News

Bacthera AG, a joint-venture contract manufacturer, has received authorisations from regulatory authorities in Switzerland and Denmark to begin supplying active ingredients to developers of live biotherapeutic products, a new therapeutic modality. The supply will be used for clinical trials of candidate therapies, and eventually for their commercialisation.

According to the consultancy Roots Analysis, more than 85 microbiome-based live biotherapeutic products were in preclinical and clinical development in mid-2020 with demand for manufacturing capacity rising.

A new drug to treat lung cancer caused by a specific genetic mutation has been approved by the US Food and Drug Administration. Lumakras (sotorasib) has been authorised for patients with non-small cell lung cancer whose tumours have a KRAS G12C mutation and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumours with any KRAS mutation. KRAS G12C mutations represent about 13% of all mutations in non-small cell lung cancers.

The Canadian real estate investor Oxford Properties Group has acquired a life science park in Cambridge, UK for £45 million as part of a strategy to service the global life science sector. The park, 310 Cambridge Science Park, is currently let to AstraZeneca Plc until November 2023, after which the company will move to new headquarters in the area.

Abivax SA has reported efficacy in a Phase 2b trial of a small molecule treatment for ulcerative colitis, paving the way for the start of a Phase 3 programme by the end of the year. Patients in the placebo-controlled trial had moderate to severe colitis and included individuals refractory to conventional drugs including biologics and/or JAK inhibitors. Significantly, the lowest dose of 25 mg was effective across the entire study population, the company announced on 24 May.

Pieris Pharmaceuticals Inc has entered into a new collaboration involving its proprietary protein technology in order to develop therapies for respiratory and retinal diseases. The agreement with Genentech, a member of the Roche Group, is the company’s fifth partnership since its founding in 2000, and the first in ophthalmology.

The European Medicines Agency has given a positive opinion to a new gene therapy for cerebral adrenoleukodystrophy (CALD), a rare inherited neurological disease that affects approximately one in 21,000 newborn males. The scientific endorsement, which is the first step towards a formal marketing authorisation, is based on data from a single-arm trial.

The US Food and Drug Administration has approved a new bispecific antibody for the treatment of non-small cell lung cancer whose tumours have a specific genetic mutation. Rybrevant (amivantamab) was authorised for patients with lung cancers which have an epidermal growth factor receptor (EGFR) exon 20 insertion mutation.

Numab Therapeutics AG has raised CHF 100 million ($111.48 million) from a Series C financing round, enabling it to accelerate development of its lead antibody programme for multiple cancer indications. The latest financing was co-led by new investors Novo Holdings and HBM Partners. It comes a little over a year after Numab completed a Series B round for CHF 22 million.

Dyno Therapeutics Inc, based in Cambridge, Massachusetts, US, has raised $100 million in a Series A financing round to expand its technology platform for designing adeno-associated virus (AAV) vectors for gene therapies. The company is using artificial intelligence to improve the performance of capsids, the cell-targeting protein shells of AAV vectors.

Novo Nordisk A/S ended the first quarter with sales of DKK 33.8 billion ($5.56 billion), unchanged from a year earlier. But turnover is expected to increase by 2% to 6% for the year as a whole on stronger demand for the company’s non-insulin products for diabetes. Sales of the company’s glucagon-like peptide-1 (GLP-1) medicines, which reduce blood glucose by mimicking the actions of a natural hormone, rose by 13% in the quarter. This compared with a decline of 7% for the company’s traditional insulins. Sales of biopharmaceuticals, which include drugs for haemophilia, were down by 6%.