A Phase 2 trial of a small molecule treatment for ulcerative colitis failed to meet its primary endpoint of clinical remission in patients due to an apparent treatment interference from corticosteroids, according to the developer Immunic Inc. The treatment, vidofludimus calcium, was being compared with placebo in patients with moderate-to-severe disease.
Minoryx Therapeutics SL of Spain has raised €51 million in order to prepare for the regulatory review and possible market launch of its drug leriglitazone for the rare orphan disease X-linked adrenoleukodystrophy (X-ALD). The company is preparing a marketing authorisation application for the European Medicines Agency and holding pre-registration talks with the US Food and Drug Administration. The EU filing would be directed at treating adult male patients with the X-ALD phenotype adrenomyeloneuropathy (AMN).
Germany-based Immatics NV is to make its cell therapy platform available to Bristol Myers Squibb Co in order to develop a further cohort of immunotherapies for cancer. The collaboration, announced on 2 June, is an expansion of an existing partnership aimed at developing off-the-shelf cell therapies for solid tumours.
Pfizer Inc plans to unwind its holding in the prospective consumer healthcare company, Haleon, once Haleon is publically listed, the US company announced on 1 June. Haleon is a joint venture company set up by GlaxoSmithKline Plc and Pfizer Inc to pool their respective consumer healthcare assets in order to bring greater scale to the business.
GSK has a controlling 68% interest in the business, while Pfizer holds 32%.
GlaxoSmithKline Plc is to pay up to $3.3 billion to acquire Affinivax, Inc of Cambridge, US, which has a portfolio of vaccines to prevent pneumococcal disease and other infections. The deal is one of the company’s largest, and consists of an upfront payment of $2.1 billion plus two milestone payments of $0.6 billion each. The milestone payments will be dispensed upon the completion of certain paediatric clinical studies. Affinivax’s lead product, AFX3772, is in Phase 2 for the prevention of infection from Streptococcus pneumoniae, a gram-positive bacterium.
A Cambridge, UK company investigating the therapeutic potential of antisense long non-coding RNAs has raised an additional £4.6 million in seed financing to accelerate the development of its product portfolio focused on diseases of the central nervous system and ophthalmology indications. Transine Therapeutics Ltd announced the additional funding on 31 May, bringing total proceeds from the seed round up to £13.7 million. The round was led by new investor Epidarex Capital with participation from existing investor the Dementia Discovery Fund.
Evotec SE has expanded its capabilities in the field of cell therapy with the acquisition of the Italian company Rigenerand Srl, a 2009 spin-off of the University of Modena and Reggio Emilia. The acquisition, valued at €23 million, comes within weeks of Evotec’s agreement with Sernova Corp of Canada to develop a beta cell replacement therapy for diabetes. The prospective therapy will use induced pluripotent stem (iPS) cells produced by Evotec, combined with a pouch developed by Sernova.
A peptide vaccine intended to prevent disease progression in patients with prostate cancer failed to show efficacy in a Phase 2b study despite promising data earlier in its development. The vaccine, RV001 (onilcamotide) was developed by RhoVac AB of Sweden which announced the study results on 30 May.
The US Food and Drug Administration has approved a new indication for Dupixent (dupilumab), broadening its role as a leading anti-inflammatory medicine for allergic diseases. The new use is for eosinophilic oesophagitis (EoE), a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the oesophagus. This can impair a person’s ability to swallow. Dupixent is a monoclonal antibody that blocks interleukin 4 and interleukin 13 – part of the inflammatory pathway.
RQ Biotechnology Ltd was launched in the UK on 17 May to develop broad-spectrum monoclonal antibodies to protect vulnerable people at risk of severe disease from existing, emerging and new viral infections. The company’s scientific co-founders are the University of Oxford and the UK medical research charity LifeArc, formerly MRC Technology. RQ Biotechnology is initially being financed under a licensing agreement with AstraZeneca Plc for candidate antibody drugs to treat SARS-CoV-2 infections.