Pipeline

Utilizing a unique discovery platform of cancer vaccines, based on decades of basic research by a distinguished lead pioneer in immuno therapy, Precision Biologics has developed several monoclonal antibodies (“mAbs”). The company is conducting studies examining these antibodies as Therapeutics and as companion diagnostic biomarkers for our ongoing clinical programs. Preliminary results have been presented at key scientific conferences.

Our leading mAb candidate currently in product development, is a clinical stage compound known as NEO-201. We have completed a first in human study in patients with chemotherapy refractory tumors including colorectal, pancreatic, non small cell lung cancer (NSCLC), breast cancer, as well as mucinous ovarian cancer in a Phase 1 clinical trial at the National Cancer Institute (NCI). An ongoing Phase 2b study at the NCI in combination with Pembrolizumab is treating patients in the 2nd line metastatic setting with Head and Neck Squamous Cell Carcinoma (HNSCC), NSCLC, endometrial cancer, and cervical cancer. Additional preclinical studies are ongoing in the laboratory looking at combination therapies in other disease states.

Our second clinical stage monoclonal antibody is referred to as Ensituximab or NPC-1C (NEO-102). It 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 patient’s tumor tissue for immunohistochemistry (IHC) for the detection of NEO-102 target on colon and pancreatic cancers.

The company has completed and published a Phase 2 clinical trial with NEO-102 treating patients with advanced metastatic colorectal cancer. This multicenter trial enrolled patients at several highly prestigious academic medical centers in the US. Preclinical studies are ongoing to evaluate the combination of this antibody with the cytokine IL-15.

Additionally, NEO-102 is undergoing preclinical studies to create an antibody drug conjugate (ADC) for the use in pancreatic and colorectal cancer.

Precision Biologics has a 3rd preclinical candidate NEO-301 (31.1). It binds to tumor specific antigens found in pancreatic, colorectal and several other types of cancer

With its proprietary library of Hollinshead cancer vaccines, antigens and antibodies, Precision Biologics is expanding its collaborations to identify further preclinical candidates that are tumor and disease specific.