Albumedix and Valneva Expand Collaboration to Include Newly Approved Inactivated COVID-19 Vaccine14 Apr 2022
Albumedix Ltd. (´Albumedix´), a recognized global leader in Recombinant Human Albumin (rHA), specializing in the enablement of advanced therapies and biopharmaceuticals, today announces the expansion of its existing collaboration with Valneva SE (´Valneva´), a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need.
This announcement comes on the back of the recent approval of Valneva´s inactivated COVID-19 vaccine (VLA2001) by MHRA, for which Valneva signed an agreement in November 2021 with the European Commission to supply up to 60 million doses over 2 years, as well as announcing an advance purchase agreement with the Kingdom of Bahrain in December 2021 for the supply of one million doses.
Albumedix Recombumin® rHA is an essential component in VLA2001, used in the manufacturing process and final formulation of the vaccine. The companies began their collaboration with the inclusion of Recombumin® in Valneva’s single-shot vaccine candidate against the mosquito-borne viral infection chikungunya, VLA1553, which successfully completed its pivotal Phase 3 trial in March 2022. Both companies are committed to producing safe, effective and scalable vaccines.
Albumedix´ Chief Executive Officer, Jonas Skjødt Møller, reflects on the announcement; “We are excited to expand our relationship with a valued partner like Valneva, thereby continuing to leverage our long track record of supporting vaccine companies in their development of safe and scalable vaccines. In the last 2 years, it has been incredible to witness and partake in the monumental achievements realized by the life science industry through purpose-led collaborations like the one we share with Valneva.”
Valneva’s Chief Operating Officer, Vincent Dequenne, added; “We wholeheartedly welcome the contribution that Albumedix is making to the manufacture of our newly approved inactivated, whole virus COVID-19 vaccine – the first of its kind developed in Europe. Our collaboration is enabling the development of vaccines to address significant unmet medical need, including this differentiated COVID-19 vaccine option for populations and physicians who need it.”
Albumin is an established enabler of advanced therapies and biopharmaceuticals and the properties of Recombumin® are shown to be beneficial across a broad range of vaccine modalities. Consequently, Albumedix´ rHA´s are already included in a range of vaccine candidates in clinical development and marketed vaccines, resulting in more than 210 million safe injections with Recombumin®.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic and for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
The Recombumin® product portfolio are the highest quality, animal and human origin-free recombinant human albumins commercially available. Albumin is a multi-functional excipient and its stabilization properties have been validated through its long-established use in multiple marketed products. Albumedix´ highly pure, safe and consistent albumins enable you to formulate with confidence.
About Valneva SE
Valneva is a specialty vaccine company focused on the development, production and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
About Albumedix – Dedicated to Better Health
Albumedix is a science-driven company and recognized leader of albumin-enabled solutions. Established in the UK in 1984, with a mission to empower excellence, Albumedix has supported its life-science partners deliver well over 200 million safe doses of clinical and marketed therapeutics. Albumedix’ solutions span its market leading recombinant human albumins (Recombumin®), client-centric development and compliance services and drug-enhancing technologies (Veltis®). By always striving for more and collaboratively challenging status quo, Albumedix enable advanced therapies and next-generation biopharmaceuticals reach patients worldwide.
For media enquiries, please contact:
Poula Maltha Krogh, Director of Market Development & Communication, BD@albumedix.com