REVEAL GENOMICS® ANNOUNCES POSITIVE TOP-LINE RESULTS FOR HER2DX® IN MEDSIR'S PHERGAIN TRIAL

• HER2DX^® pCR-score was significantly associated with pathological complete response in patients with HER2+ breast cancer treated with trastuzumab and pertuzumab, with or without chemotherapy.
• HER2DX^® risk-score identified 85% of patients with an invasive disease event as high-risk, and 98% of patients identified as HER2DX^® low-risk were disease-free at last follow-up.
• HER2DX^® is the world's first diagnostic test formulated specifically for HER2+ breast cancer.

BARCELONA, Spain, June 15, 2023 /PRNewswire/ -- REVEAL GENOMICS, S.L., a Barcelona-based biotech start-up seeking to revolutionize precision oncology through diagnostic innovation, today announced another validation of HER2DX^®, the world's first specialized genomic test for HER2+ breast cancer. The results were obtained from analysis of HER2DX^® in tumor samples from the PHERGAIN phase II clinical trial, led by MEDSIR (Spain). Last year, REVEAL GENOMICS^® and MEDSIR announced a strategic partnership.

MEDSIR´s PHERGAIN trial, the first results of which were published in the Lancet Oncology in 2021 and recently announced at ASCO Congress, randomized 356 patients with newly diagnosed HER2+ breast cancer to neoadjuvant systemic therapy with 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab (i.e., arm A) or 2 cycles of chemotherapy-free dual HER2 blockade with trastuzumab and pertuzumab (i.e., arm B). After 2 cycles of treatment in arm B, patients underwent a ¹⁸F-FDG-PET. If a metabolic response was observed, patients continued treatment with 6 additional cycles of chemotherapy-free dual HER2 blockade (i.e., a total of 8 cycles). If no metabolic response was observed by ¹⁸F-FDG-PET, patients received 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab. The co-primary endpoints were pathological complete response (pCR) rate after surgery following 8 cycles of chemotherapy-free dual HER2 blockade, and 3-year invasive disease-free survival (iDFS) of patients in arm B.

HER2DX^® genomic test was applied in 292 (82.0%) baseline pre-treatment tumor biopsies. The HER2DX^® pCR-score was found to be significantly associated with pCR, regardless of the treatment regime, ¹⁸F-FDG-PET metabolic response, and hormone receptor status. Despite a short median follow-up of 3.6 years, 85.0% and 100.0% of events were identified as high-risk according to the 2 pre-specified cutoffs of the HER2DX^® risk-score. In contrast, 98% and 100% of patients with HER2DX^® low-risk were disease-free at last follow-up, according to the 2 pre-specified cutoffs of the HER2DX^® risk-score.

"The results of HER2DX^® in PHERGAIN are remarkable and support the strong predictive and prognostic value of the test in patients with early-stage HER2+ breast cancer. The test will help to select which patients might be treated with trastuzumab and pertuzumab without chemotherapy, a treatment strategy with better quality of life than multi-agent chemotherapy," commented Dr. Antonio Llombart, Principal Investigator of the PHERGAIN trial, Co-founder of MEDSIR, and Head of the Medical Oncology Department at Hospital Arnau de Vilanova (Valencia, Spain).

Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC, Spain) and Co-founder of MEDSIR, added, "Today's positive results confirm the ability of the HER2DX^® scores to predict pCR and survival outcome following different anti-HER2-based treatments, including chemotherapy-free regimes. The test has extensive clinical validation across many studies and patients, and, in my opinion, should be recommended and included in clinical guidelines".

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS^® concluded, "Today's positive results for HER2DX^® are a significant step forward for our company. We look forward to continuing to work with healthcare payers and providers to make this test reimbursed and available worldwide."

Detailed results of this study will be presented at a future medical congress and submitted for publication.

About the HER2DX^® test
HER2DX^® is the world's first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS^® since January 2022, the HER2DX^® is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX^®️ is a prognostic, predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX^® predicts:

• Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
• pCR likelihood score (high vs. medium vs. low): the likelihood of a patient to respond to anti-HER2-based treatment before surgery.
• ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.

About HER2+ breast cancer
HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically, and biologically heterogeneous, and standard clinical-pathologic assessment is not sufficient to capture this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

About MEDSIR
Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life: www.medsir.org  

About REVEAL GENOMICS^®️
REVEAL GENOMICS, S.L. is a biotechnology start-up seeking to change the way biomarkers are used in oncology. It is focused on developing innovative diagnostic tools to define the best therapeutic options for patients with cancer. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.

REVEAL GENOMICS, S.L. is a spin-off of Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona (UB), and Vall d'Hebron Institute of Oncology (VHIO).

REVEAL GENOMICS^® and HER2DX^® are registered trademarks of REVEAL GENOMICS, S.L.

Web: www.reveal-genomics.com. Twitter: @revealgenomics

Further information: Adriana Herrera, aherrera@reveal-genomics.com

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