BioPharm Insight

CRO hired for Phase II is SanaClis

BiondVax Pharmaceuticals (TASE: BNDX) is considering partnership and funding options for a Phase III study on its universal flu vaccine M001 as a primer to seasonal flu vaccines, said CEO Dr Ron Babecoff. The company is considering a licensing options deal or returning to the public market, he added.

Potential big pharma partners interested in vaccines are aware of the M001’s development, though no formal partnership discussions are ongoing, he said. Babecoff said he would be happy to talk to potential partners, though anticipated partnering discussions to intensify when M001 produces Phase II results in 2H16.

The Ness Ziona, Israel based company is also in discussions with several CMOs for Phase III productions, he said, noting this should be finalised by 2H15. The company could potentially accept new CMO bids, though Babecoff stressed it has already spoken to many producers and is very familiar with players in the space. Expertise required from the CMO includes fermentation in E coli, he added, noting the contract will be straight forward fee for service.

In a 7 July 014 article, Babecoff told this news service BiondVax would hire its Phase III CMO around 1Q15. This week, he explained the company had planned to complete its NASDAQ flotation in 1Q15, though since the transaction only completed in May (raising around USD 10m) the company has only just received the funding to hire its provider. Flotation delay was down to small documentation technicalities, plus the fact New York financial authorities were forced to close offices for several days in the winter due to the heavy snow, he said.

The Phase III trial should be pivotal and will run in either 2017 or 2018 and in multiple centres across Europe and the US, running for around two years, he added. Options for Phase III include raising funds an option more readily available to the company since its recent secondary listing on the NASDAQ beside Tel Aviv collaborating with big pharma for the trial with the partner  in licensing some rights afterwards and non-dilutive funding from various government agencies and consortia, Babecoff said.

Meanwhile, BiondVax has selected SanaClis as its CRO for the European Phase II trial (BVX007) for M001, which will lead to the Phase III, he said. The trial will begin in 4Q15, and will recruit around 200 participants between the ages of 18 to 60, with results anticipated for 2H16, he added. Phase II will run using facilities such as laboratories from companies within the European
UNISEC consortium (Universal Influenza Vaccines Secured), he said. UNISEC has also provided 75% of the Phase II funding (EUR 0.5m) whilst BiondVax provided the remaining 25%, Babecoff added. SanaClis is a preferred provider of this consortium, he noted.

An Investigational New Drug application has also been accepted for a US Phase II trial, which will be completed prior to Phase III initiation, he said, though declined to comment further on US development. The drug will first be developed as a primer focusing on elderly subjects where it will be administered prior to flu season followed by a dose of their regular flu vaccinations which cover limited strains. Since M001 utilises a common denominator to all flu strains the company believes the vaccine could protect against even newly developed strains, he said. M001 uses
conserved epitopes derived from the influenza virus as immunogens, which is common to most human strains, according to the company website.

Current flu vaccines, which do not cover new strains of flu, are only protective in 9% of cases, according to World Health Organisation figures, Babecoff said.

Previous Phase II research shows dosing M001 before flu season as a primer gives up to 40% more protection than standard vaccination alone, he said.

The idea is to first market the drug as a primer then use the proceeds to fund late-stage development as a standalone universal flu vaccine, Babecoff said. In the aforementioned July 2014 article, Babecoff explained that many more trial participants would be required for M001 as a standalone flu vaccine since, for every 100 patients enrolled, only 5% to 15% typically get the flu. The company would have to demonstrate whether fewer participants caught the flu or had decreased severity, he said.

For this reason, discussions are ongoing with EU authorities over the possibility of trialling the vaccine as a standalone product under adaptive licensing pathways, he said.

The EMA and vaccine developers are keen to use adaptive licensure for vaccines since it could mean early EU approval could be granted based on limited trial populations with a bigger emphasis on post-approval data, experts told this news service in a 15 June article.

by Natalie Morrison in London