Immatics NV has raised $110 million in a public share offering to advance development of its T cell receptor T cell therapies for cancer. The financing coincides with the disclosure of interim clinical data for the company’s lead product IMA203 which is being studied in multiple solid cancers.
Muna Therapeutics, a biotech company co-located in Denmark and Belgium, has received a $4.9 million grant from the Michael J Fox Foundation of the US to support preclinical research and development into small molecule potassium channel type 1.3 (Kv1.3) blockers to stop neuroinflammation and enhance neuroprotection in Parkinson’s disease.
NMD Pharma A/S, a spin-out from Aarhus University in Denmark, has reported positive top-line data from a Phase 1/2a trial of a small molecule drug for myasthenia gravis, a chronic autoimmune disease. The drug, NMD670, recently received an orphan designation from the US Food and Drug Administration in light of the seriousness of the disease. Myasthenia gravis causes potentially life-threatening muscle weakness due to impaired neuromuscular transmission. NMD670 inhibits the skeletal muscle-specific chloride ion channel CIC-1.
The European Medicines Agency has launched a new project to help academic scientists and those working for non-profit organisations understand the regulatory requirements for developing and eventually commercialising cell, gene and tissue engineered therapies. The project complements the agency’s priority medicines scheme, PRIME, which was launched in 2016 to provide support to developers of medicines that meet a major public health need.
The US Food and Drug Administration has approved a new drug for amyotrophic lateral sclerosis, a rare disease that attacks and kills the nerve cells that control voluntary muscles. In a Phase 2 trial, the drug Relyvrio (sodium phenylbutyrate and /taurursodiol), showed an ability to slow the rate of neuromuscular decline. Moreover in a follow-up study, it extended patient survival compared with a placebo.
Lecanemab, an antibody therapy targeting amyloid-beta protofibrils in patients with early Alzheimer’s disease, achieved positive results in a Phase 3 study, paving the way for regulatory reviews in the US, EU and Japan, the developer Eisai Inc announced on 28 September. The study, called Clarity AD, met the primary endpoint as well as key secondary targets, confirming that lecanemab’s mechanism of action is able to reduce cognitive clinical decline in Alzheimer's patients. Lecanemab works by binding to soluble amyloid-beta protofibrils.
It is not too early to draw lessons from the Covid-19 pandemic, a health emergency that is still affecting the global community. At a meeting of the Sachs Biotech in Europe Forum on 21 September, five pharma executives discussed what has been accomplished thus far, and what still needs to be done to protect against future health crises.
Genfit SA of France is to acquire a small Swiss company that specialises in liver diseases in order to expand its clinical-stage portfolio for these complex disorders. The purchase of Versantis AG is expected to complete in the fourth quarter and give Genfit control of VS-01, a liposomal-based therapy for acute-on-chronic liver failure (ACLF), a condition for which no drugs have yet been approved. Genfit will also acquire a small molecule asset and a diagnostic.
A new treatment designed to protect infants from infection from the respiratory syncytial virus (RSV) has received a positive opinion from the European Medicines Agency. The accelerated review was in response to evidence that infections from RSV are on the rise following a relaxation of restrictions that have been in place to prevent Covid-19.
France-based SparingVision SAS has raised €75 million in a Series B financing round to bring its two lead gene therapy assets into clinical development for the treatment of retinitis pigmentosa, an inherited retinal disorder. The adeno-associated virus vector therapies will deliver mutation agnostic treatments to the eye with a view to correcting the disorder.