Pharma COVID Roundup: News from J&J, Moderna, GSK, LillyBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from J&J, Moderna, Novavax, GSK, CSL, Lilly, Roche, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna Increases Supply of COVID-19 Vaccine to Switzerland
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced the Swiss government has increased its confirmed order commitment of its COVID-19 vaccine from 7.5 million to 13.5 million doses.
The initial procurement by the Swiss government for 4.5 million doses was announced in August 2020 and was increased to 7.5 million doses in December 2020. The additional 6 million doses will be delivered beginning in the summer of 2021, with an option to receive doses in the first half of 2022 as Moderna explores potential vaccine boosters to address emerging variants.
Last month (January 2021), Swissmedic, the Swiss pharmaceutical regulatory agency, authorized Moderna’s COVID-19 vaccine based on a rolling submission of data, including a data analysis from a Phase III clinical study announced in November 2020.
In a separate development, the Singapore Health Sciences Authority (HSA), the national authority regulating health products agency in Singapore, has approved the interim authorization of Moderna’s COVID-19 vaccine. The Singapore Ministry of Health secured access to the vaccine through a supply agreement announced in December 2020.
Moderna ;has also received authorization for its COVID-19 vaccine from health agencies in the US, Canada, Israel, the European Union, and the UK. Additional authorizations are currently under review in other countries and by the World Health Organization.
Novavax, Canadian Gov’t in Agreement To Produce COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has announced a memorandum of understanding with the Canadian government to produce its COVID-19 vaccine, NVX-CoV2373, in Canada.
Novavax plans to produce its COVID-19 vaccine at the National Research Council’s Biologics Manufacturing Centre in Montréal once both the vaccine and the facility receive Health Canada approvals. The memorandum of understanding also includes a broader intention for the Canadian government and Novavax to work to increase the company’s Canadian presence. They will explore a range of partnership opportunities for Novavax to expand vaccine production in Canada, including partnerships with Canadian contract manufacturers.
Last month (January 2021), the Canadian government signed an agreement with Novavax to provide up to 76 million doses of Novavax’s COVID-19 vaccine. Novavax recently initiated the rolling submission process for regulatory approval to Health Canada.
EU, UK begins rolling review
In a separate development, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of Novavax’s COVID-19 vaccine.
Novavax reported that the vaccine achieved efficacy of 89.3%, in a Phase III clinical trial in the UK. The company initiated a rolling submission to the UK’s regulatory agency in mid-January (January 2021).
Testing for COVID-19 variants
Novavax has initiated development of new constructs against the emerging strains of COVID-19 in early January (January 2021) and expects to select ideal candidate for a booster and/or combination bivalent vaccine for the new strains in the coming days (as reported on January 28, 2021). The company plans to initiate clinical testing of these new vaccines in the second quarter of 2021.
Valneva Starts Mfg of COVID-19 Vaccine; To Supply the UK
Valneva, a Saint-Herblain, France-headquartered vaccine company, has begun production of its inactivated, adjuvanted COVID-19 vaccine (VLA2001) with the UK government exercising its option to order 40 million additional doses of the vaccine for supply in 2022.
This brings the total volume of the Valneva vaccine ordered by UK government to 100 million doses. The UK government retains options for a further 90 million doses for 2023 and 2025. The total value of the 190 million doses, if all options are exercised, is up to EUR 1.4 billion ($1.6 billion).
Th option exercise further triggers the reservation of additional quantities of the advanced adjuvant, CpG 1018, from Dynavax, an Emeryville, California-based biopharmaceutical company, to support production of 40 million doses of the vaccine.
Last month (January 2021), Valneva announced advanced discussions with the European Commission regarding supply of up to 60 million doses of the vaccine.
Valneva has commenced production of the COVID-19 vaccine in parallel to ongoing clinical studies in order to optimize the timeline for potential deliveries of the vaccine. The Phase I/II clinical study is fully enrolled, and initial results are expected in April 2021.
In September 2020, Valneva announced its partnership with the UK government, and Valneva and Dynavax announced a commercial partnership for the supply of Dynavax’s CpG 1018 adjuvant for use in VLA2001, to support Valneva’s agreement with the UK government to provide up to 190 million doses of VLA2001 over a five-year period. Dynavax expects to supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase additional quantities of CpG 1018 to support the production of up to an additional 90 million doses of VLA2001 through 2025.
The Coalition for Epidemic Preparedness Innovations, a public–private coalition partnership for vaccine development, will provide Dynavax funding of up to $99 million through a forgivable loan for the manufacturing of CpG 1018 with the potential to support hundreds of million doses of COVID-19 vaccine for delivery in 2021 through COVAX, a global initiative to ensure rapid and equitable access to COVID-19 vaccines.
Updates on COVID-19 treatments and vaccines
J&J Files for Emergency Use Authorization for Its COVID-19 Vaccine
Johnson & Johnson (J&J) has filed for emergency use authorization to the US Food and Drug Administration for its single-dose COVID-19 vaccine following positive results from a Phase III trial.
The company has also initiated rolling submissions with several health agencies outside the US and says it will submit a conditional marketing authorization application with the European Medicines Agency in the coming weeks (as reported on February 4, 2021). .
The Phase III study was designed to evaluate the efficacy and safety of the vaccine in protecting moderate-to-severe COVID-19. The vaccine was found to be 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as Day 14. The level of protection against moderate-to-severe COVID-19 infection was 72% in the US, 66% in Latin America, and 57% in South Africa, 28 days post-vaccination. The vaccine was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. The vaccine demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination.
If authorized, the company expects to have product available to ship immediately following authorization. J&J expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized. The company says its anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.
