Sanofi Advances Testing of Antiviral Drug Kevzara Against COVID-19
Sanofi reports that the first patient outside of the US has been treated as part of a global clinical program evaluating Sanofi’s and Regeneron Pharmaceuticals’ Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the US, all countries that have been impacted by COVID-19. Sanofi is leading trials outside the US while Regeneron is leading US trials.
This is the second multi-center, double-blind, Phase II/III trial as part of the Kevzara COVID-19 program, and the companies say that they are continuing to work with authorities around the world to secure initiation at additional sites. This follows Sanofi and Regeneron’s earlier announcement of the initiation of the first trial, which is US-based.
Kevzara is a fully human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection, according to information from the companies. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor inhibitor.
The trial outside of the US will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo. The trial has an adaptive design with two parts and is anticipated to enroll approximately 300 patients. The trial will recruit hospitalized patients from several countries who are severely or critically ill with COVID-19 infection.
Scientists have preliminary evidence that IL-6 may play a key role in driving the inflammatory immune response that causes acute respiratory distress syndrome (ARDS) in patients critically ill from COVID-19, according to information from the company. In an initial, non-peer-reviewed case series from China, a 21-patient cohort of COVID-19 patients experienced rapidly reduced fevers and 75% of patients (15 out of 20) reduced their need for supplemental oxygen within days of receiving another IL-6 receptor antibody (tocilizumab). Based on these results, China updated its COVID-19 treatment guidelines and approved the use of that IL-6 inhibitor to treat patients with severe or critical disease, according to the companies.
The use of Kevzara to treat the symptoms of COVID-19 is investigational and has not been evaluated by any regulatory authority.
Sanofi, Translate Bio Pact for Vaccine Candidate Against COVID-19
Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have entered a licensing agreement to develop a novel mRNA vaccine for COVID-19. This collaboration leverages an existing agreement from 2018 between the two companies to develop mRNA vaccines for infectious diseases.
Translate Bio has started to produce multiple mRNA constructs and will use its mRNA platform to discover, design, and manufacture a number of SARS-CoV-2 vaccine candidates. Sanofi will provide vaccine expertise and support from its external research networks to advance vaccine candidates for potential further development. Translate Bio has established 100-gram single-batch production with its clinical-stage mRNA therapeutics platform. Build-out is underway of dedicated manufacturing space through a contract manufacturing partner to accommodate at least two 250-gram batches per month.
In 2018, Translate Bio entered into a collaboration and exclusive licensing agreement with Sanofi Pasteur to develop mRNA vaccines for up to five infectious disease pathogens. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a three-year research term.
Translate Bio and Sanofi Pasteur have advanced the preclinical development vaccine programs, including screening, optimization and production of mRNA and LNP formulations across multiple targets.
AbbVie Donates $35-M for COVID-19 Relief
AbbVie has donated $35 million to support COVID-19 relief efforts. In the US, AbbVie's funds will be used to support healthcare capacity for hospitals as well as protect vulnerable populations by enabling access to food and essential supplies. In Europe, the donation will provide critical equipment and supplies to patients and front-line healthcare workers in the hardest-hit countries.
As part of its $35-million commitment, AbbVie is designating up to $5 million in reserve funding for additional near-term commitments to help address the COVID-19 pandemic. AbbVie is creating the Community Resilience Fund, which will provide funding to organizations improving community resilience in under-resourced areas impacted by the COVID-19 pandemic.
AbbVie's donation to International Medical Corps will further support increased healthcare capacity at overwhelmed hospital emergency departments in the US, where International Medical Corps is deploying a total of 20 mobile field hospitals to help increase surge capacity at overburdened hospitals. These mobile field units enable hospitals to expand the available triage and treatment space at existing facilities, improve patient flow, and keep COVID-19 patients separated from other patients.
AbbVie is the sole donor funding the procurement of the tents, equipment, supplies as well as all of the operating expenses for these field hospitals through the end of 2020. AbbVie launched International Medical Corps' response in cities across the US, including Boston, Chicago, Cleveland, Detroit, Los Angeles, New Orleans, New York City, and Puerto Rico.
