News

Molnupiravir efficacy downgraded

Country
United States

Merck & Co Inc and its partner Ridgeback Biotherapeutics LP published new efficacy data for their Covid-19 treatment on 26 November showing that the anti-viral drug reduced the risk of hospitalisation or death by 30%, compared with a placebo, instead of the earlier reported 50%. The updated efficacy figure is based on additional data presented to the US Food and Drug Administration. The FDA’s Antimicrobial Drugs Advisory Committee was scheduled to meet on 30 November to evaluate the latest information.

Quell Therapeutics raises $156 million

Country
United Kingdom

A cell therapy company launched by Syncona Ltd in 2019 has completed an oversubscribed Series B financing round to start the clinical development of a compound to prevent organ rejection in liver transplant patients. Quell Therapeutics Ltd raised $156 million from a consortia co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC. Syncona also participated in the round.

Quell is developing engineered T regulatory (Treg) cells as therapies.

Valo Therapeutics prepares for the clinic

Country
Finland

Finland-based Valo Therapeutics Oy has raised €11 million in an over-subscribed financing round to support a first clinical trial of it lead cancer drug – an antigen-coated oncolytic virus. The financing, announced on 15 November, was led by the corporate advisory firm Ironside Capital. Existing investor Freeman Road Pty Ltd participated in the round as did new investor MMJ Group Holdings of Australia. The round is being described as a prelude to an initial public share offering.

GSK gets rights to drug for NASH

Country
United Kingdom

GlaxoSmithKline Plc has negotiated rights to a candidate treatment for non-alcoholic steatohepatitis (NASH) from Arrowhead Pharmaceuticals Inc which uses RNA interference (RNAi) technology to reduce levels of the liver enzyme ALT and address the disorder. The candidate therapy, ARO-HSD, targets the protein-coding gene HSD17B13 which is involved in the metabolism of hormones, fatty acids and bile acids. NASH is a disorder in which excessive fat builds up in the liver, causing inflammatory damage and fibrosis.

Novo to acquire Dicerna Pharmaceuticals

Country
Denmark

Novo Nordisk A/S is to acquire Dicerna Pharmaceuticals Inc, a company developing candidate RNA interference (RNAi) therapeutics for multiple diseases including cardiometabolic, viral, and chronic liver indications. Under the terms of the agreement, Novo will acquire all of the outstanding shares of Dicerna for $38.25 per share for a total equity value of $3.3 billion.

Sanofi invests in AI enterprise

Country
France

Sanofi SA has announced an equity investment of $180 million in Owkin, a company with an AI platform which enables scientists to conduct research on diseases without having to pool data centrally. The model, called ‘federated learning,’ enables data scientists to securely connect to decentralised, multi-party data sets and create AI models for targeted drug discovery. Owkin is based in New York City, US but has scientific roots in France.

Migraine treatment gets positive opinion

Country
Denmark

A preventive treatment for migraine, Vyepti (eptinezumab), has received a positive opinion from the European Medicines Agency – the first step towards getting an authorisation for the EU market. If approved, it will be the first and only intravenous treatment for migraine prevention in the region, the developer H. Lundbeck A/S, announced on 12 November.

Drug for polycythemia vera

Country
United States

A new drug has been approved by the US Food and Drug Administration for polycythemia vera, a rare disease that causes the bone marrow to make too many red blood cells, which can thicken the blood and cause clots. Besremi (ropeginterferon alfa-2b-njft) is the first approved medicine for this disease that patients can take, irrespective of their treatment history. It is also the first interferon therapy specifically approved for polycythemia vera.

Robert Califf to head FDA

Country
United States

Robert Califf, a professor of medicine at the Duke University School of Medicine, is to be nominated to lead the US Food and Drug Administration – a position he held during the final year of the Obama administration and will return to under the Biden presidency. A cardiologist, Dr Califf has been vice chancellor for clinical and translational research at Duke and was founding director of the Duke Clinical Research Institute, where he led many clinical trials.

Syncona leads cell therapy financing

Country
United Kingdom

Syncona Ltd has taken the lead in financing a new cell therapy company that is developing induced pluripotent stem cell (iPSC) derived medicines. Clade Therapeutics, located in Cambridge, US, has a platform technology that ‘cloaks’ human pluripotent stem cells and their adult derivatives enabling the development of immune compatible cell transplantation therapies. The company is initially focused on demonstrating the potential of cloaked immune cells as cancer treatments.