News

The developer of a new antifungal agent designed as an inhaled therapy for invasive pulmonary aspergillosis, has received $92 million in new capital. UK-based Pulmocide Ltd will use the Series C financing to carry out a Phase 3 registration trial for the drug PC945, which is a triazole antifungal agent.

Three industry associations have issued an appeal to the European Commission to exempt advanced therapy medicinal products (ATMPs) from the EU’s genetically modified organism (GMO) legislation. This is to make the region more competitive as a site for clinical trials. The appeal was issued in a statement from the Alliance for Regenerative Medicine; the European Federation of Pharmaceutical Industries and Associations; and the European Association of Bioindustries. A paper was also published online on 24 May in the journal Human Gene Therapy.

Innovative Molecules GmbH of Germany has raised €20 million from a Series A financing round to progress a treatment for herpes simplex virus, a microbe that jumped from chimpanzees to humans more than 1.6 million years ago and now infects around two-thirds of the global population. There are two forms of the virus, type 1 and type 2, which can present either as cold sores on the mouth or blisters on the genitals. Once infected, an individual has the virus for life, though in many people it remains latent.

Aspirin has been eliminated as a possible treatment for patients hospitalised with Covid-19. This follows a large randomised clinical trial in the UK that assessed the effects of the compound on the survival of Covid-19 patients and their risk of developing a rare type of blood clot. Aspirin is widely used to reduce blood clotting in other diseases.

The UK-based oncology company Iksuda Therapeutics Ltd has completed a $47 million financing round to progress a pipeline of antibody-drug conjugates (ADCs), a drug class that is seeing renewed interest from investors because of advances in conjugation technologies. The financing was co-led by the South Korean entities Mirae Asset Financial Group and Celltrion Inc.

argenx SE is to take back rights to the antibody therapeutic cusatuzumab after its partner Cilag GmbH International, one of the Janssen Pharmaceutical Companies of Johnson & Johnson Inc, announced plans to quit the three-year-old collaboration. Cusatuzumab is in a Phase 1b study in newly-diagnosed, elderly patients with acute myeloid leukaemia (AML). It is being tested with venetoclax and the chemotherapy azacitidine.

A new treatment for Alzheimer’s disease was approved by the US Food and Drug Administration on 7 June using a surrogate end point for clinical benefit: a reduction of amyloid beta plaque in the brain. Aduhelm (aducanumab) was given an accelerated approval. It is the first new treatment approved for Alzheimer's disease in the US since 2003.

Novo Nordisk A/S has received US Food and Drug Administration approval for its drug Wegovy (semaglutide) for the treatment of obesity – the first weight management drug to be approved by the agency since 2014. More than one-third of US adults are estimated to be obese with the highest prevalence among those in middle age. Obesity is a risk factor for multiple disorders including heart disease, stroke and diabetes.

The scientific journal Nature Communication has published data from a Phase 1/2 study of an autologous faecal microbiota transfer treatment in patients with acute myeloid leukaemia (AML). Top-line data from the study were first presented at the American Society of Hematology Annual Meeting in December 2018. With further outcome data now available, the treatment has been shown to have had a positive impact on survival after two years.

NOXXON Pharma NV has reported more positive data from a study of its RNA oligonucleotide drug, plus radiotherapy, in patients with newly diagnosed brain cancer. The drug, NOX-A12, targets a chemokine protein in the tumour microenvironment with the goal of breaking tumour protection against the immune system.