Data Presented at SABCS Demonstrate the Significant Promise of Precede Biosciences’ Novel Liquid Biopsy Platform to Define HER2 and ER Status in Patients With Advanced Breast Cancer

Boston, MA – December 6, 2023 – Precede Biosciences, a company impacting the development and use of precision medicines with a first-in-class liquid biopsy platform, today announced that data from its platform were presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, TX. The data demonstrate the ability of the platform to reveal disease-defining transcriptional biology of metastatic breast cancer and to accurately classify patients as HER2 3+ vs. HER2 0 and ER+ vs. ER- from just 1mL of plasma.

“Determination of HER2 and ER status is foundational to therapeutic decision-making in patients with advanced breast cancer,” said Heather A. Parsons, MD, MPH, Dana-Farber Cancer Institute, lead author. “Assessing HER2 and ER status from a blood test would represent a significant advance, overcoming issues associated with both obtaining and reliably scoring invasive tissue biopsies, offering the opportunity to assess patients for receptor class switching, and enabling a potential therapeutic change at metastatic progression and potentially throughout the metastatic cancer journey.”

Using Precede Biosciences' novel liquid biopsy technology, researchers profiled 130 metastatic breast cancer patients from the Dana-Farber Cancer Institute and three commercial biobanks. All patients had plasma drawn within six weeks of a tissue biopsy that was assessed for HER2 and ER by immunohistochemistry. Breast cancer cell lines were profiled to enable initial feature selection for the HER2 and ER classifiers. Final classifiers were multi-modal, integrating data from active gene enhancers, active gene promoters, and DNA methylation, and validated using a Leave-one-Out scheme. Classifier performance was summarized as an Area Under the Curve (AUC) statistic, where a maximum score is 1, and the higher the number, the better the performance.

For the HER2 3+ vs. HER2 0 classifier, AUC for patients with detectable circulating tumor DNA (ctDNA) was 0.97, and for the ER+ vs. ER- classifier, the AUC for patients with detectable ctDNA was 0.90.

“Therapies addressing transcriptionally regulated targets such as HER2 and ER are the mainstay of treatment today in advanced breast cancer, and these data highlight the potential of the Precede liquid biopsy platform to one day inform therapeutic decisions in practice,” said Carl Barrett, Ph.D., Chief Scientific Officer of Precede Biosciences. “The platform’s genome-wide nature means that it can read out on essentially any target or pathway of interest from the same 1mL of plasma, a unique capability that has relevance given the numerous therapies under development against distinct targets and pathways in this setting.”

Additional data, including data supporting the potential of the Precede approach to classify HER2 low status can be found in the SABCS presentation and the poster in the News section of the website.

About Precede Biosciences’ Liquid Biopsy Technology

Development and clinical use of precision medicines have been hampered by challenges in accessing, analyzing, and integrating actionable biological and clinical data. The result, all too often, has been a "trial and error" approach to both developing medicines and to treating patients in practice.

Precede's genome-wide platform addresses the need to have resolution into the activation status of the disease-defining genes and pathways that drive response and non-response to therapy from a simple blood test. Using sophisticated and proprietary molecular biology and machine learning, Precede profiles circulating chromatin and the DNA methylome from 1mL of plasma, giving access to a dynamic and feature-rich space of ~20K gene promoters, ~1M gene enhancers, and ~50K CpG islands.

Precede's platform is available to drug developers and academic researchers at Precede is also using its platform to develop blood-based tests for precision use of cancer medicines in practice, medicines that are associated with the need for invasive tissue-based tests.

About Precede Biosciences

Precede Biosciences is breaking down the barriers to precision medicine by redefining what can be learned from a simple blood draw. By understanding the fundamental biology behind disease at any given moment, researchers and clinicians can better target medicines to the right patients in both drug development and clinical practice. Precede seeks to improve success rates in drug development and to be a part of building a future where every patient can receive a rapid, minimally invasive diagnosis and therapy that is precise to the biology of their disease. To learn more, visit or follow us on X/Twitter and LinkedIn.

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Related Presentations:

December 6, 2023: 2023 SABCS Presentation: Liquid biopsy determination of HER2 status in breast cancer: results from a novel epigenomic platform


December 6, 2023: 2023 SABCS Poster: Liquid biopsy determination of HER2 status in breast cancer: results from a novel epigenomic platform

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