The UK-based oncology company Iksuda Therapeutics Ltd has completed a $47 million financing round to progress a pipeline of antibody-drug conjugates (ADCs), a drug class that is seeing renewed interest from investors because of advances in conjugation technologies. The financing was co-led by the South Korean entities Mirae Asset Financial Group and Celltrion Inc.
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.
A new treatment for Alzheimer’s disease was approved by the US Food and Drug Administration on 7 June using a surrogate end point for clinical benefit: a reduction of amyloid beta plaque in the brain. Aduhelm (aducanumab) was given an accelerated approval. It is the first new treatment approved for Alzheimer's disease in the US since 2003.
Novo Nordisk A/S has received US Food and Drug Administration approval for its drug Wegovy (semaglutide) for the treatment of obesity – the first weight management drug to be approved by the agency since 2014. More than one-third of US adults are estimated to be obese with the highest prevalence among those in middle age. Obesity is a risk factor for multiple disorders including heart disease, stroke and diabetes.
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.
MorphoSys AG has announced plans to acquire Constellation Pharmaceuticals Inc, one of the first US companies to develop drugs in the field of epigenetics. Germany-based MorphoSys will pay $1.7 billion for the company, which has two clinical-stage cancer programmes and several projects in preclinical development.
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.
The Japan Patent Office (JPO) has upheld a patent awarded to Dr Emmanuelle Charpentier and colleagues while giving intellectual property protection for a third discovery. As a result, the inventors have three Japanese patents for their discovery of the Crispr/Cas9 genome editing technology. The legal victories were announced on 1 June by ERS Genomics Ltd which licenses access to the technology.