Pharma COVID Roundup: News from Sanofi, Moderna, and Pfizer

The latest on manufacturing and potential treatments for COVID-19 with news from Sanofi, Moderna, Pfizer, AstraZeneca, Merck & Co., GlaxoSmithKline, Lilly, and others.

Manufacturing and supply of COVID-19 vaccines and drugs

Sanofi To Manufacture Pfizer’s/BioNTech’s COVID-19 Vaccine
Sanofi and BioNTech, a Mainz, Germany-based immunotherapy company, have entered into an agreement under which Sanofi will support manufacturing and supply of Pfizer’s/BioNTech’s COVID-19 vaccine.

Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of the COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt, Germany beginning in the summer of 2021.

Separately, Sanofi is pursuing development of its own COVID-19 vaccines in partnership with other companies. It is collaborating with GlaxoSmithKline (GSK) on a COVID-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of its seasonal influenza vaccines, combined with GSK’s adjuvant platform. Sanofi is also developing a messenger RNA vaccine in partnership with Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company.

Source: Sanofi

COVAX Provides Updates on COVID-19 Vaccines Supply
COVAX, a global initiative to ensure rapid and equitable access to COVID-19 vaccines, has announced separate agreements with Pfizer and AstraZeneca for their respective COVID-19 vaccines.

COVAX is a global initiative coordinated by Gavi, a global public health partnership, the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization (WHO), to ensure equitable access to COVID-19 vaccines for all countries, regardless of income levels. COVAX includes an Advanced Market Commitment (AMC) financial mechanism that aims to ensure that 92 low- and lower-middle-income countries will be able to secure access to COVID-19 vaccines at the same time as higher-income countries.

COVAX signed an advance purchase agreement with Pfizer for up to 40 million doses of the Pfizer-BioNTech vaccine, which has already received WHO emergency use listing. Rollout will commence with the successful negotiation and execution of supply agreements. For the COVAX AMC 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price. Financial terms of the agreement were not disclosed.

COVAX also confirmed that it will exercise an option, via an existing agreement with the Serum Institute of India (SII), a vaccine manufacturer, to receive its first 100 million doses of the AstraZeneca/Oxford University-developed vaccine manufactured by SII.

Of these first 100 million doses, the majority are earmarked for delivery in the first quarter of 2021, pending WHO emergency use listing. The WHO review process, which is currently underway, follows approval for restricted use in emergency situations by the Drugs Controller General of India earlier this month (January 2021) of the AstraZeneca/Oxford University vaccine. According to the latest WHO update, a decision on this vaccine candidate is anticipated by the middle of February (February 2021).

COVAX also anticipates that, via an existing agreement with AstraZeneca, at least 50 million further doses of the AstraZeneca/Oxford vaccine will be available for delivery to COVAX participants in the first quarter of 2021, pending emergency use listing by WHO of the COVAX-specific manufacturing network for these doses. A decision on this candidate is also anticipated by WHO in February (February 2021).

Preparations, led by WHO, UNICEF and Gavi, are already under way for COVAX to deliver vaccines to economies eligible for support via the COVAX AMC, with Gavi making $150 million available from its core funding as initial, catalytic support for preparedness and delivery.

COVAX now has agreements in place to access just over two billion doses of several vaccine candidates. Negotiations continue for further doses to be secured through existing R&D agreements by COVAX co-lead with CEP.

Based on this, COVAX anticipates being able to provide participating economies doses of vaccines beginning in the first quarter of 2021. At least 1.3 billion of these doses will be made available to the 92 economies eligible for the Gavi COVAX AMC by the end of 2021.

Source: World Health Organization, Pfizer, and BioNTech

Novavax, Canada Gov’t Finalize Purchase Agreement for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has finalized an agreement with the Canadian government to supply up to 76 million doses of NVX-CoV2373, the company’s recombinant protein-based COVID-19 vaccine.

Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase III clinical development for the prevention of COVID-19.

The company expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada’s regulatory agency. Novavax is currently conducting three efficacy, safety and immunogenicity studies of NVX-CoV2373 and expects to announce initial efficacy results as early as the first quarter of 2021.

Source: Novavax

Updates on COVID-19 treatments and vaccines

Moderna Reports Results of its COVID-19 Vaccine Against New Variants
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has reported results from in vitro neutralization studies of sera from individuals vaccinated with its COVID-19 vaccine that showed activity against emerging strains of SARS-CoV-2, the virus that causes COVID-19.

Vaccination with the vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and South Africa, respectively. This study was conducted in collaboration with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

The two-dose regimen of the vaccine at the 100-µg dose is expected to be protective against emerging strains detected to date (as reported on January 25, 2021). Moderna says it will test an additional booster dose of its COVID-19 vaccine to study the ability to further increase neutralizing titers against emerging strains beyond the existing primary vaccination series.

It is also advancing an emerging variant booster candidate (mRNA-1273.351) against the B.1.351 variant first identified in South Africa. It is advancing mRNA-1273.351 into preclinical studies and a Phase I study in the US to evaluate the immunological benefit of boosting with strain-specific spike proteins. Moderna expects that its mRNA-based booster vaccine (whether mRNA-1273 or mRNA-1273.351) will be able to further boost neutralizing titers in combination with all of the leading vaccine candidates.

Source: Moderna

Pfizer, BioNTech Report Results of Their COVID-19 Vaccine Against New Variants
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have reported results from in vitro neutralization studies of sera from individuals vaccinated with their COVID-19 vaccine that showed activity against emerging strains of SARS-CoV-2, the virus that causes COVID-19.

The companies reported that sera neutralized SARS-CoV-2 with key mutations present in the UK and South Africa variants, as measured by studies conducted by Pfizer and the University of Texas Medical Branch. The results were published on the preprint server bioRxiv and submitted to a peer-reviewed journal. Full details of the studies can be found here.

