COVID-19 Update for 8/6/2020

COVID-19 Vaccines
Sanofi and GlaxoSmithKline received a $2.1 billion grant from Operation Warp Speed to fund clinical trials, scale up manufacturing, and deliver 100 million doses of their COVID-19 vaccine to the U.S. The deal also includes an option for an additional 500 million doses.
 
The Departments of Defense and Health and Human Services, as part of Operation Warp Speed, have awarded Johnson & Johnson $1 billion for the first 100 million doses ($10 per dose) of its experimental COVID-19 vaccine. The supply will be used for clinical trials or provided, at no charge, through a U.S. vaccination program. The U.S. government also has an option for an additional 200 million doses.
 
Moderna has signed some early vaccine supply deals, pricing their COVID-19 vaccine at $32 to $37 per dose or $64 to $74 per two dose regimen. These early deals were for smaller supplies, so larger orders could have a lower cost per dose, but Moderna has not specified what the price might be. A price for a U.S. government purchase has not yet been determined.
 
Novavax announced that in a 131 patient, Phase I trial (NCT04368988), the antibody level increased with all doses of its NVX-CoV2373 COVID-19 vaccine with or without the Matrix-M adjuvant. Either formulation of the vaccine with adjuvant induced neutralizing antibody levels greater than what is seen in recovered COVID-19 patients. The trial was sponsored by the Coalition for Epidemic Preparedness Innovations and performed in Australia. Novavax is evaluating NVX-CoV2373 in a 1,500 patient, Phase II trial in the U.S. and Australia.
 
Zydus is developing a DNA vaccine (ZyCoV-D)

1. Zydus reported the vaccine was well tolerated in a 7-day review of data in a Phase I trial involving an unspecified number of patients.
2. Zydus initiated a 1,000 patient trial for ZyCoV-D on 8/6/2020.

COVID-19 Antibodies
Lilly initiated the NIAID sponsored, 2,400 patient, Phase III, BLAZE-2 trial to assess the prophylactic potential of LY-CoV555 in long-term care residents. BLAZE-2 will assess whether a single dose of LY-CoV555 reduces the rate of COVID-19 through 4 weeks and COVID-19 complications through 8 weeks. 
 
The Pharmaceutical Pipeline Tracker COVID-19 Antibody page now includes new clinical trials for two products (BRII-196 and BRII-198) and two new monoclonal products that have also entered clinical testing:
Sinocelltech is evaluating SCTA01 as a potential treatment for COVID-19 infection.

• Sinocelltech is evaluating SCTA01in a 33 patient, Phase I trial (NCT04483375) that began in June 2020.

Tsinghua University and 3rd People’s Hospital of Shenzhen researchers identified two antibodies for clinical testing. Brii Bioscience is evaluating the two monoclonal antibodies, BRII-196 and BRII-198, that bind to different sites on the SARS-CoV-2 spike protein as potential treatments for COVID-19 infection.

• Brii is evaluating BRII-196 in a 12 patient, Phase I trial (NCT04479631) that began in July 2020.
• Brii is evaluating BRII-198 in a 12 patient, Phase I trial (NCT04479644) that began in July 2020.

Tychan is evaluating TY027 as a potential treatment for COVID-19 infection.

• Tychan is evaluating TY027 in a 25 patient, Phase I trial (NCT04429529) that began in June 2020.

IL-6 inhibitors
BARDA ceased funding IL-6 inhibitor trials evaluating tocilizumab and sarilumab as treatments for severe COVID-19 in August 2020. Tocilizumaband sarilumab have each failed to demonstrate improvements in clinical trials. 
 
In a 28-day, 56-patient, observational study, 28 patients that received sarilumab were compared to 28 that did not receive the drug. Treatment with sarilumab did not improve clinical status or mortality in patients with severe COVID-19 pneumonia and systemic hyperinflammation. The study suggested that sarilumab may speed recovery in patients with minor lung consolidation at baseline. This study used a subset of patients from the Italian, 1,000 patient, COVID-BioB observational study (NCT04318366).