a Chimeric Monoclonal Antibody (mAb), in Adults with Chemotherapy Refractory Metastatic Colorectal Cancer (mCRC): Initial results
Saturday, January 23, 2016 at 7:00am-9:00am and 12:30pm-2:00pm Pacific Time at the ASCO 2016 Gastrointestinal Cancers Symposium, Moscone West Building, San Francisco, CA.
Abstract Title: # 160196
About Precision Biologics
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. The company’s antibody drug candidates and diagnostics are designed to detect and target the tumor without destroying healthy cells. 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. By marrying this platform with today’s breakthrough technologies, the company is developing antibody therapeutics that could change the way we detect and treat cancer. For more information on Precision Biologics, please visit http://www.precision-biologics.com/.