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About 3 million commercial honeybee colonies in the United States contribute to pollinating more than 100 crops annually that are worth an estimated $15 billion. The parasitic Varroa destructor mite, which many beekeepers consider to be the top threat to honeybees, reproduces in hives, feeds on honeybees, and spreads disease, destroying colonies across the globe.  

Having acquired the rights to portions of Bayer’s topical RNA intellectual property portfolio, which include bee-health assets, we are developing our RNA-based syrup that targets reproductive Varroa mites, degrades in soil and water, is easy to use, and adds another tool for beekeepers looking for more options.

2022 trial locations

Currently in field trials in several states, we submitted the product candidate for EPA approval in 2023. The data from our trials to treat Varroa mite infestation in beehives supports our progress toward commercialization.

We plan to launch our Varroa destructor mite-control product in 2024.

There are thousands of genetic diseases caused by mutations in single genes. Patients with these diseases are not yet well served by therapies.

There are treatments for a few diseases, but they may alleviate symptoms temporarily or require organ, bone marrow, or stem cell transplants. These are costly, time-consuming, and logistically challenging—not to mention incredibly demanding on the patient. 

We aspire to develop our technology to edit the specifically targeted gene to cure such diseases by simple injections of mRNA/LNP formulations consisting of the gene and molecular machinery for its integration into the genome.

Our sickle cell disease gene therapy candidate

Sickle cell disease affects about 100,000 people in just the United States and is prevalent in people of African and Middle Eastern descent. There is no cure for sickle cell disease, and current treatments focus on managing the pain crises and other effects such as anemia. 

Current treatment regimens—including blood transfusions and bone marrow transplants—are costly, invasive, and impractical for treating large segments of affected patient populations, especially in low-income countries. Gene therapies currently in development for sickle cell disease are cell therapies, which require facilities close to the patient that can edit the cells outside of the body, posing an additional challenge for populations in remote areas or without adequate facilities to perform the editing.

Current approaches to gene therapy have challenges to overcome. Therapies that use adeno-associated viruses (AAVs) as vectors can encapsulate and deliver genetic material of up to 5,000 base pairs only, which limits the diseases it can be applied to.

Our RNA-based gene therapy candidate is designed to deliver a healthy copy of the gene to stem cells. Our concept of simple injections of mRNA/lipid nanoparticle formulations is a treatment method we are actively researching to treat sickle cell anemia, and we have achieved a Bill & Melinda Gates Foundation milestone, allowing for the next phase of grant work.

The main attributes of our gene therapy concept are expected to be:

• Accessible: Based on our cost-competitive RNA platform and with an in vivo administration, our therapy is intended to bypass the need for facilities required to edit the cells ex vivo.
• Targeted: The delivery technology targets specific cells in tissue.
• One dose and done: Our strategy is to target precursor stem cells to provide long-lasting expression.
• Versatile: Our therapy has the potential to encode for full-length genes and address genetic indications that require therapy in nondividing cells.

The objective of a prophylactic vaccine is to expose the body to a protein from the pathogen, called an antigen, toward which it can generate an immune response in the absence of the pathogen in preparation to fight the actual infection, should it occur. mRNA can be used to encode the antigen as a safe way to expose the body to a component of the pathogen without the risk of causing an infection.

Our mRNA platform has significant advantages compared to non-mRNA vaccines, including:

• The antigen expressed is a true match to the protein present in a viral pathogen, thus increasing the quality of the immune response as compared to vaccines produced through other methods.
• The short development time from antigen selection to clinical trials makes mRNA ideal for emerging epidemics or pandemic response. This is one reason why mRNA vaccines have been among the fastest developed for COVID-19.
• The same manufacturing process and facility can be used to produce different mRNA vaccines.

COVID-19 vaccine candidates

Our candidates have shown promising antibody response and cell-mediated immunity in pre-clinical studies. We plan to start Phase I clinical trials in Africa in early 2022.

Seasonal influenza vaccine candidate

We anticipate a multivalent vaccine consisting of mRNA encoding for two types of antigens, hemagglutinin (HA) and neuraminidase (NA), formulated in lipid nanoparticles (LNPs). This combination of antigens is expected to provide a robust and potentially broad protective immune response to influenza viruses. We are conducting preclinical studies to enable candidate selection for phase 1 clinical studies to commence late 2022.

GreenLight’s purpose is to solve some of the world’s largest and most difficult problems by delivering on the full potential of RNA.

Humanity faces numerous challenges. 

There are more than seven and a half billion people sharing the diminishing resources of Earth. This growing population needs to produce more food with the same amount of land and, at the same time, honor the global desire to replace chemical pesticides. Not only are these pesticides facing increased consumer opposition and threat of outright bans due to environmental damage, many are losing their effectiveness.

More than half the world’s population now lives in cities, breathing the same air that carries pathogens and causes infections. Humanity needs to adapt and tackle pandemics both for those who have and for those who do not have equitable access to quality health care around the planet.

To address these issues, we need to develop high-quality, cost-effective solutions that can be deployed on a global scale, including to developing countries. 

We believe RNA can be the critical aspect to these solutions.

There is vast unrealized potential for RNA to begin addressing many of Earth’s biggest problems, but only with the right discoveries, the right development, and the right delivery. 

Many brilliant scientific breakthroughs never achieve their full potential. They are too complex and expensive to be applied on the largest scale, meaning that many people are denied their benefits. Big problems persist, even when we have the science to solve them.

The ethos of GreenLight Biosciences is to challenge this dynamic. Our emphasis is to deliver solutions to major problems that are not only highly effective, but also affordable and sustainable. Solutions that reach the whole world, not just its richest parts. 

Our discovery and development expertise, coupled with our proven manufacturing platform, means that we can work successfully with partners to address a whole range of difficult problems, from COVID-19 to the Colorado potato beetle, from sickle cell anemia to the parasitic varroa mites that threaten our honeybees.

Humanity faces numerous challenges. 

There are more than seven and a half billion people sharing the diminishing resources of Earth. This growing population needs to produce more food with the same amount of land and, at the same time, honor the global desire to replace chemical pesticides. Not only are these pesticides facing increased consumer opposition and threat of outright bans due to environmental damage, many are losing their effectiveness.

More than half the world’s population now lives in cities, breathing the same air that carries pathogens and causes infections. Humanity needs to adapt and tackle pandemics both for those who have and for those who do not have equitable access to quality health care around the planet.

To address these issues, we need to develop high-quality, cost-effective solutions that can be deployed on a global scale, including to developing countries. 

We believe RNA can be the critical aspect to these solutions.