Pharma COVID Roundup: News from AstraZeneca, Moderna, J&J, BMS, AbbVieBy
The latest on manufacturing and potential treatments for COVID-19 with news from AstraZeneca, Moderna, Roche, J&J, BMS, AbbVie, Sanofi, Fujifilm, and others.
Manufacturing and supply news for COVID-19 vaccines and drugs
AstraZeneca in Supply Pact for COVID-19 Vaccine with Switzerland
AstraZeneca and the Swedish government have signed an agreement for the delivery of up to 5.3 million doses of AstraZeneca’s COVID-19 vaccine, AZD1222, in Switzerland.
The contract is based on an agreement between the European Commission and AstraZeneca for the delivery of up to 400 million doses for Europe. These doses can be ordered by individual EU member states according to their population numbers and procured once the vaccine has been approved. Sweden will order doses for states in the European Economic Area (EEA) and the European Free Trade Association (EFTA) that are not EU member states and resell them at no profit to relevant countries. If approved, the vaccine will be delivered directly to Switzerland by AstraZeneca, which already submitted an application for approval at the start of October (October 2020) to Swissmedic, the Swiss regulatory agency that authorizes and supervises therapeutic products.
AstraZeneca developed AZD1222 in collaboration with the University of Oxford and its spin-out company, Vaccitech. AZD1222 is a vector-based vaccine (adenovirus) that expresses the surface protein of the coronavirus (SARS-CoV-2 spike protein).
The Swiss federal government says it is aiming to procure several COVID-19 vaccines based on different technologies, mRNA, protein-based, and vector-based. It is holding talks with other manufacturers of vaccine candidates in order to possibly conclude further agreements. In August 2020, the Swiss federal government concluded an agreement with Moderna for 4.5 million doses of its mRNA vaccine. Switzerland is also participating in the international COVAX initiative to procure vaccine for up to 20% of the Swiss population.
Source: Switzerland Federal Office of Public Health
CEPI Forms Pacts To Expand COVID-Vaccine Mfg Capacity
The Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition focused on vaccine development against emerging infectious diseases, has signed agreements with Biofabri, a Pontevedra, Spain-based biopharmaceutical company, and GC Pharma (formerly Green Cross Corporation), a Yongin, South Korean-based biopharmaceutical company, to reserve vaccine-manufacturing capacity for more than 1 billion doses of COVID-19 vaccines designated by CEPI.
Under the agreements, both Biofabri and GC Pharma will reserve manufacturing capacity exclusively for the production of drug product of COVID-19 vaccines designated by CEPI. One or more CEPI-supported vaccine candidates will be manufactured at each facility, and it is anticipated that vaccines manufactured under these agreements would be procured and distributed through the COVID-19 Vaccines Global Access (COVAX) Facility, a global initiative to enable equitable access to COVID-19 vaccines for participating countries.
Biofabri will reserve manufacturing capacity for CEPI-designated COVID-19 vaccines from November 2020 to May 2022 with an option to extend or expand the reservation. During this period, it is estimated that the reserved capacity could produce more than 500 million doses of vaccine.
GC Pharma will reserve manufacturing capacity for CEPI-designated COVID-19 vaccines from March 2021 to May 2022 with an option to extend or expand the reservation. During this period, it is estimated that the reserved capacity could produce more than 500 million doses of vaccine.
The agreements with Biofabri and GC Pharma are the latest in a series of strategic investments that CEPI is making to accelerate the manufacture of COVID-19 vaccines at scale. CEPI says its strategic investments in vaccine manufacturing at global facilities will support the COVAX goal to produce 2 billion doses of a safe and effective vaccine by the end of 2021. CEPI has already reserved capacity for manufacturing of the drug substance and has secured a supply of glass vials to hold up to 2 billion doses of vaccine.
Source: Coalition for Epidemic Preparedness Innovations
UNICEF To Stockpile Syringes for COVID-19 Vaccines
UNICEF, a child care and relief organization, has announced plans to stockpile 520 million syringes in its warehouses as part of a larger plan to obtain 1 billion syringes by 2021 for use with COVID vaccines.
UNICEF says it anticipates delivering over 1 billion syringes to support COVID-19 vaccination efforts during 2021, assuming there are enough doses of COVID-19 vaccines, on top of the 620 million syringes that UNICEF will purchase for other vaccination programs against other diseases such as measles and typhoid.
In line with its collaboration with Gavi, a global public health partnership, Gavi will reimburse UNICEF for the procurement of the syringes and safety boxes, which will then be used for the COVID-19 Vaccines Global Access (COVAX) Facility, a global initiative to enable equitable access to COVID-19 vaccines for participating countries and for other Gavi-funded immunization programs.
Besides syringes, UNICEF is also buying 5 million safety boxes so that used syringes and needles can be disposed in a safe manner by personnel at health facilities, thus preventing the risk of needle-stick injuries and blood-borne diseases. Every safety box carries 100 syringes. Accordingly, UNICEF is “bundling” the syringes with safety boxes to ensure enough safety boxes are available to go along with the syringes.
News on COVID-19 treatments and vaccines
Moderna Eligible To File for EU Authorization for COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has received written confirmation from the European Medicines Agency (EMA) that mRNA-1273, the company’s vaccine candidate against COVID-19, is eligible for submission of a marketing authorization application in the European Union under the agency’s centralized procedure.
Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year of its vaccine and possibly up to 1 billion doses per year, beginning in 2021. In Europe, the company is working with its strategic manufacturing partners, Lonza and Laboratorios Farmacéuticos Rovi of Spain, a pan-European pharmaceutical company and CDMO, for manufacturing and fill-finish of its vaccine.
mRNA-1273 is currently being studied in a Phase III trial of 30,000 participants at the 100-µg dose level in the US. As of October 22, 2020, Moderna completed enrollment the Phase III study being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
To date, more than 25,650 participants have received their second vaccination. Moderna says it will determine whether to submit a dossier to the US Food and Drug Administration requesting emergency use authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once two months of median safety follow-up have accrued.
Moderna worked with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase III study under Operation Warp Speed, a US government initiative to speed the development of COVID-19 vaccines and treatments. Moderna’s partner PPD, a contract research organization, has also helped to execute the study. PPD also supported the Phase II study of mRNA-1273.
Source: Moderna (EU authorization) and Moderna (Phase III study)
Roche, Atea in $350-M Pact for Oral COVID Treatment
Roche has formed a $350-million licensing pact with Atea Pharmaceuticals, a Boston-based biopharmaceutical agreement, for the exclusive rights to research, develop and distribute outside the US AT-527, Atea’s investigational oral antiviral for treating COVID.
AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication and is currently being studied in a Phase II clinical trial for hospitalized patients with moderate COVID-19. A Phase III clinical trial, expected to start in the first quarter of 2021, will explore the potential use in patients outside of the hospital setting. In addition, AT-527 may be developed for post-exposure prophylactic settings.
Under the agreement, Atea will receive an upfront payment of $350 million in cash from Roche with the potential for future milestone payments and royalties. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, If AT-527 proves safe and effective in clinical trials and regulatory approvals are granted, Atea will be responsible for distributing the drug in the US, with the option to request support from Roche’s Genentech, and Roche will be responsible for distribution outside the US.
Source: Roche and Atea Pharmaceuticals
NIH To Test Drugs from J&J, BMS, AbbVie in Phase III COVID Trial
The National Institutes of Health has launched an adaptive Phase III clinical trial to evaluate the safety and efficacy of three immune modulator drugs from Johnson & Johnson (J&J), Bristol-Myers Squibb, and AbbVie in hospitalized adults with COVID-19.
The clinical trial aims to determine if modulating immune response can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system. Three agents have been selected for the study: (1) J&J’s Remicade (infliximab), a drug to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis; (2) Bristol-Myers Squibb’s Orencia (abatacept), a drug to treat certain autoimmune diseases, such as rheumatoid arthritis; and (3) AbbVie’s cenicriviroc, an investigational late-stage drug for treating HIV and non-alcoholic steatohepatitis (NASH).
Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public–private partnership, the trial expects to enroll approximately 2,100 hospitalized adults with moderate-to-severe COVID-19 at medical facilities in the US and Latin America.
Source: National Institutes of Health
Sanofi’s COVID-19 Vaccine Shows Promising Preclinical Results
Sanofi Pasteur, the vaccines business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have reported promising preclinical results for MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
The companies reported that preclinical evaluation of MRT5500 demonstrated a favorable immune response profile against SARS-CoV-2. These data support the selection of MRT5500 for clinical development. A Phase I/II clinical trial is anticipated to begin in the fourth quarter of 2020. MRT5500 is being developed under a collaboration agreement between Sanofi Pasteur and Translate Bio.
Source: Sanofi and Translate Bio
Fujifilm Files for COVID-19 Indication for Antiviral Drug in Japan
Fujifilm Toyama Chemical has filed an application with Japan’s Ministry of Health, Labour and Welfare for partial changes to manufacturing and marketing approval matters for Avigan (favipiravir), an antiviral drug for influenza that is being evaluated for treating patients with COVID-19, to add an indication and for other items relating to COVID-19 infection.
