Pharma COVID Roundup: News from Lilly, Moderna, J&J, and Gilead

The latest on COVID-19 vaccines/drugs and manufacturing from Lilly, Moderna, J&J, Gilead Sciences, Novavax, SAB Biotherapeutics, Inovio, and pHOXBIO.

Manufacturing and supply of COVID-19 vaccines and drugs

Lilly, EU in Supply Pact for COVID-19 Combo Therapy
Eli Lilly and Company has entered into a joint procurement agreement with the European Commission (EC) to supply up to 220,000 doses of its COVID-19 treatment of bamlanivimab and etesevimab, administered together. The product was developed by Lilly and AbCellera, a Vancouver, British Columbia, Canada-based bio/pharmaceutical company.

This agreement allows participating countries in the European Union (EU) and European Economic Area to purchase the products directly from Lilly, following national approval for emergency use, or marketing authorization at the EU level. Bamlanivimab administered with etesevimab is available under emergency pathways in 15 countries globally for the treatment of COVID-19.

Separately, the US Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for bamlanivimab and etesevimab to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2, the virus that causes COVID-19. The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older. This authorization follows the national reopening of distribution earlier this month (September 2021).

Last week (September 15, 2021), the US government agreed to purchase 388,000 doses of etesevimab, the monoclonal antibody that is part of Lilly’s antibody combination of etesevimab and bamlanivimab.

Source: Eli Lilly and Company (EU), Eli Lilly and Company (FDA), and the US Food and Drug Administration

Updates on COVID-19 treatments and vaccines

Health Canada Approves Moderna’s COVID-19 Vaccine
Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), the COVID-19 vaccine from Moderna, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

Moderna’s COVID-19 vaccine was originally authorized in Canada under an interim order for individuals 18 years of age and older granted by Health Canada on December 23, 2020. On August 27, 2021, Health Canada expanded the interim order authorization for Moderna’s COVID-19 vaccine to include adolescents 12 years of age and older.

Source: Moderna

J&J Reports Data for COVID-19 Vaccine Booster
Johnson & Johnson (J&J) reports data for a booster of its COVID-19 vaccine that showed strong protection. The company reported that a COVID-19 vaccine booster shot at two months provided 94% protection against COVID-19 and a booster shot at six months provided a 12-fold increase in antibodies. Full details of the new data can be found here.

The company provided available data to the US Food and Drug Administration and plans to submit the data to other regulators, the World Health Organization, and the National Immunization Technical Advisory Group, a global group that provides technical support to national bodies.

Source: Johnson & Johnson

Gilead Reports Additional Data on COVID-19 Drug Remdesivir
Gilead Sciences reports positive results from a Phase III to evaluate a three-day course using intravenous administration of Veklury (remdesivir), its antiviral drug for treating COVID-19, in non-hospitalized patients at high risk for disease progression.

In the US, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Gilead continues to study the efficacy and safety of Veklury in hospitalized patient populations with ongoing unmet needs, such as patients with renal impairment, children and pregnant women.  

Gilead is also developing oral treatment options for non-hospitalized patients with COVID-19 and hopes to file investigational new drug applications with the US Food and Drug Administration by early next year (2022).

Source: Gilead Sciences

SAB Biotherapeutics Gets $60.5 M from US Gov’t To Fund COVID-19 Drug Candidate
SAB Biotherapeutics, a Sioux Falls, South Dakota clinical-stage bio/pharmaceutical company has been awarded an additional $60.5 million by the US Department of Defense to advance clinical development through licensure and commercial manufacturing of SAB-185, the company’s therapeutic candidate for treating COVID-19. It is currently being assessed in a Phase II/III trial in non-hospitalized patients with mild-moderate COVID-19 infections at risk for disease progression

Since March 2020, SAB have been awarded more than $200 million from the US government to advance its COVID-19 drug candidate.

Source: SAB Biotherapeutics

Novavax To Participate in Mixed Regime COVID-19 Study
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, is participating in an expanded Phase II clinical trial for adolescents 12-16 years of age to explore a heterologous regimen of COVID-19 vaccines from different manufacturers

Novavax’s recombinant nanoparticle COVID-19 vaccine candidate, NVX-CoV2373, is one of the three COVID-19 vaccines that will be studied in adolescents to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19. The study is led by the University of Oxford and funded by the UK Vaccines Taskforce and the National Institute for Health Research.

Results from the study are expected within a few months (as reported on September 16, 2021). The UK Medicines and Healthcare products Regulatory Agency and Joint Committee on Vaccination and Immunization will formally assess the safety and efficacy of any new vaccination process before advising whether it is rolled out.

Novavax is also participating in University of Oxford’s other study in which NVX-CoV2373 is one of four COVID-19 vaccines being studied to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19. Results from Com-COV2 are expected in the coming weeks (as reported on September 16, 2021).

Source: Novavax

Inovio Gets OK To Conduct Phase III Trial of COVID-19 Vaccine in Mexico
Inovio, a Plymouth Meeting, Pennsylvania-based bio/pharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received authorization from Comisión Federal para la Protección contra Riesgos Sanitarios, the national health regulatory agency of Mexico, to conduct a clinical trial in that country as part of the Phase III segment of its global Phase II/III trial, for INO-4800, its COVID-19 vaccine candidate.

Inovio is working with its partner, Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based bio/pharmaceutical company, on the Phase III segment in multiple countries. Inovio recently received regulatory authorization to proceed with Phase III clinical trials in Brazil and the Philippines and is seeking authorization to conduct trials in additional countries.

Last month (August 2021), Inovio received regulatory allowance in China for two clinical trials evaluating mixed boosted regimens of INO-4800 and CoronaVac, a COVID-19 vaccine developed by Sinovac Biotech, a Beijing-based bio/pharmaceutical company.

Source: Inovio

pHOXBIO Reports Phase II/III Results for Nasal COVID-19 Treatment
pHOXBIO, a London-based bio/pharmaceutical company, reports results from its Phase II/III study evaluating pHOXWELL, its nasal COVID-19 vaccine. The Phase II/III clinical trial demonstrated 63% fewer SARS-CoV-2 infections in high-risk healthcare workers given pHOXWELL compared to placebo.

Source: pHOXBIO