Aegirbio: Point-of-care diagnostic device for COVID-19

Case

Aegirbio: Developing a mimetope based point-of-care diagnostic device for COVID-19

After a successful Eurostars application in the October 2020 funding round, Aegirbio have been awarded €419,750 to perform their ‘TESTOMETIC’ project, for the development of a novel point-of-care diagnostic platform for COVID-19. Dr. Bradley Messmer, CSO, and Dr. Ela Heussen, Director of Corporate Strategy at Abreos Biosciences, describe the project and experience of applying to Eurostars with the support of Catalyze.

Dr. Bradley Messmer. Photo from Aegirbio.

Who are Aegirbio?

Recently founded through a partnership between Abreos Biosciences (USA) and LifeAssays (Sweden), Aegirbio are specialized in the measurement of therapeutic biologic drugs, most of which are monoclonal antibodies. Their aim is to provide quantitative analysis of biologic drug concentrations in patients, in order to counter the all-to-often side effects that occur due to suboptimal patient drug dosing. The impact? A platform can be provided for clinicians to optimize treatments between patients, potentially leading to better results, while also reducing costs to healthcare providers. To perform their analysis Aegirbio utilize the Magnasense technology; magnetic lateral flow immunoassays, and the Veritope technology; proprietary mimetopes (peptide fragments) that mimic the epitope (specific target region) of biologic targets. Through these two technologies, they can detect and quantify the amount of antibody drug in the patient sample, thus allowing calculation of the drug concentration in patient sera.

What is the TESTOMETIC project?

In the ongoing COVID-19 pandemic, improved diagnostics are central to overcoming the SARS-CoV-2 virus. However, existing diagnostics cannot provide quantitative analyses of patient samples, instead offering simple positive/negative results, often with insufficient reliability. In the TESTOMETIC project, Aegirbio are both reactive and proactive to the COVID-19 crisis by adapting and developing their existing Magnasense technology, with the aim of implementing specific SARS-CoV-2 mimetopes into the platform. This will form the basis of a highly sensitive point-of-care (POC) diagnostic test, which will allow POC providers to quantify patient antibodies against specific regions of SARS-CoV-2 proteins. Thus, Aegirbio’s technology will lead to essential advancement in the resolution of data available, both on a micro scale, by improving patient insights for clinicians, and the macro, by increasing the capacity of public health bodies to resolve the escalating pandemic. Importantly, TESTOMETIC will constitute an essential Proof-of-Concept, for the first time applying Aegirbio technology to a polyclonal antibody setting, opening the door for further applications in infectious disease diagnostics.

TESTOMETIC will run for 30 months, in partnership with Lionex (Germany), a biotech company specialized in biomedical diagnostics and therapeutics.

Applying to Eurostars

The TESTOMETIC project ranked in the top 30 of 500 submitted projects in the final EUREKA Eurostars funding round of 2020. The Eurostars programme supports R&D performing small- and medium-sized enterprises in international collaborative ventures. With a stringent application process and a highly competitive selection process, framing your project proposal in the correct light, and forming the best possible partnerships are essential to a successful application. This also makes for a challenging application process, as Dr. Heussen describes, “Applying for Eurostars is a very complex process and very different from the NIH grants we apply for in the US. I also did not have any people in my network who have applied to Eurostars.”

To perform a Eurostars project, you must have at least one other partner who provides essential and unique expertise. For the TESTOMETIC project, Catalyze built a network of possible candidates, which Ela describes as an important aspect of the support they received from Catalyze: “[Catalyze consultant] Dalila pre-screened and reached out to all candidates. If there were potential fits, she would connect us. She connected us to a few companies, and we were able to choose one that worked within the Eurostars guidelines. This was a very useful part of the help we received from Catalyze.”

Dr. Messmer adds, “We have submitted a Eurostars application before, so we know what it takes and we can see quality work, so I was very comfortable with letting Catalyze do their thing and positioning what we had in the right way. It was a relatively straight forward process, Catalyze helped us immensely.”

As Dr. Heussen explained further, another useful aspect of submitting their application with Catalyze came in the expertise Aegirbio had access to throughout the process.

“In terms of working with Catalyze, I really appreciated that you can provide a lot of helpful insight, for example in terms of which countries to target for partnerships and what can be included in the budget. Two things stood out, there is a wealth of information online and with Catalyze you do not have to go through that, but also Catalyze provide access to further information that is not publicly available.”

Foresight at the start of the pandemic

With a total deficiency in quantitative serological tests, there was a clear opportunity to develop a POC test that could deliver greater insights into patient immunization to COVID-19. Aegirbio scrutinized unanswered questions surrounding COVID-19 and saw significant potential for their cutting-edge mimetope-based technology. As Dr. Messmer pointed out, many open questions remain about COVID-19, “We still do not know if all antibodies to COVID-19 are the same; are some antibodies better at protecting against the virus than others? How long do those protective antibodies persist? If you have a particular antibody are you protected or do you need the right ones?”

With these questions in mind, Aegirbio saw great potential for their existing expertise to provide a huge boost to COVID-19 diagnostic efforts. Bradley describes the thinking that formed the genesis of the project: “We measure antibodies, so measuring COVID-19 in patients is adjacent technology to what we already do. Early in the crisis we looked ahead and saw a future where there would be a need for serological testing, and that by leveraging our platform we could make something more informative and more quantitative than existing diagnostics, which only provide yes/no answers.”

Which antibody is best? Enhancing resolution of SARS-CoV-2 antibody detection

Antibodies bind to specific regions (epitopes) on the surface of proteins. While existing COVID-19 tests effectively detect all antibodies against SARS-CoV-2 as one (whichever antibody is detected, the result is only ‘positive’), Aegirbio’s POC test will detect antibodies to specific epitopes. Consequently, the resolution of detection increases, providing data on which protein and what region on that protein a patient’s antibodies are binding to. As research on COVID-19 progresses, Bradley explained, the power to distinguish between epitopes could allow more accurate predictions of whether a patient possesses the ‘correct’ antibodies, and if they are effectively immunized to the virus. It all depends on whether specific antibodies are found to be more effective at protecting against COVID-19.

“The issue I foresee worldwide, is that people will receive different vaccines of varying quality. This means it will be crucial to be able to reliably test for effective immunization. It may turn out positive/negative answers are sufficient, but from our perspective, it is better to develop the technology and not need it, than the reverse.” Bradley continues, “The other aspect to the project is that even if we do not need this for coronavirus, then maybe during the next pandemic it will be needed. Technology validation is never a bad thing!”

While quantitative diagnostics have been developed before, for example, to determine if patients are sufficiently immunized after hepatitis vaccination, Aegirbio’s addition of epitope level discrimination to their new POC test is a world first.

Catalyze was very excited to play a role in securing Aegirbio funding for this vital project in the fight against COVID-19. It is the mission of Catalyze to support projects like TESTOMETIC towards securing funding, which is now using its Eurostars award make meaningful impact through their brilliant and innovative technology.