Milestones :: Perspectives :: Research

COVID-19 R&D

[Editor’s Note:
IFPMA appears to be updating and extending its “backgrounder” each week, providing an inventory of company initiatives involving development of vaccines, treatments and diagnostics. We will monitor and provide an excerpt as it is the most comprehensive list we have encountered]

IFPMA Backgrounder – COVID-19
10 April 2020
[Excerpts]
… Vaccine development
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 coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.
:: 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-
:: 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.
:: Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a 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. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval.
:: 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.

Treatment development
Currently a number of existing and new treatments are in various research phases and clinical trials to test their efficiency and safety for treating COVID-19. Listed below is a snapshot of the different areas of research focused on finding an effective 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.
:: Amgen and Adaptive Biotechnologies (Seattle, USA) are partnering to combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.
:: 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.
:: Boehringer Ingelheim is searching for novel virus-neutralizing antibodies. It is also screening its entire molecule library for compounds that could target the virus. Boehringer Ingelheim actively participates with its COVID-19 projects in the Innovative Medicines Initiative (IMI) of the European Union and the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation.
:: Bristol Myers Squibb (BMS) identified 1,000 compounds in its discovery library that they are making available to collaborators for screening for potential treatments for COVID-19. BMS is actively evaluating certain medicines in its portfolio that could be included in near-term clinical trials with a focus on agents impacting the inflammatory immune response associated with COVID-19.
:: Chugai (daughter of Roche) is working to start a Phase III clinical trial in Japan with Actemra® Chugai filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency on April 8th, 2020. It hopes to enroll patients hospitalized with severe COVID-19 soon.
:: CSL Behring (CSL Limited is the parent company) together with Takeda set up a partnership bringing together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.
:: 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.
:: Eisai is participating in the COVID-19 Therapeutics Accelerator initiated by the Bill & Melinda Gates Foundation. The company is planning to provide its natural product libraries as well as its new vaccine adjuvant.
:: 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.
:: GSK and Vir Biotechnology, Inc. signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks.
:: GSK announced plans to collaborate with China’s Xiamen Innovex on a potential vaccine to treat the COVID-19 coronavirus. The companies are testing a recombinant protein-based coronavirus vaccine candidate, which is being developed by Innovax with Xiamen University.
:: Ipsen donated financial resources to the Institut Pasteur to support research on COVID-19. Since January, the Institut Pasteur has devoted a portion of its research to understanding the emerging COVID-19 virus, in terms of epidemiology, biological characteristics, pathogenicity.
:: 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.
:: Merck is donating 290,000 units of its interferon beta-1a (Rebif®) to the WHO for use in their global SOLIDARITY trial which investigates several potential therapeutics for the treatment of COVID-19.
:: 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.
:: Novartis plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.
:: 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.
:: Pfizer shared preliminary data confirming the anti-SARS-CoV-1 compound shows antiviral activity against SARS-CoV-2. Pfizer will perform pre-clinical confirmatory studies, including further anti-viral profiling and assessment of the suitability of the lead molecule for IV administration clinically.
:: Pfizer and the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group are launching two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2. The SAFER study and FASTER study will help demonstrate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia and if having both infections leads to more severe disease and poorer outcomes.
:: 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.
:: Takeda together with CSL Behring set up a partnership bringing together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.
:: Teva is actively looking through its range of products to determine if it can help provide any products that may be relevant in addressing acute and substantial need during the COVID-19 crisis.

Diagnostics
Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world, especially in the United States and Europe, and governments are trying to ramp up their testing capacities.
:: AstraZeneca is accelerating the development of its diagnostic testing capabilities to scale-up screening and is also working in partnership with governments on existing screening programmes to supplement testing.
:: Bayer is making more than 40 virus diagnostics devices available from its research operations to scale up Germany’s COVID-19 analysis by several thousand tests daily.
:: Novo Nordisk scientists are working in R&D laboratories to boost Denmark’s COVID-19 testing capacity.
:: Roche announced that the FDA issued an Emergency Use Authorization for its diagnostic kit cobas® SARS-CoV-2 Test, advancing coronavirus testing to meet urgent medical needs. Roche is committed to delivering as many tests as possible and is going to the limits of production capacity.
:: Shionogi and Micro Blood Science (MBS) entered into a partnership to develop COVID-19 antibody-test kits using MBS’ original technology, including unique trace-blood collection devices.
:: Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative (IMI) in Europe to leverage collective expertise in the hope of developing diagnostics for COVID-19 as well as inhibitors to help prevent future outbreaks.

In addition to the individual contributions companies are already making, a consortium of life sciences companies announced an important collaboration on March 25 to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19, alongside the Gates Foundation. Co-chaired by Vas Narasimhan, chief executive officer of Novartis, the consortium seeks out to accelerate solutions to this pandemic.

Companies participating in the collaboration include BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi…