Due to its proprietary library of cancer vaccines, Precision Biologics has an unusual capacity for innovation. By marrying this platform with today’s breakthrough technologies, the company is now able to develop compounds that could change the way we detect and treat cancer.
The progress and promise of Precision Biologics is rooted in sound science:
- The company’s chimeric monoclonal antibody Ensituximab (NPC-1C) recognizes a Tumor-Specific Antigen that appears on cancer cells but not normal cells.
- The company also believes that Ensituximab has potential as both a therapeutic drug and a diagnostic reagent due to great specificity for cancer versus normal tissues.
- Product candidates are being developed from vaccines and tumor-associated antigens (TAAs) that were administered to cancer patients in Phase I, II and III clinical trials in the US in the late 1970s and early 1980s. Data from these trials suggested anti-tumor responses and prolonged survival for patients with cancer, with no significant adverse effects.
- Precision Biologics believes that Ensituximab can rapidly trigger cancer-cell death by ADCC (antibody dependent cellular cytoxicity), and has demonstrated efficacy in an animal model (a xenograft mouse model utilizing the AsPC1 Human Pancreatic Tumor Cell Line).
- U.S. patents have been issued for the novel molecular aspects of Ensituximab antibody and the genes encoding it. Other patents are in process or pending, including a filing on Ensituximab-binding epitope, and numerous filings in foreign jurisdictions.
- The company is conducting studies examining these antibodies as a diagnostic biomarker for pancreatic and colorectal cancers Preliminary results are encouraging and are available here.
- Cell lines for optimized GMP manufacturing are currently being prepared.
In addition, a randomized multi-centered Phase 2b study is accruing patients in with metastatic pancreatic cancer who have previously received frontline therapy with FOLFIRINOX. Patients are randomized to receive Gemcitabine/Abraxane+ NPC-1C.
A multi-center Phase 2a clinical trial of its lead therapeutic antibody candidate for advanced pancreatic and colorectal cancer is ongoing at well known Cancer Centers in the US.