Pfizer and BioNTech are currently evaluating the full set of mutations in the spike protein of the South African variant. While these findings do not indicate the need for a new vaccine to address the emerging variants, the companies say they are prepared to respond if a variant of SARS-CoV-2 demonstrates evidence of escaping immunity by their COVID-19 vaccine. They say they will continue to monitor emerging SARS-CoV-2 strains and conduct studies and say that BioNTech’s proprietary mRNA vaccine platform is well suited to develop new vaccine variants if required.

Source: BioNTech

BioNTech, Fosun Gets OK in Hong Kong for COVID-19 Vaccine
BioNTech, a Mainz, Germany-based immunotherapy company, and Fosun Pharma, a Shanghai-based pharmaceutical company, have reported that BioNTech’s COVID-19 vaccine, Comirnaty, has received authorization for emergency use in Hong Kong. BioNTech is partnered with Pfizer for the Comirnaty COVID-19 vaccine globally, excluding China, where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialization.

The vaccine will be produced in BioNTech’s manufacturing facilities in Germany and supplied to Hong Kong for administration under the Hong Kong SAR Government’s COVID-19 Vaccination Program.

The vaccine has approved for emergency use in more than 50 countries and regions, including the UK, the US, Canada, and the European Union.

Source: BioNTech and Fosun Pharma

Merck & Co. Discontinues Development of COVID-19 Vaccines
Merck & Co. is discontinuing development of its COVID-19 vaccine candidates, V590 and V591, and plans to focus its COVID-19 research strategy and production capabilities on advancing two therapeutic candidates.

This decision follows the company’s review of findings from Phase I clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other COVID-19 vaccines. Merck continues to advance clinical programs and to scale up manufacturing for two investigational medicines, MK-7110, and molnupiravir, which Merck is developing with Ridgeback Biotherapeutics, a Miami, Florida-based biopharmaceutical company.

MK-7110 is a recombinant fusion protein that targets the innate immune system. MK-7110 was acquired by Merck from OncoImmune, a Rockville, Maryland-based clinical-stage biopharmaceutical company, in a $475-million deal that was announced last year (November 2020).

Molnupiravir is an oral antiviral agent currently being evaluated in Phase II/III clinical trials in both the hospital and outpatient settings. The primary completion date for the Phase II/III studies is May 2021. The company anticipates initial efficacy data in the first quarter of 2021, which Merck plans to share publicly if clinically meaningful.

Merck says it will also continue to evaluate other COVID-19 research, including the potential of the measles-virus vector and vesicular stomatitis virus vector-based platforms.

Source: Merck & Co.

Lilly Reports Positive Results for COVID-19 Combo Therapy
Eli Lilly and Company has reported that bamlanivimab and etesevimab, its neutralizing antibodies against COVID-19, significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of its Phase III trial.

The company also reported that bamlanivimab and etesevimab together demonstrated statistically significant improvements on all key secondary endpoints, which provides evidence that the therapy reduced viral load and accelerated symptom resolution.

Bamlanivimab is authorized for emergency use by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in high-risk patients, and it has also been granted authorizations in several additional countries.

In November 2020, Lilly submitted a request to the FDA for emergency use authorization for bamlanivimab and etesevimab together for treating mild-to-moderate COVID-19 in high-risk patients. It remains under review by the FDA.

Source: Eli Lilly and Company

GSK, Lilly, Vir Biotechnology in Pact for COVID-19 Therapies
GlaxoSmithKline (GSK), Eli Lilly and Company, and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have entered into a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild-to-moderate COVID-19.

Lilly has expanded its ongoing trial to evaluate the administration of Lilly’s bamlanivimab 700-mg with another monoclonal antibody, GSK’s/Vir’s VIR-7831 (500 mg), two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein.

Bamlanivimab is authorized for emergency use in the US for treating mild-to-moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. It was developed under a pact between Lilly and AbCellera, a Vancouver, British Columbia, Canada-based biopharmaceutical company. Vir and GSK are advancing VIR-7831 as part of their collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2. VIR-7831 is being evaluated in a global Phase II/III trial for the early treatment of COVID-19 in adults at high risk of hospitalization.

Source: GlaxoSmithKline, Eli Lilly and Company, and Vir Biotechnology

Regeneron Reports Results of COVID-19 Antibody Cocktail Against New Variants
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, reports that its antibody cocktail (consisting of casirivimab and imdevimab) successfully neutralizes the circulating SARS-CoV-2, the virus that causes COVID-19, variants first identified in the UK and South Africa.

Researchers at Columbia University and Regeneron assessed in vitro neutralization potency of numerous COVID-19 antibodies (including those that have received emergency authorization and those still in development) against various mutated strains of the virus.

The variant first identified in Brazil and recently seen in a patient in the US contains the same receptor binding domain mutations as the B.1.351 variant, therefore Regeneron says the antibody cocktail is expected to remain similarly potent. Regeneron is conducting additional preclinical research against this particular strain to confirm.

Separately, the company reported positive initial results from an ongoing Phase III clinical trial evaluating its antibody cocktail as a passive vaccine for the prevention of COVID-19 in people at high risk of infection. The trial is being run jointly with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Full details of the results can be found here.

In November 2020, Regeneron received an emergency use authorization from the US Food and Drug Administration for its antibody cocktail for treating mild-or-moderate COVID-19 in patients who are at high risk of developing severe symptoms and requiring hospitalization and are not currently hospitalized. Under agreements with the US government, Regeneron is supplying up to approximately 1.5 million doses of the antibody cocktail.

Source: Regeneron (variants) and Regeneron (interim results)

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