Pharma Companies Advance Potential COVID-19 Treatments

The latest from pharma companies on potential COVID-19 treatments with news from Lilly, Sanofi, GSK, AstraZeneca, CSL Behring, and Bausch Health.

Lilly, US Gov’t Partner To Study Potential COVID-19 Therapy
Eli Lilly and Company and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have formed an agreement to study Lilly’s Olumiant (baricitinib), an approved treatment for moderately to severely active rheumatoid arthritis, in an arm of the NIAID’s Adaptive COVID-19 Treatment Trial. The study will investigate baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19, beginning this month (April 2020) in the US with a planned expansion to additional sites, including Europe and Asia. Results are expected within the next two months (as reported on April 10, 2020).

Lilly also announced it will advance LY3127804, an investigational selective monoclonal antibody against angiopoietin 2 (Ang2), to Phase II testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS). Ang2 is known to be elevated in ARDS patients, and Lilly will test whether inhibiting the effects of Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients. This trial will begin later this month (April 2020) at several US centers.

Source: Eli Lilly and Company

Sanofi, GSK Sign Pact for Adjuvanted COVID-19 Vaccine Candidate
Sanofi and GlaxoSmithKline (GSK) have signed a letter of intent to develop an adjuvanted vaccine for COVID-19 using technology from both companies.

Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology, and which has provided an exact genetic match to proteins found on the surface of the virus. The DNA sequence encoding this antigen has been combined into the DNA of the Baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.

GSK will contribute its pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, thereby allowing more vaccine doses to be produced. 

The companies plan to initiate Phase I clinical trials in the second half of 2020 and, subject to regulatory considerations, are aiming to complete the development required for availability by the second half of 2021. 

The development of the recombinant-based COVID-19 vaccine candidate is being supported through funding and a collaboration with 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. The companies plan to discuss funding support with other governments and global institutions prioritizing global access.

The companies have set up a Joint Task Force, co-chaired by David Loew, Global Head of Vaccines, Sanofi, and Roger Connor, President Vaccines, GSK. The task force will seek to mobilize resources from both companies to accelerate the development of the candidate vaccine.

The companies have entered into a material-transfer agreement to enable them to start working together immediately (as reported on April 14, 2020). Definitive terms of the collaboration are expected to be finalized over the next few weeks.

Source: Sanofi and GlaxoSmithKline

AstraZeneca Initiates Trial of Cancer Drug Calquence for COVID-19
AstraZeneca has initiated a randomized clinical trial to assess the potential of Calquence (acalabrutinib), indicated to treat adults with mantle cell lymphoma, in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients.

The trial design is based on scientific evidence supporting the role of the Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines and on encouraging early clinical data. Calquence is a selective BTK inhibitor currently used to treat certain types of blood cancers.  The goal of the trial is to evaluate adding Calquence to best supportive care to reduce mortality and the need for assisted ventilation in patients with life-threatening COVID-19 symptoms.

The trial is expected to open for enrollment in the coming days (as reported on April 14, 2020) in the US and several countries in Europe.

Source: AstraZeneca

AstraZeneca, GSK, University of Cambridge Enter COVID Testing Pact
As part of the UK government’s announcement of a new five-pillar plan to boost testing for COVID-19, AstraZeneca, GlaxoSmithKline (GSK), and the University of Cambridge have formed a joint collaboration to support this effort.

A testing laboratory will be set up by GSK, AstraZeneca, and the University of Cambridge at the university’s Anne McLaren laboratory. This facility will be used for high-throughput screening for COVID-19 testing and to explore the use of alternative chemical reagents for test kits in order to help overcome current supply shortages. 

Alongside this new testing facility, GSK and AstraZeneca are working to provide process optimization support to UK testing centers for COVID-19 in Milton Keynes, Alderley Park, and Glasgow by providing expertise in automation and robotics to help the national testing system to continue to expand capacity over the coming weeks (as reported on April 9, 2020).

Source: GlaxoSmithKline and the University of Cambridge

CSL, SAB Biotherapeutics in Pact to Develop COVID-19 Therapeutic
CSL Behring and SAB Biotherapeutics, a Sioux Falls, South Dakota-based clinical-stage biopharmaceutical company, have partnered to address the COVID-19 pandemic with the development of SAB-185, a COVID-19 therapeutic candidate on track for clinical evaluation by early summer (summer of 2020).

The partnership combines CSL Behring’s protein-science capabilities with SAB’s immunotherapy platform capable of developing and producing fully human polyclonal antibodies without the need for blood-plasma donations from recovered patients. The therapeutic candidate, SAB-185, is generated from SAB’s proprietary platform that can produce large volumes of human polyclonal antibodies targeted to SARS-CoV-2, the virus that causes COVID-19.

CSL Behring has provided seed funding to offset initial development costs that were funded by SAB. SAB has secured approximately $7.2 million in funding through an interagency agreement with the US Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense and the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services, to support SAB to complete manufacturing and preclinical studies. CSL Behring will then commit its clinical, regulatory, manufacturing, and supply-chain expertise and resources to deliver the therapeutic to the market, on terms to be agreed with SAB.

Source: CSL Behring and SAB Biotherapeutics

Bausch Initiates Virazole Clinical Study in COVID-19 Patients
Bausch Health Companies has initiated a clinical trial program in Canada evaluating an investigational use of Virazole (ribavirin for inhalation solution, USP), an aerosol indicated to lower respiratory-tract infection due to respiratory syncytial virus, in combination with standard of care therapy, to treat hospitalized adult patients with respiratory distress due to COVID-19.

Virazole is currently approved in several countries, including the US and Canada, for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus.

The initial clinical study has been approved by Health Canada, Canada’s national pharmaceutical regulatory authority, and is expected to begin within the next few weeks (as reported on April 13, 2020). The company is also in discussions with the US Food and Drug Administration and health authorities in multiple countries regarding additional studies to evaluate Virazole as a treatment for COVID-19 infection. The Bausch Foundation is also continuing to work directly with health authorities in Italy to make Virazole for inhalation available free of charge in compassionate use in Italian hospitals.

Source: Bausch Health Companies

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