Blenrep (belantamab mafodotine), an antibody-drug conjugate given speedy approvals in both the US and the EU in 2020, and later withdrawn for insufficient efficacy, has won approval for a new market entry in the UK on the basis of two combination studies. The drug was developed by GSK Plc to treat patients with relapsed or refractory multiple myeloma, the third most common blood cancer globally.
The Alzheimer’s disease drug, Leqembi (lecanemab), has been approved by the European Commission following extra reviews of the product’s safety. The decision was announced on 16 April by the product’s co-developer BioArctic AB which will make the drug available to adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease. The patient group is specifically identified as people who have only one, or no copy, of the ApoE4 gene, a risk factor for the disease.
A vaccine designed to prevent disease caused by the chikungunya virus, a mosquito-borne virus, has been approved in Brazil, an endemic country. Developed by Valneva SE of France, the vaccine IXCHIQ, is intended for individuals 18 years and older. Chikungunya disease, which causes muscle pain and joint swelling, has occurred in Africa, Asia, the Americas, Europe and islands in the Indian and Pacific oceans. According to the US Centers for Disease Control and Prevention, there is a risk that the virus could spread to unaffected areas by travellers.
A digital twin lung simulation technology, Twinhale, has been used for the first time in idiopathic pulmonary fibrosis (IPF) in a groundbreaking new study. The study by Munich, Germany-based company Ebenbuild, supports the development of a novel inhaled anti-CCN2 (formerly called CTGF) biologic, PRS-220, developed by Pieris Pharmaceuticals - now Pavella Therapeutics Inc.
A new drug for haemophilia that targets antithrombin, a protein that inhibits blood clotting, has been approved by the US Food and Drug Administration. Discovered by Alnylam Pharmaceuticals Inc and licensed to Sanofi SA, Qfitlia (fitusiran) will be used to treat patients with both haemophilia A and haemophilia B with or without inhibitors. The standard treatment for patients with haemophilia are clotting factor replacement therapies where patients with haemophilia A receive replacement for factor VIII and those with haemophilia B, replacement for factor IX.
Isomorphic Labs Ltd, a pioneer in the use of artificial intelligence for drug discovery, announced a capital raise of $600 million on 31 March, the company’s first external financing since its launch in 2021. Isomorphic is a spin-out of the DeepMind laboratory of Alphabet Inc, the parent of Google, and led by Demis Hassabis, a Nobel laureate. DeepMind is the developer of the AlphaFold artificial intelligence programme. Isomorphic will use the new funds to develop a portfolio of drugs both in-house and in partnership with Novartis and Eli Lilly and Co.
The UK biotech Epsilogen has significantly expanded its repertoire of antibody technologies with the acquisition of TigaTx Inc, of Boston, US, in order to treat more patients with cancer. The deal, announced on 7 April, equips Epsilogen, a clinical-stage company, with technology and assets of the IgA antibody subtype. These activate neutrophils, a type of white blood cell that is an essential part of the immune system. Epsilogen already has IgG antibody assets, the most abundant subtype, and IgE assets, a less common isotype which can activate macrophages.
GSK Plc has entered into a licensing agreement with ABL Bio Inc of South Korea for rights to a delivery platform for carrying prospective drugs across the blood-brain barrier to treat neurodegenerative diseases. The deal, valued at up to £2.15 billion, is one of the company’s largest transactions, reflecting its interest in treating diseases of the brain.
Arvinas Inc, a US biotech with a portfolio of protein degrader molecules, has reported positive data for a potential treatment for neurological diseases. The data were presented at the International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria on 4 April, showing that the molecule was both safe and able to engage with the cellular target. The target is leucine-rich repeat kinase 2 (LRRK2), a protein that has been implicated in Parkinson’s disease and progressive supranuclear palsy. The Phase 1 study was conducted in healthy male volunteers.
A prospective vaccine against infection from the Nipah virus moved closer to clinical development on 21 March with the award of $13.38 million from the Coalition for Epidemic Preparedness Innovations (CEPI). The new grant follows $3.6 million in funding in 2023, bringing total cash available to $16.98. CEPI, a public-private partnership, is working with Gennova Biopharmaceuticals Ltd of India and the US-based Houston Methodist Research Institute on the project, which will deliver a self-amplifying messenger RNA (mRNA) vaccine to the market.