Clinical Research

Data from two Phase 3 studies of the antibody therapeutic ofatumumab in relapsing multiple sclerosis have been published in the 6 August 2020 edition of The New England Journal of Medicine, illustrating the drug’s possible role as a first-choice option for patients with the disease, Novartis announced on 5 August. The data compared ofatumumab with teriflunomide (Aubagio), a marketed multiple sclerosis treatment.

Germany-based Medigene AG continued to progress its pipeline of cellular immunotherapies for cancer in the first half year of 2020 with the launch of a Phase 1 trial of a candidate product for patients suffering from relapsed blood cancers.

A Phase 3 trial of the checkpoint inhibitor Tecentriq (atezolizumab), combined with paclitaxel, did not reach statistical significance on its primary endpoint of progression free survival in patients with metastatic triple negative breast cancer, the developer Roche announced on 6 August. This is despite the fact that an earlier study of the same drug showed a benefit.

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.

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.