Clinical Research

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.

A multi-year study of the asthma drug Nucala (mepolizumab) has shown the treatment to be effective in asthma control and reducing acute episodes of the disease, according to GlaxoSmithKline Plc. The company disclosed the data on 20 May at a meeting of the American Thoracic Society.

Dupixent (dupilumab) has delivered positive results in a Phase 3 trial involving adolescents with moderate-to-severe atopic dermatitis. The drug is already approved for the same disease in adults and is the first biologic to show a benefit in this patient group.