Navidea Biopharmaceuticals Announces Publication of Study Investigating Tc99m Tilmanocept Imaging of Arterial Inflammation in People Living with HIV
DUBLIN, Ohio–(BUSINESS WIRE)–Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company specializing in the development of precision immunodiagnostic agents and immunotherapies, today announced the publication of a manuscript titled “Increased Macrophage Specific Arterial Inflammation Uniquely Relates to Noncalcified Plaque and Specific Immune Activation Pathways in People Living with HIV: A Targeted Molecular Imaging Approach,” based on work performed at Massachusetts General Hospital (“MGH”) and Harvard Medical School, Boston MA, and sponsored by the company. The Journal of Infectious Diseases (PMID: 35856671), was led by lead researcher Steven Grinspoon, MD, head of the Metabolism Unit at Mass General Hospital and professor of medicine at Harvard Medical School.
Persistent immune activation and specific arterial downstream macrophage infiltration are thought to contribute to the increased risk of atherosclerotic cardiovascular disease (plaque) in people living with HIV on antiretroviral therapy (“ART”). In this study, tilmanocept Tc99m imaging was applied to study macrophage-specific arterial inflammation in participants with versus matched participants without HIV. The hypothesis was that people living with HIV would show higher levels of aortic arterial inflammation in relation to atherosclerotic plaque and immune activation.
Results showed that HIV-positive patients on antiretroviral therapy (N=20) had significantly higher macrophage-specific arterial inflammation demonstrated by tilmanocept Tc99m than risk-matched non-HIV-positive people (N=10). Total, non-calcified, and calcified aortic plaque volume calculated from CT scans did not differ significantly between groups. Macrophage-specific arterial inflammation linked to non-calcified plaque in HIV patients (not HIV-free participants) and further linked to levels of specific inflammatory markers. Aortic uptake of Tc99m-tilmanocept was significantly higher for different uptake thresholds in seropositive participants (P = 0.03) and demonstrated a stronger relationship between arterial inflammation and volume of non-calcified plaque (P = 0.0001 for the interaction between HIV status and plaque volume) but non-calcified plaque volume (P = 0.83 for the interaction). Among people living with HIV (not among participants without HIV), the volume of non-calcified aortic plaque was directly related to aortic uptake of Tc99m-tilmanocept at different uptake thresholds.
Macrophage-specific arterial inflammation, quantified using a new molecular imaging approach, was higher in HIV-positive patients on ART than in matched participants with similar atherosclerotic cardiovascular risk without HIV. Arterial inflammation related to non-calcified plaque volume only in HIV-infected patients. Cellular biomarkers of inflammation are also linked to macrophage-specific arterial inflammation. These key immune pathways may contribute to an increased risk of cardiovascular disease in people living with HIV and are therefore relevant for identifying new therapies.
These data suggest that increased arterial inflammation specific to non-calcified plaque macrophages may be a mechanism for increased cardiovascular risk in people living with HIV. The use of Tc99m tilmanocept imaging may help identify future targets for new immunomodulatory therapies to reduce the risk of atherosclerotic cardiovascular disease in people living with HIV on ART.
Dr. Michael Rosol, Navidea’s Chief Medical Officer, said: “We are delighted to have helped sponsor this important work with Dr. Grinspoon at MGH. This is another research collaboration we have had with top researchers at leading institutions. Dr. Rosol continued, “Today’s announcement illustrates the broad reach of our tilmanocept platform. Developing applications of tilmanocept Tc99m as a biomarker in people living with HIV could have far-reaching implications for monitoring patient treatment and making decisions about therapeutic benefit.
Dr Grinspoon said: “This study provides another key piece of evidence for increased arterial inflammation in relation to monocytes and activation and major pathways of innate immune activation in people living with HIV. . Tilmanocept may be useful for evaluating new immunomodulatory strategies to reduce inflammation and improve cardiovascular disease risk in PWH.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company specializing in the development of precision immunodiagnostic agents and immunotherapies. Navidea is developing several precision-targeted products based on its Manocept platform to improve patient care by identifying sites and pathways of disease and enabling better diagnostic accuracy, clinical decision-making and targeted treatment. Navidea’s Manocept platform relies on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of tilmanocept Tc99m, the first product developed and marketed by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing new products to market and advancing the company’s pipeline through global partnership and marketing efforts. For more information, please visit www.navidea.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections regarding future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among others: our history of operating losses and the uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete the research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals for our drug candidates; our ability to successfully commercialize our drug candidates; reliance on royalty and grant income; our ability to implement our growth strategy; anticipated trends in our business; our limited product range and distribution channels; technological advances and the development of new competitive products; our ability to comply with NYSE American continuous listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other filings with the SEC. You are urged to carefully review and consider the information contained in our filings with the SEC, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to review statements that include the words “will”, “may”, “could”, “should”, “plan”, “continue”, “designed”, “objective”, “expect”, ” future”, “believe”, “intend”, “expect”, “anticipate”, “estimate”, “project” and similar expressions, as well as the negatives of these words or other comparable words , are uncertain forward-looking statements.
You are cautioned not to place undue reliance on forward-looking statements, any of which may prove to be incorrect. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied by the forward-looking statements.