The field hospital can be stood up in approximately six hours and withstand 80-mph sustained winds. International Medical Corps will pull from its roster of nearly 300 medical professionals to fill critical gaps in nursing and infection prevention and control. Each hospital will determine specifically how it intends to use the additional space and resources.
AbbVie is donating to Direct Relief to provide equipment and supplies in the hardest-hit European countries. Direct Relief is procuring and delivering personal protective equipment (PPE) for front line healthcare workers as well as oxygen concentrators and ventilators for patients.
AbbVie also announced that it is doubling the AbbVie Foundation match for COVID-19-related contributions by its employees. Through this program, AbbVie seeks to increase the impact the company can make on this crisis. Instead of the typical 1:1 match, the AbbVie Foundation will match $2 to every $1 employees donate to a nonprofit for this purpose.
Bayer Boosts Germany’s COVID-19 Analysis Capacity
At various sites in Germany, Bayer is making available more than 40 virus diagnostics devices from its research operations, thereby enabling Germany’s COVID-19 analysis capacity to be increased by several thousand tests daily. At its Berlin campus, Bayer is establishing a two-story testing laboratory, and in North Rhine-Westphalia, Germany, the company is providing equipment to certified external testing laboratories.
At the Berlin site, more than 140 employees have volunteered in the past few days to staff the new testing laboratory. Bayer is giving them a leave of absence from their regular jobs for this purpose. The equipment needed for the tests comes from all areas of research and development at Bayer. In the future, it will be possible to conduct up to 1,000 additional SARS-CoV-2 tests each day just in Berlin. Bayer is working closely with the Robert Koch Institute in Berlin to ensure that all the scientific requirements are met. The contracting parties for the Bayer laboratory are the Berlin-Brandenburg State Laboratory, the Berlin health authorities and the Brandenburg State Ministry of Health.
Furthermore, in North Rhine-Westphalia, Bayer is supplying three certified clinical diagnostic laboratories with company apparatus from its Leverkusen, Monheim, Wuppertal, and Cologne sites. The current daily analysis capacity of these three laboratories can potentially be doubled by technically integrating the apparatus and complementing the infrastructure.
The company plans to supply the largest hospital in the state of Brandenburg (1,200 beds) and a hospital in Wuppertal with ventilators for COVID-19 patients. In addition, Bayer has helped to address the sanitizer shortage in cities such as Unna, Dormagen, and Wuppertal by producing disinfectants and has donated breathing masks to the city of Leverkusen.
Gates Foundation Issues $1.73-M Grant for Consortium
The La Jolla Institute for Immunology (LJI) has been awarded a $1.73-million grant by the Bill & Melinda Gates Foundation to establish a Coronavirus Immunotherapy Consortium (CoVIC) as part of the foundation’s global efforts to stem the current coronavirus outbreak. Carterra, a high-throughput antibody screening and characterization tools company, and LJI, have entered an agreement allowing CoVIC to move therapeutic candidates to the clinic as early as this summer.
Headquartered at LJI, CoVIC will serve as a clearinghouse to understand which antibodies are most effective against the novel coronavirus, SARS-CoV-2, and to accelerate the research pipeline to provide immunotherapeutics in order to protect vulnerable individuals from severe manifestations of COVID-19 in all parts of the world, including low-resource settings.
This effort is being funded as part of the COVID-19 Therapeutics Accelerator launched in early March by the Gates Foundation, Wellcome and Mastercard. The Accelerator provides funding at key stages of the development process to de-risk the pathway for drugs and biologics to prevent and treat COVID-19.
CoVIC is an academic-industry, non-profit collaborative research effort that enable scientists to share and evaluate candidate antibodies side-by-side in a blinded, multidisciplinary analysis. They are focused on identifying optimal therapeutic combinations, the assays that best predict efficacy, and the features that provide protection.
Antibody-based immunotherapies can also treat those who have already become sick, lessening disease and improving survival. The most potent antibodies will provide insights to help guide the development of vaccines to stop the current outbreak and protect against future pandemics.