A Phase 3 trial of a small molecule drug designed to treat patients with metastatic non-small cell lung cancer failed to meet its primary endpoint of overall survival, the sponsor Ipsen SA announced on 8 December. Cabozantinib was being investigated in 366 patients with both squamous and non-squamous non-small cell lung cancer whose disease had progressed after treatment with a checkpoint inhibitor and chemotherapy.
Belgium-based UCB SA has reported positive Phase 3 data for its monoclonal antibody bimekizumab in hidradenitis suppurativa, a chronic inflammatory skin disease that is estimated to affect about one percent of the population in countries where the disease has been identified. Data from the two studies is expected to form the basis of global regulatory applications starting in the third quarter of 2023.
C4X Discovery Holdings Plc of the UK has secured a licensing deal with AstraZeneca Plc to apply its small molecule drug discovery technology to identify new treatments for inflammatory and respiratory diseases. The initial plan is to develop a product to treat chronic obstructive pulmonary disease (COPD).
The first faecal transplant therapy derived from the gut microbiome of healthy donors was approved by the US Food and Drug Administration on 30 November, paving the way for regulatory reviews of other products in the sector. The therapy, Rebyota, was developed by Ferring Pharmaceuticals Inc and approved for the prevention of recurrent Clostridioides difficile infection, a potentially life-threatening disease.
AstraZeneca Plc is to acquire a Dutch company with technology for developing T cell therapies for cancer which target antigens specific to a patient’s tumour. The company, Neogene Therapeutics Inc, was founded in Amsterdam, the Netherlands in 2018 and has a pipeline of candidate therapies that consist of engineered T cells equipped with receptors targeting tumour-specific antigens, also known as neoantigens.
A new German neuroscience company was formally launched in Heidelberg on 17 November with plans to develop small molecule drugs for the treatment of neurodegenerative diseases including amyotrophic lateral sclerosis and Huntington’s disease. FundaMental Pharma GmbH has received €10 million in seed financing from a consortium led by BioGeneration Ventures and Thuja Capital of the Netherlands and High-Tech Gründerfonds in Germany.
CatalYm GmbH has closed a Series C financing round, raising €50 million to support development of a therapy directed at the immune system for cancer. The Munich, Germany company has a candidate monoclonal antibody engineered to neutralise the tumour-produced growth differentiation factor-15 (GDF-15). GDF-15 acts as a regulator of immune cell activation and as an inhibitor of immune cell infiltration into the tumour tissue.
Merck & Co Inc is to acquire Imago BioSciences Inc, a clinical-stage biopharmaceutical company, for $36 per share in cash in order to strengthen its presence in haematology. The deal, valued at $1.35 billion, is expected to close in the first quarter of 2023. It will be one of the first big transactions executed by the company’s new chief executive Robert Davis, who has succeeded Kenneth Frazier.
Syncona Ltd has set out an ambition to organically grow its net assets to £5 billion by 2032, while resolving to continue a strategy of evergreen investing in promising life science companies. On 30 September, the end of the company’s first half year, net assets were valued £1,366 million, up from £1,309 million on 31 March, giving a net asset value return of 4.3%.
Researchers from nine academic centres, together with PACT Pharma Inc of the US, have reported data from a Phase 1 study of a novel cell therapy which produced initial signs of clinical activity in patients with a variety of solid tumours. The treatment is an allogeneic T cell receptor (TCR) T cell therapy which has been edited to recognise the patient’s specific cancer. This was done by equipping the TCR with a neoantigen specific to the cancer.