Utilizing its unique platform of cancer vaccines, Precision Biologics has developed several monoclonal antibodies (“mAbs”). The company is conducting studies examining these antibodies as a diagnostic biomarker for pancreatic and colorectal cancers. Preliminary results have been presented at key scientific conferences.
Recently the company completed a Phase 2a clinical trial of its lead therapeutic antibody candidate for advanced pancreatic and colorectal cancer. This multicenter trial is currently enrolling patients at several well known academic medical centers in the US.
We are also sponsoring a multi-center randomized study with our lead antibody in combination with 2nd line chemotherapy, actively enrolling patients with metastatic pancreatic cancer.
The leading mAb candidate currently in product development-referred to as Ensituximab (or NPC-1C (NEO-102)-is one that recognizes a particular epitope of tumor specific antigens (“TSAs”) from pancreatic/colorectal adenocarcinoma. The Precision Biologics antibody is being developed as a therapeutic drug candidate for pancreatic and colorectal cancers and as companion diagnostic using patients tumor tissue for immunohistochemistry (IHC) for the detection of NEO-102 target on colon and pancreatic cancers. NEO-201 is currently undergoing GMP manufacturing at Catalent, Inc. We have signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to conduct a first in man clinical trial which we anticipate enrolling patients with refractory solid tumors in the 2nd half of 2017.
Precision Biologics has two additional preclinical candidates, NEO-201 (h16C3) and NEO-301 (31.1C). Both bind to tumor specific antigens found in pancreatic, colorectal and several other types of cancer.
With its proprietary library of cancer vaccines, antigens and antibodies, Precision Biologics is expanding its collaborations to identify further preclinical candidates that are tumor and disease specific.