Adaptive Biotechnologies Stock

Adaptive Biotechnologies Corporation engages in advancing the field of immune medicine by harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease.

The company’s immune medicine platform applies its proprietary technologies to read the diverse genetic code of a patient’s immune system and aims to understand precisely how the immune system detects and treats disease in that patient. The company captures these insights in its dynamic clinical immunomics database, which is underpinned by computational biology and machine learning, and use these insights to develop and commercialize clinical products and services that the company is tailoring to each individual patient. The company has launched multiple commercial products and services and a robust pipeline of clinical products and services that the company is designing to diagnose, monitor and enable the treatment of diseases, such as cancer and autoimmune disorders.

The company’s immune medicine platform is the foundation for its expanding suite of products and services. The cornerstone of the company’s platform and core immunosequencing product, immunoSEQ, serves as the company’s underlying research and development engine and generates revenue from academic and biopharmaceutical customers. The company’s first clinical diagnostic product, clonoSEQ, is the first test authorized by the Food and Drug Administration (‘FDA’) for the detection and monitoring of minimal residual disease (‘MRD’) in patients with multiple myeloma (‘MM’), B cell acute lymphoblastic leukemia (‘ALL’) and chronic lymphocytic leukemia (‘CLL’); and is also available as a CLIA-validated laboratory developed test (‘LDT’) for patients with other lymphoid cancers, including diffuse large B-cell lymphoma (‘DLBCL’). Leveraging the company’s collaboration with Microsoft Corporation (‘Microsoft’), the company is creating a map of the interaction between the immune system and disease (‘TCR-Antigen Map’). The company is using this map to identify and validate disease signatures to improve the diagnosis and treatment of many diseases.

In 2022, the company made key strategic and operational changes, including a reorganization into two main business areas – MRD and IM. The MRD business area focuses on the use of the company’s highly sensitive, next-generation sequencing (‘NGS’) assay to measure MRD in patients with hematologic malignancies. It is consisted of the company’s clonoSEQ clinical diagnostic test, offered to clinicians, and the company’s clonoSEQ assay, offered to biopharmaceutical partners to advance drug development efforts (‘MRD Pharma’). clonoSEQ is the test of choice in MRD testing for hematologic malignancies with industry leading sensitivity. With the use of clonoSEQ, the company is transforming how lymphoid cancers are treated by working with providers, pharmaceutical partners, and payors.

The IM business area leverages the company’s platform’s proprietary ability to sequence, map, pair and characterize T cell receptors (‘TCRs’) and B cell receptors (‘BCRs’) at scale to drive research and clinical opportunities in the company’s therapeutic areas of focus: cancer, autoimmune, infectious diseases, and neurodegenerative disorders. It is consisted primarily of two main growth areas: IM Pharma Services and drug discovery (‘Drug Discovery’). Within IM Pharma Services, the company uses its core immunosequencing capabilities to deliver rich immune receptor data back to the company’s biopharmaceutical and academic customers. These data are used to aid in understanding biomarkers of drug response, which may accelerate the company’s customers’ clinical development programs in its therapeutic areas of focus. The company’s portfolio is consisted of more than 140 active studies with more than 85 biopharmaceutical companies. The company continues to scale the research use of its immune receptor data and to increase penetration in later stage, larger clinical trials, including more phase 3 trials. In Drug Discovery, the company uses its proprietary capabilities to discover new drug targets and leverage the company’s validated TCR and BCR discovery approaches to develop TCR and/or antibody therapeutic candidates against these novel targets. Within Drug Discovery, the company’s programs are focused on cancer and autoimmunity. These programs may be developed on the company’s own or the company may choose to work with partners. The company’s initial partnered pipeline includes the programs in development with Genentech, Inc. (‘Genentech’) to advance TCR cellular therapies in oncology.

In addition, part of the company’s strategy within the IM business area is to develop a diagnostic test for many diseases from a single blood test, known as T-Detect. In 2020 and 2022, the company launched two diagnostic tests, T-Detect COVID and T-Detect Lyme; however, in 2022, the company decided to defer further commercialization of T-Detect until the company has multiple signals with strong enough data to impact physician behavior with a clear path to reimbursement.

