News

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.

The gene therapy developer Freeline Therapeutics Ltd has closed a $120 million extended Series C financing round in order to bring its lead programme for haemophilia B into a pivotal trial. Simultaneously on 30 June, it announced a possible initial public offering (IPO) of its shares in the US. The timing and the terms of such an offer have not been decided. Freeline’s majority shareholder is Syncona Ltd, formerly part of the Wellcome Trust.

A new Irish-German medical device company, OneProjects Ltd, has raised €11 million in a Series A financing round to develop imaging technology for cardiac arrythmias, including atrial fibrillation. The financing was led by Netherlands-based Life Sciences Partners BV, investing from its LSP Health Economics Fund 2. It was co-led by the Atlantic Bridge University Fund of Ireland, with participation from Enterprise Ireland.

Germany’s BioNTech SE has reached an agreement to place shares with the Singaporean investment group Temasek Holdings Private Ltd and other investors to raise $250 million for the ongoing development of its messenger RNA (mRNA) portfolio which includes an experimental vaccine programme for COVID-19. The transaction is expected to close in early to mid-August. It consists of an investment of $139 million in BioNTech shares and $112 million in four-year mandatory convertible notes.

The German biotech company Immatics Biotechnologies GmbH has become the latest European enterprise to list its shares on the US Nasdaq market in order to finance the development of immunotherapies for cancer. However Immatics chose an uncommon strategy for gaining market entry: it executed a reverse merger with a special purpose acquisition company.

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.