This story has been updated to clarify that Adaptive Biotechnologies' partnership with Amgen on COVID-19 antibody development is new.
NEW YORK – Adaptive Biotechnologies is recruiting subjects for a sequencing-based study of T cell response in people who have or have been exposed to COVID-19, with designs on making the disease an early indication for the company's planned immunoSeq Dx test.
The Seattle-based immune cell sequencing firm has signed up about 300 people already and is looking for up to 1,000 people who either have coronavirus, have recovered from it, or who live with someone who had it but were not diagnosed themselves.
"If you're exposed to SARS-CoV-2, your body is going to first respond with a cellular response," Adaptive Chief Medical Officer Lance Baldo said. "T cells tend to be first cells, especially in infectious disease. We would expect to see a signal from T cells within hours and definitely within a day." Adaptive said its next-generation sequencing-based T cell profiling assay could more reliably determine immunity than some antibody-based COVID-19 tests already on the market could.
Other potential use cases include identifying patients at high risk of developing severe cases of COVID-19 and diagnosing coronavirus infection early — even in asymptomatic individuals.
The utility of the test for COVID will depend on the data Adaptive obtains in its study, Baldo said. "Until we see data, we can't really know whether to develop the test for one, or two, or all three" applications.
But, based on previous work in obtaining T cell response profiles in infectious disease, the firm is confident it will see a signal, possibly even by the end of June. Data will be made available to public health officials, academic researchers, and even other parts of the biotech industry.
The study is just one way that the company is responding to the coronavirus pandemic, which has affected all areas of the firm's business with slowdowns in both the research and clinical markets. On a conference call following the release of the Adaptive's first quarter financial results, company officials also noted that the firm is working on COVID-19 neutralizing antibodies as part of a new partnership with pharma giant Amgen.
Adaptive's COVID-19 T cell response test is an additional branch of its efforts on immunoSeq Dx, which is based on the firm's T cell sequencing and antigen mapping capabilities. The ultimate goal is to develop a multi-indication test that could diagnose one or more of several diseases that elicit immune response, including infectious disease, autoimmune disease, and cancer.
Adaptive has already made fast progress on the infectious disease front. In February, company officials announced a diagnostically useful T cell profile for Lyme disease, which they said was twice as sensitive as serology testing, the current standard of care, with a lower false positive rate. They found that signal in just a few months. Adaptive President Julie Rubinstein noted that the firm completed market research confirming commercial viability of a Lyme disease diagnostic and is on track to submit a marketing application to the US Food and Drug Administration by the end of the year. Adaptive has also launched a clinical validation in partnership with IQVIA, a contract research organization.
That Lyme disease work, which continues in parallel, is a major reason why Adaptive is confident it will succeed in finding a T cell response for COVID-19 and rolling out its study, dubbed ImmuneRACE.
Subjects may come from up to 24 cities around the country, including Seattle, New York, and Boston, and will fit into one of three cohorts: patients with active COVID-19, people who have recovered from coronavirus, and people who were exposed to someone who had the disease. Baldo noted that subjects are being consented for up to four blood draws and suggested the study could end up analyzing around 1,600 samples overall.
Baldo declined to provide a figure for how much the study would cost. He noted that the firm is leveraging partnerships with Microsoft and Illumina, who will provide in-kind contributions of cloud computing and machine-learning resources and sequencing reagents, respectively.
The study has also adapted to the new social environment precipitated by the pandemic. Adaptive has partnered with LabCorp and its subsidiary Covance to have mobile phlebotomy units collect samples. All subject onboarding has been done virtually. "It's the first time I've ever done a study this way," Baldo said. "It's pretty interesting and there's a lot of learning for all of us." The firm is already taking practices developed for ImmuneRACE and applying them to its other programs.
Rubinstein added that the firm's LabCorp partnership would soon enable patients to have clonoSeq sample collection performed at any of LabCorp's service centers. Adaptive is also negotiating agreements with at-home blood collection providers for both clonoSeq testing and its Lyme disease study.
Rubinstein told investors the company is already developing its plans for market development and commercialization efforts "assuming the data are strong, which we expect to confirm in the next few weeks." The company may even submit the COVID-19 test to the FDA ahead of the Lyme test, depending on how the study goes, she said.
Baldo also noted that Adaptive is planning to pursue Emergency Use Authorization (EUA) from the FDA and has already engaged with the regulator about "what an EUA might look like."
"But we have to do the testing and then build a case that there's enough incremental benefit," from the test, he said. A laboratory-developed test is "always a possibility," he said.
One potential market is large employers who might wish to test employees to enable them to return to work. Robins said that high-volume serology testing costs can be in the range of $50 to $100 per sample and "depending on the utility… and what it's being used for, I do believe the payor community, both public and private, would support a higher price point" for the immunoSeq Dx COVID-19 test.
Adaptive officials also noted that they are working with Amgen to discover and develop neutralizing antibodies for COVID-19. According to documents filed with the US Securities and Exchange Commission on May 12, the firms signed a memorandum of understanding in April and Adaptive is "planning to execute a collaboration and license agreement with Amgen in the near future." Adaptive's partnership with Genentech is also progressing: the firm recently executed a lease expansion to construct a personalized cell therapy prototyping lab in South San Francisco, which they anticipate opening in the first quarter of 2021.
Rubinstein noted that the company remains on track for previously announced clonoSeq regulatory milestones. The firm anticipates that by mid-year it will obtain FDA clearance to offer clonoSeq minimal residual disease monitoring for chronic lymphocytic leukemia from blood samples. Adaptive is also on track to file a second label expansion with FDA for monitoring acute lymphoblastic leukemia with blood samples.
The firm is also slowing investment in its research-use-only immunoSeq kit as it reprioritizes certain activities due to the pandemic.