The German biotech Topas Therapeutics GmbH has raised €22 million in a Series B financing round to advance technology for inducing antigen-specific immune tolerance. The technology is thought to have application across a wide range of autoimmune diseases, allergies and a condition known as anti-drug antibodies where the body throws up resistance to the repeated administration of monoclonal antibodies.
Ireland-based Neuromod Devices Ltd has raised €10.5 million in a Series B financing round to to accelerate the European commercialisation of a device to treat tinnitus, a condition in which sufferers experience a ringing in the ears. The device is a bimodal neuromodulation treatment which has received a CE-mark in the EU and is being rolled out in Europe. The company also plans to target the US market with a particular focus on the Department of Veterans Affairs.
A small molecule drug being developed jointly by Galapagos NV and Laboratoires Servier has failed to meet the primary endpoint of a Phase 2 trial in patients with knee osteoarthritis (OA), the two companies announced on 15 October. The candidate treatment, GLPG1972, targets ADAMTS-5, an enzyme implicated in cartilage degradation. Osteoarthritis occurs when the protective cartilage that cushions the ends of bones wears down.
The European Medicines agency is recommending conditional approval of Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of relapsed or refractory mantle cell lymphoma. The chimeric antigen receptor (CAR) T cell therapy is the third medicine of its type to be reviewed by the agency. It follows the 2018 approvals of Kymriah for leukaemia and lymphoma and Yescarta for lymphoma.
Disruptions caused by the coronavirus pandemic depressed sales at Roche in the first nine months of the year but the company responded to the health crisis with the launch of new diagnostics and a partnership with Regeneron Pharmaceuticals Inc to develop an antibody treatment for the disease. In the third quarter, Roche received six medicine approvals in the US, the EU and Japan.
The US Food and Drug Administration has given its first approval to a treatment for Ebola virus, a potentially fatal disease affecting people in the Democratic Republic of the Congo (DRC) and several other African countries. The treatment, Inmazeb, is a mixture of three monoclonal antibodies which bind to the glycoprotein on the surface of the virus, blocking its attachment to cell receptors and preventing its entry into cells.
Evotec has acquired a new long-term strategic investor and received fresh funds from an existing shareholder to finance an expansion of its drug discovery portfolio and its geographical footprint in Europe and the US. The new investor is the Mubadala Investment Company PJSC, a sovereign wealth fund wholly owned by the government of Abu Dhabi. The existing investor is Novo Holdings A/S. Together they have purchased 11.5 million Evotec shares for €250 million, of which €200 represents the Mubadala investment and €50 million, the investment by Novo.
A preclinical study of an experimental cancer therapy has shown single-agent activity in models of glioblastoma, inducing long-term tumour eradications in a proportion of the treated animals. The results were published on 8 October, 2020 in Science Translational Medicine. The developer is Philogen SpA, a clinical-stage biotechnology company with headquarters in Italy.
A Phase 1/2a study of a candidate factor replacement therapy BIVV001 in adults with severe haemophilia A has shown significant levels of factor activity. The results were published on 10 September in The New England Journal of Medicine. The developer is Swedish Orphan Biovitrum AB which is collaborating with Sanofi SA on the programme.
Haemophilia A is an inherited bleeding disorder in which the blood does not clot properly. It is caused by a lack, or a decrease, of clotting Factor 8.
Switzerland-based Santhera Pharmaceuticals AG has discontinued development of Puldysa (idebenone), its candidate therapy for Duchenne muscular dystrophy after an independent review of an ongoing Phase 3 trial concluded that the trial was unlikely to meet its primary endpoint. The Data and Safety Monitoring Board based its conclusion on an interim analysis of the study, SIDEROS, which was being conducted in Duchenne muscular dystrophy patients using concomitant glucocorticoids.