The company launched clonoSEQ as a CLIA-validated blood test for patients with DLBCL and secured clonoSEQ coverage with Medicare for DLBCL patients regardless of line of therapy, treatment regimen, or testing timepoint. clonoSEQ is the first and only MRD test to receive Medicare coverage in DLBCL.

In October 2022, the company entered into an agreement with Epic Systems Corporation (‘Epic’) to integrate the clonoSEQ assay into Epic’s comprehensive electronic medical record (‘EMR’) system to enable easier test ordering and results access.

The company’s clonoSEQ assay is being used by over 60 biopharmaceutical partners and in 187 active trials, representing about 21% penetration of industry sponsored clinical trials in lymphoid cancers.

In Drug Discovery, the company made significant advances in connection with the company’s worldwide collaboration and license agreement with Genentech (the ‘Genentech Agreement’) with respect to both the shared and personalized products. For the shared product, the company delivered three TCR fully characterized data packages against validated neoantigen targets, and Genentech selected the first neoantigen TCR to advance as a potential cell therapy product. For the personalized product, the company successfully completed proof of concept for the identification and characterization of patient-specific TCRs specific to each patient’s unique tumor mutations.

The company has narrowed the focus of its target and drug discovery efforts to cancer and autoimmunity. The company’s approach is to discover and develop TCR or antibody therapeutics to targets that T cells hit naturally. These targets are known as HLA-presented disease specific epitopes, which the company is discovering and validating using the company’s immune medicine platform. The company is also developing novel drug modalities against those targets by leveraging the TCR and antibody discovery capabilities.

The company also saw continued portfolio expansion across partners, disease states and study phases, with over 85 partners and more than 140 active studies utilizing immune receptor data across the company’s therapeutic areas of focus.

Immune Medicine Platform

The company’s immune medicine platform combines a suite of proprietary chemistry, computational biology and machine learning to generate clinical immunomics data to decode the adaptive immune system. It extracts and interprets insights from the adaptive immune system with the scale, precision and speed required to enable the design of clinical products tailored to the specific genetics of each patient’s immune system.

The company’s immune medicine platform performs the following key functions related to immune receptors:

Sequence with immunoSEQ: immunoSEQ sequences single chains of ‘Y-shaped’ TCRs or BCRs using NGS, enabling the company to understand the quantity and diversity of T and B cells in a biological sample. This provides deep insights into individual and collective immune responses at a scale that is thousands of times greater than was previously possible. The company applies a similar approach for BCR sequencing. All of the data generated by immunoSEQ is uploaded to the company’s clinical immunomics database and accessed through its proprietary cloud-based visualization and analytic tool called the immunoSEQ Analyzer.

Map with MIRA: The company’s proprietary MIRA technology enables the identification of TCRs specific to thousands of antigens simultaneously. MIRA (Multiplexed Identification of T cell Receptor Antigen Specificity) maps millions of TCRs to thousands of clinically relevant antigens. Combined with immunoSEQ, MIRA elucidates what potential diseases a patient’s immune system has been exposed to or is actively fighting.

Pair with pairSEQ: pairSEQ builds on immunoSEQ by using a combinatorial strategy to accurately pair both chains of Y-shaped immune cell receptors at high-throughput, which is challenging to do at scale using other methods because the two chains of the Y-shaped receptors are located on different chromosomes. The ability to accurately pair both chains of the receptors in a sample enables the company to reconstruct receptors for therapeutic purposes.

Characterize: The company’s platform characterizes binding, cytotoxicity and safety properties of antigen-specific, paired TCRs to identify a subset that is therapeutic-grade, enabling the discovery and development of optimal clinical candidates to be engineered into TCR-mediated cellular therapies. The company also has a high-throughput antibody discovery process that enables the selection of potent, naturally occurring, full length antibodies for therapeutic or prophylactic development. As of December 31, 2022, the company identified and characterized to different stages more than 5,000 unique antigen-specific TCRs against 600 different clinically relevant targets, constituting its pipeline of possible clinical candidates.

