IAVI, Merck, and Serum Institute of India Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
Today, IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, and Serum Institute of India Pvt. Ltd., a leading manufacturer of vaccines and biologics, announced an agreement with Merck, a leading science and technology company, to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.
The agreement builds on the advanced antibody discovery and optimization expertise of IAVI and Scripps Research, gained from years of experience in HIV broadly neutralizing antibody research and development, and on Merck’s and Serum Institute’s significant capabilities in design and scale up of accelerated manufacturing processes for mAb production. The global development plan is being led by the three organizations in partnership.
The two companies have broad networks across complementary geographic areas that will be crucial to reach given the worldwide spread of COVID-19. If the highly potent and broadly cross-reactive SARS-CoV-2 neutralizing antibody candidates being advanced through this partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck will lead commercialization in developed countries. Serum Institute has a proven track record of more than 50 years in developing affordable medicines and is the world’s largest producer of vaccines. Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India.
“We’re acutely aware of the tremendous potential for monoclonal antibodies to be used in COVID-19 response. By combining the scientific achievements of IAVI and Scripps Research with our partners’ development, manufacturing, and distribution expertise, we are hopeful that this partnership will result in globally accessible antibodies that are available to all who can benefit from them,” said Mark Feinberg, M.D., Ph.D., president and CEO of IAVI.
Belén Garijo, vice chair of the executive board and deputy CEO, Merck, as well as CEO Healthcare, said, “Together with IAVI and Serum Institute, we look forward to demonstrating the potential application of these monoclonal antibodies in the management of COVID 19. We share a common purpose to accelerate this promising science and deliver effective solutions that address global challenges presented by this pandemic.”
“I am extremely pleased that we have joined forces with IAVI and Merck in the fight against COVID-19 with the aim of developing monoclonal antibodies for global access. Given the breadth and scale of our technology and our long-standing devotion to improving health especially in low-income countries, I am confident that we and our partners are on a productive path that will lead to a much-needed, globally available tool for COVID-19 treatment and possibly prevention,” said Adar Poonawalla, CEO, Serum Institute.
Neutralizing mAbs against SARS-CoV-2 are widely considered to be promising candidates for COVID-19 treatment and prevention.1,2 Encouraging results for COVID-19 antibody treatment have emerged from preclinical research3 and from initial clinical trials.4,5 Not only are innovative therapies such as SARS-CoV-2 neutralizing antibodies urgently needed for immediate pandemic response, they will likely also continue to be needed even after an effective vaccine is available. mAbs have the potential to play an important complementary role to COVID-19 vaccines both for treatment and potentially for prevention, especially for those individuals who, due to age or medical conditions, may not benefit from vaccination. Given that many experts speculate that COVID-19 will become an endemic, or permanently circulating, disease6,7, and given the severity of symptoms in a significant proportion of people affected, effective therapies will be necessary to treat those who remain unvaccinated or whom vaccination does not protect.
Scientists at IAVI’s Neutralizing Antibody Center (NAC) based at Scripps Research, along with fellow immunologists at Scripps Research, were part of a team that identified antibodies from the blood of recovered COVID-19 patients that are capable of potently neutralizing SARS-CoV-2, the virus that causes COVID-19. Animals that received these neutralizing antibodies were protected against disease after challenge with SARS-CoV-2. The results were published in Science in June 2020. The portfolio of mAbs identified by IAVI and Scripps Research scientists and their partners provides the foundation for a comprehensive program with potential application to COVID-19 treatment and prevention as well as to other coronaviruses that may arise or re-emerge in the future.
Dennis Burton, Ph.D., professor and chair of the Department of Immunology and Microbiology at Scripps Research and scientific director of the IAVI NAC said, “The accelerated discovery of highly potent SARS-CoV-2 neutralizing antibodies by IAVI and Scripps Research scientists was achieved by a tremendous collaborative effort of a team committed to translating state-of-the-art monoclonal antibody science into public health interventions that we all hope will have an important role in ameliorating the individual and societal impact of the COVID-19 pandemic.”
