Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
Researchers from Purdue University and Eradivir Inc. presented a newly developed bispecific small molecule (zanDR) that bound and inhibited influenza neuraminidase on both free virus and virus-infected cells and also recruited the immune system. zanDR recruited naturally occurring anti-rhamnose and anti-dinitrophenyl (DNP) antibodies with rhamnose and DNP haptens.
The influenza virus undergoes rapid and frequent antigen shifts that usually force seasonal vaccine updating. The mismatch between vaccine strains and circulating viruses leads to limited vaccine effectiveness, mainly in immunocompromised and older individuals.
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.
TFF Pharmaceuticals Inc. has announced promising preclinical data advancing a multivalent universal influenza vaccine manufactured by its Thin Film Freezing (TFF) technology to protect against seasonal and pandemic viruses.
The efficacy of seasonal flu vaccines varies due to the ability of the influenza virus to mutate rapidly. The achievement of a universal flu vaccine conferring protection against all strains, including those with pandemic potential, for longer than a single season would provide a great benefit and has not yet been achieved.
Researchers have identified a gene associated with whether patients hospitalized with respiratory viral infections recover rapidly or face life-threatening complications. The gene has the potential to be used as a diagnostic tool or biomarker, which could help triage patients suffering from severe respiratory infections. Having such a biomarker would help clinicians in their early risk assessments to manage their intervention strategies.
“There are hundreds of strains of bird flu, and most of them don’t infect humans, or even mammals,” Stephen Cusack told BioWorld. “There are two main reasons for that.” To be able to cause an infection, a virus “has to be able to get into the cell, and for that it needs a receptor,” Cusack said. For influenza viruses, those receptors are hemagglutinin receptors, and they differ in subtle but important ways between birds and mammals.
Arcturus Therapeutics Holdings Inc. has announced its pandemic influenza vaccine is on track to enter a phase I clinical trial in Q4 of 2024. The vaccine, ARCT-2304, utilizes Arcturus’ STARR self-amplifying mRNA and LUNAR delivery platform technologies to deliver antigens designed to elicit a protective response against the H5N1 strain of avian influenza.
