Johnson & Johnson Inc said that its single-shot vaccine against Covid-19 was 66% effective in preventing moderate to severe disease following a Phase 3 trial that included participants from the US, South Africa and countries in Latin America.
Novavax Inc has reported that its protein-based Covid-19 vaccine achieved an efficacy rate of 89.3% in a Phase 3 trial conducted in the UK, even as a new strain of the virus was circulating in that country. Meanwhile, a separate Phase 2b study of the same vaccine achieved a 60% efficacy rate in South Africa in a study population that was HIV-negative. For the overall trial population, including those with and without HIV, the efficacy rate was 49.4%.
The German vaccine producer CureVac NV has announced the pricing of a follow-on share issue on Nasdaq giving total gross proceeds of $450 million. This comes five months after the company, which is developing a messenger RNA (mRNA) vaccine for Covid-19, raised $245.3 million in an initial public offering. In the latest financing, CureVac issued five million common shares at a price of $90 per share.
An oncology drug developed by PharmaMar SA of Spain has shown potent antiviral activity against SARS-CoV-2 in both laboratory and animal experiments, suggesting promise as a candidate for treating Covid-19, according to an article in Science on 25 January 2021. The drug, plitidepsin (Aplidin) is an anticancer agent of marine origin.
It was approved for the treatment of multiple myeloma in Australia in December 2018 and holds orphan drug designations in both the US and the EU.
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 INTR@PID 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).