Clinical Research

AstraZeneca Plc is to further evaluate the dosing for its candidate Covid-19 vaccine AZD1222 in light of interim data from trials in the UK and Brazil showing different efficacy rates for different dosing regimens. The data were disclosed on 23 November and showed vaccine efficacy of 90% when given as a half dose followed by a full dose at least one month apart. An efficacy rate of 62% was achieved when given as two full doses at least one month apart.

Genmab A/S has stopped development of enapotamab vedotin, an antibody-drug conjugate being investigated for the treatment of solid tumours after early clinical data did not meet the company’s criteria. “While enapotamab vedotin has shown some evidence of clinical activity, this was not optimised by different dose schedules and/or predictive biomarkers,” the company said on 24 November.

AstraZeneca Plc and the University of Oxford have become the third developers to report high levels of efficacy for their experimental vaccine to prevent Covid-19. The partners are now preparing for regulatory submissions, and have reaffirmed a commitment to supply their vaccine globally on a not-for-profit basis for the duration of the pandemic.

Novartis has entered into a licencing and collaboration agreement with Australia-based Mesoblast Ltd to further develop and commercialise remestemcel-L, an allogeneic cell therapy for the treatment of a number of inflammatory disorders. These include acute respiratory distress syndrome, and that associated with Covid-19. Acute respiratory distress syndrome is a type of respiratory failure characterised by the rapid onset of inflammation in the lungs.

BioNTech SE of Germany and its partner Pfizer Inc, announced final Phase 3 data for their Covid-19 vaccine on 18 November which showed a vaccine efficacy rate of 95%. The vaccine BNT162b2 is based on messenger RNA (mRNA) technology. The study met all of its primary efficacy endpoints. The efficacy rate applies to participants without prior SARS-CoV-2 infection, the first primary objective, and also to participants with and without prior SARS-CoV-2 infection, the second primary objective.

Moderna Inc said that its candidate vaccine, mRNA-1273, was 94.5% effective in preventing Covid-19 disease in a large Phase 3 study that enrolled more than 30,000 participates in the US. The compound is a messenger RNA (mRNA) vaccine against Covid-19 encoding for a prefusion stabilised form of the SARS-CoV-2 spike protein. It was co-developed by Moderna and the US National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.

Germany-based Cardior Pharmaceuticals GmbH has announced positive results from a Phase 1b study of its lead compound CDR132L, an antisense oligonucleotide, for heart failure. The study was performed in cooperation with Richmond Pharmacology Ltd in London, UK and the results were published in the European Heart Journal on 12 November 2020. In the trial, CDR132L met all the endpoints including safety and tolerability. The drug’s pharmacokinetic profile was found to be dose-dependently linear and target engagement data confirmed the mode of action.

BioNTech SE and its partner Pfizer Inc, have announced positive interim Phase 3 data for their Covid-19 vaccine which is based on messenger RNA (mRNA) technology. The vaccine candidate was found to be more than 90% effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced on 9 November.

Bimekuzumab, a monoclonal antibody developed by UCB SA, has achieved superior skin clearance in a Phase 3 trial of patients with plaque psoriasis compared adalimumab (Humira), a standard of care for the disease. Data from the study were presented at the European Academy of Dermatology and Venereology Congress on 31 October.

A Phase 2 study evaluating the safety and efficacy of bamlanivimab, an experimental antibody treatment developed by Eli Lilly and Co, has shown potential for treating Covid-19 patients outside a hospital setting. The study was published in The New England Journal of Medicine on 28 October 2020.

Bamlanivimab is an IgG1 monoclonal antibody that binds to the receptor-binding domain of SARS-CoV-2 in order to block entry of the virus into human cells. The antibody was derived from convalescent plasma from a Covid-19 patient.