Small Business Innovation Research (SBIR) Small Business Technology Transfer (STTR)

Small Business Grantees Can Make Big Impacts

The National Institutes of Health (NIH) has been a vital resource for responding to the COVID-19 pandemic, from developing health guidelines to partnering with pharmaceutical companies on vaccines and drug development to funding essential coronavirus research. Another investment however, made decades ago, has started paying off in unexpected ways.

In 1982 the NIH joined other government research agencies to participate in the Small Business Innovative Research (SBIR) program, which provides funds for small businesses to commercialize basic science and technology discoveries. In 1992 the NIH added the Small Business Technology Transfer (STTR) program to increase small business collaborations with nonprofit research institutions.

Through these two programs, the NIH now provides over $1.2 billion each year to small businesses to improve public health. Many of the companies that received funding from NIH’s Small Business Program are now harnessing their expertise and resources to respond to COVID-19.

When the pandemic hit, BioMedomics CEO Frank Wang said he felt a responsibility to use the company’s resources to develop a rapid blood test for the novel coronavirus. The company was well-equipped to act because in 2015 they had received Small Business Program funds to design a rapid, point-of-care blood test for diagnosing sickle cell disease.

BioMedomics currently sells their rapid COVID-19 blood test to customers in around 40 countries. The company recently teamed up with medical technology company BD in hopes of distributing the test in the U.S. pending FDA approval. The test works by detecting proteins, called antibodies, made by the immune system in response to the virus. Results can be read within 15 minutes in a format similar to a pregnancy test. BioMedomics is also working on another test that can identify a COVID-19 infection before antibodies are detectable. This new test will be able to provide results faster than the current nose swab tests.

Seattle-based Adaptive Biotechnologies is responding to the pandemic by using their immune medicine platform, both to design diagnostics through a partnership with Microsoft and to develop therapeutics with the biopharmaceutical company Amgen. “The world defines therapeutics and diagnostics and research as very different entities, but the immune system doesn't do that,” says Harlan Robins, chief scientific officer of the company.

Before the pandemic, the company focused on characterizing a person’s adaptive immune system to detect diseases like cancer. But when COVID-19 hit a nursing home near headquarters “we all just looked at each other and said, ‘it would be ridiculous not to apply our platform here.’ We didn't have to create new technology, especially on the diagnostics [side],” says Robins, adding that Small Business Program funding helped “bolster our fundamental technology.”

To develop a more reliable test, the company is mapping the complex way the immune system responds to the novel coronavirus, differentiating the response from other common and less severe coronaviruses. They are currently developing a test to verify cellular immunity against COVID-19. For a therapeutic, the team is working to identify virus-neutralizing antibodies in the blood of infected and recovered COVID-19 patients. Clinical trials and manufacturing will then be led by Amgen.

While treatment and testing are vital to an effective pandemic response, a vaccine is critical for ending it. Eric von Hofe, President of NuGenerex Immuno-Oncology (formerly Antigen Express), also says NIH Small Business Program funding laid the foundation for their ability to respond to COVID-19. His company is developing a coronavirus vaccine with hopes to start clinical trials in 3-5 months. The company has experience developing vaccines for HIV and influenza as well as for SARS, the coronavirus that infected more than 8,000 people in 2003.

For the novel coronavirus, NuGenerex is developing what’s known as a peptide vaccine—small portions of the virus that will evoke an immune response, which teaches the body to recognize the virus in the event of an infection. To find the best peptide for the job, the company used a computer algorithm to identify about 30 peptide candidates, and then altered them to increase their potency. The team plans to test the most promising peptide candidates by measuring the immune response they elicit in blood samples from recovered individuals. The final candidate can then be scaled up quickly because the peptides are synthesized, not harvested.

The NIH-funded company Sylvatica doesn’t specialize in treatments, tests, or vaccines but its team of scientists has found a creative way to join the pandemic response. They are working toward building a library of human tissues using cryopreservation technology. The hope is that this library—which includes infected lung and eventually heart, blood vessel, and brain tissue—will be a resource for research, testing vaccines, and treatments.

The Small Business Program grants awarded by NIH have had a tremendous impact on public health. Because of the strong foundations companies have built through long-term NIH support, many of these small businesses are proving well-equipped to join in the fight against COVID-19. As populations grow and the threat of viral outbreak remains, small businesses that receive NIH funding today may well play a vital role in future solutions.