Universal flu vaccine developer BiondVax signs CRO to advance Ph III trial
The Israelis biopharmaceutical company BiondVax Pharmaceuticals Ltd. has signed a Master Service Agreement (MSA) with a European-headquartered contract research organization (CRO), the name of which was not disclosed.
BiondVax is the developer of the universal flu vaccine candidate M-001. Conceived in Ruth Arnon’s lab at the Weizmann Institute of Science in Israel, M-001 is comprised of nine epitopes common to the vast majority of influenza virus strains, including influenza Type A and B.
“As far as I know, this is the first true universal flu vaccine to be heading into Phase III,” said Joshua Phillipson, business development manager at BiondVax.
The double-blind placebo-controlled trial will enroll 9,630 participants over the age of 50 in four to six Eastern European countries, where flu vaccines are not widely provided for free by the government or healthcare authorities and where flu vaccine uptake is very low, explained Phillipson.
The patient number is based on a certain number of flu attack rate assumptions, he told us. “If we find after the first season that the flu instance is much lower than usual, we will have the flexibility to enroll more people for year two,” he said.
Participants will be divided into two cohorts, with the first expected to enroll later this year. Nurses will monitor participants throughout the flu season, calling twice weekly, explained Dr. Ron Babecoff BiondVax co-founder, president and CEO. If flu-like symptoms are reported, the nurses will visit the patients to collect samples to undergo polymerase chain reaction (PCR) and culture confirmation of influenza, he told us.
The company has completed six successful clinical trials (two Phase I/II and four Phase II) to-date. The studies have shown M-001 to be safe, well-tolerated, and immunogenic to a range of influenza strains.
“I believe in the product,” said Babecoff – who took the vaccine himself in the summer three years ago. “There is a real need for it ... Especially when we see the hard flu season that we all experienced this year.”
In-house and outsourced manufacturing
BiondVax also is working with a US-based contract manufacturing organization (CMO), which will provide clinical batches for the first cohort and a subset of the second cohort.
The second cohort will be divided in half to enable BiondVax to establish lot-to-lot consistency, as half the participants in the cohort will receive the vaccine produced at its upcoming facility in Israel. Blood will be taken pre- and post-vaccination from the selected participants for testing.
When completed, the mid-sized facility, located in the Jerusalem BioPark (JBP), will be able to annually produce tens of millions of doses of M-001 either in single-dose syringes or bulk.
Construction is expected to begin soon and is supported by a grant from Israel’s Ministry of Economy and Industry and a €20m ($24.65m) agreement with the European Investment Bank (EIB), which also supports the Phase III trial.
“If the study is successful we will have a commercial facility that will enable us to provide the market – at least in the countries where we started in Europe, and maybe then in other territories as well,” said Babecoff.
As to why BiondVax chose not to outsource all manufacturing, Babecoff said having its own facility gives the company flexibility and control over production.
“When you are working with a CMO sometimes they have time constraints, other clients, so it’s not necessarily easy to manage. So, we want to have this flexibly,” he said.
Additionally, because M-001's formulation doesn’t change strain to strain, the company can manufacture it year round and stockpile, he added. The product currently has a 24-month shelf life, Babecoff believes this could eventually be extended to three years.
Collaboration and tech transfer
Although some product will be manufactured in-house, Babecoff said the company will grow through collaborations, as its facility will be limited in its production capabilities.
“Our facility will have the capacity to produce up to 20 million doses in syringes or 40 million in bulk. So it’s not enough for what the world needs,” said Babecoff.
“The tech transfer once you have an ongoing mid-sized manufacturing facility … it’s easier to go from one commercial facility to another one, rather than from lab scale to commercial size,” he explained, noting that this is another reason the company wanted to build the facility in Israel.
“This is something we are investing the time and resources now instead of wasting time after the study is completed,” Babecoff added.
