akoya announces publication of the mitre study, the first
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MITRE Reproducibility Study
The MITRE Study establishes the highreproducibility and robustness of AkoyaBiosciences’ Phenoptics platform for spatialphenotyping in clinical research. Shown hereare multiplex immunofluorescence images, fromall the sites involved in the study, where sixbiomarkers were analyzed in breast cancersamples.
MITRE Spatial Proximity Analysis
Shown here is a representative image of abreast cancer sample where the spatialproximity of two of the six biomarkers wereanalyzed in the tissue. Measuring the proximityof PD-1+ and PD-L1+ cells in the tumormicroenvironment, in addition to other spatialparameters, can enhance the predictive value ofimmunotherapy biomarkers.
Akoya Announces Publication of the MITRE Study, the First Multi-Institutional AnalyticalDemonstration of a Spatial Biology Workflow, in the Journal for ImmunoTherapy of Cancer
July 19, 2021
Results from the study provide evidence of standardization of an automated spatialbiology workflow, based on the company’s Phenoptics™ multiplex immunofluorescence(mIF) platform, for clinical and translational research
MARLBOROUGH, Mass., July 19, 2021 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc.,
(Nasdaq: AKYA) The Spatial Biology Company®, today announced that the Phenoptics™ mIFsolution was used in a multi-site study to demonstrate and validate an automated end-to-endworkflow that characterizes PD-1/PD-L1 immune checkpoint signaling in tumor tissue samples.The paper titled, “Multi-institutional TSA-amplified Multiplexed ImmunofluorescenceReproducibility Evaluation (MITRE Study),” was published in the Journal for ImmunoTherapy ofCancer (JITC) in July 2021. The MITRE results are an important step toward standardizing anautomated mIF-based spatial biology workflow that provides the level of performance needed tosupport clinical trials and that can be applied to clinical testing in the future.
Top immuno-oncology and pathology experts from five institutions collaborated with Akoya toconduct the MITRE study, including Johns Hopkins University School of Medicine, YaleUniversity School of Medicine, Earle A. Chiles Research Institute, The University of Texas MDAnderson Cancer Center, and Bristol Myers Squibb.
“I am very excited by the results of this study because it is the first multi-institutional study of itskind involving mIF, representing an approach that should be part of every effort to develop abiomarker platform for trials and eventual clinical use,” said Dr. David Rimm, Professor ofPathology at Yale University School of Medicine and one of the lead principal investigators on thestudy.
Immunotherapy utilizes the patient’s immune system to fight cancer and has delivered durablebenefit to some subsets of patients with advanced disease, representing a significant stepforward in the quest to conquer cancer. However, a majority of the patients still do not respond totreatment. There is a pressing need for accurate, predictive biomarkers to differentiateresponders from non-responders. Recent studies have demonstrated that spatial biomarkers are
able to predict immunotherapy response with greater accuracy than current methods1,2.
Spatial biology, a rapidly emerging field of science, allows researchers to map the interactions oftumor and immune cells across an entire tumor tissue section, without destroying the spatialcontext of the tissue, enabling a more accurate assessment of tumor-immune biology.
With the MITRE study, the authors sought to develop and validate a spatial biology workflow thatis transferable among sites and delivers site-independent and reliable quantitative data forimmunotherapy research.
Study details
The multi-institutional effort optimized an automated 6-plex biomarker assay focused on thePD-1/PD-L1 axis and assessed the inter- and intra-site reproducibility of the assay by measuringspatial biology parameters of tumor and immune cells within tissue samples. Among theparameters examined were tumor cell and immune cell subset densities, PD-L1 expression andlocation, and PD-1/PD-L1 spatial proximity.
Akoya’s Phenoptics™ workflow, which enables spatial phenotyping using mIF, demonstratedhigh concordance across multiple institutions. The study confirmed that quantitative measures ofmultiple biomarkers in a tissue section are reproducible at levels aligned with typical clinical testing standards. The authors also reported thatquantitative mIF substantially outperforms challenging visual assessments, such as assessing PD-L1 positivity in immune cells, particularly innon-small cell lung cancer (NSCLC) samples.
“The foundational requirement for any platform including those delivering spatial phenotyping is the ability to fully demonstrate analytical robustnesswith a workflow that has the necessary throughput for large scale clinical studies. With the MITRE study and the robust end-to-end Phenopticsworkflow, we believe Akoya is ideally positioned to support our customers’ translational and clinical research needs,” said Brian McKelligon, CEO ofAkoya. “Along with our recent announced partnerships with AstraZeneca and Johns Hopkins, the MITRE Study is another significant milestone inmoving spatial biology into the realm of patient phenotyping and improving immunotherapy outcomes in the future.”
For more information about Phenoptics, go to: akoyabio.com/Phenoptics
About Akoya Biosciences
As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power ofspatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial contextand visualize how they organize and interact to influence disease progression and treatment response. Akoya offers two distinct solutions, the
CODEX® and Phenoptics™ platforms, to serve the diverse needs of researchers across discovery, translational and clinical research. To learn moreabout Akoya, visit www.akoyabio.com.
Cautionary Note Regarding Forward Looking StatementsThis press release contains “forward-looking statements” under applicable securities laws. In some cases, such statements can be identified by wordssuch as: “may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue,""ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements regarding our ability to achieve our business strategies, growth, or other future events orconditions. Such statements are based on our current beliefs, expectations, and assumptions about future events or conditions, which are subject toinherent risks and uncertainties, including the risks and uncertainties discussed in the filings we make from time to time with the Securities andExchange Commission. Actual results may differ materially from those indicated in forward-looking statements, and you should not place unduereliance on them. All statements herein are based only on information currently available to us and speak only as of the date hereof. Except asrequired by law, we undertake no obligation to update any such statement.
Investor Contact:David DeuchlerGilmartin Group [email protected]
Media Contact:Michelle LinnBioscribe, [email protected]
References:
Berry S, et al. Analysis of multispectral imaging with the AstroPath platform informs efficacy of PD-1 blockade. Science2021
1.
Lu S, Stein JE, Rimm DL, et al. Comparison of Biomarker Modalities for Predicting Response to PD-1/PD-L1 CheckpointBlockade: A Systematic Review and Meta-analysis. JAMA Oncol. 2019
2.
Photos accompanying this announcement are available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/bb00942d-f13c-49be-b7b5-5e0bdfbf23bc
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