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News Breaks
July 16, 2014
07:37 EDTNAVBNavidea forms joint enterprise with Rheumco
Navidea announced that it has formed a joint enterprise with Essex Woodlands-backed Rheumco to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, will combine Navidea’s proprietary Manocept CD206 macrophage targeting platform and Rheumco’s proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need. R-NAV will be initially funded primarily through a $4M investment from Infinity Capital III and other third-party private investors working closely with Essex Woodlands, and underpinning the technology contributions from Rheumco and Navidea. Navidea has committed an additional $1M to support R-NAV’s development efforts to be paid in equal installments over three years. In exchange for its cash, in-kind and technology contributions, Navidea has received both common units and Preferred Series A units of R-NAV and will initially own approximately 30% of the combined entity. Joint oversight of R-NAV is shared between Navidea, Rheumco, Infinity Capital III of Houston-based McRay Money Management, and the other investors. Navidea also has an option to acquire, at its sole discretion prior to Phase 3 clinical study, imaging products derived from the Manocept platform, and therapeutic products combining Manocept agents from Navidea with the Tin-117m technology for commercialization.
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March 25, 2015
07:32 EDTNAVBNavidea to present Lymphoseek injection data at SSO meeting
Navidea Biopharmaceuticals announced that data from its Lymphoseek injection studies in melanoma, breast and oral cavity squamous cell cancers will be presented at the 68th Annual Cancer Symposium of the Society of Surgical Oncology meeting held in Houston, TX, March 25-28. An oral presentation by Douglas Chepeha, M.D. of the University of Toronto-Princess Margaret Hospital reveals that analysis from Phase 3 data for detection of sentinel lymph nodes in head and neck oral cavity squamous cell carcinoma patients demonstrated high concordance between preoperative lymphoscintigraphy and intraoperative SLN biopsy findings. Notably, 95.2% of patients had agreement between their preoperative and intraoperative findings. This high concordance when using Lymphoseek confirms its role in the utility of preoperative lymphoscintigraphy imaging for planning and conducting SLN biopsy. Results of a follow-up outcome study presented as a poster by Julian Kim, M.D. of the University Hospitals Seidman Cancer Center indicated that in patients who were confirmed to be node-negative after sentinel lymph node biopsy the regional recurrence-free ratewas 98.8% at three years. An overall false negative rate for the two tumor types was 5.6% and the negative predictive value was 98.6%. These results demonstrate that Lymphoseek accurately identified SLNs and is likely predictive of pathological staging.

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