Navidea Biopharmaceuticals Announces Publication of Study Investigating Use of Tilmanocept Tc99m for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Melanoma and Oral Cancer in Australia

DUBLIN, Ohio, August 01, 2022–(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 “Tilmanocept as a new tracer for lymphatic mapping and sentinel node biopsy in melanoma and oral cancer”, based on work done at the Crown Princess Mary Cancer Center (“CPMCC”) of the University of Sydney, Sydney, Australia The research, published in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., from the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery at CPMCC University of Sydney.

Sentinel lymph node biopsy (“SLNB”) is widely accepted as an important clinical step in the staging of cutaneous melanoma (“CM”) and is also a validated procedure for staging the neck in squamous cell carcinoma of the oral cavity (“OCSCC “). Despite this widespread acceptance, several different radiocolloids and dyes have been used, resulting in a non-standardized method of locating and retrieving sentinel lymph nodes. Tilmanocept Tc99m (approved as ‘Lymphoseek’ in the US, EU and UK; ‘Lymphoaim’ in India) was developed to overcome the limitations of radiocolloids (lack of specific binding sites in lymph nodes, for example, resulting in desired false negative rates in some studies) and works by selectively targeting and binding CD206 receptors on the surface of macrophages and dendritic cells. The use of tilmanocept Tc99m as a radiopharmaceutical for SLNB in ​​CM and OCSCC has not been studied in Australia to date. This prospective study aimed to investigate the use of tilmanocept Tc99m to assess its application, appropriateness and reliability in an Australian setting.

A total of thirty-five patients were included in this study (N = 26 with CM; N = 9 with OCSCC). Tilmanocept Tc99m lymphoscintigraphy identified at least 1 GLS (100% sensitivity) in all patients. There was an intraoperative recovery rate of GS in all patients of 100%, with positive nodes found in 20% of patients. Tilmanocept Tc99m also demonstrated high tissue specificity (100%), with histologically confirmed lymph node tissue, with no false positives.

This is the first study to evaluate the use of tilmanocept Tc99m in the Australian setting, adding to a growing list of studies worldwide, and further confirms that tilmanocept Tc99m is a reliable radiotracer for assessing the nodal state in patients with CM and OCSCC.

Dr. Michael Rosol, Chief Medical Officer of Navidea, said: “We are delighted to see the continued exploration of Lymphoseek’s usefulness for sentinel node biopsy in solid tumors. This study confirms that Lymphoseek can provide high sensitivity and specificity for detection. nodes and supports our continued expansion of Lymphoseek outside of North America.”

Dr Abdul-Razak said: “This study, the first of its kind in the Australian setting, provides further evidence that tilmanocept Tc99m-based lymphoscintigraphy is both a feasible and accurate method for assessing nodal status in patients with CD and OCSCC. Furthermore, our study adds to the growing body of literature supporting its use for these indications.”

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on 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.

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Navidea Biopharmaceuticals, Inc.
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Jacob L. Thornton