Agendia Presents Data at ASCO 2022 Indicating New ImPrint Immunotherapy Prediction and Expanding Utility of Proprietary Genomic Testing to Identify Patients Who Will Benefit Most From Specific Treatments

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Data Demonstrates the Ability of the Research-Only ImPrint Test to Identify High-Risk Early Breast Cancer Patients Who May Benefit from PD-1/PD-L1 Checkpoint Inhibition

IRVINE, CA and AMSTERDAM, June 04, 2022–(BUSINESS WIRE)–Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with diagnostic solutions and next-generation information to inform optimized treatment decision-making, announced today it will share results in a poster discussion featuring initial data from its ImPrint assay, a 53-gene signature in development, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

The poster discussion, titled ImPrint immune signature identifies patients with high-risk early breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2 [Kuilman, M., et al.], is modeled after the neoadjuvant biomarker-rich I-SPY2 trial, which set a new benchmark for efficacy in Phase 2 clinical trials and is widely considered the pioneer of the trial platform. In this study, the entire transcriptome data collected by Agendia was evaluated in patients with high-risk early breast cancer who received immunotherapy (IO). The goal was to migrate I-SPY2 results to a robust clinical-grade signature – a biomarker that did not previously exist in early-stage breast cancer – to predict susceptibility to IO drugs that target PD- 1/PDL-1, a cellular pathway that, when overexpressed, allows many breast tumors to escape destruction by the immune system.

Importantly, the results showed that in the development phase, the gene expression biomarker ImPrint performed this task and had the potential to predict pathological complete response (pCR) to PD-1/PDL-1 checkpoint inhibitors. with high sensitivity and specificity, especially in ER+. breast cancer, which represents a large population of women likely to benefit from it.

“We are extremely encouraged by the data we are sharing regarding the ImPrint test, which is currently under development,” said Annuska Glas, senior vice president of research and development and innovation at Agendia. “ImPrint appears to be very effective in identifying a subset of HR+HER2- patients who might benefit from IO. information is not currently available for a wide range of breast cancer patients, and although we are at the research use only stage, we look forward to further validation to ensure get ImPrint into the hands of doctors as soon as possible.

The effect of these findings on patients is potentially significant, ultimately having the potential to influence outcomes. Data shared at ASCO 2022 indicates the ability of the RUO ImPrint assay to find those who will benefit from PD-1/PDL-1 therapy as initial therapy, regardless of receptor subtype, providing the information needed to define a more specific treatment plan shortly after diagnosis.

“There has been a substantial increase in new IO drugs in many types of disease, which are incredibly effective in some cases but not a panacea for all. This has led to the urgent need for biomarkers to identify patients who might benefit. said Midas M. Kuilman, Research and Development, Agendia NV, Amsterdam and first poster author. “We consider this signature to fill an unmet need, as various predictive biomarkers have been developed, but none have consistently predicted efficacy. Here we see that ImPrint appears to predict with high sensitivity and specificity in discovery and validation sets – this is an incredibly promising data set and we look forward to validating it in the I-SPY 2.2 trial.”

Redefining breast cancer care in post-neoadjuvant settings

Another poster, presented by Agendia in partnership with researchers at Cedars-Sinai Medical Center in Los Angeles, examines matched tumors before and after neoadjuvant chemotherapy analyzed by MammaPrint® and BluePrint® to report differential gene expression and pathway analyzes in tumors that can help distinguish different responses. The poster, titled Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy [Chung, A., et al.], found more robust transcriptional change in tumors that remain MammaPrint High Risk between pre- and post-neoadjuvant chemotherapy. Although these tumors remained high-risk, they also exhibited numerous changes in gene expression before and after neoadjuvant chemotherapy, revealing clues of resistance and inspiring further research.

The study also found that tumors that transitioned from high-risk MammaPrint to low-risk MammaPrint after treatment had an activated immune response that may be a biomarker of treatment response and improve outcomes based on it. .

Taken together, these posters represent Agendia’s ongoing commitment to producing and evolving products that lead to information across the continuum of breast cancer care, from initial diagnosis to personalized treatment advice.

Additionally, Agendia will present six posters and a second poster discussion centered on its groundbreaking FLEX trial, which is accelerating the generation of impactful data aimed at redefining cancer care. Its patient-centered design and national network of participating sites are supported by Agendia’s infrastructure, enabling its investigator-initiated sub-studies to yield important results that have the potential to advance science.

Agendia will be sharing updates throughout the conference on its TwitterFacebook and LinkedIn.

About Agendia

Agendia is a mission-driven, commercial company focused on enabling better decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve cancer patient outcomes. breast all over the world. The company currently offers two commercially available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s risk of breast cancer recurrence. Plan® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic treatment. Together, MammaPrint® and BluePrint® offer a holistic view of the biology underlying a patient’s breast cancer, allowing physicians to objectively select the best treatment plan.

For more information on Agendia’s testing and ongoing trials, please visit www.agendia.com.

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contacts

Terri Clevenger
Westwicke/ICR Healthcare PR
Tel: 203.856.4326
Terri.Clevenger@icrinc.com

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