Navidea Biopharmaceuticals (NYSE: NAVB) Precision Immunodiagnostics, a Game Changer for Patients and Physicians

Precision medicine and precision diagnostics in particular play a major role in today’s medical world, by helping patients and physicians detect various diseases in time, which in turn allows for the proper treatments and care to be prescribed. Companies such as Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) are at the forefront of precision medicine, developing innovative immunodiagnostics and immunotherapeutic platforms that can make a real difference for patients suffering from serious ailments such as cancer or infectious, autoimmune or inflammatory diseases.

A leader in precision medicine via the development and commercialization of precision diagnostics and therapeutics based on immune system functions, Ohio-based biopharma company Navidea is working on multiple products built around its proprietary Manocept™ platform. The platform is based on the ability to target macrophages – a type of white cells essential to immune systems, whose main role is to detect microscopic foreign bodies or substances and eat them, for the detection, monitoring and treatment of specific diseases. Manocept™ is able to specifically target the CD206 mannose receptor present in targeted macrophages, allowing for enhanced flexibility and versatility and, ultimately, leading to increased diagnostic accuracy and improved targeted treatment and patient care.

The platform is at the core of Navidea’s flagship product, Lymphoseek®, a state-of-the-art, receptor-targeted radiopharmaceutical agent used for the mapping of lymphatic basis or the biopsy of sentinel lymph nodes in patients with different types of cancers. Administered as an injection of technetium Tc 99m tilmanocept, Lymphoseek® has been successfully used for diagnostics in patients with clinically node negative breast cancer, squamous cell carcinoma of the oral cavity or melanoma.

Lymphoseek® has been approved by the U.S. Food and Drug Administration and has been in use nationwide since its launch in 2013. Recently, Navidea sold American rights to the diagnostic tool to Cardinal Health Inc. (NYSE: CAH) for a guaranteed $100 million in payments over the next three years (http://nnw.fm/X05d9). The sale’s value could rise to $310 million throughout the life of the agreement. In addition, Navidea already has European distribution in place for the cancer diagnostic aid and is seeking further commercialization opportunities in the rest of the world.

Aside from Lymphoseek®, the company is looking for other ways to expand the use of its Manocept™ platform, for diagnostics across a wide range of disorders such as rheumatoid arthritis, Crohn’s disease, tuberculosis, Kaposi’s sarcoma and others. Navidea is already looking into expanding the targeted macrophages-based platform diagnostic for many of these disorders, with clinical studies underway for rheumatoid arthritis, cardiovascular disease and more.

Another potential use for the Manocept™ platform is the development of macrophage therapeutics using the Lymphoseek® delivery system. The company is currently working on the development of immunotherapeutics for cancer, inflammatory, autoimmune and infectious diseases and has so far reported encouraging results in preclinical trials, data suggesting several positive drug properties in terms of safety, duration of action, deliverability and costs. Results of animal testing have also indicated clear progress of macrophage therapeutics for various disorders including arthritis, asthma, Nonalcoholic Steatohepatitis-related inflammation, neuro-inflammation and multiple cancers.

For more information about Navidea Biopharmaceuticals and its innovative precision immunodiagnostic tools, visit the company’s website at www.Navidea.com

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