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 Encouraging results for COVID-19 antibody treatment have emerged from preclinical research and from initial clinical trials. 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, disease, 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.

About IAVI

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.

About Merck

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.