The massive amount of data generated by the company’s immune medicine platform is stored in the company’s dynamic clinical immunomics database. The application of machine learning, supported by the company’s collaboration with Microsoft, has the potential to exponentially accelerate the company’s ability to derive novel insights from this database and use them to inform the company’s robust product development efforts. Further, the company’s platform supports a robust portfolio of products and services, including commercial products and services in clinical diagnostics, and the company has developed products and services in both the clinical diagnostics and drug discovery areas. In collaboration with Genentech, the company plans to apply a similar process to screen, identify and characterize in real-time patient-specific TCRs targeting the patient’s specific cancer antigens, advancing the next generation of cellular therapy in oncology.

Antibody Discovery

The company’s platform enables the discovery and characterization of BCRs for use as therapeutic antibodies. In April 2020, the company deployed its platform to identify neutralizing antibodies to the SARS-CoV-2 virus that causes COVID-19. The company processed blood from more than 300 recovered and symptomatic COVID-19 patients. The company then applied its high-throughput BCR pairing technology and paired more than 490,000 antibody heavy and light chains. The company evaluated these BCR sequences in silico and selected more than 3,300 likely attractive antibody candidates for downstream functional characterization, including affinity binding and live virus neutralization.

Clinical Immunomics Database

The company is developing a large, dynamic clinical immunomics database. The company uses its proprietary software and core competency in computational biology to structure and store immune receptor data and to create tools for rapid analysis and easy visualization. All immunosequencing data is processed and uploaded to a secure cloud-based database.

Products and Pipeline (MRD)

The MRD business area focuses on the use of the company’s highly sensitive, FDA-authorized NGS assay to measure MRD in patients with hematologic malignancies. It is consisted of the company’s clonoSEQ clinical diagnostic test, offered to clinicians, and the company’s clonoSEQ assay offered to biopharmaceutical partners to advance drug development efforts. clonoSEQ is the test of choice in MRD testing for hematological malignancies with industry leading sensitivity of 1 out of 1,000,000 cells, given sufficient sample input. By taking a baseline measurement prior to starting therapy and then tracking the number of cells at several time points following therapy initiation, hematologists can improve their ability to assess treatment response, predict long-term patient outcomes, monitor disease burden over time and detect potential relapse. With the use of clonoSEQ, the company is transforming how lymphoid cancers are treated by working with biopharmaceutical partners, providers and payors. For instance, with the use of clonoSEQ the company has the potential to accelerate the development of drugs in lymphoid cancers, assist physicians with critical clinical decisions, and enable treatment decisions which may lower payor cost through the discontinuation of costly drugs that are no longer needed.

clonoSEQ

The company’s clonoSEQ diagnostic test detects and monitors the remaining number of cancer cells that are present in a patient’s body during and after treatment, known as MRD. In September 2018, clonoSEQ was granted marketing authorization from the FDA, under the de novo process, for patients with MM (multiple myeloma) and ALL to monitor their MRD from bone marrow samples. In August 2020, the clonoSEQ label was expanded to include patients with CLL from bone marrow and blood samples. clonoSEQ is also available for use in other lymphoid cancers as an LDT. In 2022, the assay was launched as a CLIA-validated test to detect MRD in blood for patients with DLBCL by measuring circulating tumor DNA (‘ctDNA’), which provides patients and clinicians with a powerful blood-based prognostic tool. The company’s strategy is to generate additional clinical data in DLBCL and file with the FDA to support clinical adoption and increase usage by the company’s biopharmaceutical partners. clonoSEQ has broad applicability across all lymphoid malignancies.

In January 2019, clonoSEQ received Medicare coverage aligned with the FDA label and National Comprehensive Cancer Network (‘NCCN’) guidelines for longitudinal monitoring in MM and ALL. Over the years, the company secured additional payor coverage for clonoSEQ aligned with the company’s FDA label with Medicare, national private payors and large regional plans for a total of over 245 million covered lives for ALL and MM, over 190 million covered lives for CLL and over 70 million covered lives for DLBCL. In November 2021, MolDX published its LCD for MRD testing. This LCD not only affirmed the importance of MRD and clonoSEQ coverage in ALL, MM and CLL in bone marrow and blood, but also provided a clear and efficient pathway for seeking expanded clonoSEQ coverage through technical assessments in Non-Hodgkin’s Lymphoma (‘NHL’). In July 2022, coverage expansion continued as the company secured Medicare coverage for DLBCL, the most common form of NHL. The company secured clonoSEQ coverage with Medicare for DLBCL patients regardless of line of therapy, treatment regimen, or testing timepoint. clonoSEQ is the first and only MRD test to receive Medicare coverage in DLBCL.

