DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology.
Financial terms have not been disclosed – indeed the deal has yet to be finalized – but the two companies have entered two agreements that will enable them to start work immediately. “The agreements are a letter of intent and a materials transfer agreement through which Sanofi and GSK will assess the technical path to develop and produce a COVID-19 pandemic vaccine,” a Sanofi spokeswoman told BioWorld by email.
Plans for a clinical trial are already advanced. “The companies plan to initiate phase I clinical trials in the second half of 2020 and, subject to regulatory considerations, complete the development required for availability by the second half of 2021,” the spokeswoman said. The scale and scope of the alliance are, necessarily, ambitious. “While it is difficult to commit to an exact number of doses, our expectation is to be able to produce hundreds of millions of doses of the vaccine,” she said. “This of course is dependent upon positive clinical trials and regulatory approvals,” she added.
That puts them on a similar timetable to that pursued by Johnson & Johnson, of New Brunswick, N.J. The latter firm aims to move its COVID-19 vaccine into the clinic by September, although it then aims – optimistically – to secure an emergency use authorization for its first batches by early 2021. J&J’s $1 billion COVID-19 vaccine play, which employs its Advac adenovirus vector technology and its Per.C6 expression system, is underpinned by an agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA).
In addition to the present initiative with GSK, Sanofi had entered a new COVID-19 vaccine development partnership with BARDA in February, which builds on a previous relationship with the same agency focused on the SARS outbreak of 2002-2004.
The technologies underpinning this present development effort are already mature. Sanofi gained ownership of Flublok, and the underlying insect-cell expression system, through its $750 million acquisition of Meriden, Conn.-based Protein Sciences LLC in 2017. Protein Sciences gained a first FDA approval for a trivalent flu vaccine, for adults, ages 18 to 49, years back in 2013. An approval for the same vaccine in all adults followed in 2014, and the quadrivalent vaccine was licensed in 2016.
GSK’s AS03 pandemic adjuvant technology is already the subject of separate COVID-19 vaccine development collaborations with the University of Queensland in Brisbane, Australia, with Sichuan Clover Biopharmaceuticals Inc., of Chengdu, China, and with Fujian, China-based Xiamen Innovax Biotech Co. Ltd. It comprises alpha-tocopherol, squalene and polysorbate 80, combined in an oil-in-water emulsion, and offers the potential for dose-sparing because of its immune-boosting properties.
AS03 was previously used in GSK’s Pandemrix H1N1 influenza vaccine, which was linked to narcolepsy cases in England, Finland, France, Ireland, Norway and Sweden. A 2015 study suggested the problem arose from an overlap between epitopes on the viral nucleoprotein A and hypocretin receptor 2, which regulates sleep.
GSK has stated that it does not expect to book a profit from its COVID-19-related collaborations. Whatever short-term profits it generates from sales will be reinvested in coronavirus-related research and in pandemic preparedness initiatives. It also plans to make its adjuvant technology available to low-income countries, through donations and other mechanisms.
The two companies have hailed the present alliance as being “unprecedented.” It is certainly unusual. Although it is very common for large vaccine manufacturers to source technologies or assets externally, these relationships typically involve small biotech firms. The big four vaccine players – Sanofi, GSK, Merck & Co. Inc. and Pfizer Inc. – rarely collaborate. The sole exception was the European joint venture between Sanofi and Kenilworth, N.J.-based Merck, but that ceased to operate at the end of 2016.