Navidea Biopharmaceuticals Announces Comparative Study to Evaluate the Potential Utility of Tilmanocept In Patients with Tuberculosis (“TB”)

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Professor Mike Sathekge, MBChB, M. Med (Nuclear Medicine), PhD Professor and Head of the Department of Nuclear Medicine in the Faculty of Health Sciences at the University of Pretoria/Steve Biko Academic Hospital, plans to initiate a comparative study evaluating the use of Tilmanocept in patients with TB.

Relevance of the Study

The purpose of the study is to explore using 68Ga-Tilmanocept as an aid in TB patient management while contributing to the better understanding of the biology of TB granulomas. The TB granuloma plays multiple roles in tuberculous infection, although much remains unknown about its biology. Macrophages constitute one of the most abundant cell types in the TB granuloma. A molecular probe such as 68Ga-labeled Tilmanocept targeting MR (CD206) expressed on macrophages, therefore, holds great promise not only in understanding the behavior of TB granulomas, but may serve as a vehicle for delivering therapeutic interventions in the future. Comparing findings on 68Ga Tilmanocept PET/CT and FDG PET/CT will contribute to the understanding of the biology of tuberculous granuloma. Navidea would provide tilmanocept for use in this study. Successful completion of this study could lead to an extended claim of 68Ga-Tilmanocept.

Principal Investigator

Professor Mike Sathekge, Principal Investigator of this study, said, “Our collaboration with Navidea promises to make pivotal contributions to the biology of the tuberculous granuloma and the development of novel targeted therapeutic interventions.”

Dr. Michael Rosol, Chief Medical Officer of Navidea, said, “We are excited to begin this comparative study in collaboration with the Department of Nuclear Medicine at the University of Pretoria. We look forward to providing updates on this study in the near future.”

“As the worldwide community further embraces TB treatments and screening to prevent the spread of the disease, we are very pleased to begin this comparative study,“ said Jed Latkin, Chief Executive Officer of Navidea. “This is an exciting milestone of innovation and continued progress for Navidea.”

Latest Statistics on the TB Epidemic

TB is the most infectious killer worldwide and is also the leading cause of death among people diagnosed with HIV. In terms of TB care and prevention, TB treatments saved fifty-four million lives worldwide from 2000-2017.¹