COMPANY:

Agendia

"Agendia, Inc. today announced that a diverse patient population of over 17,000 has been successfully enrolled in the FLEX Study, a prospective real-world evidence, whole transcriptome, observational breast cancer study (NCT03053193). The FLEX Study, which intends to enroll 30,000 patients, employs a patient-centric design to accelerate impactful data generation through a national network of participating sites."

"Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint FFPE Microarray, BluePrint FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation."

P3 | N=3966 | "Agendia, Inc. today announced that the NSABP B-42 study evaluating the MammaPrint assay in predicting the benefit of extended endocrine therapy (EET) in early-stage breast cancer patients was published in the July issue of Journal of Clinical Oncology.... The data revealed that only MammaPrint Low (non-UltraLow) Risk tumors showed a statistically significant 10-year EET benefit of 9.5% for disease-free survival (DFS) and 7.9% for breast cancer-free interval (BCFI). Conversely, MammaPrint UltraLow and High Risk tumors did not derive statistically significant EET benefit."

P=Obs | N=2, 5000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc. today announced it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on June 3rd, 2024....Results of the analysis showed that MP High-2 tumors had a significantly higher frequency of antigen presenting cells (APCs) (including activated dendritic cells and macrophages, CD4+ memory T cells, CD8+ T cells, memory B cells and antibody producing plasma cells) relative to High-1 tumors, highlighting an increased immune active state in High-2 tumors. The increased antigen presentation and presence of APCs, which are critical in activating T- and B-cells, may explain why High-2 tumors display improved response rates to immunotherapy."

"Additional data supporting MammaPrint utility in treatment selection will be presented by investigators from the ISPY2 trial in a poster...By using data from the ISPY-2 trial, this poster demonstrates that MammaPrint H2 tumors have molecular and clinical similarities to triple negative breast cancer tumors, underscoring critical insight into how treatment plans can be optimized to achieve the best result for the patient."

P=Obs | N=25,000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc. today announced it will present new data on the 3-year outcome of patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer when treated with two different chemotherapy regimens at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on May 31st, 2024....Results showed that patients with MammaPrint H1 Luminal B-Type tumors demonstrated similar 3-year outcomes when treated with either TC (97.1%) or AC-T (95.3%), suggesting that patients who are classified as H1 may be able to avoid the toxicity of an anthracycline. However, patients with MammaPrint H2 Luminal B-Type tumors demonstrated a significantly higher relapse-free survival when treated with AC-T (97.7%) than with TC alone (86.4%). These findings indicate that MammaPrint H2 tumors benefit from the addition of an anthracycline to their adjuvant chemotherapy regimen."

"Agendia, Inc., announced today that new data on its comprehensive genomic tests will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO), taking place May 31st – June 4th, 2024, in Chicago, Illinois....The two abstracts that have been selected by ASCO for oral discussion will 1) feature an investigation of underlying biology that mediates immune therapy response and, 2) will provide an evaluation of the MammaPrint Index and 3-year recurrence-free interval in patients treated with CT, with and without anthracycline. Both presentations utilize whole transcriptome data from the prospective, observational real-word evidence FLEX Study (NCT03053193)."

"Agendia®, Inc...announced...that the company’s 80-gene molecular subtyping assay, BluePrint®, is now included in the latest version of German Gynecological Oncology Group (AGO) guidelines. The assay was added to the list of predictive factors for neoadjuvant chemotherapy decision making."

P2 | N=5,000 | I-SPY 2 (NCT01042379) | Sponsor: QuantumLeap Healthcare Collaborative | "Agendia, Inc. today announced new data from the I-SPY 2 trial showcasing its ImPrint signature for patients with triple negative (TN) breast cancer, shared by I-SPY 2 researchers in an oral presentation at the 14th European Breast Cancer Conference in Milan, Italy.... The study, examining the responses of patients who received a variety of IO regimens in the I-SPY 2 trial, showed that ImPrintTN predicts both response and non-response, suggesting that the test may help inform prioritization of IO versus other treatments for TN patients to best balance likely benefit versus the risk of the serious adverse effects that often accompany IO."

