A prospective drug for Alzheimer’s disease that failed to show efficacy in late 2017 based on a Bayesian analysis of patient data, has now demonstrated its promise using more conventional statistical methods, according to Eisai Co Ltd and Biogen Inc.
The drug, BAN2401, is a monoclonal antibody targeting beta-amyloid, protein fragments in the brain which are thought to contribute to the neurodegenerative process in Alzheimer’s disease.
Ipsen SA received further validation of its in-licensed compound cabozantinib following the publication in the 5 July edition of the New England Journal of Medicine (NEJM) of Phase 3 data showing the drug’s effectiveness in advanced liver cancer. Cabozantinib, which trades commercially as Cabometyx, has already been approved in the US and Europe for advanced kidney cancer. The drug was developed by Exelixis Inc and out-licensed to Ipsen in 2016 for commercialisation outside the US, Canada and Japan. Ipsen later acquired rights to Canada.
A candidate vaccine to prevent infection from the chikungunya virus has been accepted into the European Medicines Agency’s PRIME scheme, a programme of regulatory support for developers of medicines that meet a major public health need.
The vaccine is a biologic developed by Themis Bioscience GmbH of Austria and is currently undergoing Phase 2 studies in 600 patients across the US, the EU and South and Central America. The company hopes to receive marketing approval within three years.
Valneva SE is poised to bring its prophylactic vaccine for Lyme disease into a Phase 2 clinical study by the end of 2018 following positive discussions with the US Food and Drug Administration, the company announced on 2 July. The agency has given the product ‘fast track’ status in light of its potential contribution to public health.
Roche has reported positive results for a Phase 3 trial of its checkpoint antibody Tecentriq (atezolizumab) in combination with chemotherapy for the treatment of patients with metastatic triple negative breast cancer. The trial showed a statistically significant improvement in progression-free survival.
A nanoparticle device designed to enhance the effect of radiation in the treatment of cancer has delivered positive Phase 2/3 results in patients with soft tissue sarcoma. The device, NBTXR3, has been developed by Nanobiotix SA of France.
In the wake of unexpectedly positive clinical results from a trial testing the folfirinox chemotherapy regimen in patients with pancreatic cancer, after surgery, Targovax ASA has decided to drop development of its therapeutic vaccine for this indication.
Two Phase 3 trials of the candidate Alzheimer’s drug lanabecestat have been stopped for futility, Eli Lilly and Company and AstraZeneca Plc announced on 12 June. Lanabecestat is an inhibitor of the beta secretase cleaving enzyme (BACE), which plays a role in the production of the amyloid beta protein. The accumulation of this protein in the brain is believed to be a major cause of Alzheimer’s disease.
AstraZeneca Plc’s biologic drug for respiratory disease, Fasenra (benralizumab), has failed a second Phase 3 trial in patients with chronic obstructive pulmonary disease (COPD). As a result, the company said it will not to make a regulatory submission for this indication.
An early clinical study of the monoclonal antibody daratumumab (Darzalex) in combination with the checkpoint inhibitor atezolizumab in patients with non-small cell lung cancer has been stopped early because of lack of efficacy as well as safety issues, Genmab A/S announced on 26 May.