Active Biotech's Anyara misses RCC endpoint

Active Biotech AB (SSE:ACTI) fell SEK7.50 (13%) to SEK51.50 on Monday after it said Anyara naptumomab estafenatox plus interferon (IFN) alpha missed the primary endpoint of improving overall survival (OS) vs. IFN alone in a European Phase II/III trial to treat renal cell carcinoma (RCC). Active Biotech said that an unexpected majority of the 513 patients had high levels of pre-formed antibodies against the superantigen component of Anyara, a 5T4 antibody combined with a mutated staphylococcal enterotoxin A (SEA). In a subgroup analysis of the 25% of patients with low or normal levels of baseline IL-6 and expected anti-superantigen antibody levels, Active Biotech said Anyara plus IFN alpha significantly improved OS (p=0.02) and the secondary endpoint of progression-free survival (p-value not disclosed) vs. IFN alpha alone. ...