EXCLUSIVE: Navidea CEO Tells BioSpace New Cancer Treatment Will See More Trial Data in 2015

EXCLUSIVE: Navidea CEO Tells BioSpace New Cancer Treatment Will See More Trial Data in 2015
April 28, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Navidea will have data later this year from its first localization trial for its new cancer-fighting Manocept molecule’s effectiveness against Kaposi’s sarcoma, Chief Executive Officer Rick Gonzalez told BioSpace Monday, as the crowded field of novel PD-1 treatments for immuno-oncology heats up.

“We anticipate providing regular updates on data, including data from the first localization clinical trial in KS later this year, and our academic collaborators are working as expeditiously as possible to commence formal therapeutic clinical studies,” Gonzalez told BioSpace.

Navidea’s first Manocept-based product, Lymphoseek, is already on the market. It was recently approved in 2014 to detect macrophages as markers of sentinel lymph nodes in breast cancer, melanoma, head and neck cancer, and for lymphatic mapping in other solid tumors.

On April 22, Navidea presented data at the American Association for Cancer Research (AACR) Annual Meeting 2015 demonstrating that the Manocept molecule selectively binds to, and is continuously internalized by, tumor-associated macrophages (TAMs) and Kaposi’s sarcoma (KS) tumor cells in a preclinical model. The company also said that early results from a clinical study showed a single subcutaneous injection of Technetium Tc 99m tilmanocept (Lymphoseek), an FDA- approved Manocept-based imaging agent, detects and localizes in KS tumors and the lymph nodes involved in draining the KS tumor fields.

“We believe the data suggest that Navidea’s Manocept could eliminate immune cells that are wrongly purposed where these cells support disease progression. KS tumor cells as well tumor cells from other types of cancer are able to thrive in large part due to their ability to mal-program certain immune cells, called macrophages,” Gonzalez told BioSpace.

“A therapeutic targeting approach has the potential to provide for management and modification of diseases that include the immediate involvement of macrophages such as cancer, inflammation, CNS disorders and cardiovascular diseases.”

Gonzalez told BioSpace the data are key to demonstrating the potential for Manocept-based molecules to be used therapeutically to treat Kaposi’s sarcoma. Manocept is designed to target CD206, which is expressed on tumor associated macrophages and KS tissue. Modulation, including killing or modification of macrophage and KS expression profiles, represents a potential for a paradigm-shifting immunotherapeutic strategy.

“This data demonstrate the potential for a new immuno-therapeutic approach to treat KS tumors as well as other forms for solid tumors,” Gonzalez told BioSpace.

“We have shown that the Manocept compound specifically binds to and is internalized by the CD206 cell surface receptor found on activated macrophages, tumor-associated macrophages, and KS tumor cells, we having discovered the latter all expressing CD206,” said Gonzalez. “By including different therapeutic moieties in the Manocept backbone, getting to and inside of activated macrophages, TAMs, and KS tumor cells would allow us the potential to eliminate unwanted immune cells and tumors cells as a way to treat cancer.”

Other companies fielding PD-1 candidates include Bristol-Myers Squibb Company , Genentech , GlaxoSmithKline , CureTech Ltd. and MedImmune . But Gonzales said Navidea’s Manocept was a standout even in such a competitive field.

“Several companies are focused on a very few number of immuno-oncology targets,” said Gonzalez. “How we differ is we’re going after the novel target of CD206, which is expressed on macrophages, tumor-activated macrophages and tumor cells. This opens the possibility for a new and unique approach to immune-therapy.’

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