Nuclea, Wilex deal

Wilex may restart development of Rencarex girentuximab after announcing diagnostic company Nuclea acquired Wilex's Wilex Inc. subsidiary in a deal the companies said is worth $5 million. Nuclea assumes responsibility of repaying a $2.5 million loan that the subsidiary acquired from Wilex. Additionally, Nuclea will develop and assume all development costs, which the companies said is worth $2.5 million, for a companion diagnostic for Rencarex. The diagnostic is an automated carbonic anhydrase IX (CAIX) in vitro diagnostic immunohistochemical (IHC) assay for stratifying patients that will be used in a pivotal trial of Rencarex for clear cell renal cell carcinoma (RCC).

Wilex said it is in talks with FDA and European regulatory authorities to discuss a Phase III trial of Rencarex in a subgroup of patients stratified by tumor levels of CAIX. Last December, Wilex restructured and discontinued development of Rencarex after the chimeric mAb against CAIX missed the primary endpoint in the Phase III ARISER trial for clear cell RCC. In June, Wilex reported a subgroup analysis that showed in patients with a high CAIX score, IV Rencarex led to a median disease-free survival of 73.6 months vs. 51.2 months for placebo. At the time, Wilex had said the Phase III trial could start as early as mid-2014. In July, Wilex retained Burrill Securities as exclusive advisor to assist the company in selecting partners to finance Wilex's projects (see BioCentury, June 10 & July 15). ...