Sanofi Pasteur, the vaccines arm of Sanofi SA, has reached an agreement with Translate Bio of the US to expand a two-year old collaboration in order to bring forward a candidate vaccine for COVID-19. The vaccine candidate uses messenger RNA (mRNA) technology and is expected to be ready for a first human trial in the fourth quarter of this year.
ISA Pharmaceuticals BV of the Netherlands has expanded a collaboration with Regeneron Inc to include a new trial for the companies’ combination treatment for human papillomavirus type 16 (HPV16)-induced cancers. The trial will recruit patients with oropharyngeal cancer, a type of head and neck cancer that affects tissues of the throat.
The UK government has approved the use of a generic corticosteroid, dexamethasone, for the treatment of patients in hospital with COVID-19 that require oxygen, including those on ventilators. This follows the results of a clinical trial conducted by the University of Oxford which showed that the drug can reduce the risk of death of patients on ventilation by as much as 35% and those on oxygen by 20%.
Eli Lilly and Company has started separate Phase 1 trials of antibody treatments that could potentially prevent and treat COVID-19. In the first trial, Lilly is collaborating with AbCellera Biologics Inc of Canada and in the second, with Junshi Biosciences of China. In both programmes, the companies will attempt to show that an antibody directed against the spike protein of the coronavirus can block the virus from attaching and entering cells, thus neutralising it.
AstraZeneca Plc has disclosed data from its Phase 3 trial of the lung cancer drug Tagrisso (osimertinib) after the trial was stopped in April because of strong efficacy signals. Tagrisso is a tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGFR). The Phase 3 trial, called ADAURA, was treating patients with early-stage disease.
Within a month of joining forces with the University of Oxford to develop a candidate vaccine for COVID-19, AstraZeneca Plc has secured manufacturing capacity to produce one billion doses of the prospective treatment as well as financial support of up to $1 billion from an agency of the US government.
The anti-inflammatory drug Dupixent (dupilumab) has generated positive data in a pivotal trial of patients with eosinophilic esophagitis, a chronic, allergic inflammatory disease of the esophagus. Part A of the Phase 3 trial, which enrolled patients 12 years and older, demonstrated significant clinical and anatomic improvements, including the ability to swallow, the developers Sanofi SA and Regeneron Pharmaceuticals Inc announced on 23 May.
Moderna Inc was set to raise gross proceeds of about $1.34 billion from a public share offering that was launched hours after the company reported positive interim data from a Phase 1 study of its messenger RNA (mRNA) vaccine for COVID-19. The company is issuing 17.6 million shares at a price of $76 per share. The offering is expected to close on 21 May. Proceeds will be used to finance the cost of manufacturing its COVID-19 vaccine which still has to complete clinical development and be approved by a regulator.
Netherlands-based Kiadis Pharma NV has raised €17 million in two private share placements enabling the cell therapy company to advance products for patients with both liquid and solid tumours. On 6 May, not long after the financing completed, the company received notice from US Food and Drug Administration that it could proceed with a Phase 2 study of its lead product – an adjunctive cell therapy for blood cancer patients undergoing a haploidentical haematopoietic stem cell transplant.
A Phase 3 trial of the small molecule drug elafibranor failed to meet its primary endpoint in adults with non-alcoholic steatohepatitis (NASH), the developer Genfit SA announced on 11 May. The trial was attempting to show a resolution of NASH without a worsening of fibrosis. The response rate among the 717 patients who were tested was 19.2% for those in the elafibranor group compared with 14.7% for patients on a placebo.