Grants Awarded to Navidea Biopharmaceuticals, Inc.

Rheumatoid Arthritis (RA)

  1. Title: 99mTc-Tilmanocept for Targeting Rheumatoid Arthritis (RA)-Driving Macrophages
    1. Awarding Entity: National Institute for Arthritis & Musculoskeletal & Skin Diseases (NIH)
    2. Grant Number: R44AR067583
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Currently Active
      1. Budget Part 1: $224,993
      2. Budget Part 2: $1,500,000
    5. Published Project Narrative: This project seeks to significantly improve patient outcomes and quality of care for patients with rheumatoid arthritis by providing these patients with an innovative targeted agent (tilmanocept) that provides more accurate and more timely (earlier) diagnosis of their illnesses. This will enable currently available therapeutics to be more effective and may make possible the development of new and even more effective therapies based on the targeted diagnostic.

Kaposi Sarcoma (KS)

  1. Title: Receptor Mediated SPECT Imaging of Kaposi Sarcoma (KS) with 99mTc-tilmanocept
    1. Awarding Entity: National Cancer Institute (NIH)
    2. Grant Number: R44CA192859
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Currently Active
      1. Budget Part 1: $300,000
      2. Budget Part 2: $1,500,000
    5. Published Project Narrative: This project, if successful, has the potential to dramatically improve life expectancies, quality of care and quality of life for patients suffering from Kaposi's sarcoma (KS). Due to the unexpected observation that KS tumor cells abundantly express the macrophage mannose receptor (CD206), we propose to test the feasibility that Navidea Biopharmaceutical's FDA approved CD206 binding diagnostic radiopharmaceutical, 99mTC-tilmanocept, can be used to identify internal and difficult to find KS lesions. If successful, follow on studies will determine if tilmanocept can be used to target delivery of therapeutics directly to KS tumor cells.
  1. Title: CD206 Targeted Therapy for Kaposi Sarcoma and Tumor Associated Macrophages
    1. Awarding Entity: National Cancer Institute (NIH)
    2. Grant Number: R44CA206788
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Currently Active
      1. Budget Part 1: $ 232,464
      2. Budget Part 2: $1,541,515
    5. Published Narrative: Kaposi sarcoma (KS) is a serious and potentially life threatening illness in persons infected with the human immunodeficiency virus (HIV), the causative agent of acquired immunodeficiency syndrome (AIDS). Tumor associated macrophages (TAMs) constitute an important tumor component for most types of cancer (including KS) that contributes to tumor growth and protection from immune responses. Navidea is developing a receptor targeted drug construct that may be able to effectively treat KS and could contribute to effective immunotherapy for a wide variety of cancers generally.

Cardiovascular (CV)

  1. Title: 99mTc-Tilmanocept Targeting of Cardiovascular (CV) Plaque in HIV Subjects
    1. Awarding Entity: Heart Lung and Blood Institute (NIH)
    2. Grant Number: R43HL127846
    3. Grant Type: Phase 1 SBIR
    4. Completed
      1. $321,838
    5. Published Narrative: The proposed efforts seek to determine the feasibility of using Navidea Biopharmaceutical's diagnostic imaging agent, 99mTc-tilmanocept, to better identify asymptomatic patients with vulnerable atherosclerotic plaques that are at high risk of near term rupture and resulting precipitation of myocardial infarctions, sudden cardiac death and strokes, accumulatively the leading cause of death in the US. If successful, this project could facilitate the delivery of life-sparing treatments to individuals at risk for major cardiovascular disease events before these events have inflicted their catastrophic tolls.

Colorectal Metastases

  1. Title: CC49/RIGS, A diagnostic radiopharmaceutical monoclonal antibody, for enhanced liver resection in colorectal metastases (NAV3000): Transitioned to Tilmanocept Tumor Localization and Imaging
    1. Awarding Entity: National Cancer Institute (NIH)
    2. Grant Number: R44CA162783
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Currently Active,
      1. Budget Part 1: $315,217
      2. Budget Part 2: $1,242,806
    5. This grant was repurposed after the award from the originally stated evaluation of a diagnostic radiopharmaceutical monoclonal antibody to evaluation of 99mTc-tilmanocept for the identification of liver metastases of colorectal primary tumors.

Cervical Cancer (Cerv.)

  1. Title: 99mTc-tilmanocept for Sentinel Lymph Node Biopsy in Cervical Cancer (Cerv) Surgeries
    1. Awarding Entity: National Cancer Institute (NCI)
    2. Grant Number: R44CA180390
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Completed
      1. Budget Part 1: $165,917
      2. Budget Part 2: $1,297,329
    5. Published Narrative: Lymphatic mapping and the sentinel lymph node theory have very significantly improved quality of care and patient outcomes in patients being surgically treated for early stage breast cancers, melanoma, and head & neck squamous cell carcinoma, with virtually no increase in recurrent disease risk as this risk relates to regional metastasis. 99mTc-tilmanocept (Lymphoseek®) is a proven superior lymphatic mapping agent in these cancer types. Navidea Biopharmaceuticals is initiating efforts to investigate the performance of 99mTc-tilmanocept in cervical cancer with the intent of extending the benefits of lymphatic mapping with 99mTc-tilmanocept to patients undergoing surgeries to remove early stage cervical cancers.