P=Obs | N=25,000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc., announced today it will share new data from the ongoing prospective, observational FLEX Trial (NCT03053193) in two poster presentations at the 41st Annual Miami Breast Cancer Conference (MBCC), taking place March 7 – 10th, 2024...The first poster....Results showed that patients with MP High 2 tumors, including Luminal B and Basal subtypes, are more likely to achieve a pCR in response to AC-T, while the addition of anthracycline to the therapy regimen does not appear to improve pCR rates for patients with MP High 1, Luminal B-type tumors."

"Agendia®, Inc., announced...that the first patient to use MammaPrint® as an enrollment biomarker for the DEBRA Trial is to be enrolled. The Phase III NRG Oncology De-Escalation of Breast Radiation (DEBRA) Trial (NCT04852887), is a clinical study looking at safely reducing the use of breast radiation after lumpectomy for people with low-risk, early-stage breast cancer."

"Agendia NV...announced...that the Dutch National Healthcare Institute (ZIN) has approved MammaPrint® for inclusion in the Dutch National health insurance basic package with immediate effect. Based on the MINDACT study data, ZIN affirmed that MammaPrint meets reimbursement criteria, paving the way for its inclusion. The reimbursement is applicable to women over 50 with hormone-positive, HER2-negative breast cancer and 0-3 lymph nodes involved (with clinical high risk). This significant decision, rendered by ZIN, represents a substantial step towards personalized care for women affected by breast cancer in the Netherlands."

"Agendia, Inc...is collaborating with National Cancer Institute (NCI), part of the National institutes of Health and SWOG Cancer Research Network, funded by NCI, for a new clinical trial that will test the effectiveness of neoadjuvant immunotherapy for high-risk HR+ breast cancer patients...SWOG Trial S2206 (NCT06058377) is a prospective, randomized, Phase III trial focused on the application of immunotherapy in patients with MammaPrint High 2 Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Stage II-III Breast Cancer...Agendia's MammaPrint gene expression profiling test analyzes 70 genes associated with breast cancer recurrence and classifies patients with early-stage breast cancer as having a low or high risk of distant metastasis within four categories: UltraLow, Low, High 1, and High 2."

"Agendia, Inc...announced...the publication of the Multi-Institutional Neoadjuvant Therapy MammaPrint Project I (MINT) trial, a prospective study designed to evaluate the utility of molecular profiling alongside traditional pathologic and clinical prognostic factors in predicting the response to neoadjuvant chemotherapy (NCT) in patients with locally advanced breast cancer (LABC)."

"At the 2023 ASCO Annual Meeting, Agendia, Inc...will present data that proves MammaPrint can predict chemotherapy sensitivity in women with early-stage, HR+HER- breast cancer. The research examined the clinical utility of MammaPrint’s two High Risk subcategories, High 1 (H1) and High 2 (H2), as an indicator of a woman’s predicted response to chemotherapy and five-year outcomes, in combination with BluePrint’s® molecular subtyping, to guide treatment decisions."

"At the 2023 ASCO Annual Meeting, Agendia, Inc...reinforces its commitment to progressing research of racial disparities in breast cancer through two poster presentations. Building off the research presented at the 2022 annual meeting, which found that BluePrint identifies stark racial disparities among women with HR+HER2- tumors...Agendia will also present a poster on MammaPrint’s ability to predict chemotherapy response in women with high-risk early-stage breast cancer, and an oral presentation on the ability of genomic biomarkers to predict a woman’s response to immunotherapy."

"Agendia...announced the first patient has been enrolled in the PROOFS Registry trial....The PROOFS Registry trial intends to enroll 1,500 patients via 100 sites in Germany by January 2025."

"Agendia, Inc...announced the updated National Comprehensive Cancer Network^® (NCCN) Clinical Practice Guidelines in Oncology – Breast Cancer Version 1.2023, recognize Agendia’s MammaPrint UltraLow Risk result and its proven impact on patient care. This inclusion is particularly critical for women with early-stage breast cancer who receive an UltraLow Risk test result and can safely forgo toxic treatments yet maintain excellent chance of survival."