Under IAVI’s agreement with Merck and Serum Institute, the partners will conduct an accelerated, integrated program of preclinical and clinical research to evaluate the antibodies for treatment of COVID-19. A Phase I clinical trial is expected to start early in 2021. Should the mAb candidates being developed be shown to be safe and efficacious, Merck and Serum Institute will help ensure that the therapy is rapidly and widely available and accessible.
Joining the partners in this development effort are two highly regarded companies with unique capabilities. Syngene International Ltd., based in Bengaluru, India, is Asia's largest contract research and manufacturing organization. Through their innovation-focused research and development capabilities they are a collaborating partner for the development and conduct of assays to support clinical development of the SARS-CoV-2 mAb candidates. ATUM, a California-based bioengineering company, has utilized its Leap-In Transposase® Platform to develop stable cell lines needed for the manufacture of the SARS-CoV-2 antibody candidates being advanced via this collaboration. This effort is enabling the rapid and robust transition from research to clinical development.
IAVI recently published a global call to action, commissioned by Wellcome, that highlights the lack of equitable access to mAbs in LMICs. The publication proposes a set of actions that could solve the access problem, including a call for global health players to form innovative partnerships to address the need for affordable mAbs worldwide. The collaboration among IAVI, Serum Institute of India, and Merck is the kind of innovative partnership identified in the call to action that could set an important precedent for enabling affordable access to SARS-CoV-2 mAbs in LMICs and potentially be applied more widely to mAbs for a range of infectious and non-communicable diseases.
1Marovich M, Mascola JR, Cohen MS. Monoclonal antibodies for prevention and treatment of COVID-19. JAMA. 2020 Jul 14;324(2):131-2.
2Gale J. Early Covid-19 treatments could be bridge to vaccine, Fauci says. Bloomberg. September 26, 2020.
3Rogers TF, Zhao F, Huang D, Beutler N, Burns A, He WT, Limbo O, Smith C, Song G, Woehl J, Yang L. Isolation of potent SARS-CoV-2 neutralizing antibodies and protection from disease in a small animal model. Science. 2020 Aug 21;369(6506):956-63.
4Wadman M. Eli Lilly reports promising first results for an antibody against COVID-19. Science. September 16, 2020.
5Cohen J. “Provocative results” boost hopes of antibody treatment for COVID-19. Science. September 30, 2020.
6Begly S. Experts envision two scenarios if the new coronavirus isn’t contained. Stat. February 4, 2020.
7Sheahan TP, Frieman MB. The continued epidemic threat of SARS-CoV-2 and implications for the future of global public health. Current Opinion in Virology. 2020 Jun 4.
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of € 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
About Serum Institute of India Pvt. Ltd.
Serum Institute is now the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). Vaccines manufactured by Serum Institute are accredited by the World Health Organization and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world.
Serum Institute is developing biosimilars of existing antibody immunotherapies for a range of diseases, and in 2017 launched a novel monoclonal antibody against rabies.
+1 212 847 1051
Serum Institute of India Pvt. Ltd.
+49 151 1454 9591
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Rhizen Pharmaceuticals Announces US FDA Acceptance of its IND Application for RP7214 in SARS-CoV-2 Infection; Phase 1 Clinical Trial of RP7214 Set to Begin Early December 20201.12.2020 18:01:00 EET | Press release
Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, today announced the approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to study its oral DHODH inhibitor for SARS-CoV-2 infection. The company announced that initial study shall evaluate single ascending doses of RP7214 in healthy volunteers and that dosing is expected to commence in early December 2020. The company also announces positive feedback from the FDA during its pre-IND discussion on its plans to follow-up this study with a multiple-ascending dose study in Covid-19 patients. Dihydroorotate dehydrogenase (DHOHD) is a key enzyme involved in pyrimidine biosynthesis in the cell. RP7214 is potentially a best-in-class selective DHODH inhibitor that has shown potent inhibition of Covid-19 viral replication. RP7214 has also been studied extensively across multiple inflammation models where it has demonstrated excellent anti-inflammatory activity
Andersen Global Adds Collaborating Firm in Azerbaijan1.12.2020 17:30:00 EET | Press release
Andersen Global expands into Azerbaijan by way of a Collaboration Agreement with independent Baku-based law firm MGB Law Offices, adding coverage and positioning the organization for further expansion between Europe and Asia. Founded in 1995, MGB Law Offices, which has ten lawyers, has been recognized by IFLR1000, Legal500 and Chambers and Partners as the leading law firm in Azerbaijan. Led by Managing Partner Ismail Askerov, the full-service firm offers solutions in various industries such as oil and gas, aviation, banking and finance, insolvency and restructuring, tax, privatization law and foreign investment. The firm’s client base includes blue-chip multinationals, international financial institutions, insurance companies, airlines, telecom companies and other business entities. “We are proud of our ability to consistently deliver best-in-class services, and our comprehensive solutions position us to be one of the most reputable law firms in the market by allowing us to meet the di
Alira Health Achieves AWS Select Consulting Partner Status1.12.2020 17:00:00 EET | Press release
Alira Health (www.alirahealth.com), a leading international healthcare and life sciences advisory firm, announced it has recently earned Amazon Web Services (AWS) Select Consulting Partner status. The firm’s newly formed Advanced Analytics practice will leverage AWS’s cloud computing capabilities to provide greater value to clients, providing fully compliant, made-to-measure digital solutions, powered by AWS, that securely enable the use of data generated by the healthcare community and clients’ own internal data. The solutions are provided to customers in the form of Software-as-a-Service (SaaS), seamlessly integrating into existing workflows and designed to support clients in prioritizing research and development (R&D) investments, identifying novel therapeutic areas suitable for corporate business development, and assessing business opportunities. “Technology has the power to solve complex problems and be a transformative tool across the healthcare and life sciences ecosystem,” said
Rimini Street Awarded Three Brazilian Public Sector Contracts to Support Oracle and SAP Enterprise Software Systems1.12.2020 17:00:00 EET | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that it has been awarded three separate contracts to provide enterprise software support to agencies linked to the Legislative, Executive and Judiciary branches of the Brazilian government, specifically the Chamber of Deputies, the Superior Labor Court and APEX Brasil, an independent social service agency. The Brazilian government public procurement processes were put in place to ensure that public sector organizations work with providers in a manner that is transparent, efficient, ensures economy of scales and the best optimization of public resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201201005501/en/ Rimini Street Awarded Three Brazilian Public Sector Contracts to Support Oracle and SAP Enterp
Market Access Transformation (MAT) Secures First Institutional Funding Led by Silversmith Capital Partners1.12.2020 17:00:00 EET | Press release
Market Access Transformation (MAT), a global healthcare company that uses cutting edge technology to automate and modernize how life sciences companies capture mission-critical insights that drive decision-making across the product lifecycle, today announced a $30 million minority investment from Silversmith Capital Partners, a Boston-based growth equity firm. The investment marks the first time MAT has raised outside capital and will be used to expand the company’s team and accelerate innovation of its product offerings. Founded in 2016, MAT has revolutionized the way Global Payer Market Research is conducted by developing Rapid Payer Response (RPR), the industry’s only on-demand global platform for gathering critical payer insights. In five years, the company has built a client base of more than 45 biopharma and device manufacturers – including all of the Top 10 pharma companies. MAT’s partnership with Silversmith solidifies its market leadership position in providing technology-driv
PCI Pharma Services Announces the Closing of the Majority Stake Acquisition by Kohlberg and Mubadala1.12.2020 17:00:00 EET | Press release
PCI Pharma Services (“PCI” or “the Company”), a leading pharmaceutical and biopharmaceutical global supply-chain solutions provider, today announced the closing of the previously announced acquisition that gives Kohlberg & Company, LLC (“Kohlberg”) a majority stake in the company. Mubadala Investment Company and Partners Group (acting on behalf of its clients) will have minority shares in the Company. This milestone is a key step for PCI, as Kohlberg and Mubadala will be partnering with PCI’s management team, led by CEO Salim Haffar, to continue the Company’s transformation journey. The team will be adding specific capabilities and geographies organically and inorganically to improve PCI’s client experience and enable its clients to bring life-changing biopharmaceutical therapies to market. Leveraging the global growth trends in biologics and specialized drug therapies, future capabilities include sterile fill finish of injectables, expanding high potency and specialized manufacturing,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom