Pharma COVID Roundup: News from Pfizer, BioNTech, and AstraZeneca
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Pfizer, BioNTech, AstraZeneca, Merck & Co., Bayer, Novavax, Regeneron, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer, BioNTech To Supply EU with 100 M Doses of COVID-19 Vaccine
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, report that they will supply an additional 100 million doses of Comirnaty, the companies’ COVID-19 vaccine, to the 27 member states in the European Union (EU) in 2021.
This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its advanced purchase agreement signed on November 11, 2020. This agreement brings the total number of doses to be delivered to the EU to 300 million. Comirnaty was granted conditional marketing authorization by the European Medicines Agency (EMA) in December 2020 in people 16 years of age and older.
Comirnaty will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. The distribution of Comirnaty by EU member states will continue to be determined according to the populations identified in EU and national guidance. Pfizer and BioNTech announced on November 11, 2020 that they reached an agreement with the EC to supply 200 million doses, with an option for the EC to request an additional 100 million doses. The companies previously stated their potential to supply up to 1.3 billion doses globally by the end of 2021 (subject to manufacturing capacity).
Merck & Co. US Gov’t in Supply Pact for Initial Doses of COVID-19 Therapy
Merck & Co. has entered into an agreement with the US government to support the development, manufacture, and initial distribution of an investigational biological therapeutic for treating COVID-19, subject to the approval or emergency use authorization (EUA) of the drug from the US Food and Drug Administration (FDA).
The drug, 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).
Under the agreement with the US government, Merck will receive up to approximately $356 million for the manufacturing and supply of approximately 60,000 to 100,000 doses of MK-7110 to the US government through June 30, 2021 to meet the government’s goals of Operation Warp Speed, a US initiative to speed the development and distribution of COVID-19 vaccines and treatments. The company says this approach is intended to expedite delivery of MK-7110, following potential EUA or FDA approval. Merck is also investing to expand its manufacturing capacity to increase supply of MK-7110.
In September 2020, OncoImmune reported findings from an interim efficacy analysis of a Phase III study evaluating MK-7110 for treating severe and critical COVID-19. An interim analysis from 203 participants indicated that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared to placebo. The risk of death or respiratory failure was reduced by more than 50%. The study is ongoing.
MK-7110 is a recombinant fusion protein that targets the innate immune system. In addition to the Phase III clinical trial for COVID-19 patients, MK-7110 has been studied for safety in healthy volunteers and in Phase II clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem-cell transplantation in patients with leukemia. A Phase III clinical trial for prophylaxis of GVHD has been initiated nationwide.
Source: Merck & Co.
Updates on COVID-19 treatments and vaccines
AstraZeneca’s COVID-19 Vaccine Gets OK in India, Other Countries
AstraZeneca’s and the University of Oxford’s COVID-19 vaccine has been granted emergency use authorization in India, Argentina, the Dominican Republic, El Salvador, Mexico and Morocco for the active immunization of adults.
AstraZeneca has partnered with the Serum Institute of India, a vaccine manufacturer, for the supply of the vaccine to the Indian government and to a large number of low- and middle-income countries.
In the European Union, AstraZeneca has submitted a data package to support a conditional marketing authorization for its COVID-19 vaccine to the European Medicines Agency (EMA) as part of an ongoing rolling review process and will continue to work with the EMA to seek authorization in the coming weeks (as reported on January 6, 2021). AstraZeneca is also seeking an emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries and has ongoing rolling reviews with other global regulatory authorities.
In addition to the University of Oxford-led trials, the company is conducting a large trial in the US as part of a global program. In total, the University of Oxford and AstraZeneca expect to enroll more than 60,000 participants globally. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.
In addition, AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals.
The vaccine is an adenovirus vector-based vaccine licensed by AstraZeneca from Oxford University and is being jointly developed. It was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus, the virus that causes COVID-19, if it later infects the body.
Bayer, CureVac in Pact for COVID-19 Vaccine
Bayer and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, have entered into an agreement for the development of CureVac’s mRNA vaccine candidate against COVID-19, CVnCoV.
Under the agreement, Bayer will support the further development, supply, and key territory operations of CVnCoV. Bayer will contribute its expertise and infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply-chain performance as well as support in selected countries.
Under the agreement, CureVac will be the marketing authorization holder for the product, and Bayer will support CureVac with country operations within the European Union and selected additional markets. Bayer holds further options to become marketing authorization holder in other markets outside of Europe. The companies plan to combine their strengths for CureVac to be in a position to supply hundreds of millions of doses of the vaccine globally, once approvals are granted.
CureVac is currently expanding its partner network for the development, production and distribution of its vaccine candidate. In November 2020, the company announced that it would ramp up its European manufacturing network, working with Wacker and Fareva, among others.
The vaccine is in Phase IIb/III development.
Novavax Initiates Phase III Trial of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has initiated a Phase III study of NVX-CoV2373, its COVID-19 vaccine candidate, in the US and Mexico.
The trial builds on research from Phase I/II studies demonstrating that the vaccine provoked an immune response, generated neutralizing antibodies against the virus, and was generally well-tolerated.
The Phase III trial is being conducted with support from the partners of Operation Warp Speed, a US initiative to speed the development and distribution of COVID-19 vaccines and treatments. The US government support also includes the Department of Defense and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. BARDA is also providing up to $1.6 billion under a Department of Defense agreement.
The company is also conducting a large Phase III clinical study in the UK, a Phase IIb safety and efficacy study in South Africa, and an ongoing Phase I/II trial in the US and Australia. Data from these trials are expected as soon as early first quarter of 2021 although timing depends on transmission rates in the regions.
Inovio, Advaccine in $111-M Pact for COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, and Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based biopharmaceutical company, have entered into a collaboration and license agreement for Inovio’s COVID-19 DNA vaccine candidate INO-4800, in a $111-million deal.
Under the agreement, Advaccine will have the exclusive right to develop, manufacture, and commercialize INO-4800 within Greater China, inclusive of Mainland China, Hong Kong, Macao, and Taiwan. Advaccine will license to Inovio its plasmid manufacturing process for use with INO-4800 and other Inovio pipeline product candidates with the right to sublicense to Inovio’s manufacturing partners. Additionally, Advaccine will provide its clinical data to Inovio in support of Inovio’s global INO-4800 regulatory filings, and Inovio will provide its INO-4800 clinical data for Advaccine to incorporate into its marketing applications in Greater China.
Advaccine will make to an upfront payment of $3 million to Inovio as well as pay an aggregate of $108 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China. Inovio will be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within Greater China.
A Phase II clinical trial of INO-4800 in China has enrolled adults who are 18-59 years old and older adults (60 years and older) with the primary endpoints of evaluating safety and immunogenicity within the Chinese population. All 640 subjects in a Phase II clinical trial of the vaccine have been dosed.
Inovio is conducting the Phase II segment of its planned Phase II/III clinical trial for INO-4800 in the US. The trial will be funded by the US Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
BI Advances COVID-19 Treatment
Boehringer Ingelheim (BI), along with other partners, has initiated a Phase I/IIa clinical investigation of BI 767551, a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19.
BI is partnered with Cologne University Hospital (UKK) in Cologne, Germany, the University of Marburg (UMR) in Marburg, Germany, the German Center for Infection Research (DZIF), a Braunschweig, Germany-based research center.
The new antibody was derived from blood samples of recovered COVID-19 patients at UKK, examined for SARS-CoV-2 neutralization at UMR, and developed further in collaboration with BI.
The Phase I/IIa studies will evaluate the safety, pharmacokinetics and antiviral activity of the antibody. In Phase I, the antibody will be administered to participants either with a single infusion or a single inhalation. If the antibody is well tolerated, the parties say that late-stage confirmatory studies will be conducted.
Regeneron Reports Positive Initial Data of COVID-19 Antibody Cocktail Trial
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has reported initial data from an ongoing Phase I/II/III clinical trial of its antibody cocktail consisting of casirivimab and imdevimab in hospitalized COVID-19 patients requiring low-flow oxygen.
The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2, the virus that causes COVID-19. The primary clinical objective of this initial analysis was to determine whether there was sufficient efficacy in these patients to warrant continuing the trial. The results passed the futility analysis, as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation.
In November 2020, Regeneron’s antibody cocktail was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission, review and approval process.
Emergent, Mount Sinai Initiate Clinical Program for COVID-19 Candidate
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, and Mount Sinai Health System, a New York-based hospital and medical research system, have initiated a clinical program to evaluate Emergent’s COVID-19 treatment, human hyperimmune globulin (COVID-HIG), in the first of two Phase I studies.
The studies will evaluate its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19. The first study will evaluate the safety and pharmacokinetics of three dose levels administered as a single or repeat IV dose in healthy adults. The second study, once initiated, will evaluate the safety, pharmacokinetics, and pharmacodynamics of two dose levels administered as a single IV dose to adults with SARS-CoV-2 infection, whether asymptomatic or with mild COVID-19.
The existing plasma collection capabilities at Mount Sinai established through its collaboration with Emergent and ImmunoTek Bio Centers, a Lafayette, Louisiana-based company procuring and collecting human blood plasma, has enabled ongoing plasma collection from recovered donors to support the development and manufacture of COVID-HIG for evaluation in clinical trials. The clinical research program, including a planned Phase II study, is designed to assess whether prophylaxis with COVID-HIG could help protect individuals following high-risk exposure to SARS-CoV-2.
The US Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense has provided $34.6 million in funding in support of this program. In addition to receiving DoD& funding to advance a post-exposure prophylaxis indication for COVID-HIG, Emergent was awarded $14.5 million in April 2020 by the US Department of Health and Human Services (HHS) to develop COVID-HIG as a potential treatment for COVID-19. Emergent’s proprietary COVID-HIG product candidate is also being evaluated in a Phase III clinical study initiated in October 2020 by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, as a potential treatment in hospitalized patients. Mount Sinai serves as a study site.
Source: Emergent BioSolutions
Bausch Health Steroid Gets New Indication To Treat COVID-19
Bausch Health Companies has announced that the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland has granted an additional new indication for Dexaven (dexamethasone phosphate) solution for injection, 4 mg/mL, for the treatment of COVID-19 in adult and adolescent patients who require oxygen therapy.
Dexaven is a corticosteroid that reduces inflammation. Dexamethasone-containing products in the US are not approved as a treatment for COVID-19 by the US Food and Drug Administration.
Source: Bausch Health
EMA Organizes Second Meeting on COVID-19 Vaccines
The European Medicines Agency (EMA) is holding a second public meeting on January 8, 2021 on the assessment, approval, and rollout of new COVID-19 vaccines.
The first COVID-19 vaccine, Comirnaty, developed by Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, was authorized in the European Union on December 21, 2020. Another COVID-19 vaccine, developed by Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, was authorized in the European Union on January 6, 2021.
The EMA says the public meeting will be an opportunity to inform citizens about the approval and use of the new vaccines, to explain how the safety of the vaccines will be assured, and to provide information on the role of the European Commission and the national public health authorities on the rollout of the vaccines. Participants will be also able to share their views, expectations and raise any concerns.
Source: European Medicines Agency
News on COVID-19 testing
Beckman Coulter Launches COVID-19 Antigen Test
Beckman Coulter has launched a new COVID-19 antigen test for mass testing in the US. The Access SARS-CoV-2 Antigen assay runs on Beckman Coulter’s analyzers capable of processing up to 200 samples per hour to enable high throughput screening in 30 minutes and addresses the scalability constraints of point-of-care tests.
The compan says it can deliver up to 25 million tests per month. The assay is priced at $4 to all healthcare providers, including public and private institutions, governments and non-profits to enable frequent testing.
Source: Beckman Coulter
Fujifilm Applies for Approval for SARS-CoV-2 Antigen Test Kit
Fujifilm Corporation has filed an application with the Japanese Pharmaceuticals and Medical Devices Agency to obtain manufacturing and marketing approval for a rapid and simple antigen test kit for detecting SARS-CoV-2, the virus that causes COVID-19.
This test kit, using silver amplification immunochromatography method, a testing method in which a specimen (nasopharyngeal swab) is processed in a reagent, has been developed with the use of detection technology based on silver halide amplification response used in the photo-developing process.
In a bid to establish a production structure for this test kit, Fujifilm is making a capital investment in Fujifilm Yuwa Medical Products Vietnam Company Limited in Bình Dương, Vietnam, which manufactures Fujifilm’s diagnostics medical products.
Fujifilm and the public university, Yokohama City University in Kanagawa, Japan, jointly developed the test kit for using the silver amplification immunochromatography method, which is Fujifilm’s proprietary detection technology. The test kit is to be produced at Fujifilm’s Ashigara site in Kanagawa. However, in anticipation for the product’s global deployment in the future, the company says Fujifilm Yuwa in Vietnam will start gradually reinforcing its production facilities this year (2021) to ensure supply stability for the test kit.