Nanobodies originated from heavy-chain antibodies naturally found in camelids like camels, llamas and alpacas. These heavy-chain antibodies do not contain light chains but have a variable domain that is able to bind antigens all on its own. This single variable domain is known as a nanobody and contains only around 12-15 kDa, about one-tenth the size of conventional antibodies. Since their discovery in 1993, nanobodies have gained significant interest from researchers for their desirable properties.
The first commercial applications of nanobodies came in the late 2000s when several biotech startups began developing nanobodies for research, diagnostics and therapeutics purposes. However, it was not until the mid-2010s that nanobody research and development began expanding rapidly. This was spurred by advances in technologies that enabled the efficient generation and screening of large nanobody libraries as well as improved molecular engineering capabilities. During this time, the United States began dedicating more resources towards nanobody research through both private sector investments and government funding initiatives.
Current Nanobody Research And Applications In The United States Nanobodies
The United States currently leads the world in nanobody research investments and commercialization efforts according to a recent report. Private sector funding for nanobody startups has accelerated over the past five years, with over $500 million invested in 2020 alone across over 30 different companies. Meanwhile, government grants from agencies like NIH and DARPA have totaled nearly $200 million yearly towards academic nanobody projects.
One of the major focuses of current nanobody work in the US is in developing treatments for hard-to-drug targets. Given their small size, high stability and selectivity, nanobodies show great promise as intracellular inhibitors. Several Phase 1 and 2 clinical trials are evaluating nanobody-based drugs against targets like KRAS, MYC and Bcl-2 which have evaded conventional antibodies. Nanobodies are also being optimized as radioimmunotherapeutics by conjugating them to radioisotopes to treat cancers.
Diagnostics is another major area benefiting from nanobody advances. Rapid at-home tests for SARS-CoV-2 using chromatic computational nanobodies were some of the first commercial implementations. Beyond COVID-19, nanobody-based diagnostic kits are in development or approval stages for diseases like Ebola, tuberculosis, sepsis and Parkinson’s. Their production is more scalable and cost-effective compared to traditional antibodies.
Imaging is an emerging application that could see widespread nanobody use in the future. Nanobodies modified with near-infrared fluorescent or PET radiotracers show promise as targeted imaging agents. Clinical studies are already demonstrating their superiority over monoclonal antibodies for sensitive detection of cancers. Nanobody-based intraoperative optical imaging tools may transform cancer surgery within this decade.
Challenges And Future Outlook
While nanobody research has progressed significantly, some technical challenges remain before the full potential of this promising platform can be realized. Developing nanobodies against more conserved membrane proteins and achieving intracellular delivery for certain applications still require more innovation. Additional engineering is also needed to extend nanobody half-life beyond a few hours when used therapeutically.
The United States is well-positioned to maintain its leadership in nanobody research and commercialization over the next 5-10 years. Continued public and private investments are directing more resources into generating larger and more diverse nanobody libraries, molecular engineering tools, and process development. If current advancements continue at this pace, nanobody drugs, diagnostics and imaging agents could start dominating certain clinical areas within a decade. Overall, substantial gains are anticipated in fields like oncology, infectious diseases, neurology and cardiovascular disorders through US-driven nanobody innovations.
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