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.
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.
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.
Two late clinical-stage trials of candidate messenger RNA (mRNA) vaccines for Covid-19 have begun, the sponsors announced on 27 July. The developers are Moderna Inc, which is working with the US National Institute of Allergy and Infectious Diseases, and Pfizer Inc, which is collaborating with BioNTech SE of Germany.
The first head-to-head study of drugs targeting the pro-inflammatory cytokine iterleukin-17 (IL-17) has shown the superiority of bimekizumab, an investigational monoclonal antibody for the treatment of plaque psoriasis, compared with secukinumab (Cosentyx), an approved drug for the same disease, according to UCB SA, the Belgium-based pharmaceutical company.
The results of the Phase 3b head-to-head trial were announced on 24 July.
The checkpoint antibody, Tecentriq (atezolizumab), in combination with three other drugs, did not meet its primary endpoint of progression-free survival in a Phase 3 trial of women with advanced ovarian cancer, the developer Roche announced on 13 July. Tecentriq was being investigated with Avastin (bevacizumab), paclitaxel and carboplatin.
ReNeuron Group Plc has reported further positive long-term data for its cell therapy for retinitis pigmentosa (RP), a group of hereditary eye diseases that can lead to the progressive loss of sight and ultimately blindness. Data from a Phase 2a trial continued to show a meaningful clinical effect from the therapy at all intervals in time from the first treatment, and for the time, out to 18 months.
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.