Amgen announced that it commenced termination of a collaboration with AstraZeneca to develop brodalumab, a human IgG2 mAb targeting IL-17 receptor. Amgen recently presented data from three Phase 3 clinical trials evaluating brodalumab in patients with moderate-to-severe plaque psoriasis, and in connection with the presentation, suicidal ideation and completed suicides in the brodalumab program were noted. According to the company, the evidence to date does not suggest a causal association between IL-17 inhibition and suicidal ideation and behavior, but the events likely would necessitate restrictive labeling.
The American Society of Clinical Oncology’s Annual meeting was held May 29-June 2, 2015 in Chicago. The meeting features an extensive program of presentations on cancer therapies. Data for numerous antibodies, including avelumab, bavituximab, ensituximab, HuMax-Axl-ADC, OBT357/MEN1112, MEDI4736, MEDI0680, PF-05082566, NI-1701, SEA-CD40, REGN1979, and the CEA-directed BiTE MEDI-565/AMG 211 were made available in abstracts. The meeting abstracts can be accessed here.
The European Medicines Agency’s Committee for Medicine Products for Human Use (CHMP) has recommended that marketing authorizations be granted for four antibody therapeutics, evolocumab, pembrolizumab, nivolumab and dinutuximab. Evolocumab is a first-in-class, human IgG2 antibody targeting proprotein convertase subtilisin/kexin type 9, and CHMP recommended it to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins, and to treat homozygous familial hypercholesterolaemia. Pembrolizumab and nivolumab both target PD1, and they were recommended to treat advanced (unresectable or metastatic) melanoma, and to treat adults with squamous non-small cell lung cancer, respectively. Dinutiximab, a chimeric antibody targeting GD2, was recommended for the treatment of high-risk neuroblastoma.