As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.
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Thermal stabilization technology used for oral delivery of Covid-19 vaccine candidate
iosBio, a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio, a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.
iosBio has claimed the OraPro platform enables oral delivery of thermally-stable, viral vector vaccines, which are engineered to withstand temperatures of up to 50°C. This allows the vaccine to pass through hostile conditions in the stomach without loss of efficacy and provides long-term product stability at ambient temperatures.
Pending ImmunityBio’s discussions with the US Food and Drug Administration, the oral vaccine will enter Phase 1 trials as a prime and boost, and will be explored as an option to provide healthcare providers with a boost to subcutaneous vaccinations.
Wayne Channon, chairman of iosBio, said: We are delighted to be able to support ImmunityBio with the oral delivery of its second-generation Covid-19 vaccine candidate. The [OraPro] technology is key to developing vaccines that can be administered orally without loss of efficacy and has the potential to truly transform vaccine development.
“Oral vaccines have the potential to overcome global challenges of traditional vaccines, many of which need to be stored and transported at freezing temperatures. They also have the potential to be self-administered, reducing health systems’ dependency on trained health professionals to run immunization programs and present a future where people could have vaccines delivered straight to their door.”
Patrick Soon-Shiong MD, chairman and CEO of ImmunityBio, said: “There is an urgent need for a vaccine that not only offers immediate protection but also activates T cells to clear the virus. When multiple mutations occur at the receptor-binding domain of the spike protein, it renders antibodies ineffective.
“Our next-generation vaccine design drives both antibody and T cells to S and N protein, and so could potentially serve as a universal boost to current vaccines that focus only on the monovalent S protein, as well as address future mutations of the S protein.”
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Novavax finalizes agreement with Australia for 51 million doses of Covid-19 vaccine
Novavax, a biotechnology company focused on developing next-generation vaccines for infectious diseases, has announced that 51 million doses of its Covid-19 vaccine candidate (NVX-CoV2373) have been authorized for distribution in Australia.
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Once regulatory approval has been obtained, initial doses of the vaccine will be expected to be delivered in mid-2021, the company claimed after executing an Advance Purchase Agreement with the Australian government. Novavax said it was continuing to work with Australia’s regulatory agency, the Therapeutics Goods Administration, to obtain product approvals upon demonstrating efficacy in clinical studies.
Novavax’s vaccine is a recombinant protein vaccine adjuvanted with Novavax’s nanoparticle technology, Matrix-M, which enhances immune response in recipients. Scientists have been aiming to complete late-stage clinical studies to demonstrate the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of Covid-19. This includes two large pivotal Phase 3 clinical trials in the UK, US and Mexico, as well as a Phase 2b trial in South Africa.
Stanley Erck, president and CEO of Novavax, said: “The continued increase in significant Covid-19 transmission in virtually all parts of the world underscores the need for multiple safe, efficacious vaccines in enormous quantities to stop the pandemic.
“We appreciate the confidence of the Australian government and the opportunity to play a role in ensuring that its citizens will have access to a protein-based vaccine that can be distributed using existing distribution channels, should it receive regulatory approval.”
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If you missed out on the new edition of our Keeping tabs series last week, Keeping tabs on pharma, you can dive into the update on the broader pharmaceutical landscape from Pharma IQ here.