checkAd

     137  0 Kommentare Ligand’s Collaborator Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials

    Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its collaborator Merck, known as MSD outside of the United States and Canada, today announced positive topline results from two Phase 3 trials evaluating V116, an investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study. In both studies, V116 had a safety profile comparable to the comparator in the studies. Results will be shared with the scientific community in the near future and will support global regulatory licensure applications.

    V116 utilizes the CRM197 vaccine carrier protein, which is produced using Ligand’s patent-protected Pelican Expression Technology platform. If approved, Ligand is entitled to a royalty on worldwide net sales.

    “We are delighted to see Merck’s continued progress with V116 and their pneumococcal conjugate vaccine franchise,” said Todd Davis, CEO of Ligand. “We look forward to the advancement of this program as well as with our multiple other collaborations involving Pelican’s cost-effective and scalable production of our CRM197 vaccine carrier protein.”

    About V116

    V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. V116 is specifically designed to address the serotypes that represent adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which account for approximately 30% of adult disease, according to 2019 pre-pandemic CDC data. V116 has potential to expand disease coverage to help protect against invasive pneumococcal disease in more than 85% of individuals 65 and older, based on the same data.

    Seite 1 von 3




    Business Wire (engl.)
    0 Follower
    Autor folgen

    Ligand’s Collaborator Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its collaborator Merck, known as MSD outside of the United States and Canada, today announced positive topline results from two Phase 3 trials evaluating V116, an investigational …