HALIX has joined a consortium of partners under the guidance of the University of Oxford, to provide GMP manufacturing services supporting the large scale production of a COVID-19 vaccine (ChAdOx1 nCoV-19), being developed by the University’s Jenner Institute. This GMP manufacturing scale-up is taking place alongside early phase clinical trials. The trials are crucial in testing whether the vaccine is proven to be effective.

The nCoV-19 vaccine is based on the Jenner Institute’s adenovirus vaccine vector (ChAdOx1) technology, which was chosen as the most suitable candidate for a SARS-CoV-2 (COVID-19) vaccine as it can generate a strong single dose immune response, and is not a replicating virus, so it cannot cause infection in the vaccinated individual.

Under the collaboration, HALIX B.V. will utilise its brand new state-of-the-art GMP facilities with capacity up to 1,000 L SUB scale, applying its viral vector bioprocessing expertise, to transfer an industrial scale drug substance process from Pall in the UK, supporting the manufacture of ChAdOx1 nCoV-19 clinical trial material. Based on this transfer, HALIX B.V. and the consortium will be in a position to manufacture at a larger scale. This is a key step in decreasing the time it would normally take to make the vaccine available for deployment and could help to halt the further spread of this pandemic.

The large-scale manufacturing project is a collaborative effort, led by Dr Sandy Douglas at the Jenner Institute. The ChAdOx1 coronavirus vaccine alliance encloses viral vector manufacturing and regulatory compliance experts from the University of Oxford’s Jenner Institute and Clinical Biomanufacturing Facility, the Vaccine Manufacturing and Innovation Centre (VMIC), Pall Biotech and Cobra Biologics.

Alex Huybens, Chief Operations Officer of HALIX, states: “We are committed to working as one team across the industry bringing our collective expertise, track record and manufacturing capabilities, to support the Jenner Institute’s rapid clinical development of this nCoV-19 vaccine candidate to combat this evolving crisis as quickly as possible.”

HALIX has an established technical and quality track record for the development and GMP manufacture of viral vectors used against infectious diseases, such as HIV, ZIKA, chikungunya and the flu. Our brand new 6,700 m² BSL2 GMP facility, located in Leiden (the Netherlands), provides both clinical and commercial scale manufacturing capabilities in fully independent, self-contained Grade B and C cleanrooms for virus products.

The clinical trial program, led by Professor Sarah Gilbert at the Jenner Institute and Professor Andrew Pollard of the Oxford Vaccine Group, will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison. Since March 23, 2020, The University of Oxford is recruiting individuals in the UK to take part in trialing the vaccine. For further information on the vaccine, visit: https://covid19vaccinetrial.web.ox.ac.uk/.

Source: Halix (press release)

De enige manier om de COVID-19 crisis effectief te lijf te gaan is door een nieuwe generatie geneesmiddelen en vaccins te ontwikkelen en betrouwbare en snelle diagnostiek van het virus en de immuniteit ter beschikking te hebben. Daarom hebben Surfix B.V. en zijn aandeelhouders Qurin Diagnostics B.V. en LioniX International B.V. vandaag bekendgemaakt een versneld ontwikkeltraject te starten om massale COVID-19 diagnostiek en immuniteitsdetectie mogelijk te maken met de financiële steun van en in nauwe samenwerking met PhotonDelta. De bedrijven werken reeds gezamenlijk aan de ontwikkeling van bio-fotonische nanochips voor de vroege opsporing van kanker en hebben hiervoor een biochip met ultragevoelige sensoren ontwikkeld.

Het nieuwe diagnostische apparaat zal binnen 5 minuten betrouwbare testresultaten kunnen produceren en zal over 6 tot 9 maanden beschikbaar zijn. Het apparaat wordt gebouwd op basis van een zogenoemde fotonische biochip die gebruikmaakt van beproefde geïntegreerde optische technologie van LioniX en is gebaseerd op siliciumnitride (TriPleX™), een sleuteltechnologie in het PhotonDelta ecosysteem. Deze technologie is oorspronkelijk ontwikkeld voor de ruimtevaart en telecommunicatie en wordt door Surfix en Qurin gebruikt voor diagnostische toepassingen. De gecombineerde expertise van deze drie bedrijven maakt een snelle en betrouwbare test voor virusdetectie mogelijk. De ontwikkeling wordt ondersteund door PhotonDelta (een Nederlands publiek-privaat samenwerkingsverband) en betreft zowel co-financiering als ondersteuning bij opschaling en exploitatie.

