Jean-Paul Kress, formerly of Biogen Inc and Sanofi Genzyme, is to take over as chief executive of MorphoSys AG on 1 September, succeeding Simon Moroney, the company’s co-founder and CEO. Dr Kress will assume the leadership position just as MorphoSys seeks to register and commercialise its first wholly-owned product tafasitamab for diffuse large B cell lymphoma.
NOXXON Pharma NV is to test its RNA oligonucleotide drug NOX-A12 in a new cancer indication after signing an agreement with an unidentified large pharma company to conduct preclinical studies of the drug.
A combination treatment for cystic fibrosis that targets patients with a specific genetic mutation, has now been approved in the US for children six years and older. The treatment, Symdeko (tezacaftor/ivacaftor), targets a common mutation in the cystic fibrosis gene – the F508del mutation – which can lead to severe respiratory and digestive problems. The cystic fibrosis gene encodes the cystic fibrosis conductance transmembrane regulator (CFTR) protein which controls the movement of chloride and sodium in and out of cells in the human body.
MorphoSys AG said that a single-arm Phase 2 study of its monoclonal antibody, tafasitamab (MOR208), in patients with relapsed lymphoma met its primary endpoint, paving the way for completion of a regulatory submission in the US by the end of the year.
Calliditas Therapeutics AB of Sweden has entered into a licencing agreement with Shanghai-based Everest Medicines II Ltd to develop and commercialise its candidate drug Nefecon (budesonide) for the Chinese market. Nefecon is currently in a Phase 3 pivotal trial for the treatment of patients with the chronic autoimmune kidney disease IgA nephropathy. The agreement gives Everest exclusive rights to develop and, depending on regulatory approval, sell the drug in mainland China, Hong Kong, Macau, Taiwan and Singapore.
Merck & Co Inc, whose checkpoint antibody Keytruda (pembrolizumab) already has 20 approved indications, received a further endorsement on 18 June with US Food and Drug Administration approval for the treatment of metastatic small cell lung cancer. Keytruda is already approved as a first-line treatment for non-small cell lung cancer. The new indication means the antibody can be used as a monotherapy for patients with small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy and at least one other prior line of therapy.
Belgium-based Imcyse SA has raised €35 million in a Series B financing round to support development of its immunotherapies for severe chronic diseases. The funding comes as the company awaits data from a multi-centre trial of its lead peptide-based product in patients with recent onset, insulin-dependent Type 1 diabetes. The double-bind, placebo-controlled Phase 1b study is expected to report results at the end of the summer.
Pfizer Inc has upped the stakes in the pharma competition for new assets with an agreed takeover of Array BioPharma Inc for $11.4 billion. The transaction has been approved by the boards of both companies and will be financed with borrowings as well as cash, Pfizer said on 17 June. The deal comes nearly six months after Albert Bourla, the company’s former chief operating officer, took over as chief executive from Ian Read.
Novo Nordisk A/S has broadened its coverage of the market for diabetes treatments following the US approval on 17 June of a new indication for Victoza (liraglutide), its glucagon-like peptide-1 (GLP-1) receptor agonist. The new indication is for the treatment of paediatric patients 10 years or older with Type 2 diabetes. Victoza is the first non-insulin drug approved for the treatment of Type 2 diabetes in children since metformin was authorised for paediatric use in 2000. Victoza has been approved to treat adult patients with the disease since 2010.
A research alliance between German BioNTech SE and Genmab A/S of Denmark has yielded its first product – a clinical stage bispecific antibody that is being investigated in patients with metastatic or unresectable malignant solid tumours. Called DuoBody-PD-L1x4-1BB, the jointly developed product started a Phase 1/2a study on 17 June. It has a dual mode of action that combines checkpoint blockade with the conditional stimulation of T cells.