Navidea forms Macrophage Therapeutics business unit to explore Therapeutic applications of Manocept

The Manocept platform serves as the molecular backbone of Navidea’s FDA-approved, activated macrophage-targeting agent, Lymphoseek (technetium Tc 99m tilmanocept) injection. Preclinical data being developed by the Company using tilmanocept linked to various therapeutic agents suggest that tilmanocept’s binding affinity to CD206 receptors demonstrates the potential for this technology to be useful in treating diseases linked to the over-activation of macrophages.

This includes various cancers as well as autoimmune, infectious, cardiovascular, and central nervous system diseases.

"Navidea’s primary focus remains the successful commercialization of Lymphoseek for use in sentinel lymph node detection and lymphatic mapping," said Rick Gonzalez, Chief Executive Officer of Navidea.

"However, given Manocept’s potential to be applied in the treatment of multiple diseases based on its unique targeting properties, we have formed this new business unit to pursue therapeutic development. The plan is to continue preclinical research, further assess therapeutic agents that may be paired with Manocept, and evaluate optimal indications and regulatory pathways to enable the most efficient path to market."

Navidea intends to structure Macrophage Therapeutics such that it will remain under Navidea’s control enabling existing shareholders to capture potential future value, but also allow funding of future development in a standalone, non-dilutive manner to Navidea’s existing shareholders. Current board members Michael M. Goldberg, M.D. and Eric K. Rowinsky, M.D. and Navidea’s Chief Scientific Officer, Frederick O. Cope, Ph.D. have been appointed to focus on the launch of the new unit.

"Manocept has a unique and powerful ability to seek out macrophages that are overactive in the body," said Michael Goldberg, M.D.

"Linking a radioisotope to illuminate the presence of disease, such as the case with the FDA-approved Lymphoseek, is just the beginning. Manocept may also be combined with well-characterized therapeutic agents designed to destroy unwanted macrophages. Based on preclinical data, we look forward to advancing Manocept-based therapeutics into clinical development."

Macrophage Therapeutics seeks to leverage Navidea’s FDA-approved diagnostic applications and patented Manocept™ platform as a delivery system to target activated macrophages and develop treatments for cancer, cardiovascular, autoimmune, inflammatory, infectious, and CNS diseases. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages.

Macrophages play important roles in many disease states and are an emerging target in many disorders where diagnostic uncertainty exists. This flexible and versatile platform acts as an engine for purpose-built molecules that may enhance diagnostic accuracy and delivery of therapeutic agents.

The Company’s FDA-approved precision diagnostic lymphatic mapping agent, Lymphoseek (technetium Tc-99m tilmanocept) injection, is representative of the ability to successfully exploit this mechanism to develop powerful, new diagnostic and therapeutic agents.