September 2, 2015 – BiondVax Pharmaceuticals (NASDAQ, TASE:BVXV) and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) intent to launch a new Phase 2 trial in the U.S. to examine the use of BiondVax’s universal flu vaccine candidate, Multimeric-001 (M-001), as a primer vaccine.
The trial will assess the ability of M-001 in humans to serve as a pandemic primer to the H7N9 avian pandemic vaccine, by enhancing protective immunity to highly pathogenic avian influenza H7 strains.
It will also look to strengthen previous clinical and pre-clinical findings on M-001 priming capacity to other seasonal and pandemic strains.
Typically, a strain-specific flu vaccine for a pandemic outbreak takes four-to-six months to manufacture, a period when the virus can spread rapidly, causing high levels of illness and mortality. Stockpiling M-001 as a pandemic primer would enable vaccination schedules to start immediately after any pandemic declaration.
BiondVax is currently producing the M-001 vaccine batch for the clinical trial.
“The recognition of the potential of our technology by a foremost public health authority in the U.S., is a significant milestone in our clinical development program,” BiondVax president and CEO, Ron Babecoff, said in a statement.
CSO, Tamar Ben-Yedidia, said the new trial is complementary to a previous clinical trial in the elderly that concluded successfully, showing enhanced immunogenicity against the H1N1 swine pandemic virus in participants that received the M-001 vaccine as primer.
The new study is also complementary to an upcoming European clinical trial, where the M-001 will serve as a primer to the H5N1 avian pandemic vaccine, he added.