Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results.
Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries. Shanghai-based Nuance plans to run its own phase I and phase III trials in China to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from Bavarian Nordic's own phase III trial planned to begin in the first half of 2022.
Shares in Glaxosmithkline plc ticked down after the U.K. pharma announced that enrolment and vaccination in three trials of its respiratory syncytial virus (RSV) maternal vaccine will stop, after a safety issue prompted a voluntary pause last week.
Glaxosmithkline plc has voluntarily paused a late-stage trial of its potential respiratory syncytial virus (RSV) maternal vaccine candidate in pregnant women following a safety warning. In a brief statement, the London-based firm said it also paused recruitment in two other trials investigating the drug in pregnant women.
“Now it’s all about time to market,” Bavarian Nordic A/S CEO Paul Chaplin said as the company disclosed positive results from the phase IIa study with its respiratory syncytial virus (RSV) vaccine, MVA-BN RSV. “We’re looking at designs [for phase III] that give us the fastest approval possible” in the competitive space, he said, adding that the previously envisioned two-season setup “has gone out the window” with the latest findings.
Targeting viral condensates could be a valuable strategy for developing fast-acting, specifically targeted drugs with a potential broad spectrum of activity against pathogenic viruses, including respiratory syncytial virus (RSV), by targeting proteins critical for condensate formation, according to an international collaborative study.
Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants.
HONG KONG – Lianbio Co. Ltd. has inked a deal for the development and commercialization of Reviral Ltd.’s sisunatovir, picking up rights to the respiratory syncytial virus (RSV) candidate in mainland China, Hong Kong, Macau and Singapore in exchange for an up-front cash payment of $14 million and development and commercial milestone payments of up to $105 million.
A multimillion dollar windfall for Icosavax Inc. will help allow the company to launch a COVID-19 vaccination program using its virus-like particle candidate (VLP), IVX-411, that displays the SAR-CoV-2 receptor-binding domain.
