Albumedix and Valneva expand collaboration to include newly approved inactivated COVID-19 vaccine
Albumedix Ltd., 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, 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.
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.”
Jonas Skjødt Møller, Chief Executive Officer, Albumedix.
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.”
Vincent Dequenne, Chief Operating Officer, Valneva.
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.
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