News

The UK gene therapy company Autolus Therapeutics Plc has raised $100.8 million in a US public share offering to support its portfolio of programmed T cell therapies for the treatment of cancer. This follows the issue of 4.2 million American Depositary Shares (ADSs) representing 4.2 million ordinary shares which were priced at $24 per ADS. In addition, Autolus has granted the underwriters a 30-day option to purchase up to an additional 630,000 ADSs at the public offering price.

An early stage chimeric antigen receptor (CAR) T cell therapy that targets an antigen expressed on myeloma cells has been singled out for a fast-track review by the European Medicines Agency. The cell-based gene therapy, JNJ-4528, is being co-developed by Nanjing Legend Biotech Co of China and Janssen Research & Development LLC.

AveXis, a gene therapy company acquired by Novartis in 2018, is to expand its manufacturing capacity with the purchase of an advanced biologics facility in Colorado, US. This coincides with the US regulatory review of the company’s gene therapy for spinal muscular atrophy (SMA), a neuromuscular disease.

The Food and Drug Administration is expected to deliver a decision on marketing authorisation in May. AveXis will also seek regulatory approvals for the therapy in the EU and Japan.

Cambridge Innovation Capital Plc, a venture capital company supporting businesses in and around Cambridge, UK has raised £150 million in new capital to support its portfolio of healthcare and technology companies. The financing is one of the largest private rounds in Europe this year and more than doubles to £275 million the resources available to the company.

Novartis is to spend $310 million upfront to acquire a portfolio of candidate small molecule drugs targeting a pathway in the innate immune system that could potentially treat chronic inflammatory disorders as well as nonalcoholic steatohepatitis (NASH), a condition in which fat builds up in the liver.

Evotec AG continued to benefit in 2018 from its dual business model as a service provider and drug discoverer and developer, delivering a 42% increase in revenue to €375 million and a near doubling of operating profit to €77.5 million. One feature of the year was the full integration of the Aptuit contract research organisation, acquired in 2017. Another was a new alliance with Celgene Corp in targeted protein degradation.

A new gene therapy has been given a favourable scientific review in Europe paving the way for its use in patients with beta-thalassaemia as early as the second quarter. The treatment, Zynteglo, uses a lentiviral vector to deliver functional copies of a beta-globin gene into a patient’s haematopoietic stem cells in order to correct for a shortage of beta-globin. It was given a positive opinion by the European Medicines Agency on 29 March.

Antibody-drug conjugates (ADCs) have assumed new prominence as cancer treatments in the wake of a deal between AstraZeneca Plc and Daiichi Sankyo Co Ltd of Japan to co-develop trastuzumab deruxtecan, an ADC for a group of HER2-mutated cancers.

AstraZeneca is to pay the Japanese company $1.35 billion initially for rights to the late-stage ADC candidate which received a ‘breakthrough therapy’ designation from the US Food and Drug Administration in 2017. The two companies expect to make a regulatory submission in the second half of this year.

A type of inflammatory arthritis that affects the spine but cannot be detected by x-ray now has an approved treatment. The US Food and Drug Administration has authorised Cimzia (certolizumab pegol) for the treatment of non-radiographic axial spondyloarthritis, a disease that starts in patients under the age of 45 years and can get progressively worse. The fact that the disorder cannot be identified by x-ray sets it apart from other inflammatory conditions in the same disease group.

Galapagos NV and Gilead Sciences Inc have announced positive data from two ongoing Phase 3 trials of the Janus kinase-1 (JAK1) inhibitor filgotinib in rheumatoid arthritis (RA). The trials, FINCH 1 and FINCH 3, met the primary and key secondary endpoints with favourable safety data at the 24 week cut-off date.