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Panthera has started vaccinating volunteers in Valneva’s double-blind, phase three, COVID prevention trial.

The trial will compare Valneva’s inactivated vaccine, VLA2001, with AstraZeneca’s conditionally approved vaccine Vaxzeria. Unlike earlier COVID-19 vaccine trials, which involved a placebo dose, everyone involved in this study will receive two active vaccine doses.

The study, which is being run at three of Panthera’s sites, North Manchester, North London, and Preston, is vaccinating healthy volunteers over the age of 18 who have not had a COVID vaccination. The study, which will include 4000 participants across 24 sites in the UK is being overseen by CRO Pharm-Olam.

Those enrolled in the study over the age of 30 will be randomised to receive two doses of either the Valneva vaccine, or the approved Oxford/AstraZeneca vaccine. Participants aged 18 - 29 can be enrolled into the study to receive the Valneva vaccine and will not be offered the approved Oxford/AstraZeneca vaccine.

This is the third COVID study being undertaken by Panthera which includes one study where patients with COVID received an antibody to treat symptoms. Panthera also runs trials in chronic disease and cancer.

Valneva’s VLA2001 vaccine is the only inactivated, adjuvanted COVID-19 vaccine in clinical development in Europe. Earlier this month, the specialty vaccine company reported positive Phase 1/2 trial data, which found that its inactivated vaccine was well tolerated with no safety concerns identified, and highly immunogenic. Valneva plans to make a regulatory license submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in Autumn 2021, subject to successful Phase 3 data.

Last year Valneva entered a major partnership with the UK government. The UK has the option to purchase up to 190 million doses through to 2025 and has ordered 100 million doses to date, to be delivered in 2021 and 2022.

The Chief Medical Officer at Valneva, Juan Carlos Jaramillo commented: “We’re delighted that the trial is underway and would like to applaud the efforts of everyone involved in making this happen. We hope that people across the UK continue to volunteer for studies so that we can continue to make progress against the pandemic.”

Stuart Young CEO of Panthera commented: “Every new vaccine is another weapon with which we can fight this pandemic and we are very pleased that we have been able to assist in these trials. We have put in place strict procedures, SOPs, and PPE at all our sites across the UK to make sure that patients, volunteers, and staff are as safe as possible. It is vital that clinical trials continue to ensure that there are new medications available to prevent and treat, not only COVID-19, but the many other conditions which afflict so many people.”

Details of the Valneva study

Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of SARS-CoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose immunization schedule administered in a four-week interval. The trial is powered to demonstrate superiority of Valneva’s inactivated vaccine VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria). The trial will be conducted in the U.K. and is supported by the National Institute for Health Research (NIHR).

About Panthera Biopartners – an Independent Site Management Organisation

Panthera Biopartners was founded by Dr Ian Smith – founder of Synexus - and Professor John Lyon – previously senior executive in Covance and serial entrepreneur - to provide CROs and pharma clients with services relating to the recruitment and running of clinical trials at customised clinical trial sites by GCP trained healthcare professionals.

Panthera has a growing network of sites across the UK managing studies in a variety of conditions in both primary care settings and hospital sites running trials in key secondary care conditions such as CNS, oncology, vaccines and NASH with specialist investigators.

VLA2001

Valneva’s vaccine, 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).

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