T-knife GmbH, a new company with technology for humanising T cell receptors derived from transgenic mice, has raised €66 million in a Series A financing round in order to develop therapies to treat solid tumours. Current gene based cell therapies for cancer have been highly successful in treating haematological malignancies. However thus far they have been unable to overcome multiple barriers for the treatment of solid tumours.
H. Lundbeck A/S has stopped a Phase 2 proof of concept study of a small molecule drug for schizophrenia after an interim analysis of the data showed the trial was unlikely to achieve statistical significance on its primary endpoint. The drug Lu AF11167 is an inhibitor of the phosphodiesterase 10A enzyme.
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.
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.