A new version of a Covid-19 vaccine being developed by CureVac NV and GlaxoSmithKline Plc has shown an improved immune response and protection in a preclinical study, compared with an earlier version of the vaccine, the two companies announced on 16 August.
A single dose vaccine in development to protect against the chikungunya virus has been shown to be effective with no safety concerns, the sponsor Valneva SE announced on 5 August. The vaccine VLA1553 met its primary endpoint in a Phase 3 pivotal trial achieving a seroprotection rate of 98.5% - well above the 70% threshold set by the US Food and Drug Administration.
A Phase 3 trial of the checkpoint inhibitor Libtayo (cemiplimab) combined with chemotherapy for patients with advanced non-small cell lung cancer was stopped early for efficacy, the sponsors Sanofi SA and Regeneron Pharmaceuticals Inc announced on 5 August. The combination therapy was found to reduce the risk of death by 29% compared with chemotherapy alone in a trial of 466 patients with locally advanced and metastatic disease.
CureVac NV’s candidate messenger RNA (mRNA) vaccine against Covid-19 has shown an overall efficacy rate of 48% in a large Phase 2b/3 trial during which multiple new strains of the SARS-CoV-2 virus were in circulation. The efficacy rate was achieved against Covid-19 disease of any severity, including single non-respiratory mild symptoms, the developer announced on 30 June.
A genome editing therapy designed to inactivate a mutated gene in the liver has reported positive Phase 1 data – the first therapy of its kind to achieve an effect inside the human body. The drug, NTLA-2001, is intended as a one-time treatment for people living with transthyretin (ATTR) amyloidosis, a rare disease caused by misfolded proteins. The study results were reported on 26 June by Intellia Therapeutics Inc and its partner Regeneron Pharmaceuticals Inc, and simultaneously published in The New England Journal of Medicine.
A Phase 3 study of an experimental gene therapy for choroideremia failed to meet its primary endpoint, and also did not show efficacy on key secondary endpoints, Biogen Inc announced on 14 June. Choroideremia is a rare, inherited retinal disease resulting in progressive vision loss, ultimately leading to blindness.
After interim data failed to meet the statistical criteria for success, CureVac NV is pressing ahead to complete development of its first Covid-19 vaccine while making plans to start studies of a second generation compound later this year. On 16 June, CureVac announced that its messenger RNA vaccine, CVnCoV, demonstrated an interim efficacy rate of 47% in a Phase 2b/3 trial. The outcome was weaker than expected.
A combination antibody treatment for Covid-19 has met its primary endpoint of improving survival in patients hospitalised with the disease, the developer Regeneron Pharmaceuticals Inc announced on 16 June. The treatment, REGEN-COV, is a combination of the monoclonal antibodies casirivimab and imdevimab, which are both investigational compounds. The US Food and Drug Administration has given the combination treatment an emergency use authorisation.
The Swedish biotech Modus Therapeutics Holding AB has entered into a partnership with a team at Imperial College London, UK to investigate the compound sevuparin in patients with severe malaria. Modus is currently developing sevuparin for sepsis and septic shock, life-threatening conditions caused by the body’s reaction to an infection. The company has now extended its research to do more work in malaria.
Aspirin has been eliminated as a possible treatment for patients hospitalised with Covid-19. This follows a large randomised clinical trial in the UK that assessed the effects of the compound on the survival of Covid-19 patients and their risk of developing a rare type of blood clot. Aspirin is widely used to reduce blood clotting in other diseases.