Shares in Synairgen plc have cratered after a phase III trial of its inhaled COVID-19 therapy SNG-001 failed to produce conclusive results, with the company blaming improvements in standard care for the disappointing findings in patients hospitalized with the disease. The Southampton, U.K.-based biotech’s shares (LSE:SNG) touched lows of 10 pence, down 94%, and stabilized around 85% below their previous closing price of £25.36 after the announcement on Monday.
After a landmark clinical trial of the first POLQ inhibitor in cancer last year, a recently formed U.K. biotech is gearing up to bring a potential rival to the clinic in the coming months. Varsity Pharmaceuticals Ltd., of Cambridge, is planning to begin a phase I trial of novobiocin, a drug previously used as an antibiotic, which has also been found to inhibit the polymerase theta inhibitor (POLQ) pathway.
Glaxosmithkline plc has voluntarily paused a late-stage trial of its potential respiratory syncytial virus (RSV) maternal vaccine candidate in pregnant women following a safety warning. In a brief statement, the London-based firm said it also paused recruitment in two other trials investigating the drug in pregnant women.
Modra Pharmaceuticals BV is planning to move its oral formulation of docetaxel into a pivotal trial, hoping to offer advanced prostate cancer patients a safer treatment option than intravenous chemotherapy. The Amsterdam, the Netherlands-based company has just announced phase IIb results in metastatic castration-resistant prostate cancer from ModraDoc-006/r, a tablet containing docetaxel and co-administered with ritonavir to enhance bioavailability.
In the bad old days of cancer treatment, it was the nasty side effects of chemotherapy that often ended up limiting treatment – and while checkpoint inhibitors have raised the bar in terms of efficacy and safety, they can have dangerous and unpleasant off-target consequences, too. Finding ways to focus the immune system on cancer and limiting any off-target effects will not only make checkpoint inhibitor therapy more tolerable but could also improve survival rates – and Sweden’s Ilya Pharma AB aims to do this with a novel approach combining synthetic biology with cell therapy.
Infectious disease specialist Aicuris Anti-infective Cures AG has signed a worldwide license agreement worth up to €100 million (US$114 million) with Hybridize Therapeutics for a potential therapy to prevent BK virus (BKV) infections in immunocompromised patients.
Lyme disease is the most common vector-borne disease in the U.S. and is also common in certain areas of Europe. Yet, despite this, there are no FDA-approved vaccines available to treat it, meaning those diagnosed must receive a dose of antibiotics. But antibiotics are problematic because of the risk of treatment-resistant strains emerging. That leaves a pressing need for a vaccine or other way to prevent infections from the tick-borne bacterium Borrelia burgdorferi.
The U.S. FDA has approved Sanofi SA’s treatment for cold agglutinin disease (CAD), sutimlimab, after the drug was initially rejected by the regulator for technical reasons in 2020. Paris-based Sanofi’s drug will be branded as Enjaymo.
In one of its familiar U-turns, the U.K. National Institute for Health and Care Excellence (NICE) has recommended NHS England should fund a rare disease gene therapy from Orchard Therapeutics plc, considered to be the world’s most expensive drug. The list price for Libmeldy (atidarsagene autotemcel) in England and Wales is £2,875,000 (US$3.9 million), making it the most expensive drug that NICE has ever evaluated.
Mersana Therapeutics Inc. has signed a potential billion-dollar agreement with Johnson & Johnson’s Janssen Biotech Inc. to research and develop antibody-drug conjugates (ADCs) for three cancer targets. Janssen will pay $40 million up front as well as more than $1 billion in potential milestone payments in a big day for ADCs, which saw Mersana’s other development partner, Synaffix BV, announce a tie-up with Macrogenics, Inc. in a deal worth up to $586 million.
