Navidea Biopharmaceuticals, Inc. (NAVB)

Overview

Navidea Biopharmaceuticals, Inc. is a specialized biopharmaceutical entity committed to the innovation and commercialization of precise immunodiagnostic agents and immunotherapeutics. Established initially as Neoprobe Corporation before rebranding in January 2012, Navidea has its roots dating back to 1983, locating its headquarters in Dublin, Ohio. The company's endeavours are split into two distinct operational segments: Diagnostic Substances and Therapeutic Development Programs. The driving force behind Navidea's scientific efforts is its proprietary Manocept platform which is designed to specifically target the CD206 mannose receptor found on activated macrophages, a significant type of immune cell involved in various diseases. This platform is instrumental in developing diagnostic tools across various modalities, including single photon emission computed tomography (PET), gamma-scanning, and more, as well as therapeutics aimed at diseases where macrophages play a crucial role.

Products and Services

• Manocept Platform:

The cornerstone of Navidea’s product pipeline, the Manocept platform, exploits the CD206 mannose receptor on activated macrophages. This innovation paves the way for various applications, from diagnosing conditions through imaging techniques like PET and single photon emission computed tomography to the targeted delivery of therapeutic agents for diseases involving macrophages and immune or inflammatory processes.

• NAV3-31:

A key product in development, NAV3-31, has successfully navigated through Phase IIb clinical trials. This product showcases the application of Tc99m tilmanocept imaging technology, aiming to enhance the management of treatments for patients with moderate to severe rheumatoid arthritis (RA) by evaluating the imaging's repeatability, reproducibility, and stability alongside the effectiveness of anti-tumor necrosis factor alpha therapy.

• NAV3-35:

Currently in a Phase IIb clinical trial, NAV3-35 signifies Navidea's ongoing efforts to refine RA imaging techniques. This product embodies the company's commitment to improving diagnostic accuracy and treatment efficacy for RA, a chronic inflammatory disorder affecting millions globally.

• NAV3-33 and NAV3-32:

Complementing the RA-focused pipeline, NAV3-33 is in a Phase III clinical trial, setting a pivotal stage for its development, while NAV3-32 is undergoing a Phase 2b trial targeted at RA-involved joints. Both products further demonstrate Navidea’s dedication to advancing RA diagnosis and treatment options through innovative imaging technologies.

• Tc99m Tilmanocept for Other Applications:

Beyond RA, Tc99m tilmanocept showcases versatility with its development for potential use in cardiovascular diseases, Kaposi's sarcoma, tuberculosis, and other immunotherapeutic applications. This extension into various therapeutics signifies the broad potential of Navidea's technology in addressing complex immunological and inflammatory diseases.