Company suspends enrolment to trials as coronavirus travel restrictions bite.
GlaxoSmithKline PLC is lending its support – and specifically its adjuvant expertise – to a high-profile initiative looking to develop a vaccine to combat the novel coronavirus outbreak from China.
The UK drugs major is teaming up with the Coalition for Epidemic Preparedness Innovations (CEPI) and making its adjuvant platform technology available to enhance the development of a vaccine against the coronavirus known as 2019-nCoV which was first identified in Wuhan and has spread to at least 24 other countries. The use of an adjuvant, added to some vaccines to enhance the immune response, is of particular importance in a pandemic situation, the partners said, since it can reduce the amount of antigen required per dose, allowing more vaccine to be produced.
CEPI, a public-private body based in Norway and launched at the Davos summit in 2017 to develop vaccines to stop future epidemics, had previously announced programs relating to 2019-nCoV in partnership with Inovio Pharmaceuticals Inc.,CureVac AG, the University of Queensland, Moderna Inc. and the US National Institute of Allergy and Infectious Diseases. GSK's first agreement is with the Australian university which originally partnered with CEPI in January 2019 to develop a “molecular clamp” vaccine platform against multiple viral pathogens. (Also see "Moderna, Inovio Coronavirus Vaccine Candidates Fast-Tracked By International Coalition" - Scrip, 27 Jan, 2020.)
Roger Connor, president of GSK Vaccines, said, "We are proud to contribute to cutting edge research from scientists at the University of Queensland, and we are open to working with other partners, who have a promising vaccine platform that could be used together with our adjuvant.” The company's adjuvant technology has previously been used successfully in the pandemic flu setting and GSK Vaccines chief medical officer Thomas Breuer added that using only small quantities of the vaccine antigen was "a crucial advantage in a pandemic.”
News of the GSK pact came as the UK government pledged £20m to CEPI. Welcoming the UK’s "continued support and funding for our vital work," CEPI’s CEO Richard Hatchett said the hope was to get an investigational vaccine from gene sequencing of the pathogen through to clinical testing in 16 weeks.
To get the vaccine into Phase I trials would take around two to four months, he said, acknowledging that "this is an extremely ambitious timeline – indeed, it would be unprecedented in the field of vaccine development." Hatchett stressed, "It is important to remember that even if we are successful – and there can be no guarantee – there will be further challenges to navigate before we can make vaccines more broadly available."
Aside from CEPI, there are several other initiatives to develop a vaccine for 2019-nCoV which to date has killed over 360 people. Johnson & Johnson's chief scientific officer Paul Stoffels noted last week that the company began work on the current novel coronavirus vaccine in the middle of January, "starting from a sequence we now know, and are optimistic that we can start testing later this year."
J&J's AdVac and PER.C6 technologies are being used to develop a vaccine, the same technologies that were employed to accelerate development and manufacturing of its investigational Ebola vaccine. The latter is currently being deployed in the Democratic Republic of the Congo and Rwanda. (Also see "Janssen’s Ebola Vaccine Added To Fight Against African Outbreak" - Pink Sheet, 25 Sep, 2019.)
Other collaborations are emerging in response to the crisis, including a pact between Wuhan-based BravoVax and US vaccine developerGeoVax Labs Inc.. Also, VGXI, a contract manufacturer and US subsidiary of Korea’s GeneOne Life Science Inc., is gearing up for clinical trial quantity production of a potential DNA vaccine against 2019-nCoV coronavirus as part of a new agreement with Inovio, backed with a grant of up to $9m from CEPI. (Also see "Asia Deal Watch: China’s BravoVax, US-based GeoVax Team Up On Coronavirus Vaccine" - Scrip, 31 Jan, 2020.) (Also see "VGXI Gears To Support Production Of New Coronavirus Vaccine" - Scrip, 2 Feb, 2020.)
A potential vaccine is some way off and in the meantime, anti-viral drugs are being explored as possible treatments for 2019-nCoV. On 31 January,
Gilead Sciences Inc. said it was working with Chinese health authorities to establish a randomized, controlled trial to determine the safety and efficacy of its investigational drug remdesivir; it was originally intended for the Ebola and Marburg viruses, although it failed to show efficacy against the former. (Also see "Gilead Joins Coronavirus Fray With Repurposed Antiviral " - Scrip, 2 Feb, 2020.)
J&J has donated 300 bottles (30 tablets each) of its HIV medication Prezcobix (darunavir/cobicistat) to the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University for use in research to support efforts in finding a solution for 2019-nCoV. So far, the only antiviral officially recommended by China’s National Health Commission to treat the new Wuhan coronavirus is AbbVie Inc.’s HIV combination Kaletra (lopinavir and ritonavir), taken twice daily together with nebulized alpha-interferon to treat infected patients.
News from around the biopharma sector and its efforts to meet the challenges posed by the coronavirus pandemic.
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