Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
Previous studies have found that the effectiveness of vaccines can be increased with the knockdown of HBsAg using a small interfering RNA (siRNA). The efficacy of a bivalent mRNA vaccine in combination with the siRNA AD-66810, which targets the X gene expression in the hepatitis B virus (HBV) genome, was tested in a murine model of AAV/HBV by scientists from Clearb Therapeutics Inc.
A preclinical trial in mice and ferrets of an experimental mRNA vaccine against the H5 highly pathogenic avian influenza (HPAI) virus generated neutralizing antibodies and prevented severe illness and mortality of the animals.
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
Achilles Therapeutics plc has established a research collaboration with Arcturus Therapeutics Holdings Inc. to evaluate best-in-class, self-amplifying mRNA (sa-mRNA) personalized cancer vaccines targeting clonal neoantigens.
Spybiotech Ltd. has entered into a sponsored research agreement with the University of Oxford for the development of a vaccine against Epstein-Barr virus (EBV).
In a paper published in the May 17, 2024, online issue of Cell, investigators from the Duke Human Vaccine Institute reported that a sequence of three immunizations in the HVTN-133 trial was sufficient for the development of heterologous or broadly neutralizing antibodies that protected against several strains of HIV.
Ygion Biomedical GmbH has completed a series A financing round of €15 million (US$ 16.3 million) to support the development of individualized neoantigen-based cancer vaccines.
TFF Pharmaceuticals Inc. has announced it is advancing into preclinical testing multivalent universal influenza vaccine candidates to protect against seasonal and pandemic viruses, in collaboration with Cleveland Clinic.