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Mission Bio Launches Early Access Program for Single-Cell Measurable Residual Disease Detection in Blood Cancers

Tapestri Platform will be leveraged in early studies demonstrating first-in-class single-cell multi-omics-based MRD detection for better prediction of disease relapse, starting with AML


SOUTH SAN FRANCISCO, Calif., July 28, 2022 – Mission Bio, Inc., the pioneer in high-throughput single-cell DNA analysis, today announced the initial availability of the industry’s first assay capable of determining measurable residual disease (MRD) in cancer down to the level of individual cells, launching a new era for the understanding of disease progression. The Single-cell Multi-omics MRD (scMRD) assay for acute myeloid leukemia (AML) improves on both the sensitivity and specificity of commercial MRD tests used today both in research and to predict cancer recurrence in patients, leveraging the Tapestri® Platform’s unique ability to measure DNA and surface protein expression (or immunophenotype) data from the same cells. Through Mission Bio’s new Early Access Program, pharma and academic partners will perform proof-of-principle studies that broaden understanding of the residual cancer cells that escape treatment for AML by spotlighting the ones that other tests miss.


Currently, MRD is measured by physicians to help guide future therapy decisions and, potentially, prevent relapse in patients with AML and other cancers. However, these assays are limited to one type of measurement at a time, like flow cytometry for immunophenotyping or bulk sequencing for mutation detection. Both have their limitations – certain cancer cells alter their immunophenotype in response to therapy, potentially giving a false MRD-negative result, while some rare but aggressive leukemia cells may acquire additional mutations that go undetected by bulk sequencing. Recent research also suggests that combining both methods to measure immunophenotype and genotype information for the detection of residual disease added significant prognostic value over one method alone.


“We need to move beyond simple detection of MRD and be able to characterize the architecture of persisting disease,” said Aaron Llanso, Senior Director of Clinical Applications at Mission Bio. “For the first time, we’re enabling researchers to gain clonal insight in tandem with cell-surface protein markers from rare residual disease cells at the time of remission.”


The key to enabling these insights is the Tapestri Platform’s integrated genotype and immunophenotype capability, powering an industry-first MRD assay that yields single-cell multi-omic insights into disease evolution, therapy resistance, and transplant chimerism.


“AML is a devastating disease that is adept at finding ways to develop resistance to known treatments,” said Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio. “We believe the future of precision medicine will rely on single-cell multi-analyte profiles that can more powerfully inform bespoke clinical practice.”


Through the Early Access Program, using fresh or cryopreserved bone marrow aspirate, academic researchers will be able to conduct proof-of-concept studies in their own labs using the Tapestri Platform, while biopharma customers will be able to leverage Mission Bio’s Pharma Assay Development Services for initial pilot studies. These findings will have near-term implications for patient stratification in clinical trials and patient care, impacting disease surveillance, therapeutic selection, and patient outcomes.


Early data from collaborators at Memorial Sloan Kettering Cancer Center will be presented at the Tapestri® Single-cell Multi-omics MRD (scMRD) for AML Summit to be held in New York on August 16, 2022. The company plans its full commercial launch for single-cell measurable residual disease detection for AML in early 2023.


For more information on the Early Access Program, visit the Tapestri® scMRD Assay for AML page.


About Mission Bio

Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio’s multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others. 


The company’s Tapestri platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our expectations regarding the transaction described above, including anticipated benefits, anticipated payments, future business and market opportunities, and anticipated growth resulting from the transaction; the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; our position as a leader in the development of genetic medicines; and the sufficiency of our cash and cash equivalents to fund our operations; These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we may not realize the anticipated benefits of the collaboration with Oxford Biomedica; the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies and clinical trials, and on general economic conditions; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; failure to obtain U.S. or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; risks relating to intellectual property and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and our other filings with the Securities and Exchange Commission (“the SEC”) could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.


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  1.  Jongen-Lavrencic, M. et. al. “Molecular Minimal Residual Disease in Acute Myeloid Leukemia.” N Engl J Med (2018)

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