clonoSEQ testing has been ordered by clinicians for over 33,000 unique patients and used by more than 60 biopharmaceutical companies in 187 active clinical trials, representing approximately 21% penetration of active industry sponsored clinical trials in lymphoid cancers as of December 31, 2022. The company continues to deepen its commercial investments to expand clinical adoption of clonoSEQ and has increased the strength of the company’s specialized sales and customer support organization and supporting infrastructure in the United States. The company has also successfully transferred the technology to seven labs in other parts of the world.

In addition, the company continues to develop product improvements for clonoSEQ. In 2021, the company launched an enhanced version of the company’s clonoSEQ B-cell Clonality (ID) reports, which include IGHV mutation status for patients with CLL. The presence of IGHV mutations have been proven prognostic of better outcomes in CLL patients. This improvement strengthens the clonoSEQ product by aiding clinicians in evaluating prognosis, simplifying diagnosis, and improving overall patient management by providing additional clinically valuable CLL information. In October 2022, the company entered into a partnership with Epic to integrate clonoSEQ into Epic’s electronic medical record system, which will enable easier test ordering and results access for the clonoSEQ test.

The company has a multi-pronged strategy to deepen penetration of clonoSEQ and improve the company’s commercial and operational infrastructure. The company is focused on utilization of blood-based testing to increase the number of tests per patient; expansion into new patient populations within NHL, starting with DLBCL; and demonstration of clinical utility at multiple points along the patient continuum of care. In parallel, the company continues to enhance customer experience with EMR integration and optimize payor coverage to increase ASP and improve margins.

MRD Pharma

The MRD Pharma business area focuses on offering the company’s clonoSEQ assay to biopharmaceutical partners to advance drug development efforts. Given the broad penetration of clonoSEQ, there is a significant growth opportunity for the company’s MRD Pharma business, as the company intend to replicate clonoSEQ's success in other indications, especially in DLBCL where there is significant ongoing drug development activity.

Evolving Clinical Utility Data

The value of clonoSEQ as a decision-making tool may enable clinicians to select the best patient treatment options based on MRD status. Two examples of recent expanded clinical use cases and drug development advances include:

Martinez-Lopez published a retrospective cohort analysis of 400 newly diagnosed myeloma patients in which MRD was used interventionaly to escalate, change, or stop therapy for 67 of those patients. Data showed that for MRD negative patients who stopped therapy, progression-free survival (‘PFS’) was not negatively impacted. Also, for MRD positive patients in whom therapy was changed or intensified, PFS was significantly better than in patients who remained on the same course of therapy. This analysis supports the potential for use of MRD to modify treatment.

DETERMINATION was a phase 3 trial evaluating a regimen of Revlimid, Velcade and dexamethasone (‘RVD’) or RVD plus autologous stem cell transplantation (‘ASCT’) in patients with newly diagnosed MM. Post initial therapy and prior to maintenance therapy, MRD was assessed by clonoSEQ in 108 patients in the RVD-alone group and 90 patients in the RVD + ASCT group. This study demonstrated the benefit of adding transplant to frontline triple therapy, however, an important result from the study showed that patients who achieved MRD negativity by clonoSEQ prior to maintenance had similar outcomes independent of whether they received transplant. Additionally, the authors stated that MRD negativity is of increasing importance in modifying treatment, in informing clinical care, and as a treatment goal given the relationship with better outcomes.

Additional prospective studies are underway, and many have shared interim data at industry conferences. As more studies read out, the company expects there may be greater adoption of MRD in clinical decision making, which could result in more patients benefiting from clonoSEQ and greater frequency of testing for each patient helped.

Products and Pipeline (IM)

The IM business primarily includes two main growth areas: IM Pharma Services and Drug Discovery. The core of the company’s immune medicine platform is the company’s immunoSEQ technology. immunoSEQ utilizes multiplex, bias-controlled PCR to accurately and quantitatively sequence millions of immune receptors at high-throughput directly from DNA. Since inception, immunoSEQ has been used for research purposes by academic researchers and biopharmaceutical companies to answer translational research questions relating to the adaptive immune system, monitor response to therapies and discover new prognostic and diagnostic signals. The company offers computational services to assist the company’s customers in realizing the power of their data and to compare their data to other publicly available datasets in the company’s clinical immunomics database. The expanding database has led to over 650 peer-reviewed publications referencing immunoSEQ and potential clinical signals to explore.

IM Pharma Services

In IM Pharma Services, the company uses its core immunosequencing capabilities to deliver rich immune receptor data back to the company’s biopharmaceutical customers in order to potentially accelerate their clinical development programs in the company’s therapeutic areas of focus, which are cancer, autoimmune disorders, infectious diseases and neurodegenerative diseases. A key application of the company’s immune receptor data is the ability to annotate T-cell signatures of disease from patient samples to understand the cellular immune response to most past and present diseases. TCRs in blood may be used to determine the genes or peptides that are being targeted by the immune system and the strength of this disease-specific immune response. Potential clinical applications of this include patient selection or stratification; understanding the mechanism of action for drugs; efficacy and / or safety of drugs and monitoring; and understanding immunity differences between responders and non-responders.

The company can achieve sustainable growth from this business as the company continue to expand its portfolio in various disease states and by study phase: the company’s data is used in preclinical, phase 1, phase 2 and phase 3 trials. The company plans to continue to scale research use of TCR and BCR data and to increase penetration in later stage, larger clinical trials, including more phase 3 trials.

Drug Discovery

In Drug Discovery, the company uses its proprietary capabilities to discover new drug targets and develop TCR or antibody therapeutic assets to those targets in commercially attractive indications. The company is focusing its drug discovery programs mainly in cancer and autoimmunity, areas where the company can pursue partnerships with others or pursue development on the company’s own.

The company’s proprietary TCR therapeutics discovery process characterizes TCRs against antigens for use in the development of therapeutics. In December 2018, the company entered into an exclusive collaboration with Genentech to leverage this capability for the development of cellular therapies in oncology. The company is pursuing two product development pathways for novel T cell immunotherapies in which Genentech intends to use TCRs screened by the company’s immune medicine platform to engineer and manufacture cellular medicines:

Shared Products: The shared products will use ‘off-the-shelf’ TCRs identified against cancer antigens shared among patients (‘Shared Products’). In 2021, the company completed an assessment of efficacy and safety data to enable a decision to select the company’s lead TCR candidate. Following review of this data in 2022, Genentech selected this TCR candidate to progress as a potential therapeutic product candidate. Also, by the end of 2022, the company delivered two additional TCR fully characterized data packages against validated neoantigen targets to Genentech for their consideration.

Personalized Product: The personalized product will use patient-specific TCRs identified by real-time screening of TCRs against cancer antigens in each patient (‘Personalized Product’). In the second half of 2020, the company started screening blood from cancer patients to identify TCRs specific to a patient’s tumor mutations. During 2021 and 2022, the company successfully completed proof of concept by identifying and characterizing patient specific TCRs to each patient’s unique tumor mutations. The company also completed initial end-to-end test runs as a foundation for the private product process and the company’s next steps are to complete the product prototype as the company move towards IND readiness.

In addition to the company’s partnership in oncology cell therapy with Genentech, the company is expanding its efforts in autoimmunity where the company is uniquely positioned to make important contributions. In autoimmune disorders, disease specific antigens are not well-known and treatment protocols are largely limited to general anti-inflammatory drugs, indicating a significant opportunity to develop therapeutics in this area to restore patient immune balance. Therefore, the company is leveraging its unique capabilities to identify specific targets that are causative of the disease, particularly in multiple sclerosis (‘MS’) and inflammatory bowel disease (‘IBD’). The company’s expertise is based on the company’s ability to find HLA presented, disease specific epitopes that T cells hit naturally. The company is also developing novel mechanisms against those targets by leveraging the TCR discovery capabilities the company developed for Genentech and the antibody discovery capabilities the company built and confirmed for COVID-19. The company’s next step is to generate data that enable the company to continue to develop these programs, either on the company’s own or with partners.

Strategy

The company’s focus is to leverage the company’s immune medicine platform and competitive strengths to develop transformative clinical solutions that are accessible to patients with a range of diseases.

