A new company has launched in the UK with the goal of using both ex vivo and in vivo cell therapy approaches for the treatment of ocular diseases. Tenpoint Therapeutics Ltd disclosed its plans on 12 July and concurrently announced a $70 million Series A financing led by F-Prime Capital, Sofinnova Partners, and British Patient Capital. The UCL Technology Fund was also part of the financing syndicate.
Switzerland-based Roche has entered into a partnership with Alnylam Pharmaceuticals Inc to co-develop and commercialise an experimental RNA interference (RNAi) therapeutic that has shown promise as a treatment for hypertension in patients at a high risk of cardiovascular disease. Announced on 24 July, the deal involves zilebesiran, a drug currently in Phase 2 which targets angiotensinogen, a protein implicated in the renin-angiotensin-aldosterone system which causes high blood pressure.
Bavarian Nordic A/S has discontinued its respiratory syncytial virus vaccine programme for adults 60 years and older after a Phase 3 study failed to show efficacy against lower-respiratory tract disease caused by the virus. The trial enrolled more than 20,000 adults who were randomised 1:1 to receive either a single dose of the vaccine, MVA-BN RSV, or a placebo.
The first clinical results from a microbiome therapy being developed for indolent non-Hodgkin B cell lymphoma were promising, indicating that a therapy based on synthetic peptides can successfully target multiple cancer cells, according to the developer Enterome SA. In a Phase 1/2 clinical study, EO2463, which consists of four synthetic peptides, selectively targeted multiple B cell markers, enabling the destruction of malignant B lymphocytes abundant in the cancer. Non-Hodgkin lymphoma is a slow-growing cancer of the white blood cells.
A new vaccine to protect against a disease caused by the respiratory syncytial virus (RSV) has received a positive accelerated assessment from the European Medicines Agency. If approved, Abrysvo would be used for the passive immunisation of infants from birth through six months of age following administration to the mother during pregnancy. It would also be indicated for the active immunisation of adults 60 years and older. A formal decision is still to be issued by the European Commission.
A new special purpose biotech company, Mage Biologics Inc, has been launched in the US to advance development of a monoclonal antibody treatment for ulcerative colitis, a chronic, inflammatory bowel disease. The candidate product is being designed for oral administration, using sustained release technology designed by one of its founders.
Sandoz, the Swiss generics and biosimilar drug developer, is to invest $90 million at its site in Ljubljana, Slovenia to produce biosimilar medicines, which are off-patent drugs similar in mechanism of action to their reference biologic drugs. The new technical center is expected to drive biosimilar development, leading to the creation of about 200 new full-time jobs. The project is anticipated to complete by 2026.
argenx SE of the Netherlands has raised $1.27 billion from a global share offering after the exercise by underwriters of their options to buy more shares. This is an increase from the initial gross proceeds of $1.1 billion and will support development of the company’s pipeline of therapies for severe autoimmune diseases.
Novartis moved a step closer to becoming a dedicated proprietary drug developer with a decision by its board of directors to approve the spin-off of Sandoz, the company’s generics and biosimilar medicines business unit. The planned divestment will go to shareholders for a vote in September and, if approved, will take effect early in the fourth quarter. Following the spin-off, Sandoz will be listed on the SIX Swiss Exchange, with an American Depositary Receipt programme in the US.
Donanemab, a monoclonal antibody targeting beta-amyloid in Alzheimer’s disease, significantly slowed cognitive and functional decline in people with early symptomatic disease, the developer Eli Lilly and Co announced on 17 July. The results, from a Phase 3 trial, were disclosed at the 2023 Alzheimer’s Association International Conference and simultaneously published in the Journal of the American Medical Association.