Milestones :: Perspectives :: Research
IFPMA Backgrounder – COVID-19
27 March 2020
While vaccines and small molecule treatments are approved through different regulatory pathways and their development programs vary, they generally both must complete three phases of clinical trials. However, there are differences in the data required to show the safety of vaccines and the size of clinical trials for vaccines relative to small molecules.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available. This is a best-case estimate that assumes one or two of the first few vaccines that enter development will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval. Therefore, the more companies taking different approaches to find a vaccine, the more “shots on goal” and significantly greater chances of success.
:: CEPI and GSK will collaborate to help the global effort to develop a vaccine for the novel
:: CSL Limited/ Seqirus is providing scientific and technical expertise and its established MF59® adjuvant technology to the University of Queensland in Australia to help fast-track the development of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology.
:: GSK announced it would partner with the Chinese biotech company Clover Biopharmaceuticals. Under the partnership, GSK will provide Clover with its proprietary adjuvants – compounds that enhance the effectiveness of vaccines. By mid-March, GSK expanded their collaborations and is now working with five partner companies and research groups across the world, including in the USA and China.
:: Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health & Human Services (HHS), and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC), to accelerate development of a potential novel coronavirus vaccine.
:: Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The collaboration aims to accelerate global development of BNT162, which is expected to enter clinical testing by the end of April 2020.
:: Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI) and sharing its vaccine R&D experience and expertise to advance vaccine solutions.
:: Sanofi and U.S. company Translate Bio announced plans to collaborate on developing a vaccine to treat the coronavirus. The companies said Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks…
As of March 2020, there are at least: 14 companies with a medicine in early phase research, 4 companies with a medicine in Phase I of development and 3 in Phase II, and one company has a medicine in Phase III trials. Listed below is a snapshot of the different areas of research focused on finding a new treatment”
:: AbbVie announced it is partnering with global authorities to determine the effectiveness of HIV drugs in treating COVID-19. AbbVie is supporting clinical studies and basic research with lopinavir/ritonavir, working closely with European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and the Biomedical Advanced Research and Development Authority to coordinate these efforts.
:: AstraZeneca’s Research and Development (R&D) teams have also been working expeditiously to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19. More than 50 virology, immunology, respiratory, and protein engineering experts across research, clinical, regulatory, and manufacturing are placing the highest priority on developing a treatment to minimise the global impact of the disease.
:: Eli Lilly and AbCellera (Canadian biotech firm) have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
:: EFPIA is working with the Innovative Medicines Initiative (IMI) on potential actions to support collaborative research programs in order to fast-track the development of therapeutics.
:: Gilead has initiated two Phase 3 clinical trials of remdesivir in countries with high prevalence of COVID-19. The company is also supporting two Phase 3 trials in China and a global Phase 2 trial led by the U.S. National Institute of Allergy and Infectious Diseases. Gilead donated drug and provided scientific input for these studies. Gilead has provided remdesivir to physicians for compassionate use to treat several hundred severely ill patients with confirmed COVID-19, and has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.
:: GSK is entering into the new collaborative research effort, the COVID-19 Therapeutics Accelerator. The aim of the Accelerator is to bring pharmaceutical companies and expert academic institutions into coordinated research programs, with the aim of bringing the most promising molecules forward that could be used to treat cases of COVID-19. GSK will contribute by making available compounds from its libraries for screening for activity against COVID-19. In addition, GSK is evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic. Further, GSK is evaluating options to make available specialised laboratory space to help in research and testing of COVID-19.
:: Johnson & Johnson, in partnership with the Rega Institute for Medical Research, University of Leuven (Belgium), are working to identify existing or new compounds with antiviral activity against COVID-19 that could contribute to providing immediate relief to the current outbreak.
:: Merck, as part of the global effort to investigate potential therapeutics for COVID-19 and their support of independent research, recently donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial. To date, Merck’s interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.
:: Novartis announced that it has entered new collaborative research efforts such as the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. Novartis is contributing by making available several compounds from its libraries that are considered suitable for in vitro antiviral testing. In addition, the company is rapidly evaluating other existing products to see if any could be utilized beyond their approved indications in response to the pandemic.
:: Pfizer announced that it completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline and expects to have the results back by the end of March.
:: Pfizer also outlined a detailed 5-point action plan to battle COVID-19. The plan includes a commitment to sharing its clinical development and regulatory expertise to support other smaller biotech companies that are screening compounds or existing therapies for activity against the virus causing COVID-19.
:: Regeneron Pharmaceuticals announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus.
:: Regeneron Pharmaceuticals and Sanofi SA started a clinical program evaluating Kevzara, originally a drug to treat arthritis, in patients hospitalized with severe COVID-19. 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.
:: Roche’s Actemra was approved by China on March 5 to treat Covid-19 patients with lung complications. Roche has donated nearly $2m-worth of Actemra to China to help the country manage the COVID-19 outbreak”. Actemra has been on the European market since 2010 for treatment of several kinds of arthritis.
:: Roche announced that they are working with the Food & Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Actemra in hospitalised adult patients with severe COVID-19 pneumonia. This is the first global study of Actemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.
:: Takeda announced that it is initiating the development of a drug to treat people infected with the novel coronavirus. The experimental drug would be derived from the blood of coronavirus patients who have recovered from the respiratory disease. In parallel, Takeda is also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients…