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Adaptive Biotechnologies to Leverage Genentech, Microsoft Deals to Advance Immune Profiling Business

SAN FRANCISCO (GenomeWeb) – Adaptive Biotechnologies plans to become "the global leader" in immune profiling and designing customized therapeutics, according to CEO and Cofounder Chad Robins.

During a presentation at the JP Morgan Healthcare conference here this week, Robins said that to do this, the firm will leverage the deals it has struck — with Genentech this week and with Microsoft last year — as well as build on its clinical immune sequencing assay, ClonoSeq, which secured US Food and Drug Administration approval last October for detecting minimal residual disease (MRD) in some blood cancers.

The ultimate goal of the Microsoft collaboration, Robins said, is to develop a universal diagnostic, such that a patient can walk into a doctor's office and the doctor can do a simple blood test in order to determine what the patient's adaptive immune system is seeing, enabling the diagnosis of multiple diseases at once.

The first step in developing such a test is to map the human adaptive immune system, an extremely computationally intensive problem that includes analyzing trillions of T cell receptors (TCRs) and millions of antigens. "But, this is tractable," Robins said.

In an interview following the presentation, Harlan Robins, head of innovation and cofounder of Adaptive, said that as part of Microsoft's investment in the company, Adaptive has built out a laboratory space that is entirely dedicated to the project. Initially, the lab will be doing in vitro analysis, but it will also analyze clinical samples from various disease cohorts. He said that the laboratory construction was just finished at the end of 2018 and the lab is expected to be running at full capacity by the end of the year.

Before launching a universal assay, however, it is important to validate it in specific diseases, Chad Robins said. As such, Adaptive plans to launch various immune sequencing-based diagnostic tests prior to the universal test, including for ovarian and pancreatic cancer, Lyme disease, type 1 diabetes, and celiac disease.

In collaboration with Genentech, Adaptive aims to develop TCR cellular therapy for oncology. The deal is exclusive for cellular oncology therapy, Chad Robins said, and will result in a $300 million upfront payment, more than $2 billion in milestone payments, as well as royalties on therapeutics that are developed.

The companies ultimately aim to develop patient-specific therapies based on identifying TCRs in a patient's blood that are specific to their tumor. This discovery work will use Adaptive's immune sequencing technology. Then, Genentech will manufacture the TCR-based therapies. As an intermediate product, the companies will first launch "off-the-shelf TCR-based therapeutics," dubbed TruTCR, Chad Robins noted. The TruTCR-based therapies won't be specific to the patient and his or her tumor but instead will harness TCRs that often occur in individuals and recognize and bind to cancer antigens.

Harlan Robins said that getting to truly personalized cancer immunotherapies would require a number of extra steps, aside from the discovery work itself. For instance, since the goal is to develop therapies that are specific to a patient's tumor, a lot of technology development will be aimed at shortening the turnaround time of the entire process, from sequencing the immune repertoire to developing the therapeutics.

Adaptive did not provide a timeline for when it anticipates the TruTCR-based therapeutics or patient-specific therapeutics will be available.

While both the Genentech and Microsoft collaborations are longer-term projects, in the nearer term, Adaptive is looking to expand the use of its FDA-approved ClonoSeq assay, Chad Robins said. Currently, it has FDA approval for MRD detection in acute lymphocytic leukemia and multiple myeloma, but he said the firm would like to expand the indications to cover most or all lymphoma malignancies. In addition, he said, ClonoSeq currently analyzes TCRs from bone marrow, but the company would like to develop it to use blood as the analyte so it would be less invasive.

Finally, he noted, the company is exploring to develop a kit version of the assay to sell to testing laboratories and to expand internationally.