GSK, Clover End Their Pact for COVID-19 Vaccine
GlaxoSmithKline (GSK) and Clover Biopharmaceuticals, a Chengdu, China-based biopharmaceutical company, have decided to discontinue their partnership to evaluate Clover’s protein-based S-Trimer COVID-19 vaccine candidate with GSK’s adjuvant system.
In its Phase I clinical trial, Clover’s S-Trimer vaccine candidates in combination with adjuvants from either Dynavax, an Emeryville, California-based biopharmaceutical company, or GSK both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand.
Clover and Dynavax plan to initiate a global Phase II/III efficacy trial with Clover’s S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 adjuvant plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially available in the middle of 2021.
BMS, Rockefeller University in Pact for mAb Combo Treatment for COVID-19
Bristol Myers Squibb (BMS) and the Rockefeller University have entered into a definitive agreement under which BMS has been granted a global exclusive license to develop, manufacture and commercialize Rockefeller’s monoclonal antibody (mAb) duo treatment that neutralizes SARS-CoV-2 for therapy or prevention of COVID-19.
The treatment is a combination of two mAbs directed at blocking the SARS-CoV-2 spike protein and neutralizing the virus. Phase I clinical trials to assess dosing for IV and subcutaneous formulations and to assess safety for the mAb duo, were initiated by Rockefeller in mid-January (January 2021). Planning is underway with the goal of moving to a registrational program following readout of the Phase I study taking place at Rockefeller University Hospital.
Under the agreement, Rockefeller is entitled to receive royalty payments on future sales. Should the clinical development be successful, Bristol Myers Squibb will work to enable availability and affordability of this potential treatment to patients globally.
Source: Bristol-Myers Squibb
CSL Australia Initiates Clinical Trial of Anti-SARS-CoV-2 Plasma Product
CSL Behring Australia, a subsidiary of CSL Limited, has announced that recruitment will begin for a clinical trial of an anti-SARS-CoV-2 plasma product with the potential to treat people with serious complications of COVID-19.
The investigational product, known as CSL760, has been developed using donations of plasma from people who have recovered from COVID-19 and collected by the Australian Red Cross Lifeblood. These donors have high levels of antibodies in their plasma, and these antibodies are pooled, purified, and concentrated to make a COVID-19 hyperimmune globulin.
In preparation for the trial, the investigational product has been manufactured by CSL Behring Australia at its manufacturing facility in Broadmeadows, Victoria, Australia.
Data from the trial will be used to recommend a dosage and will be supplemented by data collected through the global CoVIg-19 Plasma Alliance, a collaboration founded by CSL Behring and Takeda and supported by other global organizations, to support the product registration process in Australia.
Source: CSL Behring
Lilly, Area Health Systems in Pact for COVID-19 Antibody Infusion Therapies
Eli Lilly and Company has partnered with local health systems to launch dedicated infusion center locations serving central, northern, and now southern Indiana that are intended to provide access to COVID-19 treatments.
Source: Eli Lilly and Company
Sinovac Files for Conditional Market Authorization of COVID-19 Vaccine in China
Sinovac Biotech, a Beijing, China-based biopharmaceutical company, has filed for conditional market authorization for CoronaVac, its inactivated COVID-19 vaccine, with China’s National Medical Products Administration (NMPA).
The vaccine candidate was tested in Phase III clinical studies outside of China. The company reported that preliminary results of the trials demonstrated a good safety profile for the vaccine.
Rigel Awarded $16.5-M from US Gov’t for COVID-19 Drug Trial
Rigel Pharmaceuticals, a South San Francisco, California-based biotechnology company, has been awarded $16.5 million by the US government to support its ongoing Phase III clinical trial to evaluate fostamatinib in hospitalized COVID-19 patients.
Fostamatinib is marketed in the US as Tavalisse (fostamatinib disodium hexahydrate) tablets, and is approved in the US, Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (low blood platelet count).
The $16.5-million award is being granted by the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. The Phase III clinical trial will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors.
Source: Rigel Pharmaceuticals
Vaxart Reports Positive Preliminary Data for Oral COVID-19 Tablet Vaccine
Vaxart, a South San Francisco, California-headquartered developer of oral recombinant protein vaccines, has reported positive preliminary data from a Phase I study of its oral COVID-19 tablet vaccine candidate, VXA-CoV2-1.
Vaxart expects to broaden its COVID-19 vaccine development plans, with efforts that could include Phase II studies to evaluate optimal dosing schedule to assess efficacy against COVID-19, and investigating single dose boosting protocol to broaden and strengthen immune responses.
News on COVID-19 testing
Roche To Launch SARS-CoV-2 Rapid Antigen Test Nasal
Roche has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test will be available in countries accepting the CE mark by mid-February 2021.
A CE Mark indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health and environmental protection requirements.
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx. The test also provides the option to self-collect nasal samples under the supervision of a healthcare professional.
The launch is a partnership with SD Biosensor, a global bio-diagnostic company, with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor, is currently preparing to submit an emergency use authorization to the US Food and Drug Administration .
Novacyt Launches Assays To Detect COVID-19 Variants
Novacyt, a Paris-based specialist in clinical diagnostics, has launched of a portfolio of assays to aid the diagnosis of the new variants of SARS-CoV-2, the virus that causes COVID-19.
The company says the SNPsig assays offer the ability to track variants onsite. Novacyt’s bioinformatics surveillance group has worked with a global network of virologists tracking variants to identify the mutations, or single nucleotide polymorphisms (SNPs). From this analysis, Novacyt has developed and patented the SNPsig portfolio. The first three SNPsig assays enable the identification of the non-variant virus and the UK, South Africa, or Brazil variants.
Note: This article was updated to include Johnson & Johnson’s filing of emergency use authorization in the US.