The key elements of the company’s business strategy include powering the age of immune medicine; entrenching the company’s products and services in clinical drug development with biopharmaceutical collaborators; leveraging foundational technology to generate revenue and address clinical diagnostic challenges in key disease states, such as autoimmune disorders, cancer, infectious diseases, and neurodegenerative disorders; driving the commercial adoption of the company’s validated, reimbursed and regulated clinical products; and maintaining an entrepreneurial, scientifically rigorous, data-driven and inclusive corporate culture.

Distribution

The company sells its products and services primarily through its own internal sales force. The company’s sales and marketing efforts are targeted at department heads, laboratory directors, principal investigators, core facility directors, clinicians, payors and research scientists and pathologists at leading academic institutions, biopharmaceutical companies, research institutions and contract research organizations. The company’s drug discovery efforts are focused on large biopharmaceutical companies.

Intellectual Property

As of December 31, 2022, the company owned or controlled 470 active patents and patent applications. The company’s granted patent protection generally expires in years ranging from 2029 to 2040.

Intellectual Property Portfolio by the Numbers

As of December 31, 2022, the company’s intellectual property portfolio consisted of 799 patent applications filed worldwide directly or in conjunction with a co-owner or licensor since 2009; 40 pending patent applications; 429 issued patents across its immune medicine platform; 24 patent families directed to methods and tools useful in its immune medicine platform for non-target specific immunosequencing and research, including immunoSEQ; 17 patent families directed to methods and tools useful in diagnosis, prognosis and disease monitoring, including clonoSEQ, T-Detect and the TCR-Antigen Map; 12 patent families directed to methods and tools useful in drug discovery, including TruTCR, MIRA and pairSEQ; 1 patent family directed to therapeutic antibodies; 1 patent family directed to SARS-CoV-2 vaccines; 3 patent families directed to gene sequencing technology; and 28 trademarks registered and pending registration worldwide.

Methods of Measuring Adaptive Immunity

Licensed exclusively to the company by Fred Hutch, the application has since spawned more than 31 additional patent applications, many of which have been granted as of December 31, 2022, including U.S. Patent No. 9,809,813.

Optimizing Nucleic Acid Amplification Reactions

More than 28 related patent applications have since been filed, many of which have been granted as of December 31, 2022, including U.S. Patent Nos. 9,371,558 and 10,214,770.

Diagnosing and Monitoring Disease

In connection with the company’s acquisition (Sequenta Acquisition) of Sequenta, Inc (Sequenta) in 2015, the company purchased Sequenta’s extensive patent portfolio. The portfolio includes 124 patent applications, which disclose and claim methods to identify and quantify T cell-based immune responses to antigen exposure using NGS. TCR and BCR DNA, RNA or cell-free DNA from samples, including blood and bone marrow, are used to detect, prognose and monitor disease, including autoimmune disease, infection and cancer. More than 112 patents have been granted in the portfolio as of December 31, 2022, including U.S. Patent Nos. 8,628,927 and 8,236,503.

The company’s diagnostic methods also apply to the detection of MRD (the target of its B cell-based clonoSEQ diagnostic test for assessing how disease burden changes in response to treatment or during remission) and T-Detect (its T cell-based diagnostic tests). Multiple patents have been granted from additional applications relating to MRD assessment, diagnostic methods and diagnostically significant TCRs filed by the company, including U.S. Patent Nos. 9,824,179 and 11,047,008. Additional patent applications are pending to TCR-based diagnostic signals in specific indications, including COVID-19.

TCR-Antigen Map

In connection with the company’s Microsoft collaboration, it is developing a diagnostic product to detect cancer and other diseases at their earliest stage by learning the signals and responses of the activated immune receptors in a patient’s blood. Pre-collaboration, the company filed 10 related patent applications for methods to produce antigen-exposed enriched T cell populations and identify their antigen specificities by comparison to a pre-exposure population of cells or by use of an algorithm. The company has filed additional patent applications relating to algorithmic-based methods to characterize antigen specificities and will continue to do so as its work proceeds with Microsoft.

