Aridis Pharmaceuticals Inc. is one of two companies posting COVID-19 data just days before Christmas. Its fully human monoclonal antibody cocktail, AR-701, was shown to be broadly reactive against COVID-19 variants, including Omicron, in preclinical research. Moderna Inc. also posted new data that showed preliminary neutralizing data against Omicron following 50-mg doses of its vaccine, which is currently authorized, and 100-mg dose boosters, which increased neutralizing antibody levels 83-fold from the pre-boost levels.
Tentarix Biotherapeutics LP broke cover with $50 million in series A funding to take forward an industrialized flow cytometry platform that enables it to screen rapidly for multifunctional antibody-based drugs.
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease.
Brii Biosciences Ltd. shared interim data from a phase III trial of its neutralizing monoclonal antibody (mAb) combination therapy for SARS-CoV-2, BRII-196 and BRII-198, that showed a 78% reduction in the risk of hospitalization or death in patients receiving single dose of the cocktail.
With the U.S. logging more than 4 million new COVID-19 cases in the past few weeks, federal purchasing of antibody cocktails from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. is continuing to grow. The government has placed orders for $2.94 billion worth of Regeneron's REGEN-COV (casirivimab and imdevimab) and about $330 million of Lilly's etesevimab to complement doses of bamlanivimab it previously purchased. Both antibody combinations, approved under FDA emergency use authorizations (EUAs), have been shown to reduce risk of hospitalization or death from COVID-19.
Delivering antibodies in the form of their DNA could enable their therapeutic use under several circumstances where traditional antibodies fall short. One of those is resource-poor settings where the current cost of antibodies makes them a nonstarter. Perhaps the largest opportunity to expand antibody use in such settings is for HIV, where broadly neutralizing antibodies have the potential to be the next best thing to a vaccine or a cure – if they can be made to last, for cheap.
Monoclonal antibodies are a triumph of modern medicine. They are also too expensive to be a standard therapy in all but the wealthiest countries. “Having 10% or 15% of your population on antibodies is not sustainable even in wealthy countries,” Rachel Liberatore told BioWorld. Liberatore is director of research and development at Renbio Inc., which is testing the intramuscular delivery of antibody-encoding DNA to prevent and treat infections, including SARS-CoV-2 and HIV.
Exevir Bio NV is honing its attack on the crowded market for COVID-19 antibodies, beginning clinical development of a potential subcutaneously administered drug targeting outpatients with early symptoms who are at risk of further progression.
Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs.
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