The European Investment Bank (EIB) and BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) have announced on June 19, 2017, that they will join forces on developing the Universal Flu Vaccine candidate M-001. Through the collaboration, EIB is to provide funding up to up to €20 million to BiondVax’s development and manufacturing plans.
Flu viruses frequently and unpredictably mutate. Since it is impossible to predict future mutations, current flu vaccines may target strains that are not represented in the current wave of influenza. Mainly due to vaccine-virus mismatch, current flu vaccine effectiveness is on average only about 40% in the general population, and in elderly people as low as 9%. In addition, current vaccines take about 4 to 6 months to produce, and a new one must be produced each year. So when a mismatch is identified at the beginning of the flu season, there is insufficient time to make a new vaccine for that specific season.
The World Health Organization (WHO) reports up to 500,000 annual seasonal flu related deaths, mostly affecting people above 65 years old. Seasonal flu is the 8th leading cause of death in the USA, and it causes high social and economic burdens to patients, their families, and health care providers.
The technology behind BiondVax’s universal flu vaccine candidate was conceptualized in the lab of Professor Ruth Arnon at the Weizmann Institute of Science in Rehovot, State of Israel.
BiondVax’s M-001 vaccine candidate, consisting of nine widely conserved flu epitopes, is designed to protect against current and future, seasonal and pandemic flu strains. Clinical and pre-clinical trials have shown that M-001 is safe and immunogenic and that it has the capacity to enhance and broaden coverage of current flu vaccines. M-001 has also shown potential to improve upon current seasonal flu vaccines, and potential to serve as an immediate effective response to new flu pandemic strains. The vaccine candidate has been tested in a Phase IIb clinical trial in collaboration with UNISEC, which is funded by the EU under the 7th Framework Programme for Research and Technological Development.
EIB support for the development of BiondVax’s Universal Flu Vaccine Candidate should be seen in the context of the Horizon 2020, the EU's Research Programme, in particular the EU Finance for Innovators finance facility "InnovFin Infectious Diseases", which offers bespoke products for financing high-risk projects in the field of infectious diseases.
The EIB-BiondVax non-dilutive financing agreement will be structured as a zero-percent fixed interest loan, available for up to 36 months with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds will be advanced in three tranches. The tranches are available up to 12, 24, and 36 months following the date of the agreement, and are dependent on achievement of certain specified milestones, with the ultimate milestone including authorization to launch a Phase 3 trial. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time.
Valneva SE, a leading pure play vaccine company, and the European Investment Bank (EIB), the world’s largest multilateral bank, announced on July 12, 2016, that the EIB granted Valneva a €25 million loan facility to support its vaccine R&D activities.
Valneva plans to use the EIB financing to support the research and development of vaccines including its Lyme Borreliosis vaccine candidate (the only active development program for Lyme Disease in the vaccine industry) which is due to enter Phase I in 2016, and amongst others, further pre-clinical R&D on Zika virus.
Valneva recently announced the successful generation of a highly purified Zika vaccine candidate, which can now be further tested in animals and potential human studies.
The €25 million loan, which is offered on favorable terms, may be utilized by Valneva in one or several tranches within a 24-month period. Each credit tranche is repayable at the end of a five-year period starting from the drawing date. The loan will be secured by collateral over Valneva’s material subsidiaries, mainly ranking behind securities in connection with Valneva’s existing asset-based financing.
The EIB loan granted to Valneva is part of the European Horizon 2020 initiative, in particular the "InnovFin MidCap Growth Finance (MGF) - EU Finance for Innovators" programme - which provides customized products for supporting the development of innovative SMEs and midcaps.