News

Data from a Phase 3 study of nirsevimab, a prospective treatment for respiratory syncytial virus (RSV) disease, showed an efficacy rate of 74.5% in infants entering their first season exposed to the virus, according to AstraZeneca Plc. The data were generated by the MELODY trial in which healthy late preterm and term infants were randomised to receive a single dose of nirsevimab or placebo. Altogether 1,490 infants were enrolled in the trial which was conducted across 21 countries. Nirsevimab is a long-acting antibody that is designed to protect infants with a single dose.

New data on a prospective vaccine for human papillomavirus type 16 (HPV-16)-induced cancers has demonstrated efficacy in combination with the checkpoint inhibitor nivolumab (Opdivo), ISA Pharmaceuticals BV announced on 1 March. The vaccine, ISA101b, consists of synthetic long peptides that are specific to the E6 and E7 proteins on the virus. These proteins play an important role in HPV-induced cancers.

Three Phase 3 studies in pregnant women of a candidate vaccine designed to prevent infection from the respiratory syncytial virus (RSV) have been stopped following a safety signal. The developer, GlaxoSmithKline Plc, announced a pause in the studies on 18 February and a halt 10 days later. The decision was based on an observation from the study’s independent data monitoring committee during a routine safety assessment. The safety observation wasn’t disclosed. Altogether, the three studies were scheduled to enrol 21,462 individuals, according to clinicaltrials.com.

A Dutch biotech company, founded in 2020, has raised €39 million in Series A financing to accelerate development of a preclinical compound that targets blood clots in order to treat acquired thrombotic thrombocytopenia purpura (aTTP) and acute ischaemic stroke. TargED Biopharmaceuticals BV is a spin-out of the University Medical Center in the Netherlands. Its top management all have experience in blood disorders.

The financing round was arranged by an international syndicate comprising Andera Partners, Fund+, Hadean Ventures, Inkef Capital and Sunstone Life Science Ventures.

GlaxoSmithKline Plc is to execute the demerger of its consumer division in July, creating two new public companies one of which will supply products to the global consumer healthcare market. The other will be a new version of the current GSK, only tightly focused on innovative biopharmaceuticals and vaccines.

First announced in late 2018, the demerger is the culmination of three years of planning. GSK’s consumer division was created in 2015 following a transaction with Novartis. It was later enlarged to include assets from Pfizer. 

A UK company founded in August 2021 to build a portfolio of new treatments for ocular diseases has raised $65 million in a Series financing round. EyeBiotech Ltd was co-founded by David Guyer and Anthony Adamis, two experienced opthalmologists. The financing was co-led by Jeito Capital, Samsara BioCapital and SV Health Investors, which also provided the new company with seed funding and helped recruit the leadership team.

BioNTech SE has entered a three-year collaboration with Medigene AG to develop immunotherapies against solid tumours using Medigene’s proprietary T cell receptor (TCR) technology. This technology involves engineering a patient’s own T cells in order to display receptors that can recognise specific cancer antigens. Under the agreement, Medigene’s TCR discovery platform will be used in the development of cancer therapies against tumour targets nominated by BioNTech.

A Phase 3 trial of Dupixent (dupilumab) in patients with chronic spontaneous urticaria has failed to meet its primary endpoints and is being stopped early, Sanofi SA announced on 18 February. Dupixent is a widely prescribed medicine for asthma and atopic dermatitis and is being investigated for a possible new indication in urticaria, a chronic inflammatory skin disease characterised by the sudden onset of hives.

The US Senate has confirmed President Joe Biden’s nomination of Robert Califf to be head of the Food and Drug Administration – a position he held during the final year of the Obama administration. The vote was 50 to 46, the narrowest margin of any confirmed FDA commissioner.

UK-based Oxford Biomedica Plc is to establish a gene therapy manufacturing presence in the US under a new agreement with Homology Medicines Inc, a clinical-stage genetics medicines company located near Boston, US. Homology has experience in the development and use of adeno-associated virus (AAV) vectors while Oxford Biomedica has a lentiviral vector delivery platform.