Coenraad K. van Kalken, CEO van Qurin Diagnostics: “De zeer snel tot stand gekomen samenwerking met PhotonDelta bevestigt onze strategische visie dat de ultragevoelige biochip die we samen aan het ontwikkelen zijn voor massale en goedkope screening van kanker breed toepasbaar is in o.a. diverse biologische agri-food markten en in diverse andere biomedische gebieden. In al deze gebieden is zeer accurate moleculair-diagnostische technologie nodig tegen een lagere kostprijs dan de complexe en arbeidsintensieve moleculaire analysemethoden die nu gebruikt worden. De huidige COVID-19 crisis maakt dit op een pijnlijke wijze aan het grote publiek duidelijk.”

Luc Scheres CTO van Surfix: “We hebben specifieke nano-coatings ontwikkeld die de gevoeligheid, detectielimiet en betrouwbaarheid van de fotonische biochip verbeteren. Uiteraard heeft elke toepassing zijn eigen specifieke eisen en uitdagingen, dus is een nauwe samenwerking met experts uit de andere disciplines essentieel om een succesvolle diagnostische test te ontwikkelen. Daarom versterken we graag de samenwerking met LioniX International en Qurin Diagnostics ten behoeve van de versnelde ontwikkeling van deze coronavirus test.”

“Het TriPleX™ platform heeft laten zien dat voor kankerdiagnostiek het een kosteneffectieve oplossing biedt. Een investering in deze nieuwe applicatie is niet slechts een commercieel gedreven keuze, maar sterk gemotiveerd door het maatschappelijke belang. Aangezien we een gedegen technologische basis en betrouwbare samenwerkingspartners hebben, hebben we een groot vertrouwen in het realiseren van een succesvolle COVID-19 test”, vertelde Arne Leinse, CEO van LioniX International.

“Dit is een mooi voorbeeld van een gezamenlijk initiatief van partners in het PhotonDelta ecosysteem, om belangrijke, betaalbare en effectieve oplossingen te ontwikkelen die mogelijk gemaakt worden met geïntegreerde fotonica technologie. Het initiatief bouwt voort op onze kennis over ultragevoelige biochips, die van groot belang kunnen zijn in de huidige COVID-19 crisis. Bio-sensing behoort tot de langetermijn ontwikkelprogramma’s (roadmaps) binnen PhotonDelta waar de industrie, universiteiten en het volledige PhotonDelta ecosysteem samenwerken aan de volgende generatie oplossingen en testapparaten voor virus-gerelateerde en andere ziektes”, vertelde Ewit Roos, CEO of PhotonDelta.

Bron: Qurin (persbericht)

Sanofi and GSK today announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic.

Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.

GSK will contribute its proven pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people. 

“As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone.” says Paul Hudson, Chief Executive Officer, Sanofi. “That is why Sanofi is continuing to complement its expertise and resources with our peers, such as GSK, with the goal to create and supply sufficient quantities of vaccines that will help stop this virus.”

“This collaboration brings together two of the world’s largest vaccines companies.” says Emma Walmsley, Chief Executive Officer, GSK. “By combining our scientific expertise, technologies and capabilities, we believe that we can help accelerate the global effort to develop a vaccine to protect as many people as possible from Covid-19.”

The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines available today. An adjuvant is added to some vaccines to enhance the immune response and has been shown to create a stronger and longer- lasting immunity against infections than the vaccine alone. It can also improve the likelihood of delivering an effective vaccine that can be manufactured at scale. 

The companies plan to initiate phase I clinical trials in the second half of 2020 and, if successful, subject to regulatory considerations, aim to complete the development required for availability by the second half of 2021. 

As previously announced by Sanofi, development of the recombinant-based COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The companies plan to discuss funding support with other governments and global institutions prioritising global access.

“Strategic alliances among vaccine industry leaders are essential to make a coronavirus vaccine available as soon as possible,” says BARDA Director, Rick A. Bright, Ph.D. “Development of the adjuvanted recombinant-based COVID-19 vaccine candidate holds the potential to lower the vaccine dose to provide vaccine to a greater number of people to end this pandemic, and help the world become better prepared or even prevent future coronavirus outbreaks.”

The companies have set up a Joint Task Force, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. The taskforce will seek to mobilize resources from both companies to look for every opportunity to accelerate the development of the candidate vaccine.

Considering the extraordinary humanitarian and financial challenge of the pandemic, both companies believe that global access to COVID-19 vaccines is a priority and are committed to making any vaccine that is developed through the collaboration affordable to the public and through mechanisms that offer fair access for people in all countries.

These efforts mark a significant milestone in Sanofi’s and GSK’s ongoing contributions to help fight COVID-19. The companies have entered into a Material Transfer Agreement to enable them to start working together immediately.  Definitive terms of the collaboration are expected to be finalised over the next few weeks.

Source: GSK and Sanofi (press release)