"Agendia, Inc...announced it will present late-breaking research at the 2022 San Antonio Breast Cancer Symposium (SABCS) that proves MammaPrint is the first FDA-cleared gene expression profiling test to predict an early-stage breast cancer patient’s benefit from extended endocrine therapy (EET). The study, which analyzed MammaPrint results of over 500 patients enrolled in the IDEAL trial, proved MammaPrint test results can effectively identify which post-menopausal, hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients will benefit from five years of EET."

"At the 2022 San Antonio Breast Cancer Symposium (SABCS), Agendia, Inc...will present data demonstrating its proprietary signatures fulfill a critical unmet need for precise, proactive treatment planning for premenopausal women with early-stage breast cancer...data suggests that many young women with early-stage breast cancer may safely avoid the toxicity of chemotherapy if treated appropriately with endocrine therapy."

"Agendia...received acceptance for all six abstract submissions that will help guide the future of personalized cancer care and will be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS). These studies focus on the impact of MammaPrint and BluePrint test results, unveiling the underlying biology of a breast cancer patient’s unique tumor to help inform more personalized treatment decisions."

"Agendia, Inc...announced the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia. In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer."

"Agendia, Inc...announced it will present seven posters derived from the company’s FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022."

"The goal was to migrate the I-SPY2 findings into a robust clinical-grade signature – a biomarker that had not previously existed in early stage breast cancer – to predict sensitivity to IO drugs that target PD-1/PDL-1, a cell pathway that, when overexpressed, allows many breast tumors to escape destruction by the immune system....Importantly, results showed that in the development phase, the gene-expression biomarker ImPrint met this task and had the potential to predict pathologic 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 who may benefit."

"Agendia...announced 10,000 patients have been successfully enrolled in the FLEX Registry. Agendia’s unique FLEX Registry is a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer....Six posters based on data from FLEX will be presented at ASCO 2022, one of which will be a poster discussion session."

"Agendia, Inc...announced it will present new data from ongoing clinical research evaluating its comprehensive genomic tests at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 in Chicago, Illinois."

"The first of the two poster presentations, entitled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the next-generation sequencing (NGS) version of MammaPrint and BluePrint is equivalent to the centralized microarray test, as demonstrated by results from various labs globally. This enables a more accurate decentralized solution to breast cancer care fostering worldwide accessibility to more reliable genomic testing."

"Agendia, Inc...announced new data published in Genes, Chromosomes and Cancer (Genes) that show MammaPrint® and BluePrint® gene signatures represent and capture all of the original 10 hallmarks of cancer (HoCs), recognized as the biological capabilities acquired during the multi-step development of human cancer, as defined by Hanahan and Weinberg."

"Agendia, Inc...announced that it is offering early access to its Digital MammaPrint platform for patients with breast cancer in Brazil, expanding the company’s offerings in the country with the goal of bringing essential information from cancer testing to the larger global breast cancer community...Brazil is the first country to have samples analyzed by Digital MammaPrint, allowing physicians and their patients to benefit from genomic insights derived from a digitized image of a breast cancer tumor."

"Illumina, Inc...announced a multi-year partnership with Agendia N.V...The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina's approach to IVD partnerships in oncology...Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeq™Dx sequencing platform to expand the range of gene panels available for solid tumor analysis. We expect Agendia's flagship test, MammaPrint™, which is FDA-cleared and currently offered via Agendia's central laboratory, to be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA."

"Agendia, Inc...announced that it will present a spotlight poster at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021) which confirms the utility of BluePrint® in guiding neoadjuvant treatment decisions."

"Agendia, Inc...presented data from a research collaboration with Vanderbilt University Medical Center demonstrating the capability of MammaPrint® and BluePrint® to identify differences in recurrence risk and tumor classification amongst different racial groups at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021)...The presentation, titled MammaPrint and BluePrint identify genomic differences in HR+ HER2- breast cancers from young Black and White women, highlights new data signaling that among young women (­<50 years of age) with localized hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, MammaPrint and BluePrint identified racial disparities in risk of recurrence and breast cancer subtype distribution not detected by existing clinical factors."

"Agendia, Inc...shared data demonstrating the ability of MammaPrint® and BluePrint® to predict patient outcomes following neoadjuvant chemotherapy (NAC) at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021)."