Avigan is approved for manufacture and sale in Japan as an influenza antiviral drug. Fujifilm Toyama Chemical conducted a Phase III clinical trial in Japan in March 2020 in COVID-19 patients with non-severe pneumonia and says that it confirmed, with a statistically significant difference, that the administration of Avigan demonstrates shorter time to resolution, with no new safety concerns. Based on the results of that trial, Fujifilm Toyama Chemical filed the application for partial change to add the COVID-19 indication, as well as related dosage and administration information, to the drug’s current approval.
To meet the requests of the Japanese government to increase stockpiles of Avigan, and by other countries to supply the drug, Fujifilm says it has been working to increase production of the drug in collaboration with strategic partners both inside and outside Japan.
In a separate development, Fujifilm Toyama Chemical announced a partnership with Carelink Pharmaceutical, a China-based pharmaceutical company, to deploy Avigan in China. Fujifilm Toyama Chemical and Carelink have signed a memorandum to grant Carelink the exclusive right to submit an application for imported drug approval of Avigan. Carelink says it plans to make use of Avigan’s nonclinical and clinical data that Fujifilm Toyama Chemical has accumulated so far and to work to submit an application to obtain imported drug approval in China.
To expand therapeutic options using Avigan, Fujifilm Toyama Chemical says it will develop an injectable form of Avigan jointly with Carelink.
Source: Fujifilm (Japan) and Fujifilm (China)
Bharat Biotech Forms Licensing Pact for Intranasal COVID-19 Vaccine
Bharat Biotech, a Hyderabad, India-based biopharmaceutical company, has signed a licensing agreement with the Washington University School of Medicine in St. Louis, Missouri for a novel chimp adenovirus, single-dose intranasal vaccine for COVID-19. Bharat Biotech owns the rights to distribute the vaccine in all markets except the US, Japan, and Europe.
While the Phase I trials will take place in Saint Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large-scale manufacture of the vaccine at its facility in Hyderabad, India.
In a separate development, Bharat Biotech’s COVID-19 vaccine, Covaxin, which has been approved for human trials, will use the adjuvant, Alhydroxiquim-II under a licensing agreement with ViroVax, a Lawrence, Kansas-based biotechnology company.
Covaxin is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the National Institute of Virology (NIV) in Pune, India. The inactivated virus is formulated with ViroVax’s adjuvant to produce the vaccine candidate. Bharat Biotech is currently conducting Phase II trials of Covaxin after receiving approval from the Drug Controller General of India.
Source: Bharat Biotech (Covaxin) and Bharat Biotech (pact)
UK Gov’t To Provide $70 M for COVID-19 Vaccine Challenge Trials
The UK government will invest up to £53.3 million ($70 million) to explore and establish human challenge trials in the UK to speed up the development of a COVID-19 vaccine.
In human challenge studies, a vaccine candidate that has proven to be safe in initial trials is given to a small number of healthy adult volunteers who are then exposed to the virus in a safe and controlled environment. Medics and scientists then closely monitor the effect on volunteers 24 hours per day to see exactly how the vaccine works and to identify any side effects.
hVIVO, a subsidiary of Open Orphan, a London-based contract research organization (CRO), has signed a contract with the UK government to develop a COVID-19 human challenge study model. The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London. hVIVO will also be expanding its clinical operations in London to facilitate work at this site.
If approved by regulators and an ethics committee, the studies would start in January 2021 with results expected by May 2021.
The aim of one study will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19 infection. This is known as a virus characterisation study and will be backed by £33.6 million ($44 million) in UK government fundng. The government is also investing £19.7 million ($25.8 million) in Public Health England (PHE) to scale up its capabilities in testing blood samples from clinical trials. The investment will fund equipment and a new laboratory facility at PHE Porton Down to accelerate testing to measure the effectiveness of COVID-19 vaccines in development. PHE’s partner, Nexelis, a CRO with operations in the US and Canada, will be providing scientific expertise and also conduct additional testing for the evaluation of COVID-19 vaccines.
Source: Open Orphan and the UK Government
News on COVID-19 testing
LabCorp Launches Quantitative Antibody Test for COVID Vaccines
LabCorp has launched a test that provides a quantitative measurement of an individual’s SARS-CoV-2 IgG antibodies. LabCorp’s Cov2Quant IgG test, which is available only for use in clinical trials and research, was developed to specifically detect and quantify antibodies to SARS-CoV-2, the virus that causes COVID-19. The company says the level of antibodies is an important indicator of the strength of a person’s immune response, which can help determine the effectiveness of vaccines and therapies. Other COVID-19 antibody tests available in the market are qualitative and detect the presence of antibodies, but do not provide information on the individual’s antibody levels.
Pharmaceutical companies will be able to use the test to help evaluate the performance of vaccine candidates in clinical trials. The test is also currently being utilized by the Centers for Disease Control and Prevention for SARS-CoV-2 seroprevalence studies to understand the level of antibodies produced through natural exposure and infection with the virus.