The European Union and AstraZeneca Plc have reached a settlement on the supply of Vaxzevria, the company’s Covid-19 vaccine, to the union ensuring that vaccine deliveries through March 2022 will meet the terms of an advance purchase agreement concluded on 27 August 2020.
Galapagos NV continued to roll out its consolidation strategy in the second quarter following the decision, taken with partner Gilead Sciences Inc in late 2020, not to pursue a US marketing authorisation for the rheumatoid arthritis drug Jyseleca. In May, the company announced plans to focus its research efforts on inflammation, fibrosis and kidney disease, while discontinuing research in metabolic diseases and osteoarthritis.
France-based Eyevensys SA has raised $12 million from a syndicate led by Korea Investment Partners to accelerate development of its preclinical programme, EYS809, for treating wet age-related macular degeneration. The Series B round extension was also supported by existing investors. The Eyevensys technology is a non-viral gene therapy delivery platform that uses an electrotransfection system to deliver DNA plasmids encoding therapeutic proteins into the eye.
Two US biotech companies have launched a new partnership in order to use gene editing to develop medicines for multiple diseases including Type 1 diabetes. Vertex Pharmaceuticals Inc, known for its work in cystic fibrosis, and Arbor Biotechnologies Inc, a genetic disease specialist, will used Crispr gene editing technology to develop ex vivo engineered cell therapies. The new partnership, announced on 24 August, builds on a collaboration established in 2018.
The Roche Group has entered into a collaboration and licensing agreement with Shape Therapeutics Inc of Seattle, US giving it access to an RNA editing technology that reportedly has promise for neurological disorders. Shape was founded in 2018, and since then has raised $147.5 million in Series A and Series B financing rounds. The deal with Roche, announced on 24 August, could generate as much as $3 billion in milestone payments for Shape should the collaboration yield marketable products.
A Phase 3 trial of Kymriah (tisagenlecleucel), the pioneering chimeric antigen receptor (CAR) T cell therapy, did not meet its primary endpoint of event-free survival in patients with aggressive B cell non-Hodgkin lymphoma, Novartis announced on 24 August.
Pfizer Inc is expanding its presence in oncology with the acquisition of Trillium Therapeutics Inc, a Canadian company with a pipeline of early-stage therapies for treating haematological malignancies and solid tumours. The company’s two lead products target CD47, a molecule that tumours use to evade the immune system.
Valneva SE has started submitting regulatory data in support of its Covid-19 vaccine candidate to the UK Medicines and Healthcare products Regulatory Agency (MHRA) with a view to receiving an initial approval before the end of the year. The vaccine, VLA2001, is currently being studied in separate Phase 3 trials in the UK and New Zealand. Top-line results from the UK study are expected early in the fourth quarter.
The European Commission has approved funding from the Danish government to Bavarian Nordic A/S to support the company’s development of a vaccine for Covid-19. The funding will take the form of a repayable advance. The candidate vaccine, ABNCoV2, was developed by AdaptVac, a joint venture spun out of the University of Copenhagen, and licensed to Bavarian Nordic in July 2020. It uses AdaptVac’s viral capsid-like virus particle technology.
Interim data from an open-label extension study of bimekizumab, a treatment for plaque psoriasis, showed that a majority of patients who responded to the therapy at Phase 3, continued to benefit from the drug after two years. Bimekizumab is currently under review by the US Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis, a chronic inflammatory skin disease for which there is no cure. In June, it was given a positive opinion by the European Medicines Agency.