Veru Pharmaceuticals Inc.’s COVID-19 therapy VERU-111 (sabizabulin) failed to win full support from the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee, which was asked to decide about endorsing the firm’s request for an emergency use authorization to market the drug.
Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19.
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones.
The soluble form of human angiotensin-converting enzyme 2 (hsACE2) could prevent SARS-CoV-2 from binding to the host cell receptors through competitive inhibition, which may avoid viral infection. However, the relatively short half-life of the recombinant hsACE2 limits its clinical application.
Formycon AG has published preclinical in vivo results for the development of its COVID-19 drug FYB-207. In in vivo studies, data were collected in two different models on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein, in order to select the most appropriate candidate to enter the clinic.
Results from a study carried out by the COVID-19 Host Genetics Initiative show that rare deleterious variants in the immune-system gene TLR7 make carriers more than five times more likely to have a severe SARS-CoV-2 infection. The TLR7 gene encodes Toll-like receptor 7 protein, which plays a protective role in the immune system by identifying pathogens and activating innate immunity.
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones. In addition, it could capture a 40% net profit share for COVID-19 vaccines and up to double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens.