Alzheimer's Dementia

  1. Title: [18F]NAV4694 Imaging to Identify MCI Patients at Risk for Alzheimer's Dementia
    1. Awarding Entity: National Institute on Aging (NIH)
    2. Grant Number: R44AG045990
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Completed
      1. Budget Part 1: $151,824
      2. Budget Part 2: $2,032,234
    5. Published Narrative: Alzheimer's disease is an emerging epidemic in the US on a trajectory that if not curtailed will result in catastrophic increases in the number of people afflicted by dementia caused by this disease with an associated enormous increase in healthcare costs. To avert this catastrophe, new medications are already in development that, if delivered to individuals at high risk for developing Alzheimer's dementia, can potentially prevent or delay the onset of Alzheimer's dementia. Navidea Biopharmaceuticals is requesting an SBIR grant to support efforts needed to commercialize [18F]NAV4694 as a diagnostic imaging agent that can assist physicians in identifying those individuals with mild cognitive impairment who are at greatest risk of progressing to Alzheimer's dementia.

Beta Amyloid Deposits

  1. Title: Comparison of Beta Amyloid Deposits Imaged with 18F-AZD4694 and Postmortem Histology
    1. Awarding Entity: National Institute on Aging (NIH)
    2. Grant Number: R44AG044130
    3. Grant Type: Fast Track SBIR (Part 1 and Part 2 combined)
    4. Completed
      1. Budget Part 1: $258,824
      2. Budget Part 2: $1,572,800
    5. Published Narrative: Navidea Biopharmaceuticals is developing 18F-AZD4694 as an imaging agent for the detection of beta amyloid deposits in the brains of living patients. Detection of beta amyloid deposits, which are diagnostic of Alzheimer's Disease, will have the immediate utility of improving the accuracy of diagnoses for patients with dementia. In the long term, 18F-AZD4694 may have the ability to identify patients that will benefit from new therapies that are currently in clinical trials that are intended to prevent or slow the progression of Alzheimer's Disease.

Lymphoseek®

  1. Title: Phase III Clinical Study Supporting Expanded FDA Claims for Lymphoseek®, a Medical Imaging Agent for Sentinel Lymph Node Mapping in Breast Cancer, Melanoma, and Head and Neck Cancer
    1. Awarding Entity: The Ohio Third Frontier
    2. Application LOI: OTFMIP 10-904
    3. Grant Type: Third Frontier Grant Supporting Lymphoseek NDA & Commercialization - NEO3-06
    4. Completed
      1. $1,000,000 matching funds
    5. Published Narrative: Lymphoseek® is a proprietary radiopharmaceutical enabling significant clinically improved medical imaging of the lymphatic system for cancer surgeries of the breast, head and neck, and melanoma in adult and pediatric patients. As the medical imaging agent with the highest lymphatic specificity ever utilized for lymphatic mapping, Lymphoseek assists surgeons to identify the lymph nodes to which a tumor may have spread or metastasized. Lymphoseek satisfies a critical and well recognized unmet need for improved means to map and identify sentinel lymph nodes (SLNs) during preoperative lymphoscintigraphy or intraoperative lymphatic mapping (ILM) procedures. As lymph node tumor status is a strong predictor of disease outcome, nodal status influences a multitude of treatment decisions for cancer patients. Accurate determination of nodal status is essential for directing cancer patients to their best therapeutic options. Use of Lymphoseek will improve patient quality of care, better direct post-surgical treatment options, and positively affect cancer patients' outcomes. These grant funds off-set a portion of expenses for Neoprobe's (now Navidea) Phase 3 clinical study of lymphatic mapping and sentinel lymph node identification in head and neck cancer patients. The results of this study were presented to the FDA and supported Neoprobe's successful request to expand the approved efficacy indications for Lymphoseek.
  1. Title: Re-Compensation Supporting Lymphoseek Development
    1. Awarding Entity: IRS
    2. Grant Type: Reimbursement for Research Development
    3. Completed:
      1. $244,479
    4. Budget Narrative: This was a one-time opportunity tied to the Federal Government stimulus funding following the recession of 2009. The award was in the form of a cash reimbursement for R&D expenses spent to support the clinical study of Lymphoseek in head and neck cancer patients. The results of this study were presented to the FDA and supported Neoprobe's (now Navidea) successful request to expand the FDA-approved indications for Lymphoseek.

Operational

  1. Title: Grants Supporting the Development of Medical Professional Students Intern Program
    1. Awarding Entity: The Ohio Third Frontier Grants Interns (42 awards)
    2. Grant Type: Matching Funds Intern Professional Development Program
    3. Completed
      1. $126,000
    4. Narrative: Navidea provides opportunity for Ohio college/university students who are majoring in medicine, pharmacy, or other areas relevant to Navidea's operations of drug and clinical development. Compensation for interns is supported by Navidea and the Ohio Third Frontier development program.