Clinical Research

Merck & Co Inc has dropped development of two candidate Covid-19 vaccines less than a year after bringing them into its portfolio from third parties. The company said both vaccines were well tolerated in Phase 1 studies but generated immune responses that were inferior to those seen from natural infections and responses reported for competitor products.

Faricimab, a bispecific antibody for neovascular age-related macular degeneration, has met its non-inferiority endpoint in two Phase 3 trials, the developer Roche announced on 25 January. The two studies showed that people who were treated with the bispecific antibody at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were equivalent to those receiving aflibercept, an approved drug, every eight weeks. Effectively this means that patients receiving faricimab would have a longer interval between treatments.

A Phase 2 trial of a candidate drug for ulcerative colitis has been stopped early following an interim analysis of data, Immutep Ltd of Australia announced on 21 January. The monoclonal antibody was being developed by GlaxoSmithKline Plc under a licensing agreement with Immutep dating from 2010. GSK is conducting an analysis of safety and efficacy data from the trial to determine the next steps.

A Phase 3 trial of a candidate immunotherapy for lung cancer, which was being compared with pembrolizumab, has been discontinued, the sponsor Merck KGaA announced on 20 January. The decision was taken on a recommendation of the trial’s independent data monitoring committee which said the study was unlikely to meet the co-primary endpoint of progression-free survival. The trial is known as [email protected] Lung 037.

A Phase 3 study of a prospective asthma treatment failed to meet its primary endpoint even though a registration trial for the same drug had positive results. The developers, Amgen Inc and AstraZeneca Plc, said the discrepancy may be due to the design of the failed study, but a further analysis of the data is ongoing.

The US Food and Drug Administration has placed a clinical hold on uniQure NV’s gene therapy programme in haemophilia B following a possibly related serious adverse event, the company announced on 21 December. The hold affects the company’s pivotal Phase 3 study called HOPE-B which recently reported positive initial data at the annual meeting of the American Society of Hematology (ASH).

The US Food and Drug Administration has issued an emergency use authorisation to Moderna Inc for a vaccine for Covid-19 following trial data showing it was 94.1% effective in preventing the disease. The decision comes just a week after the agency issued an emergency authorisation for a vaccine developed by BioNTech SE and its partner Pfizer Inc. Both vaccines are based on messenger RNA (mRNA), a technology never before used in a human vaccine. The two vaccines work by instructing cells in the body to make copies of the SARS-CoV-2 spike protein.

Sanofi SA and its partner GlaxoSmithKline Plc are to test a new antigen formulation for their  Covid-19 vaccine in order to generate a better response from older adults. Assuming all data are positive, the vaccine would be available in the 2021 fourth quarter rather than mid-2021, the companies announced on 11 December 2020.

Astra Zeneca Plc has announced the publication on 8 December of interim Phase 3 data of a Covid-19 vaccine that it is developing with the University of Oxford in The Lancet. The interim analysis for efficacy and safety, as outlined in the article, are in line with previous disclosures, the company said.

An estimated 44% of patients with advanced lymphoma are still alive four years after receiving a single infusion of Yescarta (axicabtagene ciloleucel) for their disease. The new long-term survival data were presented by Gilead Sciences Inc at the annual meeting of the American Society of Hematology (ASH), further illustrating the efficacy of the chimeric antigen receptor (CAR) T cell therapy class.