MER4101 for seasonal flu combines the MAS-1 adjuvant with FDA approved standard seasonal TIV (trivalent inactivated influenza vaccine) antigens. MAS-1 adjuvant is compatible with any approved egg-derived TIV, or recombinant, or cell culture-derived influenza virus antigens.
MER4101 influenza vaccines are expected to: (1) Improve protection in the most vulnerable populations, (2) provide superior protection against divergent or drifted viral strains, (3) provide up to at least 30-fold dose sparing benefits translating to cost savings and expanded access to limited vaccine supplies, and (4) can be manufactured by traditional bulk-fill techniques or at point-of-use providing for rapid and versatile responses to an emerging pandemic.
Preclinical and Toxicology studies have been completed under a grant from NIH (1 R43 A1074119). Toxicology studies in two rodent species showed an absence of systemic toxicity and that the product was well tolerated for its intended use. Immunopharmacology studies with MER4101 performed by Mercia with Dr John Treanor of University of Rochester, NY, demonstrated higher antibody levels for a longer duration with significant dose sparing and superior cross-protection against divergent viral strains when compared with licensed TIV.
Compared with standard vaccines, MER4101 demonstrated:
- significantly higher protective titers at lower doses over those provided by standard dose of licensed vaccines
- significant prolonged duration of elevated protective titers
- comparable protective titers achieved at significantly reduced antigen doses with dose sparing benefit of at least 30-fold
- protection against antigenically drifted virus strains increased up to 10-fold
- safe and well tolerated and without any evidence for systemic toxicity
Mercia has presented these data to the FDA in preparation for finalizing plans for clinical evaluation of MER4101 in elderly volunteers.