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.

Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). Millions of people continue to fall sick with TB each year. In 2017, TB caused an estimated 1.3 million deaths (range, 1.2–1.4 million) among HIV-negative people and there were an additional 300 000 deaths from TB (range, 266 000–335 000) among HIV-positive people. Globally, the best estimate is that 10.0 million people (range, 9.0–11.1 million) developed TB disease in 2017: 5.8 million men, 3.2 million women and 1.0 million children. There were cases in all countries and age groups, but overall 90% were adults (aged ≥15 years), 9% were people living with HIV (72% in Africa) and two thirds were in eight countries: India (27%), China (9%), Indonesia (8%), the Philippines (6%), Pakistan (5%), Nigeria (4%), Bangladesh (4%) and South Africa (3%). These and 22 other countries in WHO's list of 30 high TB burden countries accounted for 87% of the world's cases. Only 6% of global cases were in the WHO European Region (3%) and WHO Region of the Americas (3%). The severity of national epidemics varies widely among countries. In 2017, there were fewer than 10 new cases per 100 000 population in most high-income countries, 150–400 in most of the 30 high TB burden countries, and above 500 in a few countries including Mozambique, the Philippines and South Africa. Drug-resistant TB continues to be a public health crisis. The best estimate is that, worldwide in 2017, 558 000 people (range, 483 000–639 000) developed TB that was resistant to rifampicin (RR-TB), the most effective firstline drug, and of these, 82% had multidrug-resistant TB (MDR-TB). Three countries accounted for almost half of the world's cases of MDR/RR-TB: India (24%), China (13%) and the Russian Federation (10%).²

1). https://www.who.int/tb/publications/factsheet_global.pdf?ua=

2). https://www.who.int/tb/publications/global_report/tb18_ExecSum_web_4Oct18.pdf?ua=1

Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. Navidea's strategy is to deliver superior growth and stockholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts.

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