News

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.

GlaxoSmithKline Plc is to provide $67 million over five years to help establish a new laboratory at the University of California to investigate how gene mutations cause disease and the role gene editing can play in discovering new treatments. The laboratory project is being led by Jennifer Doudna, co-inventor of the Crispr gene editing technology, and Jonathan Weissman, a leader in Crispr screening technology. Hal Barron, GSK’s chief scientific officer, has also played a role in launching the project. Dr Barron has been the CSO at GSK since January 2018.

The UK medical charity LifeArc has provided £1.5 million in seed funding to a four-year old company, Ducentis BioTherapeutics Ltd, that is investigating molecules for treating inflammation and autoimmune disease. Ducentis was co-founded in 2015 by Philip Huxley, an expert in drug discovery, and David Blackbourn, head of the School of Biosciences and Medicine at the University of Surrey, UK to exploit the CD200 axis. CD200 is a glycoprotein expressed on multiple cells and tissues which uses a receptor, CD200R, to transmit signals affecting responses in multiple physiological systems.

The first diagnostic test for Zika virus infection, which can lead to birth defects if contracted during pregnancy, was approved on 23 May by the US Food and Drug Administration. The test, developed by InBios International Inc, is designed to detect antibodies to the pathogen which indicate that the body has generated an early immune response. It is meant to be used for people who show clinical signs of the disease or who have lived or travelled to Zika-infected areas. Prior to this decision, the InBios’ test and others, were authorised for emergency use only.

A new gene therapy has been approved in Europe, paving the way for its use in patients with beta-thalassaemia, a rare blood disorder. The treatment, Zynteglo, uses a lentiviral vector to deliver functional copies of a beta-globin gene into a patient’s haematopoietic stem cells in order to correct for a shortage of beta-globin. It was given a positive opinion by the European Medicines Agency on 29 March and a conditional approval by the European Commission on 29 May.