A second rheumatoid arthritis drug has failed to improve the condition of patients with severe Covid-19 associated pneumonia. Actemra (tocilizumab) did not meet its primary endpoint in a Phase 3 trial of hospitalised Covid-19 patients, Roche announced on 29 July. This follows news earlier in the month that a trial of Kevzara (sarilumab), also for hospitalised Covid-19 patients, was stopped early on lack of efficacy and adverse events.
The chimeric antigen receptor (CAR) T cell therapy Kymriah (tisagenlecleucel) has delivered positive data in a Phase 2 study of patients with relapsed or refractory follicular lymphoma, the second most common form of non-Hodgkin lymphoma, Novartis announced on 4 August. The global ELARA trial met its primary endpoint of complete response rate as assessed by an independent review committee. No new safety signals were observed.
MorphoSys AG has secured regulatory approval from the US Food and Drug Administration for its first proprietary antibody therapeutic, Monjuvi (tafasitamab), to treat adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). The approval was based on data from the Phase 2 L-MIND study, a multicentre, single arm trial of Monjuvi in combination with lenalidomide, a drug for multiple myeloma. DLBCL is the most common type of non-Hodgkin lymphoma that can develop in the lymph nodes or any organ of the body.
Sangamo Therapeutics Inc is to help develop genomic medicines for neurodevelopmental disorders under a new agreement with Novartis valued at up to $795 million. The two companies will use Sangamo’s zinc finger protein transcription factor technology to upregulate the expression of three undisclosed genes involved in diseases which include autism spectrum disorder and intellectual disability.
F-star Therapeutics Ltd is set to gain a listing on Nasdaq through a merger with Spring Bank Pharmaceuticals Inc of the US giving it a fresh source of capital to advance its pipeline of bispecific antibodies. The transaction is expected to complete in late 2020 and give F-star’s shareholders 61.2% of the new group to be called F-star Therapeutics Inc.
Eliot Forster, the current chief executive of F-star, will become president and chief executive of the combined group which will be co-located in Cambridge, UK and Cambridge, Massachusetts, US.
The US government is to provide up to $2.1 billion to Sanofi SA and GlaxoSmithKline Plc to help them develop and manufacture a Covid-19 vaccine. The two European companies are among eight others selected for support under the government’s Operation Warp Speed programme. The goal is to secure supplies of a variety of vaccines for the US population.
Sanofi and GSK are working on a candidate vaccine that combines the French company’s recombinant protein-based technology with adjuvant from GSK. Sanofi has used the same technology for an influenza vaccine.
Sanofi SA reported a strong performance of the specialty medicine Dupixent in the second quarter, a period which also saw the French multinational seal an agreement with GlaxoSmithKline Plc to develop a new vaccine for Covid-19. On 31 July, the two companies announced supply agreements with both the US and the EU for the vaccine, which is based on recombinant protein-based technology developed by Sanofi and adjuvant from GSK.
Immunic Inc has reported positive Phase 2 data for its small molecule drug for multiple sclerosis. The study of IMU-838 achieved primary and key secondary endpoints of the trial, which enrolled patients with relapsing-remitting disease. In a statement on 3 August, Andreas Muehler, chief medical officer, said the data showed robust responses across all study endpoints as well as a favourable safety and tolerability profile.
AstraZeneca Plc ended the first half with higher sales across all product groups and geographical areas as well as an increase in its operating profit margin. The sales increases were led by products for lung and ovarian cancers, as well as the asthma medicine Symbicort. Geographically, sales were higher in the emerging markets than in the US, driven by sales in China.
Belgium-based UCB SA is to out-license an experimental anti-tau antibody to the Roche group for development as a potential treatment for Alzheimer’s disease, the most common form of dementia. The antibody, UCB0107, targets a central tau epitope which is being developed to block or reduce the spread of tau pathology.