Source : 'Scrip Intelligence'
Pfizer Inc. and BioNTech SE have concluded preliminary talks with the European Commission to supply the EU with 200 million or more doses of their SARS-CoV-2 vaccine candidate. The deal is subject to the mRNA-based vaccine, BNT162, which is in a Phase II/III trial, proving successful in the clinic and gaining regulatory authorization. The companies said deliveries could start before the end of 2020, and claimed they could seek regulatory review by October 2020.
The exploratory talks also envisaged the EU having an option on a further 100 million doses of BNT162.
Vaccine doses for Europe would be manufactured by BioNTech in Germany and by Pfizer in Belgium, while allocation among the 27 EU member states would be led by the European Commission, which may also donate them to low and middle-income countries or redirect them to European countries. Pfizer CEO Albert Bourla said the company was starting to manufacture at its site in Belgium so that its vaccine would be available “as soon as possible.”
Pfizer and BioNTech’s Phase II/III trial is studying a 30μg dose in a two-dose regimen in up to 30,000 participants aged 18-85. They have enrolled more than 25,000 participants in the US, Argentina and Brazil as of 9 September. Additional enrollment is planned in Germany, Turkey and South Africa.
Should they receive approval this year, the partners plan to supply up to 100 million doses worldwide by the end of 2020 and about 1.3 billion doses by the end of 2021.
The companies have already reached agreements to supply more than 250 million doses of BNT162 to the US, Japan, Canada and the UK in 2020 and 2021, while BioNTech and its Chinese partner Shanghai Fosun Pharmaceutical (Group) Co., Ltd. have also agreed a potential collaboration to supply 10 million doses of BNT162 to Hong Kong and Macao.
The European Commission signed its first SARS-CoV-2 vaccine purchase contract on behalf of EU member states in August. It secured the right to purchase 300 million doses of AstraZeneca’s vaccine, with an option on a further 100 million doses. AstraZeneca on 9 September confirmed a clinical hold on its Phase III trial following an adverse event. ("AZ Exercises Caution With COVID Vaccine Safety Pause As Questions Remain Over Vector" "Scrip" )
Besides AstraZeneca and Pfizer/BioNTech, the Commission has already concluded exploratory talks on vaccine purchase arrangements with Sanofi/GlaxoSmithKline plc, Johnson & Johnson, CureVac BV and Moderna, Inc.
Pfizer and BioNTech on 9 September also issued a separate press release announcing that preclinical data in mouse and non-human primates showed that BNT162 protected rhesus macaques against SARS-CoV-2. The manuscript describing the data is still undergoing scientific peer review before potential publication but has been posted on the preprint server bioRxiv.
After initially saying it will continue Phase II/III Indian trials of partner AstraZeneca PLC’s COVID-19 vaccine candidate AZ1222, Serum Institute of India Pvt. Ltd. has also now announced a temporary halt to trials of the vaccine originally developed by the University of Oxford's Jenner Institute. ("Indias Serum Joins Oxford Efforts To Expedite COVID19 Vaccine" "Scrip" )
AstraZeneca stopped trials after an adverse event in the UK, which the company did not detail but reports in The New York Times suggested was transverse myelitis (TM), a rare immune-mediated inflammation which causes neural injury to the spinal cord. The condition usually has autoimmune origins and has been observed in earlier vaccine studies. ("AZ Exercises Caution With COVID Vaccine Safety Pause As Questions Remain Over Vector" "Scrip" )
Serum's change of heart seem to have been prompted by a show-cause notice issued by the Drugs Controller General of India (DCGI), asking why the Indian regulator was not informed about the reported serious adverse events that led to a temporary halt of trials and why approval for Phase II/III trials should not be suspended till patient safety is established.
In response to a question by Scrip earlier on whether trials would be suspended in India too, Serum Institute had initially said it had not been asked by the DCGI to pause the trials and that if the DCGI had any safety concerns, it will follow instructions and abide by standard protocols.
