Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, to collaborate with investigators at the University of Alabama at Birmingham (UAB) on a clinical study to evaluate the safety and activity of a radiolabeled, humanized monoclonal antibody (Mab) from its RIGS Monoclonal Antibody Targeting technology.

The study will evaluate up to 20 patients with colorectal cancer (CRC) by administering the RIGS tumor-specific radiolabeled, CH2 domain-deleted, anti-TAG-72 Mab-targeting agent and assessing by SPECT/CT imaging for the presence of liver metastasis.

The co-principle investigators for the study are Andres Forero, MD, the O'Neal-Sokol Breast Cancer Research Foundation of Alabama Endowed Professorship, Director, Protocol/Data Management Shared Facility, and Co-Leader, Experimental Therapeutics, UAB Comprehensive Cancer Center; Kurt Zinn, DVM, MS, PhD, Director, Advanced Medical Imaging Research, UAB; and Janis P. O’Malley, MD, Director, Division of Molecular Imaging and Therapeutics, and Professor of Radiology, UAB School of Medicine. Investigators at UAB have published extensively on the use of TAG-72 targeted monoclonal antibodies in the cancer setting.

“The detection of metastasis of colorectal cancer to the liver has had less than acceptable sensitivity and low specificity using traditional CT. There is the need to find better modalities to evaluate the liver at the time of the initial diagnosis of CRC,” commented Dr. Forero. “We are looking forward to working with Navidea to evaluate this tumor-specific imaging agent that may benefit surgeons in effectively locating cancerous tissues leading to better patient outcomes.”

The study is to be funded in part through the Company’s Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), National Institutes of Health (NIH) announced in 2012. The SBIR grant has the potential for grant money up to a total of $1.5 million over three years if fully funded. The first-year Phase I funding of $315,000, which has already been approved, focused on completing preclinical bridging activities using the CH2 domain-deleted, anti-TAG-72 Mab and preparing a standardized clinical trial protocol. Phase II funding of up to $1.2 million will be used in support the clinical study and is contingent upon meeting certain Phase I success criteria, including Institutional Review Board (IRB) approval of the clinical trial protocol. Commencement of the clinical study is also contingent upon completing certain antibody stability and quality tests currently in process.

“We are excited to work with UAB as we re-initiate human clinical trials with our RIGS agent,” said Frederick Cope, PhD, FACN, Senior Vice President and Chief Scientific Officer at Navidea. “We are also pleased with the current and potential future support of the NCI/NIH grant funding as we advance development efforts in this important technology.”

RIGS (radio-immuno-guided surgery) monoclonal antibody targeting technology includes an investigational, tumor-specific, radiolabeled humanized monoclonal antibody (CH2 Domain-Deleted, Anti-TAG-72). It may be useful prior to, during, or after surgery to identify cancerous tissue undetectable by traditional diagnostic and intraoperative techniques. The RIGS agent may enable more effective detection and surgical intervention of colorectal cancers, and potentially other cancers, leading to improved patient management and survival. By binding specifically to the target TAG-72 cancer antigen, the RIGS agent accumulates within affected tissue and is then detected by imaging or a gamma probe.

The tumor-associated glycoprotein (TAG-72) is a target for detection of the spread of CRC to the liver. TAG-72 is expressed on the surface of a wide range of carcinomas and prompted the development of antibodies to TAG-72 for investigation in the diagnosis and treatment of carcinomas.