Novartis has secured approval in the US for Isturisa (osilodrostat), a new treatment for Cushing’s disease, a rare disorder in which the adrenal glands make too much of the cortisol hormone. Announcing the decision on 7 March, the Food and Drug Administration said that Isturisa is the first drug to directly address this cortisol overproduction by blocking the enzyme 11-beta-hydroxylase and preventing cortisol synthesis.
The Swiss oncology company, Numab Therapeutics AG has raised CHF 22 million (€21 million) in a Series B round to advance a portfolio of cancer therapies based on multi-specific antibodies that can engage two or more antigens at once. The new investors include 3SBio and its subsidiary Sunshine Guojian Pharmaceutical Co Ltd, which recently concluded a collaboration with Numab, giving the Chinese company rights to up to five antibody molecules in its portfolio.
A drug previously approved to treat idiopathic pulmonary fibrosis, Ofev (nintedanib), has received a new indication in the US – to treat patients with chronic fibrosing interstitial lung diseases. Announcing the decision on 9 March, the Food and Drug Administration said it was the first treatment authorised for this group of fibrosing lung diseases which worsen over time. Ofev was developed by Boehringer Ingelheim GmbH.
Gilead Sciences Inc is to expand its presence in immuno-oncology with the acquisition of Forty Seven Inc whose lead product, magrolimab, is in clinical development for the treatment of several cancers. Gilead will acquire Forty Seven for $95.50 per share in cash giving a transaction value of about $4.9 billion. The deal is expected to close during the second quarter.
Immunocore Ltd has secured $130 million in Series B funding from new and existing investors to progress its portfolio of biologic drugs for cancer, infection and autoimmune disease. The company’s technology involves engineering T cell receptors and linking them to an antibody fragment that can activate the immune system to kill a cancer or a viral cell. Proceeds from the offering will enable to company to advance two wholly owned clinical stage programmes for chronic hepatitis B and a compound targeting PRAME, an antigen expressed on a wide range of tumours.
The UK synthetic biology company Evonetix Ltd has raised $30 million in a Series B financing round led by Foresite Capital, a San Francisco, US-based venture capital company. Evonetix will use the proceeds for the development of technology enabling the synthesis of DNA on a chip. The silicon chip, which is made by a process technology known as MEMS, integrates physics with biology, and controls the synthesis of DNA at many thousands of independently controlled reaction sites or pixels on the chip surface.
A new antibiotic capable of treating infections from aerobic Gram-negative bacteria has been given a positive opinion by the European Medicines Agency. Fetcroja (cefiderocol) was shown to be effective in complicated urinary tract infections, nosocomial pneumonia and in critically ill patients with confirmed carbapenem-resistant infections. It was developed by Shionogi & Co Ltd in Japan and approved by the US Food and Drug Administration in November 2019. Once the EMA positive opinion is confirmed by the European Commission, the drug will be available to health authorities in Europe.
Results from a Phase 2 study of a new treatment for the chronic skin condition, prurigo nodularis, showed that the antibody performed better on a pruritus rating scale than placebo and also delivered clear or nearly clear skin for over one third of participants. Results of the trial were published in the New England Journal of Medicine on 20 February.
An experimental therapeutic cancer vaccine with a dual mode of action has passed its first clinical hurdle and will continue to be investigated as a first-line therapy in patients with metastatic non-small cell lung cancer (NSCLC). The vaccine, IO102 is being developed by IO Biotech ApS of Denmark in combination with Keytruda. An interim Phase 2 analysis, designed as a futility analysis, showed that the vaccine delivered an objective response rate that was substantially higher than Keytruda monotherapy had done in patients with a similar profile.
Thermo Fisher Scientific Inc is to acquire Qiagen NV of the Netherlands, significantly expanding its service offering to the global life sciences industry. The transaction values Qiagen at approximately $11.5 billion, which includes the assumption of Qiagen’s $1.4 billion in net debt. The offer price of €39 per share represents a premium of about 23% to the closing price of Qiagen’s shares on the Frankfurt Stock Exchange on 2 March.