Clinical Research

Delay in Sanofi and GSK Covid-19 vaccine

Sanofi SA and its partner GlaxoSmithKline Plc are to test a new antigen formulation for their  Covid-19 vaccine in order to generate a better response from older adults. Assuming all data are positive, the vaccine would be available in the 2021 fourth quarter rather than mid-2021, the companies announced on 11 December 2020.

AZ-Oxford vaccine trial in The Lancet

Country
United Kingdom

Astra Zeneca Plc has announced the publication on 8 December of interim Phase 3 data of a Covid-19 vaccine that it is developing with the University of Oxford in The Lancet. The interim analysis for efficacy and safety, as outlined in the article, are in line with previous disclosures, the company said.

Yescarta shows four-year survival rate of 44%

Country
United States

An estimated 44% of patients with advanced lymphoma are still alive four years after receiving a single infusion of Yescarta (axicabtagene ciloleucel) for their disease. The new long-term survival data were presented by Gilead Sciences Inc at the annual meeting of the American Society of Hematology (ASH), further illustrating the efficacy of the chimeric antigen receptor (CAR) T cell therapy class.

Targovax reports promising oncolytic virus data

Country
Norway

Norway-based Targovax ASA has reported promising Phase 1 data for its oncolytic virus treatment ONCOS-102 in combination with pembrolizumab in patients with advanced, unresectable melanoma. The patients had experienced disease progression despite treatment with a checkpoint inhibitor, yet in the study tumour responses were observed in seven out of 20 evaluable patients.

Galapagos reports data for IPF treatment

Country
Belgium

Galapagos NV has reported positive topline data from an early clinical trial of a small molecule antagonist of GPR84 in patients with idiopathic pulmonary fibrosis. The placebo-controlled study enrolled 68 patients but was not powered to show statistical significance. Nevertheless, patients receiving the treatment GLPG1205 on top of a standard of care showed a smaller decline in forced vital capacity, a measure of lung function, than those receiving a placebo and standard of care.

Moderna makes Covid-19 regulatory filings

Country
United States

Moderna Inc is poised to make regulatory filings in the US and Europe today for its Covid-19 vaccines. This follows the release of new data from a Phase 3 study showing that the messenger RNA (mRNA) vaccine achieved an efficacy rate of 94.1%. The placebo-controlled study involves 30,000 participants.

AZ to further evaluate Covid-19 vaccine dose

Country
United Kingdom

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 stops development of ADC

Country
Denmark

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.

AZ and Oxford report vaccine efficacy

Country
United Kingdom

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 gets rights to allogeneic cell therapy

Country
Switzerland

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.