Pharm-Olam Enrolling UK Volunteers for Phase 3 Valneva COVID-19 Vaccine Study

HOUSTON, Texas, May 10, 2021 – Pharm-Olam, a global, midsized CRO offering full-service clinical development solutions for infectious diseases, vaccines, rare and orphan diseases along with oncology, is now enrolling volunteers in the United Kingdom into a pivotal Phase III COVID-19 vaccine study. Visit ukcovid19study.com for more information about participation.

The Phase III “Cov-Compare” trial (VLA2001-301) will compare Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria [1], in a comparative immunogenicity trial. There will be roughly 4,000 people participating in this study. Pharm-Olam is the full-service provider for this study, utilizing leading technology platforms.

Kelly Garner, Senior Project Manager said: “It is an incredible opportunity and privilege to have a leading role with Pharm-Olam, supporting Valneva with their VLA2001 COVID-19 vaccine candidate, of which the UK Government have secured 100 million doses. We have been able to successfully achieve all study milestones for Phase 1/2 and 3 of the VLA2001 program. It gives me a great sense of pride to be successfully contributing towards overcoming the global pandemic on behalf of Pharm-Olam, in strong collaboration with Valneva.”

Maria-Cruz Morillo, Director, Project Management said: “In my role of oversight of the Valneva program, I am proud to be part of a team working together to meet extremely tight timelines with a high level of quality and commitment to deliver quality results. It is exciting working in a clinical program which will make a difference and help all to return to a normal lifestyle.”

Dr. Robert J. Davie, Chief Executive Officer said: “Pharm-Olam is delighted to partner with Valneva in their on-going clinical development programme for the tremendously important SARS-CoV-2 vaccine candidate, VLA2001. Our Clinical Team, together with our investigative sites throughout the UK, are fully committed to the delivery of the Cov-Compare trial and we look forward to having played our part in overcoming COVID-19 and the challenges it has caused around the world.”.

Pharm-Olam has worked with and augmented the infectious disease prevention and therapeutic efforts of a variety of entities, including divisions of the U.S. Department of Health and Human Services: the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response; the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) as well as the DOD and several non-governmental organizations. Pharm-Olam also holds memberships in the Medical CBRN Defense Consortium and has a strong history of drug development related to medical countermeasures.

ABOUT PHARM-OLAM LLC

Pharm-Olam is a global clinical research organization that delivers right-sized trial services to pharmaceutical, biotechnology, government, and public health organizations around the world. They specialize in small molecule therapies and biologics in infectious disease, and vaccines oncology-hematology, rare disease, allergy, autoimmune, infectious disease, and vaccines. Founded in 1994, with operations in 60 countries, this CRO goes the distance to create a healthier world through agile, innovative, and customized CRO solutions for Phase I-IV research. Learn how Pharm-Olam helps studies succeed at www.pharm-olam.com.

ABOUT VLA-2001

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 ongoing pandemic and potentially later 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. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

ABOUT VALNEVA SE

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our 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.