Cancer Breakthroughs 2020 Reaches First Clinical Trial Milestone: Immunotherapy Trial Demonstrates Encouraging Survival Rates in Patients w/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 and the Cancer Breakthroughs 2020 Program ‎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.

“These results underscore the promise of immunotherapy to improve the standard of care in cancer patients, which is the underlying mission of the Cancer Breakthroughs 2020 program. This is an exciting demonstration that neo-epitope immunotherapy holds tremendous promise. Even in the face of very late stage disease the trial demonstrated that patients could generate an immune response with very little toxicity. We now plan combinations of immunotherapy molecules with Ensituximab to activate both the natural killer and the dendritic cell” said Patrick Soon-Shiong, MD, Founder, Cancer Breakthroughs 2020.

“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. The Cancer MoonShoot 2020 marks the pivotal moment when the field of oncology emerges from the dark ages of the past into the Enlightenment of the future. The success of this is a key clinical milestone toward that future.”

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/.

About Cancer Breakthroughs 2020

The Cancer Breakthroughs 2020 Program is the nation’s most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the aspirational Breakthroughs to develop an effective vaccine-based immunotherapy to combat cancer by 2020. For more information, visit http://www.CancerBreakthroughs2020.org.

1 Neo-epitopes are a unique mutation found specifically in the patient’s tumor (not normal tissue) that can be targeted by the immune system to attack the tumor with minimal off target toxicity.

 

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