Navidea Biopharmaceuticals
Navidea Biopharmaceuticals, Inc. is a leader in precision medicine with immuno-targeted products designed to help identify the sites and pathways of undetected disease, enabling better diagnostic accuracy, clinical decision-making, targeted treatment, and patient care. The company focuses on developing innovative immunodiagnostic agents and therapeutics for conditions such as cancer, autoimmune, infectious, and inflammatory diseases, leveraging its Manocept™ platform and other diagnostic products. Navidea's first commercial product, Lymphoseek®, is FDA-approved and from the Manocept platform, used in lymphatic mapping and sentinel lymph node biopsy procedures. The company aims to expand its product pipeline through acquisitions, global partnerships, and commercialization efforts. Additionally, Navidea is developing therapeutic applications through its subsidiary Macrophage Therapeutics, which focuses on macrophage-targeted therapies for oncology, inflammatory, autoimmune, and cardiovascular diseases.
Industries
Nr. of Employees
small (1-50)
Navidea Biopharmaceuticals
4100 Horizons Drive, Suite 205, Columbus, OH 43220
Patents
CD206 targeted drug delivery vehicles carrying novel bisphosphonate drug payloads via a degradable linker
US-12297222-B2
View DetailsAltering net charge on mannosylated dextrans to maximize target tissue uptake and off target competitive blocking
US-12178829-B2
View DetailsCD206 targeted drug delivery vehicles carrying novel bisphosphonate drug payloads via a degradable linker
US-12006339-B2
View DetailsSynthesis of uniformly defined molecular weight mannosylated dextrans and derivatives thereof
US-11859023-B2
View DetailsAltering net charge on mannosylated dextrans to maximize target tissue uptake and off target competitive blocking
US-11833170-B2
View Details
CD206 targeted drug delivery vehicles carrying novel bisphosphonate drug payloads via a degradable linker
US-12297222-B2
View DetailsAltering net charge on mannosylated dextrans to maximize target tissue uptake and off target competitive blocking
US-12178829-B2
View DetailsCD206 targeted drug delivery vehicles carrying novel bisphosphonate drug payloads via a degradable linker
US-12006339-B2
View DetailsSynthesis of uniformly defined molecular weight mannosylated dextrans and derivatives thereof
US-11859023-B2
View DetailsAltering net charge on mannosylated dextrans to maximize target tissue uptake and off target competitive blocking
US-11833170-B2
View DetailsProducts
Receptor-targeted technetium-99m lymphatic mapping kit
A small-molecule receptor-targeted diagnostic kit intended for preparation of a technetium-99m labeled product for lymphatic mapping and intraoperative sentinel lymph node detection using handheld gamma detection.
18F-labeled beta-amyloid PET radiotracer
Fluorine-18 labeled PET tracer developed to bind beta-amyloid deposits in the brain for detection of amyloid pathology and differentiation of Alzheimer's disease and related dementias; evaluated in late-stage clinical programs including postmortem histopathology correlation.
Iodine-123 DAT-targeted SPECT radiotracer (clinical candidate)
An investigational iodine-123 labeled small-molecule SPECT tracer developed to bind the dopamine transporter (DAT) for assessment of nigrostriatal neuron integrity to aid differential diagnosis of Parkinsonian syndromes and related movement disorders; evaluated in multi-phase clinical trials and advanced into pivotal Phase 3 development.
Receptor-targeted technetium-99m lymphatic mapping kit
A small-molecule receptor-targeted diagnostic kit intended for preparation of a technetium-99m labeled product for lymphatic mapping and intraoperative sentinel lymph node detection using handheld gamma detection.
18F-labeled beta-amyloid PET radiotracer
Fluorine-18 labeled PET tracer developed to bind beta-amyloid deposits in the brain for detection of amyloid pathology and differentiation of Alzheimer's disease and related dementias; evaluated in late-stage clinical programs including postmortem histopathology correlation.
Iodine-123 DAT-targeted SPECT radiotracer (clinical candidate)
An investigational iodine-123 labeled small-molecule SPECT tracer developed to bind the dopamine transporter (DAT) for assessment of nigrostriatal neuron integrity to aid differential diagnosis of Parkinsonian syndromes and related movement disorders; evaluated in multi-phase clinical trials and advanced into pivotal Phase 3 development.
Services
Negotiation and execution of region-specific development and commercialization agreements including milestone and royalty structures; joint pre-market planning and support for local regulatory filings.
Design and management of multicenter Phase 2/3 clinical trials for imaging agents, including statistical endpoint planning, crossover and within-patient comparison designs, site coordination, and data presentation to regulators and scientific audiences.
Preparation and submission of regulatory filings and management of interactions with health authorities, including pursuit of expedited pathways and use of formal protocol agreements for pivotal study designs.
Provision of adverse event reporting channels, call-center support, and safety contact points for marketed and clinical products.
Negotiation and execution of region-specific development and commercialization agreements including milestone and royalty structures; joint pre-market planning and support for local regulatory filings.
Design and management of multicenter Phase 2/3 clinical trials for imaging agents, including statistical endpoint planning, crossover and within-patient comparison designs, site coordination, and data presentation to regulators and scientific audiences.
Preparation and submission of regulatory filings and management of interactions with health authorities, including pursuit of expedited pathways and use of formal protocol agreements for pivotal study designs.
Provision of adverse event reporting channels, call-center support, and safety contact points for marketed and clinical products.
Expertise Areas
- Radiopharmaceutical development
- Macrophage-targeted diagnostics and therapeutics
- Dopamine-transporter (DAT) SPECT imaging
- Imaging biomarker validation with histopathological correlation
Key Technologies
- Receptor-targeted molecular ligands for CD206 (mannose receptor)
- Technetium-99m radiolabeling (SPECT)
- Fluorine-18 radiotracers (PET)
- Iodine-123 radiolabeling for DAT-targeted SPECT
News & Updates
Navidea announced a joint enterprise with Rheumco to develop radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases, combining Manocept™ with Tin-117m radioisotope technology.
Navidea entered an exclusive agreement with Sinotau to develop and commercialize Lymphoseek® in China, with Sinotau responsible for clinical studies, regulatory approval, and sales.
Navidea announced a positive opinion from the European Medicines Agency recommending marketing authorization for Lymphoseek in the EU for sentinel lymph node detection in melanoma, breast, and head and neck cancers.
Navidea formed a joint enterprise with Rheumco to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases, leveraging Tin-117m and Manocept™ platforms.
Navidea announced a joint enterprise with Rheumco to develop radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases, combining Manocept™ with Tin-117m radioisotope technology.
Navidea entered an exclusive agreement with Sinotau to develop and commercialize Lymphoseek® in China, with Sinotau responsible for clinical studies, regulatory approval, and sales.
Navidea announced a positive opinion from the European Medicines Agency recommending marketing authorization for Lymphoseek in the EU for sentinel lymph node detection in melanoma, breast, and head and neck cancers.
Navidea formed a joint enterprise with Rheumco to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases, leveraging Tin-117m and Manocept™ platforms.