23 October 2020 - - Indian nonprofit scientific research organisation IAVI and Indian vaccines and biologics manufacturer Serum Institute of India Pvt. Ltd have inked an agreement with German science and technology company Merck to develop SARS-CoV-2 neutralizing monoclonal antibodies co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic, the principals said.

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.

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.

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.

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.