argenx SE is to take back rights to the antibody therapeutic cusatuzumab after its partner Cilag GmbH International, one of the Janssen Pharmaceutical Companies of Johnson & Johnson Inc, announced plans to quit the three-year-old collaboration. Cusatuzumab is in a Phase 1b study in newly-diagnosed, elderly patients with acute myeloid leukaemia (AML). It is being tested with venetoclax and the chemotherapy azacitidine.
The scientific journal Nature Communication has published data from a Phase 1/2 study of an autologous faecal microbiota transfer treatment in patients with acute myeloid leukaemia (AML). Top-line data from the study were first presented at the American Society of Hematology Annual Meeting in December 2018. With further outcome data now available, the treatment has been shown to have had a positive impact on survival after two years.
NOXXON Pharma NV has reported more positive data from a study of its RNA oligonucleotide drug, plus radiotherapy, in patients with newly diagnosed brain cancer. The drug, NOX-A12, targets a chemokine protein in the tumour microenvironment with the goal of breaking tumour protection against the immune system.
Sanofi SA has stopped a clinical programme in autosomal dominant polycystic kidney disease after its small molecule drug venglustat failed to show a meaningful reduction in the total kidney volume growth rate. The programme was halted during the first stage of a pivotal Phase 2/3 study. Venglustat was targeting glycosphingolipids (GSL), which modulate membrane-to-protein functions and contribute to cell-to-cell communication.
Novartis has stopped a Phase 3 study of its eye treatment Beovu (brolucizumab) early following incidents of intraocular inflammation including retinal vasculitis and retinal vascular occlusion. Called MERLIN, the study was evaluating Beovu in a new four-week dosing regimen for patients with wet age-related macular degeneration (AMD). The drug has already been approved in the US and elsewhere, but at a longer dosing interval.
Abivax SA has reported efficacy in a Phase 2b trial of a small molecule treatment for ulcerative colitis, paving the way for the start of a Phase 3 programme by the end of the year. Patients in the placebo-controlled trial had moderate to severe colitis and included individuals refractory to conventional drugs including biologics and/or JAK inhibitors. Significantly, the lowest dose of 25 mg was effective across the entire study population, the company announced on 24 May.
The French vaccine company Valneva SE has raised $107.6 million from an initial public offering of shares on the US Nasdaq market, enabling it to accelerate development of candidate vaccines to prevent Covid-19 as well as Lyme disease. The company also has a prophylactic vaccine in development against the chikungunya virus, which is prevalent in Africa, Asia and India. The company’s American Depositary Shares began trading on Nasdaq on 6 May.
Valneva is also listed on Euronext Paris.
Technology that integrates clinical trial data from patients with dementia and machine learning has received financial support from public and private funders in the UK. The company responsible for the technology is Cumulus Neuroscience Ltd (formerly BrainWaveBank) of Belfast, Northern Ireland. On 4 May, it announced receipt of £6 million from the Dementia Discovery Fund, the Future Fund and the charity, LifeArc.
An experimental long-acting antibody has reduced infections caused by the respiratory syncytial virus (RSV) in a Phase 3 trial of healthy infants. Nirsevimab met its primary endpoint of significantly reducing the incidence of lower respiratory tract infections, the developers AstraZeneca Plc and Sanofi SA announced on 26 April.
Bimekizumab, a monoclonal antibody directed against interleukin-17A and interleukin-17F, has outperformed two marketed products in separate Phase 3 trials of patients with moderate-to-severe plaque psoriasis, a chronic inflammatory skin disease for which there is no cure.
The trial results were published in separate articles in The New England Journal of Medicine on 23 April 2021.