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Zanubrutinib is approved in >15 countries, including the United States and European Union, for pts with relapsed/refractory ( I R i / I R i ) marginal zone lymphoma (MZL) who received >=1 anti-CD20-based regimen, based on the single-arm MAGNOLIA trial (Opat et al. I Clin Cancer Res i 2021). B Introduction: b Inhibition of Bruton tyrosine kinase (BTK) has emerged as a strategy for treatment of patients (pts) with B-cell malignancies including indolent non-Hodgkin lymphomas. MAHOGANY: A PHASE 3 TRIAL OF ZANUBRUTINIB PLUS ANTI-CD20 VERSUS LENALIDOMIDE PLUS RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR OR MARGINAL ZONE LYMPHOMA. [Extracted from the article]

The aim of this study was to investigate the effect of whey protein isolate (WPI) gel microentrapment on the viability of Lactobacillus rhamnosus R011 during the production and storage of biscuits, frozen cranberry juice, and vegetable juice. Viability of microentrapped (ME) cells was compared to free cells freeze-dried in a milk-based protective solution as well as in a WPI-based solution (ungelled). During the production of biscuits and their storage for 2 wk at 23 °C, the highest stability was obtained with the cells ME in WPI gel particles. However, free cells prepared in the milk-based matrix were those that maintained the highest viability during storage of vegetable juice as well as during freezing and storage of cranberry juice. The culture prepared in a WPI-based solution had the highest drops in viable counts following the heating process of biscuits as well as during storage of vegetable juice and freezing and storage of cranberry juice. Although the WPI-based solution was not efficient in protecting free cells, it is concluded that the process of microentrapment in WPI can help in protecting the freeze-dried cells against subsequent acidic and alkaline pH conditions as well as heating and freezing of food products. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to assess safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of ensovibep, a designed ankyrin repeat protein antiviral being evaluated as a COVID-19 treatment, in healthy volunteers in a first-in-human ascending single-dose study., Methods: Subjects were dosed intravenously, in a randomized double-blinded manner, with either ensovibep at 3, 9 or 20 mg/kg or with placebo, and followed until Day 100. PK and safety were assessed throughout the study duration. Immunogenicity and PD via viral neutralization in serum were also assessed., Results: All adverse events were of mild to moderate severity, and no serious adverse events were observed. One subject who received the 20-mg/kg dose presented with moderate hypersensitivity vasculitis 3 weeks after infusion, which fully resolved using standard procedures. In most subjects ensovibep showed expected mono-exponential decline with a half-life of around 2 weeks. Anti-drug antibodies were detected in 15 of 17 subjects, with the earliest onset detected on Day 29. Viral neutralization assays on subject serum showed effective viral neutralization over the first 3 weeks following dosing with titre values in a dose dependent manner., Conclusion: Ensovibep proved safe in this first-in-human safety study and exhibited PK and PD parameters consistent with the expected treatment period required for acute COVID-19 infection., (© 2023 The British Pharmacological Society.)