The European Medicines Agency is studying the T cell immune response generated by the currently approved Covid-19 vaccines to find out whether anything can be learned for the future. In a briefing with journalists on 3 March, Marco Cavaleri, head of biological health threats and vaccines strategy, said the review covers all platforms represented by the currently approved vaccines. One of the objectives is to find out if the T cell component of immunity can offer protection against new variants of the virus.
The diabetes and cardiovascular medicine Jardiance (empagliflozin) has been approved in the US to treat a wider range of patients with heart failure, giving it a new role in reducing the risk of cardiovascular death and hospitalisation in adults. Jardiance is already approved as a supplement to diet and exercise to improve glucose control in adults with Type 2 diabetes, and to reduce the risk of cardiovascular death in adults with diabetes and cardiovascular disease.
A new medicine for uveal melanoma, a rare cancer of the eye, has received a positive opinion from the European Medicines Agency, putting it on course to be the first T cell receptor (TCR) therapy on the market in Europe. Kimmtrak (tebentafusp) is a bispecific protein comprised of a T cell receptor fused to an effector molecule that redirects T cells to cancer cells. The sponsor is Immunocore Holdings Plc which is developing TCR bispecific therapies for cancer as well as for autoimmune and infectious diseases.
The European Medicines Agency has proposed to extend the use of two messenger RNA (mRNA) vaccines for Covid-19 in order to give protection against the SARS-CoV-2 virus to younger people. In separate decisions, the agency is recommending that primary vaccination with Spikevax be approved for use in children from the ages of six to 11 years. Spikevax was developed by Moderna Inc. The agency is also proposing that Comirnaty, developed by BioNTech SE and Pfizer Inc, be authorised as a booster dose for adolescents from 12 years of age.
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.
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.
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.
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.