A nonprofit scientific research organization known as IAVI, dedicated to addressing urgent unmet global health challenges, has spent years in a research and development partnership with Scripps Research targeting HIV antibody treatments. Recently, in a commitment to addressing the SARS-CoV-2 challenge worldwide, IAVI cleveraged the joint breakthroughs with Scripps and formed a partnership with Serum Institute of India Pvt. Ltd. (SII), the world’s busiest vaccine manufacturer, and Merck KGaA, Darmstadt, Germany, to further develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs). A coming together of three complementary groups while IAVI has brought the underlying intellectual property “German Merck” and SII bring compelling capabilities in design and scale-up of accelerated manufacturing processes for mAb production. A globally focused partnership committed to health equity in the worst global public health crisis in a century, both Merck Germany and SII brings broad networks across complementary geographic areas that represent a crucial reach given the worldwide spread of SARS-CoV-2, the virus behind COVID-19.
Driving this deal is essentially a global call to action, commissioned by Wellcome and published by IAVI, highlighting the lack of equitable access to mAbs in low to middle-income countries (LMICs). The publication calls for several actions to help solve access issues, such as innovative partnerships like this one.
TrialSite breaks down this deal for the network.
Did IAVI and Scripps develop the intellectual property that forms the basis of this partnership?
Do the monoclonal antibodies need to be tested in clinical trials before going to market to help people around the world fight COVID-19?
Yes. The highly potent and broadly cross-reactive SARS-CoV-2 neutralizing antibody candidates now under advancement by this partnership must go through clinical trials.
What happens if the drugs demonstrate efficacy and safety in clinical trials?
If the partnership can prove efficacy and safety via this formal research, either as a single antibody or a potential combination, Merck KGaA (again, known as German Merck, contrary to the American company with the same name) will lead commercialization in developed countries.
SII would lead global manufacturing as well as commercialization in low-and middle-low-income countries, including India.
Why did IAVI ink the deal with this particular partnership configuration?
As mentioned above, this type of partnership was called out in the Wellcome commissioned IAVI published call to action to boost equitable access to mAbs, particularly in light of the COVID-19 crisis.
Perhaps IAVI CEO Mark Feinberg, MD, PhD, summarized it best by declaring, “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.”
Merck’s vice-chair of the executive board and deputy CEO Bélen Garijo further commented, “…We share a common purpose to accelerate this promising science and deliver effective solutions that address global challenges presented by this pandemic.” Adar Poonawalla, CEO of SII, also expressed his intense commitment to this endeavor, highlighting his organization’s ability to mass-produce therapeutic products for low-income countries.
The Intellectual Property
As it turns out, the basis for this promising partnership goes back to a collaboration between IAVI and Scripps. Scientists at IAVI’s Neutralizing Antibody Center (NAC) based at Scripps Research, coupled with fellow Scripps immunologists, were part of a team that identified antibodies from the blood of recovered COVID-19 patients that are capable of potentially neutralizing SARS-CoV-2.
Preclinical Animal Studies
The team reported that during animal testing (preclinical), they found that the neutralizing antibodies protected the animal subjects challenged with SARS-CoV-2 (meaning deliberately infected animals). With results published in Science in June 2020, the underlying intellectual property portfolio developed by IAVI, Scripps Research scientists and partners represent the foundation for a comprehensive program with potential applicability to COVID-19 treatment and prevention and to other potential coronaviruses that could rise or rem-emerge in the future.
It takes Collaboration
Production of complex life science-based intellectual property is a collaborative affair. Dennis Burton, PhD, professor and chair of the Department of Immunology and Microbiology at Scripps Research and scientific director of the IAVI NAC, was quoted in the partnership’s press release, “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.”
In this deal with IAVI, Merck KGaA and SII will conduct an accelerated, integrated program of preclinical and clinical research to investigate the antibodies for the treatment of COVID-19. A Phase 1 clinical trial is scheduled to start in early 2021. Should the trials ultimately evidence safety and efficacy, SII and Merck KGaA will rapidly commercialize the product, ensuring broad access.
The IAVI/Merck KGaA and SII partnership had other needs that they contracted out, including 1) contract research and management services and 2) manufacturing the monoclonal antibody candidates. For the former, the team opted for Syngene International Ltd., a Bengaluru, India-based contract research and manufacturing organization. Based on their innovation-focused research and development capabilities, Syngene will develop and conduct assays to support the clinical development of the SARS-CoV-2 mAb candidates.
ATUM, a California-based bioengineering company, will utilize its Leap-In Transposase® Platform to develop stable cell lines needed for the manufacture of SARS-CoV-2 antibody candidates being advanced via this collaboration. This effort is enabling the rapid and robust transition from research to clinical development.
Call to Action: Merck KGaA (German Merck), IAVI, and Serum Institute of India should be commended for coming together to explicitly address the global access issue. Remember, the pathogen behind COVID-19 doesn’t know or care about national boundaries, race, class, or religion. It comes after everybody just the same. Of course, the social determinants of health ensure that some groups, often poorer, face greater challenges (e.g., lack of ability to socially distance in a crowded slum). How the organizations understand that and are willing to invest in addressing it demonstrates global leadership.