COMPANY:

Reveal Genomics

"Reveal Genomics, S.L...and the Istituto Europeo di Oncologia (IEO) today announced the start of an impact study of the HER2DX® test, the first genomic test in the world specialized in HER2+ breast cancer...The project, entitled "Prospective observational monocentric study to evaluate the impact of the HER2DX® assay on treatment decisions in patients with early-stage HER2+ breast cancer: HER2-BREAST-DX," aims to determine the impact of applying the test in medical decisions regarding treatment for patients diagnosed with localized HER2+ breast cancer (stage I-IIIA). These patients are candidates for either neoadjuvant treatment (prior to surgery) or adjuvant treatment (post-surgery). The project therefore seeks to advance the personalization of treatments."

"REVEAL GENOMICS...today announced both the development and the clinical validation of TNBCDX, the first genomic test designed specifically for patients with early-stage TNBC. This dual milestone will be presented at the ESMO Congress 2024 in Barcelona (Spain)...Across two independent validation studies with 418 patients, the TNBCDX scores showed a strong association with pathological complete response (pCR), distant disease-free survival (DDFS), and overall survival (OS), providing a more refined risk stratification. Notably, the TNBCDX test outperformed tumor-infiltrating lymphocytes (TILs) in predicting both pCR and survival outcomes...The results will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona (Spain) on Saturday, September 14th."

P3 | N=808 | CLEOPATRA (NCT00567190) | Sponsor: Genentech, Inc. | "REVEAL GENOMICS S.L...released further evidence supporting HER2DX, the world’s first specialized genomic test for HER2+ breast cancer. These results were obtained in collaboration with F. Hoffmann-La Roche Ltd (Basel, Switzerland) after analyzing HER2DX in tumor samples from the CLEOPATRA phase III clinical trial (NCT00567190)....For the first time, the investigators evaluated the ability of the HER2DX ERBB2 mRNA score to predict long-term survival outcomes in 214 patients treated with THP in the pivotal CLEOPATRA phase III trial3. The results showed a strong association of HER2DX ERBB2 mRNA score with PFS and OS....Detailed results of this study will be presented at an upcoming medical congress and submitted for publication."

"REVEAL GENOMICS, S.L... announced the results of the study 'HER2DX ERBB2 mRNA assay Following Trastuzumab-Based Chemotherapy in HER2-Positive Advanced Gastric Cancer' presented at ESMO Gastrointestinal Cancers Congress 2024 in Munich, showing that HER2DX genomic test demonstrates significant potential in refining patient selection for trastuzumab-based chemotherapy in HER2-positive advanced gastric cancer."

"REVEAL GENOMICS, S.L...has announced the start of a prospective study in collaboration with the Dana-Farber Cancer Institute (Dana-Farber). This trial will evaluate the turnaround time of the HER2DX genomic test to determine its feasibility in clinical practice in the US....The study will also examine how the HER2DX test results influence therapeutic decisions by Dana-Farber physicians for patients with stage I-III HER2+ breast cancer, and the confidence levels of both patients and physicians before and after the test."

"REVEAL GENOMICS...announced the forthcoming prospective validation of its groundbreaking diagnostic tool HER2DX® within the framework of the ongoing CompassHER2 pCR Trial."

P=NA | N=NA | "MEDSIR...presenting the results of two sub-studies focused on biomarkers: transFal, focused on patients with HR+/HER2- advanced breast cancer and METSGain, centered on patients with early breast cancer....Notably, high expression of Ki67 and CDK6, along with elevated ctDNA density at baseline, were correlated with shorter progression-free survival and overall survival. These findings illuminate potential avenues for understanding and overcoming resistance to CDK4/6 inhibitors, marking a significant step forward in personalized cancer treatment....Notably, patients with high-risk scores at surgery and less molecular changes after anti-HER2 therapy were more likely to develop metastasis, further highlighting the potential of HER2DX tool developed by REVEAL GENOMICS S.L. in guiding treatment decisions for HER2+ early breast cancer patients."

"REVEAL GENOMICS, S.L...has announced the start of the DEFINITIVE study, led by FRCB-IDIBAPS, representing the first prospective trial for HER2DX. This landmark study will be pivotal in bolstering the clinical validations already acquired for HER2DX. The study seeks to secure the prospective validation for endorsement by clinical guidelines and ensure recognition and reimbursement across Europe."

P2 | N=486 | PARSIFAL (NCT02491983) | Sponsor: MedSIR | "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....'We are pleased to announce that the Spanish Ministry of Science and Innovation has granted funding for the analytical and clinical validation of DNADX®.'"

"REVEAL GENOMICS...announced the inclusion of its HER2DX test in the clinical guidelines for early-stage breast cancer prepared by the Spanish Society of Medical Oncology ( SEOM)."

