• DNADX^® was assessed in 80 pre-treatment plasmas from the RELIEVE study led by the Dana-Farber Cancer Institute (DFCI). This study involved patients with both HER2+ and HER2- metastatic breast cancer treated with trastuzumab deruxtecan (T-DXd).

• Additionally, DNADX^® underwent evaluation in 122 pre-treatment plasmas from the PARSIFAL phase II trial led by MEDSIR. This trial focused on hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer treated with palbociclib +/- fulvestrant or letrozole.

• Presented at the San Antonio Breast Cancer Symposium 2023 (SABCS23), the findings showed that the DNADX^® test significantly correlates with patient outcomes in both studies.

REVEAL GENOMICS, S.L., a pioneering biotechnology start-up headquartered in Barcelona committed to advancing cancer care through innovative diagnostic solutions, emphasized the excellent results of DNADX^® in data presented at the San Antonio Breast Cancer Symposium 2023 (SABCS23). Highlighting the trials' exploration of the efficacy of the impact of T-DXd monotherapy and the combination of endocrine therapy with a CDK4/6 inhibitor, the results underscore the variability in patient response, emphasizing the critical role of precision diagnostics in cancer care.

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DNADX^® in RELIEVE Study

The RELIEVE study, conducted by the Dana-Farber Cancer Institute (DFCI), analyzed plasma samples from patients with HER2+ and HER2- metastatic breast cancer receiving T-DXd monotherapy. DNADX^® subtypes, evaluated across 80 pre-treatment plasma samples, exhibited significant associations with time-to-next-treatment (TTNT) and overall survival (OS). Moreover, the DNADX^® HER2 signature demonstrated a significant association with TTNT, indicating its potential for predicting patient outcomes in the context of T-DXd monotherapy.

Dr. Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, stressed that “The ability of the DNADX test to predict patient outcomes in blood and in the context of T-DXd monotherapy is remarkable. This test should be further explored in pivotal clinical trials of T-DXd and other studies with targeted therapies, including antibody-drug conjugates.”

DNADX^® in PARSIFAL Study

MEDSIR, a company specializing in the strategic design of independent clinical research, sponsored PARSIFAL phase II trial (NCT02491983), which randomized 486 patients with HR+/HER2- metastatic breast cancer to receive first-line palbociclib with either fulvestrant or letrozole; DNADX^® was evaluated in 122 pre-treatment plasma samples. The liquid biopsy-based DNADX^® subtypes exhibited a significant association with both progression-free survival (PFS) and overall survival (OS), revealing their potential to guide therapy and follow-up in patients with endocrine-sensitive HR+/HER2- advanced breast cancer.

Dr. Javier Cortés, MD PhD, co-founder of MEDSIR, Head of the International Breast Cancer Center and investigator of the PARSIFAL trial, says that “Prior to DNADX, no tool existed to identify patients whose tumors would progress to therapy in the first 12 months. This is important as we need new therapeutic approaches for these patients. Our study shows that the DNADX subtypes in plasma are strongly associated with prognosis in patients treated with first-line endocrine therapy and a CDK4/6 inhibitor.” These findings are consistent with validation studies of DNADX^® in this context published this year in Nature Communications.

Furthermore, DNADX^® subtypes demonstrated a positive interaction with the type of endocrine therapy in terms of PFS, suggesting a potential benefit of fulvestrant over letrozole in specific DNADX^® subtypes.

Dr. Antonio Llombart-Cussac, MD PhD, co-founder of MEDSIR, Head of the Medical Oncology Department at Hospital Arnau de Vilanova, and principal investigator of the PARSIFAL trial, stated that “The association of DNADX subtypes with fulvestrant benefit is intriguing, and suggests that phenotypic characterization of breast tumors using DNADX might allow us to identify the optimal endocrine treatment for each patient beyond ESR1 mutation.”

Funding and Recognition

Dr. Patricia Villagrasa, Co-Founder and CEO of REVEAL GENOMICS^®, announced, “Our commitment lies in creating and advancing innovative genomic-based assays in oncology, such as our successful first product, HER2DX^®, for early-stage HER2+ breast cancer. Our forthcoming liquid biopsy-based assay, DNADX^®, marks our second product, slated for release in the short-term.”

She concluded, “We are pleased to announce that the Spanish Ministry of Science and Innovation has granted funding for the analytical and clinical validation of DNADX^®. This endorsement not only signifies the recognition of DNADX^® as an innovative tool, but also underscores its clinical utility.”

About PARSIFAL

PARSIFAL is a randomized, multicenter, open-label, phase II clinical trial that involved researchers from 47 hospitals in Spain, France, Italy, the United Kingdom, Russia, and the Czech Republic. The PARSIFAL study, designed and coordinated by MEDSIR, is the first clinical trial to directly compare the therapeutic efficacy of fulvestrant or letrozole in combination with palbociclib as first-line treatment in patients with endocrine-sensitive, hormone receptor-positive HER2-advanced breast cancer.

A total of 486 patients were randomly assigned to two cohorts that received palbociclib in combination with either fulvestrant (group A, 243 patients) or letrozole (group B, 243 patients) until disease progression. The results, which were awaited with great interest by the medical community, demonstrated that there was no difference between use of palbociclib in combination with fulvestrant or letrozole in terms of progression-free survival. Furthermore, the side effects were similar and acceptable for both combinations. The relevance of the study results was endorsed by its publication in JAMA Oncology and The Oncologist.

About DNADX^®

DNADX^® is a novel machine learning-based approach that utilizes sequencing DNA data from tumor tissue or plasma circulating tumor DNA to identify clinically relevant phenotypic tumor features and classify breast cancer into 4 subtypes or clusters. The development and clinical validation of the assay was described in Nature Communications.

About Liquid Biopsy

The liquid biopsy market in oncology can potentially become the future gold standard, considering its range of benefits over conventional cancer diagnostic approaches. The global market boasts a total value of $4.3 billion in 2022 and a projected growth rate of 18.3%, reaching $10.0 billion by 2027. The market is driven by the rising incidence and prevalence of cancer in the developing world, and the increasing preference for noninvasive treatment procedures.

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 company of Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona, and the Vall d’Hebron Institute of Oncology.

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

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

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