Clinical Research

NodThera Ltd of the UK, with offices in Boston and Seattle, US, has reported data from a small molecule drug being tested in volunteers which showed reductions in neuroinflammatory and inflammatory biomarkers – the first human data from a project intended to treat Parkinson’s disease. The results were reported on 11 July. The drug, NT-0796, was administered to elderly volunteers and within seven days, showed a decline in biomarkers including the cerebrospinal fluid (CSF) neurofilament light chain (NfL), a key indicator of neurodegeneration.

Twenty years after its launch as a nanomedicines company, Nanobiotix SA of France has secured a major licensing deal enabling it to complete development and commercialise a radioenhancer for use with radiotherapy to treat patients with multiple, difficult cancers. The agreement with Janssen Pharmaceutica NV, part of Johnson & Johnson Inc, was announced on 10 July. It carries potential payments of up to $1.8 billion in development, regulatory and sales milestones as well as royalties on net sales of the product NBTXR3.

AstraZeneca Plc said that its antibody-drug conjugate (ADC) datopotamab deruxtecan generated positive data from patients in a Phase 3 lung cancer trial, but that some Grade 5 events were observed in the study. A spokesperson for AstraZeneca said on 11 July that some Grade 5 interstitial lung disease events were observed which are being investigated. Overall the safety profile of the drug was consistent with previous studies, she added.

MoonLake Immunotherapeutics AG of Switzerland has completed an upsized public share offering which is expected to yield an estimated $400 million, before commissions and underwriting discounts. The shares were priced on 27 June ahead of the close of the offering which is expected to be on or about 30 June.

A bispecific T cell engaging antibody developed by Roche for diffuse large B-cell lymphoma (DLBCL) received an accelerated US approval on 16 June, the second authorisation this year for the Swiss multinational in this indication. The drug, Columvi (glofitamab) was authorised by the Food and Drug Administration based on response rate and durability of response in a Phase 1/2 trial. In April the FDA approved Polivy, an antibody drug conjugate from Roche in combination with other drugs, also for DLBCL.

A candidate vaccine designed to protect against chikungunya virus infection has met its primary endpoint in a Phase 3 study paving the way for a regulatory review and possible launch in geographies where the disease is prevalent. The results of the study were published in The Lancet on 12 June 2023. The vaccine, VLA1553, has been developed by Valneva SE of France.

Switzerland-based BC Platforms AG is to strengthen its position as a provider of real world data for clinical research with the acquisition of 4Pharma Ltd, a contract research organisation located in Turku Finland. The acquisition, announced on 1 June, will bring the Finnish company’s research capabilities, which include medical writing and data collection, into BC Platform’s global service offering. The financial terms of the transaction were not disclosed.

Data from a Phase 3 trial of a combination vaccine candidate to prevent meningococcal disease, a bacterial infection that can cause death or permanent disability, were positive, according to the developer GSK Plc. The vaccine candidate showed non-inferiority in primary endpoints for five Neisseria meningitidis serogroups compared with Bexsero and Menveo, two marketed GSK vaccines, which together cover the same serogroups. The five Neisseria meningitidis serogroups account for nearly all invasive meningococcal disease cases in the world.

Gene editing technology has been used by an international team of researchers to create a new therapeutic that targets Escherichia coli in the guts of patients with blood cancers who are at risk of infection. A preclinical study of the new therapy was published in Nature Biotechnology on 4 May. The therapy, SNIPR001, was developed by Denmark-based SNIPR Biome ApS which is currently conducting a Phase 1 trial of the drug in the US. The drug has received a fast track designation from the Food and Drug Administration.

Preclinical data for the small molecule drug vidofludimus calcium has revealed its activity in relation to a neuroprotective transcription factor in addition to its ability to inhibit an enzyme which plays a key role in the metabolism of overactive immune cells and virus-infected cells, Immunic Inc announced on 17 May. The findings have been published in the Journal of Medicinal Chemistry.