P2 | N=377 | PHERGAIN (NCT03161353) | Sponsor: MedSIR | "REVEAL GENOMICS...announced another validation of HER2DX®, the world's first specialized genomic test for HER2+ breast cancer....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)....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."

P=NA| N=459 | "REVEAL GENOMICS, S.L...announced today a new addition to its pipeline consisting of a novel biomarker approach in liquid biopsy for patients with advanced cancer....Firstly, REVEAL GENOMICS^®' proprietary machine-learning multi-gene signatures were applied in plasma and linked to DNA/RNA/protein data from tumor tissue (paired samples). The results showed, for the first time, that multi-gene signatures tracking complex biological features can be successfully identified in ctDNA. These complex biological features include, among others, measures of tumor proliferation and estrogen receptor signaling, similar to what is accomplished using direct tumor tissue DNA or RNA profiling....Secondly, the authors discovered that the combination of 150 biologically relevant signatures identified 4 new DNA-based molecular subtypes of breast cancer."

"REVEAL GENOMICS...announced positive results for HER2X® in a range of clinical scenarios, demonstrating the test’s reliability....The HER2DX pCR score predicted response to chemotherapy in combination with trastuzumab and pertuzumab in DAPHNe and GOM clinical trials....The results of 4 studies (APT, ATEMPT, DAPHNe and GOM) have been made public during the San Antonio Breast Cancer Symposium (SABCS), held from December 6 to 10 in San Antonio, Texas (USA)."

"REVEAL GENOMICS, S.L...announced another validation of HER2DX, the world's first specialized genomic test for HER2+ breast cancer....The APT clinical trial, published in the New England Journal of Medicine in 2015, demonstrated that a de-escalation treatment strategy based on weekly paclitaxel for 3 months and one year of trastuzumab (TH) is highly efficacious for patients with small node-negative HER2+ tumors. The ATEMPT clinical trial, published in the Journal of Clinical Oncology in 2021, demonstrated that 17 cycles of the anti-HER2 antibody drug-conjugate trastuzumab emtansine (T-DM1, Kadcyla, Roche) is highly effective for patients with stage 1 HER2+ breast cancer....In both trials, the HER2DX risk score was found to be significantly associated with relapse-free interval (RFI)....'The results of HER2DX in APT and ATEMPT are remarkable, and support the test's strong prognostic value in early-stage HER2+ breast cancer..."

"REVEAL GENOMICS, SL, a biotechnological start-up dedicated to revolutionizing precision oncology through innovation in biomarkers, has participated in two studies that have sought to demonstrate the clinical potential of HER2DX ®️ as well as its usefulness in therapeutic management of patients with early HER2+ cancer."

"The companies will cooperate to implement precision oncology in clinical trials with the aim of optimizing their design and developing new treatments...HER2DX®, the world's first specialized genomic test for HER2+ breast cancer and marketed by REVEALGENOMICS®, will be validated in the PHERGain and PHERGain-2 trials conducted by MEDSIR."

P2 | N=64 | "The data obtained from the analysis of tumor samples from the PerELISA phase II clinical trial showed that the HER2DX pCR-score and the HER2DX ERBB2-score predicted the probability of a patient responding to the triple-drug combination of trastuzumab, pertuzumab and letrozole, when given before surgery (i.e., the neoadjuvant setting). These findings in patients with newly diagnosed HER2+/hormone receptor positive (HER2+/HR+) breast cancer can help identify better who might benefit from dual HER2 blockade with trastuzumab and pertuzumab."

"Reveal Genomics...announced today a new collaborative project with the Dana-Farber Cancer Institute to evaluate the HER2DX® genomic test across three clinical trials (APT, ATEMPT, and DAPHNE) in early-stage HER2+ breast cancer...Today’s agreement represents a step forward in seeking more clinical evidence of the HER2DX® test to help personalize therapy in patients who have early-stage HER2+ breast cancer."

"Reveal Genomics...has launched its first genomic test. The HER2DX® test predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients and the likelihood that they will respond to pharmacological treatment. This innovative tool, which combines a patient's clinical data and the tumor's genomic profile, is the world's first specialized genomic test for HER2+ breast cancer."

"Researchers from Hospital Clínic-IDIBAPS-UB, VHIO, University of Padua (Italy) and REVEAL GENOMICS have developed and validated HER2DX, a genomic test that uses the clinical details and genomic data of early-stage HER2+ patients to predict their prognosis and probability to respond to drug therapies prior to undergoing surgery. HER2DX is the world's first genomic test intended for patients with HER2+ breast cancer...'Just one year after setting up REVEAL GENOMICS, we are happy to launch the company's first precision oncology test."