The US Food and Drug Administration has approved a new indication for Nucala (mepolizumab) for hypereosinophilic syndrome (HES), a group of rare blood disorders characterised by the overproduction of eosinophils, a type of white blood cell. It is the first approval for this patient group in nearly 14 years.
A case study of a 45-year old woman with severe Covid-19 has shown that administration of APN01, an experimental biologic, enabled the generation of neutralising antibodies against SARS-CoV-2 and a rapid drop in virus load. The results of the study were reported online in The Lancet Respiratory Medicine on 24 September 2020.
APN01 is being developed by the Austrian company Apeiron Biologics AG and has been shown to be safe in Phase 1 studies of healthy volunteers. It is currently being investigated in Phase 2 trials in Austria, Germany, Denmark, the UK and Russia.
The gene and cell therapy industry has significant potential. But this will only be realised if manufacturers share information about their technologies, enabling the advanced therapies to be produced at scale and marketed at affordable prices.
ADC Therapeutics SA of Lausanne, Switzerland has priced an upsized US public offering of its common shares yielding gross proceeds of $204 million to support the commercialisation of an antibody-drug conjugate (ADC) for diffuse large B cell lymphoma. The offering of six million shares was priced at $34 per share and will close on 28 September. In addition, certain existing shareholders have granted the underwriters a 30-day option to purchase up to 900,000 additional common shares.
ADC Therapeutics is listed on the New York Stock Exchange.
Nordic Nanovector ASA has raised NOK 231 million ($25 million) in a private share placement to support Betalutin, an antibody radionuclide conjugate that is being developed for follicular lymphoma, a type of non-Hodgkin’s lymphoma.
Semorinemab, an antibody directed against the tau protein, has failed to have an impact on patients with early Alzheimer’s disease despite earlier promise, the developer AC Immune SA announced on 23 September. Semorinemab is being developed with Genentech, a member of the Roche Group.
The life science investor Medicxi Ventures (UK) LLP has created a new fund, supported by private equity, to accelerate the development of six biotech companies being held by Index Ventures Life VI, a Jersey-based venture capital fund set up by its former parent company Index Ventures. Medicxi announced the transaction on 22 September, saying it will enable the companies to reach the next stages of value creation. The companies were not identified.
Salvia BioElectronics BV, a three-year old Dutch medical device company, has raised €26 million in Series A financing to advance development of an implant for the treatment of migraine. The product uses mild electrical impulses to influence nerve activity.
The Roche group is to acquire Ireland-based Inflazome Ltd and its portfolio of compounds for the treatment of a range of inflammatory diseases. The small molecule drugs inhibit the protein NLRP3 which is expressed in macrophages and is a component of the inflammasome. Activation of the NLRP3 inflammasome is implicated in many diseases caused by chronic, uncontrolled inflammation.
Verona Pharma Plc, a clinical-stage British company developing treatments for respiratory diseases, has announced plans to delist its shares from the AIM market in London portion of the London Stock Exchange on 30 October because a parallel listing on the US Nasdaq market has accounted for 98% of trading in the past six months.
Shareholders who convert their shares into American Depository Shares (ADSs) prior to the delisting will not be subject to stamp duty or charges by the depository bank, the company said.