BALTIMORE – Touting recent progress with its T-cell-based assays and ClonoSeq product, Adaptive Biotechnologies plans to focus on two major and diverging business arms, immune medicine and minimal residual disease testing, going forward.
The Seattle-based company's near-term plans include expanding its ClonoSeq sales force by midyear, initiating clinical validation of its T-cell assay for inflammatory bowel disease, and continuing to develop its T-Detect Lyme disease test for launch during the Lyme season.
During a call discussing the company's fourth quarter and full-year 2021 financial results on Tuesday, CEO Chad Robins highlighted revenue trends and provided an outlook for the company’s immune medicine and MRD businesses. “We're not only looking to align our revenues to these business areas,” he said. “We're also looking to align organizationally so that we can better execute and be focused and nimble against these opportunities.”
Adaptive’s MRD business includes its ClonoSeq diagnostic test, offered to clinicians as a clinical diagnostic, and its ClonoSeq research assay, offered to pharma partners to support drug development and approvals, according to Robins.
Currently, the ClonoSeq blood test for multiple myeloma and non-Hodgkin lymphoma is available through Adaptive’s CLIA lab, while the ClonoSeq research assay “is currently being used in 155 active trials by more than 60 pharma companies,” Robins said, adding that the product is “embedded across all phases of clinical development and used as a clinical endpoint across multiple indications with different drug modalities.”
In October 2021, Adaptive launched an enhanced version of the ClonoSeq assay for chronic lymphocytic leukemia patients, which provides “additional mutation status information at the time of diagnosis,” Robins said. With multiple clinical studies published to demonstrate the clinical utility of ClonoSeq and having signed “two major pan-portfolio agreements” with pharma companies last year, ClonoSeq continues to be “the MRD test of choice in pharma clinical trials,” he added.
According to Robins, the number of ordering healthcare providers and ordering accounts for the clinical tests "experienced significant growth" in 2021, increasing 57 percent and 32 percent, respectively, compared to 2020. As a result, he said, the company is doubling the size of the ClonoSeq sales team to about 70 individuals. “Our goal is to have the sales team fully built out and trained by midyear," he said, "which will allow us to deepen our penetration in academic centers and increase our reach into the community.”
Adaptive’s immune medicine space is spearheaded by its T cell-based products, driven by the company’s T-cell mapping efforts with Microsoft, for drug discovery, research, and diagnostics, Robins said.
The company has been partnering with Genentech, a Roche subsidiary based in South San Francisco, California, since 2019 to develop cancer T-cell therapies. Robins said Genentech has “selected a prioritized TCR candidate to progress as a therapeutic product,” though he did not disclose any technical details at this point. “[The candidate] is against a neoantigen which is expressed in tumors and not on healthy tissue,” and as a result, “there's inherently a better safety profile associated with that,” he said.
Additionally, Adaptive has “made significant progress on the personalized product and successfully completed initial proof of concept in which we identified tumor-specific TCRs using blood from about 60 cancer patients,” he said.
“Another key achievement was the extension of our drug discovery capabilities into vaccines with our Nykode collaboration,” he added. “This is the first time that our T-cell data will be used to inform the design and development of a T-cell-based vaccine.” According to Robins, Nykode has initiated a Phase I/II clinical trial for the SARS-CoV-2 vaccine, with data expected to come out in the first half of this year.
Notably, Adaptive’s T-Detect COVID, the first commercialized product of the company’s T-Detect franchise, obtained Emergency Use Authorization from the US Food and Drug Administration, and secured a Medicare coverage recommendation from the MolDx program in 2021. However, he noted that the company is “currently enabling the software infrastructure for the reimbursed product” and “the new rate hasn't started yet.”
Still, by the end of 2021, more than 30,000 consumers ordered the test, according to Robins, and the company “will continue to offer the test to consumers with modest promotional activities to maintain awareness and monitor the demand behaviors as the pandemic evolves." “[T-Detect COVID] gave us a lot of experience in launching a test to consumers,” he added. “We're going to leverage some of that consumer-related experience.”
In that regard, Robins said Adaptive expects to launch T-Detect Lyme as a CLIA lab offering during the next Lyme disease season. Although the Lyme test will first be released "in the acute setting,” he said, the company’s goal is to “get into the larger segment of the post-treatment Lyme disease setting, which enables us to access a larger testing population.” Adaptive is still “finalizing the pricing,” he added.
Furthermore, Robins said Adaptive plans to launch the T-Detect test for the IBD panel in 2023, noting that the company is “in the final stages of designing our protocol to initiate clinical validation.” According to Robins, the goal for developing the T-Detect series is to “get that whole machinery and infrastructure in place” so that Adaptive can rapidly deploy different tests in the CLIA environment with “an extremely high specificity” and “a high positive predictive value” to patients.
Outside of the T-Detect product line, Robins said Adaptive’s T-Map COVID product is also being used by multiple pharma partners, including Johnson & Johnson, AstraZeneca, and Moderna, to understand the T-cell response to COVID vaccines. “This is just the beginning of our ability to leverage mapping data as a product for pharma to understand the immune response across diseases,” he said.