Scrip: industry news and insights
26 Nov 2020
Executive appointments at MyoKardia, Scancell Holdings and Sutro Biopharma
The Coalition for Epidemic Preparedness Innovations adds new deal with mRNA specialist Moderna for rapid development of coronavirus vaccine.
WUHAN, A CITY OF 11M PEOPLE AROUND 800KM WEST OF SHANGHAI, IS THE CENTER OF THE CORONAVIRUS OUTBREAK
As the death toll from the coronavirus mounts in China, international action to fast-track potential vaccines against the new strain is underway. Companies including Inovio Pharmaceuticals, Moderna, Novavax and Atriva Therapeutics and Gilead area all looking at ways to tackle the new threat.
The number of people killed by the coronavirus, known as nCoV-2019, has now risen to 81 in China, with a further 3,000 confirmed ill with the infection. The outbreak has coincided with China's national new year holiday, which has been extended by three days to Sunday, in order to contain the virus' spread. The director-general of the World Health Organization, Tedros Adhanom Ghebreyesus is visiting Beijing to discuss the outbreak with the Chinese government and health experts.
On 23 January, CEPI, the Coalition for Epidemic Preparedness Innovations announced the initiation of three programs to develop vaccines against nCoV-2019, with the aim of advancing vaccine candidates into testing and available as quickly as possible - which it believes could be just 16 weeks.
The nCoV-2019 vaccine development efforts will build on existing partnerships with Inovio Pharmaceuticals Inc. and The University of Queensland in Australia. CEPI has also announced a new partnership with Moderna Inc. and the U.S. National Institute of Allergy and Infectious Diseases.
CEPI was established at the Davos meeting in 2017 with the express purpose of co-ordinating a global response to epidemics, following outbreaks such as the Ebola and Zika viruses in recent years.
"Given the rapid global spread of the nCoV-2019 virus the world needs to act quickly and in unity to tackle this disease," said Richard Hatchett, chief executive of CEPI.
"Our intention with this work is to leverage our work on the MERS coronavirus and rapid response platforms to speed up vaccine development. There are no guarantees of success, but we hope this work could provide a significant and important step forward in developing a vaccine for this disease. Our aspiration with these technologies is to bring a new pathogen from gene sequence to clinical testing in 16 weeks – which is significantly shorter than where we are now."
CEPI announced a partnership agreement Inovio with worth up to $56m in April 2018, to advance DNA vaccine candidates against MERS and another of its priority diseases, Lassa fever, through to Phase II trials.
The agreement provides funding to develop the candidate up to the end of Phase II, providing clinical safety, immunological data, and the establishment of investigational stockpiles that will be ready for clinical efficacy trial testing during outbreaks.
The MERS DNA vaccine candidate is being developed using Inovio’s DNA Medicines platform to deliver optimised synthetic antigenic genes into cells, where they are translated into protein antigens that activate an individual’s immune system to generate robust targeted T-cell and antibody responses. Inovio’s immunotherapies function exclusively in vivo, and have generated an antigen-specific immune response against targeted diseases in all clinical trials to date.
CEPI is also already working with with University of Queensland in a $10.6m collaboration to develop a “molecular clamp” vaccine platform, a potentially transformative technology that enables targeted and rapid vaccine production against multiple viral pathogens.
Finally, the new agreement with Moderna will see the company manufacture an mRNA vaccine against 2019-nCoV, to be funded by CEPI. The Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, collaborated with Moderna to design the vaccine. NIAID will conduct IND-enabling studies and a Phase 1 clinical study in the U.S.
STEPHANE BANCEL, CEO OF MODERNA
“We believe our mRNA vaccine technology offers potential advantages in the speed of development and production scalability, which positions Moderna to potentially develop a vaccine against coronavirus, 2019-nCoV,” said Stéphane Bancel, CEO of Moderna.
Bancel added that public-private partnerships are necessary in global public health, and said it was "impressive" that CEPI had been able to commit to the grant and a multi-year collaboration in a matter of days.
Developers Caution On Expectations
Inovio and Moderna have seen a steep rise in their share prices thanks to their potential role against the outbreak, but are not the only ones. Gilead, an established player in virology, says it is considering the repurposing of its NUC inhibitor remdesivir. This was tested against the Ebola vaccine, but failed to show efficacy.
Another company with potential to help is Novavax Inc., which has developed an innovative nanoparticle vaccine technology, and has seen its share price shoot up 60%. Greg Glenn, president of R&D at the company told Yahoo Finance's The Ticker that public-private collaborations could help accelerate development, but that timelines for developing products nevertheless remained "extensive".
Atriva Therapeutics GmbH is another company working in the field, developing new therapeutic options for treating respiratory infections with RNA viruses. The Tubingen, Germany-based company's lead substance ATR-002 is a MEK inhibitor (best known from oncology drugs in melanoma) and is about to enter Phase II trials.
Its chief executive Rainer Lichtenberger told Scrip that its candidate could in principle be effective against the coronavirus, but its researchers first need to gain access to a sample of 2019-nCoV to establish potential efficacy. He said it would be neither "professional nor ethical" to say that his company could treat patients in the near future, but was nevertheless encouraged by potential public-private partnerships.
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