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Adaptive Biotechnologies Plans New Product Launches, Expanded FDA Label for ClonoSeq

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NEW YORK – In Adaptive Biotechnologies' first ever quarterly results conference call, officials unveiled plans for new products and regulatory approvals.

The Seattle-based immune sequencing firm is developing new research and clinical assays — including a new research-use-only kit and a blood-based diagnostic test dubbed "immunoSeq Dx" — and is pursuing additional regulatory approvals for its existing clinical test, clonoSeq.

Adaptive officials also painted a promising picture of payor coverage for clonoSeq.

"We continue to invest heavily in our platform," Adaptive CFO Chad Cohen said on the call following the release of the firm's second quarter 2019 financial results. This year will be "a significant investment year," he said "as we plan to increase efforts in product development and sales infrastructure to aggressively attack the larger opportunity our platform has created."

Revenues for the firm's sequencing services have grown to $11.9 million in Q2, with 9,084 immunoSeq tests and 2,388 clonoSeq tests performed during the quarter. Both tests use the firm's next-generation sequencing-based platform for immune cell profiling.

Offered to the academic and biopharma research markets, immunoSeq profiles T cell and B cell receptors. The firm's first product approved by the US Food and Drug Administration, clonoSeq, is a test for minimum residual disease, a measure of cancer cells in a patient used at or after the time of treatment. The test can be used to predict treatment outcomes, assess response to treatment, monitor patients in remission, and detect potential relapse.

Adaptive officials previously hinted at new directions for both products and provided a clearer picture of how the firm plans to move forward in the rest of this year and into 2020.

Adaptive CEO and Cofounder Chad Robins announced that the firm would launch a "state of the art research-use-only [immunoSeq] kit by year end."

President Julie Rubinstein added that the kit would enable "even more quantitative results for any sample type a researcher is using in their lab. We also plan to further increase utilization in biopharma by moving into later-stage clinical trials and expanding beyond oncology."

Adaptive has not yet finalized the price of the kit, she said, but it will be disclosed at the product launch.

Adaptive is also in the processes of developing its second clinical test, immunoSeq Dx, a blood test that would enable "early and accurate detection of many diseases all at the same time," Robins said.

The project leverages Adaptive's partnership with Microsoft, using machine learning to map interactions of T cell receptors with disease-specific antigens. "We envision a future where this map will enable a doctor to get a clear picture of what a patient's immune system is seeing from a single blood test," Rubinstein said.

To begin, Adaptive is focusing on one disease in each of three separate disease areas: ovarian cancer in high risk women as a test case for cancer, Celiac disease for auto-immune diseases, and Lyme disease for infectious diseases.

"We already have two early clinical signals for both Celiac and Lyme diseases," Rubinstein said. "We expect to confirm at least one of these clinical signals and initiate a clinical validation study by the end of 2019, with a path towards submission to FDA for our first indication in 2020." These test cases were selected after considering several criteria including unmet needs, access to clinical samples, and the firm's understanding of antigens involved.

"The economic model for immunoSeq Dx, of one test with many results, is very compelling," Rubinstein said. "Signal validation for multiple diseases can be done using retrospective samples," and the Adaptive platform's ability to run a variety of sample types, including formalin-fixed paraffin-embedded samples, "allows us to more rapidly and cost-effectively validate early detection tests in multiple diseases simultaneously," she said.

"When multiple tests are ordered, the marginal cost for each additional test is negligible," Rubinstein added.

The lab where these samples will be run came online in June and will ramp to full capacity soon, Adaptive said. The firm has been acquiring "large amounts of samples of various disease states," Harlan Robins, chief scientific officer, said. "Also, we're scaling the antigen map lab. ... We've accelerated the rate at which we're doing this and using increased funds to increase both personnel as well as samples running through the lab."

"We are beginning the early market development efforts now where we're coordinating with key opinion leaders in each of these areas, and others," Rubinstein said. "We are going to be expediting additional studies to really validate these signals." 

The difficulty of finding disease signals differs between the three areas, Harlan Robins noted. "Infectious disease is reasonably straightforward and it's proved to be easier. Autoimmune is in the middle and cancer, because of the diversity of antigens, is a longer road to tow," he said.

Adaptive also is continuing to expand the label for clonoSeq, pursuing FDA clearance for indications in chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. The firm is also looking to get the test approved for use with blood samples.

"We've engaged with a set of presubmissions to FDA," Harlan Robins said. "We've agreed, to the extent the FDA agrees, on our plans for the analytical validation" of blood-based clonoSeq tests for CLL, multiple myeloma (MM), acute lymphoblastic leukemia (ALL), and non-Hodgkin's lymphoma." The test is currently approved for MRD testing for MM and ALL from bone marrow samples.

"We have our set of clinical validations being completed as we speak, as well," he said. "We're on path to submit by end of year for CLL in blood and the analytical validation will cover as many lymphoid malignancies as we can."

Rubinstein said the firm expects expanded labelling will help grow the number of tests per patient. "Overall, we're moving to this paradigm where clinicians can use the same standardized, sensitive MRD test from blood in longitudinal timepoints for all of their patients with lymphoid malignancies," she said.

She added that the firm is also looking to expand utilization and is focusing on medical education, publications, and "more heavy engagement with patient groups."

Following Medicare coverage in January, "private insurer access has rapidly increased over the first half of 2019," Rubinstein said. The firm has secured contractual agreements or positive medical policies with some of the largest national private health insurers, as well as regional payors.

Medical policies for Aetna, Anthem Blue Cross Blue Shield, and Cigna "are closely aligned" with clonoSeq's FDA-cleared indications for use, as is a United Healthcare policy that will go into effect Sept. 1, she said. "Additionally, several regional payers, such as Kaiser [Permanente], have new or existing medical policies deeming use of NGS for detecting MRD as medically necessary."

Finally, Rubinstein suggested that the firm is developing a clinical kit for use in diagnostic laboratories. Previously, GenomeWeb reported that Adaptive was "exploring to develop" such a kit.

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