ViiV Healthcare has received US approval for a combination drug to treat HIV-1. Cabenuva (cabotegravir and rilpivirine) is the first injectable, long-acting regimen for the treatment of the viral infection in adults who are on a stable antiretroviral regimen. It was authorised by the Food and Drug Administration after a priority review.
MiNA Therapeutics Ltd has secured a new collaboration for its small activating RNA (saRNA) technology which can potentially restore normal cell function by activating gene expression. The partner is Servier of France which has agreed to pay up to €220 million for access to the technology to identify the first target for an undisclosed neurological disorder.
Small activating RNAs are short, double-stranded oligonucleotides that selectively increase gene transcription. Proponents of the technology say it can reach disease targets that are inaccessible with other approaches.
Verquvo (vericiguat), a drug for heart failure, has been approved by the US Food and Drug Administration. It has a novel mechanism of action which demonstrated superiority to placebo in a Phase 3 trial of 5,050 patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than 45%, following a worsening heart failure event. In the trial, the drug reduced the risk of cardiovascular death or hospitalisation for heart failure, according to the developer Merck & Co Inc.
Ireland-based Neurent Medical Ltd has raised $25 million in Series B financing to prepare its lead product for chronic rhinitis for a regulatory application and commercialisation in the US. The product is a medical device to treat symptoms of chronic rhinitis and other inflammatory conditions. The funding round was led by new investor LSP (Life Sciences Partners), from its Health Economics Fund 2, and co-led by Atlantic Bridge. Fountain Healthcare Partners also participated as a returning investor.
A Phase 3 trial of a candidate immunotherapy for lung cancer, which was being compared with pembrolizumab, has been discontinued, the sponsor Merck KGaA announced on 20 January. The decision was taken on a recommendation of the trial’s independent data monitoring committee which said the study was unlikely to meet the co-primary endpoint of progression-free survival. The trial is known as INTR@PID Lung 037.
Merus NV of the Netherlands has secured a research collaboration with Eli Lilly and Co to develop three bispecific antibody therapies for cancer. The deal gives Merus a financial lift while enabling Lilly to enter the bispecific antibody space which is currently occupied by other large pharma companies such as Amgen Inc and Roche.
A new US company has been launched to progress a small molecule drug to inhibit the replication of SARS-CoV-2 and other RNA viruses. CoviCept Therapeutics Inc has received seed funding of $2.3 million from Forbion, the Netherlands-based life sciences venture capital firm. The new company is based in San Diego, US.
The venture capital firm Forbion has announced a large financing for one of its portfolio companies, NewAmsterdam Pharma BV, which is planning Phase 3 development of a cholesterol lowering drug for patients who aren’t well controlled on statins. The oversubscribed €160 million Series A round was led by Forbion and co-led by Morningside Ventures and Ascendant BioCapital.
Sanofi SA is to acquire Kymab Ltd of the UK in order to gain full rights to a monoclonal antibody therapy, KY1005, with potential for treating a wide variety of immune-mediated and inflammatory disorders. The French pharma group is to pay $1.1 billion upfront for the company in addition to milestone payments of up to $350 million. The lead asset reported positive data from a Phase 2a study of patients with atopic dermatitis in August 2020. The same molecule is being studied in acute graft-vs-host disease and other immune disorders.
The European Commission has granted a conditional marketing authorisation for a Covid-19 vaccine developed by Moderna Inc based on clinical data showing an efficacy rate of 94.1%. The vaccine, COVID-19 Vaccine Moderna, is to be administered to people from 18 years of age. It is the second Covid-19 vaccine to be approved by the EU following a recommendation by the European Medicines Agency. The first was a vaccine developed by BioNTech SE and Pfizer Inc. Both vaccines are based on messenger RNA (mRNA) technology.