H. Lundbeck A/S has entered a collaboration with a US start-up company specialising in small molecules that target RNA, as part of a drive to expand its portfolio of medicines for central nervous system disorders. The collaboration is with Rgenta Therapeutics Inc of Cambridge, Mass, US, which has technology for identifying regulatory sites in RNA that are amenable for modulation by small molecules.
A new enzyme replacement therapy for Pompe disease has been approved by the US Food and Drug Administration, which has been shown to help reduce glycogen accumulation in muscles – a feature of the disease. The therapy, Nexviazyme (avalglucosidase), is a version of Myozyme (alglucosidase alfa), which was approved by the FDA in 2006. Both therapies were developed by Genzyme, which is part of Sanofi SA.
A new biologic for systemic lupus erythematosus has been approved by the US Food and Drug Administration, marking the first innovation in the treatment of the disease in more than a decade, the sponsor AstraZeneca Plc announced on 2 August. Saphnelo (anifrolumab) blocks a receptor in the type 1 interferon pathway preventing aberrant activation of the immune system. It is this activation that can cause immune cells to mistakenly attack healthy tissues in the body, a hallmark of lupus.
A bidding contest between Philip Morris and Carlyle, a private equity firm, for ownership of the UK pharma company Vectura Group Plc has taken an unexpected turn. Vectura’s board of directors has received a higher offer for the company from Carlyle and has announced plans to recommend that shareholders approve it. This comes just a month after the board recommended an offer from Philip Morris International, which in turn had outbid an earlier offer from Carlyle.
A single dose vaccine in development to protect against the chikungunya virus has been shown to be effective with no safety concerns, the sponsor Valneva SE announced on 5 August. The vaccine VLA1553 met its primary endpoint in a Phase 3 pivotal trial achieving a seroprotection rate of 98.5% - well above the 70% threshold set by the US Food and Drug Administration.
Bayer AG has expanded its oncology portfolio with the acquisition of Vividion Therapeutics Inc of the US and its proprietary drug discovery platform. Vividion’s technology involves identifying previously unknown pockets on well-validated protein targets implicated in a wide range of diseases. The company’s lead programmes are small molecule drugs targeting NRF2 mutant cancers as well as NRF2 activators for a number of inflammatory diseases. NRF2 is a protein that helps regulate the work of antioxidant proteins that protect against oxidative damage.
A Phase 3 trial of the checkpoint inhibitor Libtayo (cemiplimab) combined with chemotherapy for patients with advanced non-small cell lung cancer was stopped early for efficacy, the sponsors Sanofi SA and Regeneron Pharmaceuticals Inc announced on 5 August. The combination therapy was found to reduce the risk of death by 29% compared with chemotherapy alone in a trial of 466 patients with locally advanced and metastatic disease.
Sanofi SA is to further extend its investment in messenger RNA (mRNA) technology with a bid to acquire Translate Bio Inc, a company with which it has had an mRNA vaccine collaboration since June 2018. The French company is offering $38 per share in cash for Translate Bio, giving a transaction value of $3.2 billion. Sanofi will finance the deal internally.
T-knife Therapeutics Inc has raised $110 million in a Series B financing round to advance its preclinical portfolio of T cell receptor (TCR) therapies for cancer. The technology originated in Germany and will be developed and commercialised by teams based in Berlin and San Francisco, US.
The Italian healthcare group, Angelini Pharma, has become the sole institutional investor in a new venture fund that will provide capital to promising neuroscience companies in North America. The fund will be managed by Lumira Ventures of Canada and is called Angelini Lumira Biosciences Fund (ALBF). Angelini will commit $35 million to the fund in addition to investing $5 million in Lumira Ventures IV, a separate fund.