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.
The checkpoint antibody Keytruda has been approved as a first-line treatment for a certain type of metastatic colorectal cancer, bringing the number of US cancer indications for the drug up to 28. The approval was based on the results of a Phase 3 trial in which Keytruda was shown to reduce the risk of disease progression or death by 40% compared with chemotherapy, the current standard of care. Patients in the trial had metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
The US Food and Drug Administration has approved a new treatment for seizures associated with Dravet syndrome, but with a warning that the drug is associated with valvular heart disease and pulmonary arterial hypertension. The drug, Fintepla (fenfluramine), is an amphetamine derivative.
Hong Kong-based Hutchison China MediTech Ltd (Chi-Med) has raised $100 million from a share placement with a global equity firm to support the development of its oncology business. The placement was with General Atlantic which has offices on four continents and a significant life science portfolio.
After reviewing data from a US trial of remdesivir, the European Medicines Agency is recommending that the anti-viral treatment be given a conditional marketing authorisation to treat patients in the EU with COVID-19-associated pneumonia who require supplemental oxygen. The recommendation now goes to the European Commission for approval.
Netherlands-based BioGeneration Ventures has closed its fourth fund BGV IV at €105 million to continue its work building new companies in Europe around single assets or technology platforms. New investors included Industriens Pension of Denmark and KfW Capital of Germany, while Bristol-Myers Squibb Co, an investor in BioGeneration’s third fund, also participated in the new vehicle.
Emer Cooke, currently a director at the World Health Organization, has been nominated to become the new executive director of the European Medicines Agency, succeeding Guido Rasi whose term ends on 15 November. Ms Cooke is scheduled to address a committee of the European Parliament on 13 July, after which the appointment will be finalised.
The France-based microbiome company Enterome SA has closed a €46.3 million Series E financing round to advance the development of a microbiome derived product for cancer. The financing was supported by Takeda Pharmaceutical Company Ltd, which also has a collaboration with the company, and the investors Seventure Partners and Nestlé Health Science.