June 17 Clinical Quick Takes: VBI's HBV vaccine misses secondary endpoint, plus ArQule, Verastem and more

VBI falls with HBV vaccine miss on secondary endpoint
VBI Vaccines Inc. (NASDAQ:VBIV) sank $1.24 (66%) to $0.65 Monday after reporting that two doses of Sci-B-Vac failed to show non-inferior seroprotection at day 168 vs. three doses of Engerix-B from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) at day 196 in the Phase III PROTECT trial. The HBV vaccine, which contains the virus’ S, preS1 and preS2 surface antigens, met PROTECT's co-primary endpoints. VBI plans to reassess non-inferiority by integrating data from PROTECT and the Phase III CONSTANT trial, for which data are expected around year end.

ArQule to begin registrational portion of AKT inhibitor trial next quarter
ArQule Inc. (NASDAQ:ARQL) gained $1.38 (17%) to $9.58 Monday after announcing plans to begin enrolling patients next quarter in the second, and registrational, portion of a Phase I/II study of miransertib (ARQ 092) to treat PIK3CA-related overgrowth spectrum and Proteus syndrome. At the European Society of Human Genetics meeting in Gothenburg, the company reported preliminary data from the first part of the trial showing that, in most patients, the AKT inhibitor led to no disease progression for over a year or improved patient-reported symptoms...