This was later updated to state "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials."
The company is conducting trials across 17 sites in the country and there has been a lot of optimism so far around the vaccine, with availability in India projected any time from December to the first half of 2021. A halt of trials would mean a delay in rollout of immunization programs.
Recently, VG Somani, of the DCGI, said that emergency use authorization for COVID-19 vaccines would not be permitted. The comment at a virtual edition of the Annual BioPharma and Healthcare Summit of the USAIC (USA-India Chamber of Commerce) on 4 September was significant given that countries like the US and UK intend doing so. ("No EUA For COVID19 Vaccines Prior To Trials Completion Says India" "Scrip" )
Japan’s Anges, Inc. has announced a collaboration agreement under which private US firm Brickell Biotech, Inc. has gained the right to develop and commercialize its investigational, adjuvanted plasmid DNA vaccine against SARS-CoV-2 in the US, South America and certain emerging markets.
Anges is currently conducting Phase I/II trials with the vaccine in Japan, with data readouts expected through the first quarter of 2021, the results of which will guide further global development efforts.
Anges will continue to lead development of its vaccine - co-developed with Osaka University - in Japan but Brickell will provide any relevant information and know-how from its trials. Financial terms of the alliance were not disclosed.
Boulder, CO-based Brickell last year went through an all-stock reverse merger with publicly traded infectious disease-focused biotech Vical, to create a 60%/40% respectively owned entity that took over Vical's NASDAQ listing but operates as Brickell Biotech. ("Deal Watch Vertex Expands GeneEditing Efforts With A Pair Of Deals" "Scrip" )
Despite the new deal, Brickell said it remained focused on initiating a US Phase III program in the fourth quarter for topical soft anticholinergic sofpironium bromide for primary axillary hyperhidrosis later this year, which is already partnered with Kaken Pharmaceutical Co., Ltd. in Japan.
Serum Institute of India Pvt. Ltd. and University of Oxford spinout SpyBiotech Limited have partnered for a novel virus-like particle (VLP) vaccine targeting COVID-19, with first participants for Phase I/II trials of the vaccine already being dosed.
The alliance will add to the multiple partnerships that Serum Institute has entered for COVID-19 vaccines, including ones with AstraZeneca and Novavax. ("Novavax-Serum Institute Seal Win-Win Deal For COVID-19 Vaccine" "Scrip" )
A company with a novel vaccine platform to target infectious diseases, cancer and chronic diseases, SpyBiotech did not disclose financial terms of the exclusive global licensing agreement signed with Serum Institute.
The company’s current lead candidate is against human cytomegalovirus, with clinical studies planned for 2021. Supported by investors including Oxford Sciences Innovation, the capital investor for the University of Oxford, and GV (formerly Google Ventures), it has raised £15m in funding to date.
The COVID-19 vaccine candidate induces an immune response using proprietary SpyTag/ SpyCatcher protein “superglue” technology to display the coronavirus spike protein on the surface of Hepatitis B surface antigen (HBsAg) VLPs.
SpyBiotech has exclusive rights from the University of Oxford to apply, commercialize and sub-license the “plug and display” technology for vaccine development.
The SpyCatcher/SpyTag platform technology allows antigens to be displayed onto VLPs with a covalent, irreversible bond in a highly stable and effective way with specific orientation/epitope presentation and high density and has established proof of concept data in a viral, bacterial, parasitic diseases and chronic diseases and cancer.
HBsAg VLPs are licensed vaccines with excellent safety and immunogenicity data in humans and billions of doses of these vaccines have been manufactured, the company said.
“For SpyBiotech, this is an opportunity to provide an accelerated proof point for our platform technology, alongside the other candidates which we are advancing into clinical development. Our technology can be combined with multiple vaccine delivery platforms to create a plug and display vaccine which is critical for generating vaccines rapidly and safely,” said Sumi Biswas, CEO and co-founder of SpyBiotech.
By Scrip Team