LONDON - The world’s first COVID-19 human challenge trial is due to start in London next year, after the government announced £33.6 million (US$42.5 million) funding for the project. In the initial phase, the aim is to establish the dose of SARS-CoV-2 needed to cause infection and to characterize the immune response to virus. That will lead on to tests of individual COVID-19 vaccines, in which volunteers will be challenged with the effective dose of SARS-CoV-2 one month after inoculation. Read More
Aptinyx Inc. CEO Norbert Riedel said the design is unclear of the pivotal trial due next year with the N-methyl-D-aspartate (NMDA) receptor modulator NYX-783 in post-traumatic stress disorder (PTSD), as fine points must be hashed out with the FDA. Read More
Privately held Cytocom Inc. and Cleveland Biolabs Inc. will merge in an all-stock transaction, with Cytocom shareholders taking the majority position. The transaction, which must be approved by Cleveland Biolabs’ shareholders, is expected to close in the first quarter of 2021. Read More
LONDON – Sparingvision SAS has raised €44.5 million (US$52.5 million) to advance SPVNo6, a gene therapy designed to be effective for all retinitis pigmentosa patients regardless of the underlying mutation, with a phase I dose-ranging study now due to start in 2021. Read More
Investors appear to be maintaining a bullish outlook on biopharma companies developing innovative medicines, with the BioWorld Drug Developers index currently tracking up over 5% in value so far this month heading into third-quarter earnings season. Read More
HONG KONG – La Chaux-de-Fonds, Switzerland-based Rhizen Pharmaceuticals SA has agreed to license its dual PI3K delta and gamma inhibitor tenalisib (RP-6530) to Shanghai-based Curon Biopharmaceutical Ltd. for as much as $149.5 million, inclusive of an upfront payment of undisclosed value and potential milestone payouts. Read More
COVID-19 continues to dominate biopharma nonprofit collaborations and grants in 2020, with the pandemic accounting for 85% of projected values reported this year, most of which have posted since the start of July. Read More
CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy. Read More
New hires and promotions in the biopharma industry, including: AM-Pharma, Assembly, Atbtherapeutics, Centogene, Heparegenix, Jubilant, Mereo, Perseus, Replimune, Vaccitech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amacathera, Asklepios, Astrazeneca, Inventiva, Selecta. Read More