MIRA

The company developed and is pursuing patent protection for bioinformatic-based methods to determine the antigen specificity of TCRs by exposing T cells to a panel of multiple antigens. Antigen exposure can be performed by incubation or presentation; for example, it can be performed via recombinant expression in another cell. These methods may also be used to pair the two TCR chains, as well as to identify high avidity TCRs. Several patents have been granted as of December 31, 2022, including U.S. Patent No. 10,066,265.

pairSEQ

The company developed and is pursuing patent protection for multiple bioinformatic-based approaches to pairing the two chains of TCRs and BCRs, including one deployed in its pairSEQ technique. The company’s methods also allow for identification of receptor chain pairs which are specific to particular antigen targets. Over fifty related patent applications have been filed, nearly half of which have matured into granted patents as of December 31, 2022, including U.S. Patent No. 10,077,478.

Assessing Responsiveness to Immunotherapy

Leveraging the company’s immunosequencing technologies, it developed methods for predicting responses to immunotherapy, vaccines and infection. To those ends, rearranged TCR or BCR sequences are quantified and their levels or frequencies compared at different points in time. More than 20 related patent applications have been filed, most of which have been granted as of December 31, 2022, including U.S. Patent No. 10,221,461.

Therapeutic Antibodies

The company developed a therapeutic antibody discovery process called TruAB from which neutralizing antibodies to SARS-CoV-2 have been produced. A patent application to these antibodies was filed in 2020 and is pending.

Vaccines

Together with the company’s partner, Nykode Therapeutics ASA, it filed a patent application, which is pending and directed to COVID-19 vaccines, the development of which was informed by its immunosequencing-based drug discovery efforts.

Therapeutic TCRs

The company has a granted patent application to TCRs responsive to WT-1 antigens with potential utility in cell therapy against WT-1 related cancers. The company is also pursuing a patent application to TCRs responsive to other cancer antigens, which are of interest in its collaboration with Genentech.

In-Licensed and Acquired Intellectual Property Rights

The company, through its Sequenta Acquisition, obtained an exclusive paid-up license, with rights to sublicense, to patents filed in the United States, Europe, Australia and China owned by iRepertoire, Inc.

In addition to the patent estate acquired from Sequenta, the company acquired ownership of immunosequencing-related patent portfolios from Imdaptive, Inc. and ImmunID S.A.S.

Government Regulation

The company’s core research product, immunoSEQ, is a RUO tool in the United States that provides data to third parties, such as biopharmaceutical companies that are themselves engaged in the research and development of potential diagnostic and therapeutic products and services for which they may later pursue investigation and clearance, authorization or approval from regulatory authorities, such as the FDA.

The company’s first diagnostic product, clonoSEQ, was granted marketing authorization by the FDA for the detection and monitoring of MRD in bone marrow samples in patients with MM and ALL under the de novo process in September 2018, which classified clonoSEQ and future DNA-based tests to measure MRD in hematological malignancies as Class II devices. In August 2020, the company received FDA clearance for clonoSEQ, following a 510(k) submission, for CLL in bone marrow, as well as blood samples. The company submitted a 510(k) premarket notification for ALL from blood samples in February 2021 and is actively advancing validation studies in certain NHL sub-types.

As a clinical laboratory, the company must obtain a CLIA certificate based on the complexity of testing performed at the laboratory, such as a Certificate of Compliance for high-complexity testing. In addition to CLIA requirements, the company elects to participate in the accreditation program of the CAP. Because the company is accredited by the CAP Laboratory Accreditation Program, it is deemed to also comply with CLIA.

Three principal data protection-related regulations with which the company is required to comply have been issued in final form under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH): privacy regulations, security regulations and security breach notification regulations.

In the United States, there are various fraud and abuse laws with which the company must comply and the company is subject to regulation by various federal, state and local authorities, including CMS, other divisions of HHS, such as the Office of Inspector General (OIG), the U.S. Department of Justice (DOJ) and individual U.S. Attorney offices within the DOJ, and state and local governments.

The company’s laboratories are subject to extensive requirements related to workplace safety established by the U.S. Occupational Safety and Health Administration.

Competition

In life sciences research, immunoSEQ faces competition from a number of companies, including 10X Genomics, Inc., among others.

History

The company was founded in 2009. It was incorporated in the state of Washington in 2009. The company was formerly known as Adaptive TCR Corporation and changed its name to Adaptive Biotechnologies Corporation in 2011.