Clinical Research

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 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. 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 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.

Bayer AG has decided to discontinue development of the Phase 2 drug candidate, eliapixant, a P2X3 receptor antagonist that was being evaluated in endometriosis, refractory chronic cough, overactive bladder and diabetic neuropathic pain.

This is based on a review of data showing that the overall benefit no longer outweighs the risk in these indications. The drug was developed in collaboration with Evotec SE which will regain rights to the assets. Bayer announced its decision on 4 February 2022.

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Pfizer Inc and Valneva SE have reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. As a result, the companies plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 trial. The trial is expected to start in 2022.

Pharming Group NV of the Netherlands has achieve positive results from a Phase 2/3 registration-enabling study of the small molecule drug leniolisib, a candidate treatment for activated phosphoinositide 3-kinase delta (PI3K delta) syndrome, an ultra-rare primary immunodeficiency disease. The placebo-controlled study consisted of two sequential parts, the first of which was a successful dose escalation study which reported results in 2018. Results from the second part of the study, reported on 2 February, showed clinical efficacy, including a normalisation of immune dysfunction.

Pfizer Inc and Ionis Pharmaceuticals Inc have discontinued development of vupanorsen, an antisense oligonucleotide intended for cardiovascular risk reduction and the treatment of severe hypertriglyceridaemia, a condition characterised by high amounts of triglycerides in the blood. Announced on 31 January, the decision was taken despite favourable results from a recent Phase 2b study.