As the unprecedented COVID-19 pandemic continues to spread around the world, Sanofi is at the forefront of multiple initiatives to fight the disease, while also carrying on the daily business of making and delivering medicines for patients. The company is studying two of its existing medicines as potential treatments for COVID-19 and leveraging its expertise to develop a new vaccine, measures that could have both an immediate and lasting impact. Dealing with a pandemic as daunting as COVID-19 requires collaboration to create as many paths forward as possible, and Sanofi is helping lead the way.
Developing a home test
Its most recent effort to fight COVID-19 is the development of an over the counter, self-testing solution, in collaboration with Californian startup, Luminostics. Early on in the crisis, the World Health Organization (WHO) called for rapid, reliable testing as a priority measure to contain the outbreak, but in reality, testing is still not widely available and there is currently no home test.
Sanofi’s goal is to provide a smartphone-based solution that can be carried out at home without a healthcare professional or laboratory tests, lowering the risk of catching the virus for all involved.
The test, designed to detect the COVID-19 virus from respiratory samples, gives a result in 30 minutes or less. It is based on a combination of Sanofi’s clinical research testing experience and Luminostics’ unique technology that uses smartphone’s optics. Controlled by an iOS/Android that comes with instructions on how to take a specimen and process it, the phone displays the test results and if necessary, connects users with a telehealth service.
Development is set to start in the coming weeks with the aim to have a self-testing solution available before the end of 2020, with Sanofi’s global distribution network ensuring global availability.
Exploring alternative treatment options
Sanofi is supporting clinical trials to determine whether two of its medicines can help patients with COVID-19. One option is currently being tested to evaluate its impact on symptoms in patients with severe COVID-19 in Italy, Spain, Germany, France, Canada, Russia, Israel and Japan, with a second trial led by Regeneron for patients in the US.
The second product is one of several medicines being investigated by the World Health Organization (WHO) in its international clinical trial to find a solution for COVID-19. To support this trial, Sanofi has launched two additional clinical studies and is also providing the medicine to some participating investigator sites and other independent research centers.
In tandem, Sanofi’s industrial affairs teams are managing available stocks and progressively increasing production to ensure supply continuity for patients receiving the treatment under current indications and preparing for the future should the treatment option prove to be safe and effective in COVID-19 patients.
Leveraging expertise in vaccine development
Sanofi Pasteur, the vaccines global business unit of Sanofi, has launched several collaborations to pursue different, innovative approaches to develop a safe and effective vaccine as quickly as possible. Most recently, it joined forces with GSK to develop an adjuvanted COVID-19 vaccine.
Sanofi brings to the partnership the antigen (the protein that stimulates the body’s immune response against the virus), which is based on recombinant DNA technology. 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), in the US.
“We are using an existing technology that was designed for influenza, and we’re applying it to the new virus that causes COVID-19 disease,” says John Shiver, Head of Sanofi Vaccine R&D. “Having the existing platform and partnerships are key to accelerating development as much as possible.”
GSK will contribute its adjuvant technology, an ingredient added to enhance the immune response, reduce the amount of vaccine protein required per dose and improve the chances of delivering an effective vaccine that can be manufactured at scale.
The candidate vaccine is expected to enter clinical trials in the second half of 2020 and to be available by the second half of 2021.
“As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone,” says Paul Hudson, Sanofi’s Chief Executive Officer. “That is why Sanofi is continuing to complement its expertise and resources with our peers, such as GSK, with the goal to create and supply sufficient quantities of vaccines that will help stop this virus.”
Additionally, Sanofi is exploring other options to discover, design, and manufacture a vaccine against COVID-19. This includes working with Translate Bio, a clinical-stage messenger RNA (mRNA) biotechnology company, where Sanofi is combining its deep vaccine expertise with Translate Bio’s mRNA platform.
Collaborations are also ongoing with the Coalition for Epidemic Preparedness Innovations, which coordinates the development of future vaccines against targeted epidemic pathogens identified by the WHO. Sanofi is also part of a consortium of 15 healthcare companies alongside the Bill & Melinda Gates Foundation working to identify concrete actions that will accelerate treatments, vaccines, and diagnostics.
Investing in Science
Sanofi’s quick response on so many fronts is not accidental. It stems from years of investment in vaccine technology and earlier work on a SARS vaccine program. The pace with which regulatory authorities globally have provided cooperation is also unprecedented, enabling clinical trials to start in days rather than months.
Sanofi is collaborating with scientific societies, patient groups and health authorities to help deliver accurate information and guidance to people affected by various conditions, including rare diseases, asthma, atopic dermatitis, diabetes, oncology and multiple sclerosis.
Maintaining manufacturing and supply to avoid shortages
Two-thirds of Sanofi medicines and vaccines are on the WHO’s list of essential medicines, so while much of the world has gone into lockdown, Sanofi’s global network of manufacturing plants remains operational to help ensure continued supply of all Sanofi medicines and vaccines. There are currently no anticipated shortages for patients resulting from the COVID-19 situation.
It is with these patients in mind that the industrial affairs teams show up for work seven days a week to meet the demand from governments, health authorities, hospitals, wholesalers and pharmacies around the world.
“We are on the front line in this battle, and patients, healthcare professionals and health authorities count on us to obtain the medicines they need,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs. “Most of our products are essential for millions of patients all over the world. We must ensure their availability during this crisis and guarantee a low level of shortages when the situation returns to normal.”
Maintaining clinical trials
While clinical trials have been launched with unprecedented speed to help find a solution to COVID-19, Sanofi is undertaking a meticulous assessment of ongoing clinical trials for other product candidates, country by country, trial by trial, investigator by investigator. “Our approach has to be diverse. We are putting patients and their needs first, while trying to protect people who are working in the healthcare system and to continue moving transformational medicines further for patients,” said Dietmar Berger, Chief Medical Officer, Global Head of Development, at Sanofi.
Sixty percent of the approximately 300 ongoing clinical studies are in the patient recruiting stage and efforts to maintain drug supply and meet distribution challenges have been made a priority. In addition, targeted direct-to-patient drug supply is being implemented on a case-by-case basis. This approach was used in China throughout February along with telemedicine to monitor patients remotely, enabling more than 90% of trials to continue.
“People are definitely stepping up, there’s so much engagement, so much connection to our real purpose as a company that shines through in these moments. People are coming with innovative and patient-focused solutions, all with the final objective of getting transformative medicines to patients as quickly as possible,” said Berger.
Each individual action counts to help slow the spread of the virus, flatten the curve of new infections, and support the healthcare professionals who are mobilized around the world to treat those already affected. Behind all Sanofi’s actions in the fight against this pandemic are its people.
Many Sanofi employees with medical training have volunteered or been enlisted to help treat critically ill COVID-19 patients to support the heavy toll on medical staff and facilities around the world, where some systems are now near a breaking point. All necessary steps have been taken to protect their health and well-being. Similar safety measures have been put in place for those working on production sites and distribution centers, who go to work so their communities can stay at home, and in the research labs to protect the scientists who are working around the clock, pushing the science to find solutions for patients.
Resilience and solidarity are key to moving this fight against COVID-19 forward and, in time, to establishing a blueprint for the future of healthcare that will bolster the ability to think, develop and create new pathways together, and prepare for future pandemics.
Additional Information and News