Akoya Announces Publication of MITER Study, the First Multi-Institutional Analytical Demonstration of a Space Biology Workflow, in the Journal for ImmunoTherapy of Cancer

MARLBOROUGH, Mass., July 19, 2021 (GLOBE NEWSWIRE) – Akoya Biosciences Inc, (Nasdaq: AKYA) The Spatial Biology Company®, today announced that the Phenoptics ™ mIF solution has been used in a multi-site study to demonstrate and validate an automated end-to-end workflow that characterizes PD-1 / PD-L1 immune checkpoint signaling in tumor tissue samples. The article titled “Multi-institutional evaluation of the reproducibility of multiplexed immunofluorescence amplified by TSA (MITER study), ”Was published in the Journal for ImmunoTherapy of Cancer (JITC) in July 2021. The MITER results are an important step towards standardizing an automated mIF-based space biology workflow that provides the level of performance needed to support clinical trials and that can be applied to clinical trials at the future.

Top immuno-oncology and pathology experts from five institutions collaborated with Akoya to conduct the MITER study, including Johns Hopkins University School of Medicine, Yale University School of Medicine, the Earle A. Chiles Research Institute, University of Texas MD Anderson Cancer Center and Bristol Myers Squibb.

“I am very excited about the results of this study as it is the first multi-institutional study of its kind involving the mIF, which represents an approach that should be part of all efforts to develop a platform for biomarkers for testing and possible clinical use, ”said Dr. David Rimm, professor of pathology at Yale University School of Medicine and one of the study’s lead investigators.

Immunotherapy uses the patient’s immune system to fight cancer and has provided lasting benefits to certain subsets of patients with advanced disease, which is an important step forward in the quest to defeat cancer. However, the majority of patients still do not respond to treatment. There is an urgent need for precise and predictive biomarkers to differentiate between responders and non-responders. Recent studies have shown that spatial biomarkers are able to predict immunotherapy response with greater accuracy than current methods1.2.

Space biology, a burgeoning scientific field, allows researchers to map the interactions of tumor and immune cells across an entire section of tumor tissue, without destroying the spatial context of the tissue, allowing a more accurate assessment of the tumor-immune biology.

With the MITER study, the authors sought to develop and validate a spatial biology workflow transferable between sites and providing reliable and site-independent quantitative data for immunotherapy research.

Study details

The multi-institutional effort optimized an automated 6-plex biomarker assay focused on the PD-1 / PD-L1 axis and assessed the inter- and intra-site reproducibility of the assay by measuring the spatial biology parameters of tumor cells and immune systems in tissue samples. . Among the parameters examined were the densities of tumor cells and immune cell subsets, expression and location of PD-L1, and spatial proximity of PD-1 / PD-L1.

Akoya’s Phenoptics ™ workflow, which enables spatial phenotyping using mIF, has demonstrated high agreement between several institutions. The study confirmed that quantitative measurements of multiple biomarkers in a tissue section are reproducible at levels aligned with typical clinical trial standards. The authors also reported that quantitative mIF significantly outperforms difficult visual assessments, such as assessing PD-L1 positivity in immune cells, especially in non-small cell lung cancer (NSCLC) samples.

“The fundamental requirement for any platform, including those providing spatial phenotyping, is the ability to fully demonstrate analytical robustness with a workflow that has the throughput necessary for large-scale clinical studies. With the MITER study and robust end-to-end Phenoptics workflow, we believe Akoya is uniquely positioned to meet the translational and clinical research needs of our clients, ”said Brian McKelligon, CEO of Akoya. “With our recent announced partnerships with AstraZeneca and Johns Hopkins, the MITER study is another important step in bringing space biology into the realm of patient phenotyping and improving immunotherapy outcomes in the future. “

For more information on Phenoptics, visit: akoyabio.com/Phenoptics

About Akoya Biosciences

As a space biology company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to treatment. Akoya offers two distinct solutions, the CODEX® and the Phenoptics ™ platforms, to meet the diverse needs of researchers in discovery, translational and clinical research. To learn more about Akoya, visit www.akoyabio.com.

Caution Regarding Forward-Looking Statements
This press release contains “forward-looking statements” under applicable securities laws. In some cases, such statements may be identified by words such as: “may”, “will”, “could”, “would”, “should”, “expect”, “intend to” , “plan”, “believe”, “estimate”, “predict”, “project”, “potential”, “continue”, “in progress” or the negative of these terms or other comparable terminology, although all forward-looking statements do not contain these words. Forward-looking statements include express or implied statements about our ability to achieve our business strategies, growth or other future events or conditions. These statements are based on our current beliefs, expectations and assumptions regarding future events or conditions, which are subject to risks and uncertainties, including the risks and uncertainties discussed in documents that we file from time to time with of the Securities and Exchange Commission. Actual results may differ materially from those shown in forward-looking statements, and you should not place undue reliance on them. All statements herein are ba are based only on the information currently available to us and speak only as of the date hereof. Unless required by law, we assume no obligation to update such statement.

Investor contact:
David Deuchler
Gilmartin SARL Group
[email protected]

Media contact:
Michelle linn
Bioscribe, Inc.
774-696-3803
[email protected]

The references:

  1. Berry S, et al. Analysis of multispectral imaging with the AstroPath platform provides insight into the efficacy of PD-1 blockade. Science 2021
  2. Lu S, Stein JE, Rimm DL et al. Comparison of biomarker modalities for predicting response to PD-1 / PD-L1 checkpoint blockade: a systematic review and meta-analysis. JAMA Oncol. 2019

The photos accompanying this announcement are available on
https://www.globenewswire.com/NewsRoom/AttachmentNg/bb00942d-f13c-49be-b7b5-5e0bdfbf23bc

https://www.globenewswire.com/NewsRoom/AttachmentNg/9140fa53-8d00-4a27-95bc-d40530de45c1

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MITER reproducibility study

The MITER study establishes the high reproducibility and robustness of Akoya Biosciences’ Phenoptics platform for spatial phenotyping in clinical research. Shown here are multiplex immunofluorescence images, of all sites involved in the study, where six biomarkers were analyzed in breast cancer samples.

MITER spatial proximity analysis

Shown here is a representative image of a breast cancer sample where the spatial proximity of two of six biomarkers were analyzed in the tissue. Measuring the proximity of PD-1 + and PD-L1 + cells in the tumor microenvironment, in addition to other spatial parameters, may improve the predictive value of immunotherapy biomarkers.

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Hector Hedgepeth

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