A Phase 3 US trial of Kevzara (sarilumab) in patients hospitalised with COVID-19 has been stopped, Sanofi SA and Regeneron Pharmaceuticals Inc announced on 2 July. The study did not meet its primary and key secondary endpoints. Furthermore, in the primary analysis group, adverse events were experienced by 80% of Kevzara patients compared with 77% of patients on a placebo.
Germany-based BioNTech SE and its partner Pfizer Inc have reported positive early data from an ongoing Phase 1/2 study of a messenger RNA (mRNA) vaccine against the coronavirus SARS-CoV-2 showing that the vaccine was well tolerated and generated a dose dependent immunogenicity. Immunogenicity was determined by measuring SARS-CoV-2 antibody titers compared with levels observed in convalescent plasma from patients who have recovered from COVID-19.
Genmab A/S has reported favourable data in cervical cancer for its experimental antibody-drug conjugate (ADC), tisotumab vedotin, that it is developing with Seattle Genetics Inc. In a Phase 2 trial, the drug achieved a 24% objective response rate in patients with metastatic disease, with a median duration of response of 8.3 months. This compares with an objective response rate of less than 15% and a median overall survival of six to 9.4 months for standard treatments, the company said on 29 June.
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.