IRVINE, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Helio Genomics (“Helio” or “the Company”), an AI-driven healthcare company specializing in diagnostics technology and test development for cancer detection, presented and discussed recent CLiMB trial data evaluating HelioLiver, a multi-analyte blood test, in patients with hepatocellular carcinoma (HCC), as well as its cell-free DNA (cfDNA) methylation biomarkers for assessing prognosis and treatment response at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting held November 18, 2024 and virtual KOL event held November 25, 2024. Both events featured Helio’s Chief Medical Advisor, Dr. Richard Van Etten, MD, PhD. Results from the CLiMB trial demonstrated that the HelioLiver test passed both co-primary and secondary endpoints for superior sensitivity and non-inferior specificity compared to abdominal ultrasound, detecting more early stage and HCC lesions < 2 cm in a diverse cohort of patients with liver cirrhosis The Company’s methylation score outperformed other established metrics in predicting patients at high-risk for HCC, demonstrating that cfDNA methylation-based biomarkers have both diagnostic and prognostic utility “Dr. Van Etten highlighted HelioLiver’s superior performance over ultrasound, especially in identifying HCC lesions < 2 cm,” said Justin Chen Li, CEO of Helio Genomics. “The importance of having an improved, blood-based diagnostic test for high-risk patients is crucial in this patient population. Dr. Van Etten also presented the promise of our methylation score, demonstrating that cell-free DNA methylation-based biomarkers also have prognostic utility, predicting treatment response and time to progression for HCC patients. Helio is making great strides inHCC cancer management, which is paramount in allowing physicians to detect HCC earlier and make better treatment decisions for improved patient outcomes.” “I was thrilled to present the promising findings from Helio’s CLiMB trial, demonstrating reliable early detection for HCC,” said Dr. Richard Van Etten, MD, PhD, UCI Health Chao Family Comprehensive Cancer Center. “Moreover, their methylation score outperformed other established metrics in predicting patients at high-risk for HCC. Both HelioLiver and their cfDNA methylation-based biomarkers have tremendous potential for addressing a large unmet medical need.” Data highlights from the AASLD presentation and virtual KOL event included: HelioLiver Dx is a multi-analyte blood-based test employing a proprietary algorithm that utilizes a wide array of biomarkers such as cfDNA methylation, serum proteins and patient demographic information to accurately detect HCC in cirrhotic patients. The performance of HelioLiver Dx in a real-world surveillance setting was assessed in the CLiMB trial, a first-of-its-kind prospective trial comparing HelioLiver Dx with ultrasound and AFP in patients with cirrhosis. 1,968 subjects were enrolled at 42 clinical sites across the U.S., of which 1,556 participants comprised the validation cohort, with 1,268 evaluable patients. 46 subjects (3.6%) were diagnosed with HCC, confirmed by MRI: 80% lesions ≤ 4 cm46% lesions < 2cm59% T1 stage lesions according to the TNM staging system Both CLiMB primary and secondary endpoints were developed with guidance from the FDA as part of a PMA approval pathway.The HelioLiver Dx test met the prespecified coprimary endpoints – overall superior sensitivity (≥ 5%) and non-inferior specificity (> –10%) compared to ultrasound for detecting HCC lesions.The HelioLiver Dx test met the prespecified secondary endpoint – superior sensitivity compared to ultrasound for detecting HCC lesions ≤ 4 cm in diameter. HelioLiver Dx outperformed ultrasound for sensitivity to detect HCC lesions in cirrhotic patients: All HCC lesions: 47.8% for HelioLiver Dx vs. 28.3% for ultrasound.HCC lesions ≤ 4 cm: 37.8% for HelioLiver Dx vs. 13.5% for ultrasound.HCC lesions < 2 cm: 28.6% for HelioLiver Dx vs. 0% for ultrasound. Notably, ultrasound failed to detect any lesions < 2 cm in the CLiMB study.T1 HCC lesions: 44.4% for HelioLiver Dx vs. 11.1% for ultrasound. HelioLiver Dx was 20% more sensitive and 6% less specific than ultrasound alone (p<0.001).HelioLiver Dx had a higher sensitivity and specificity than the combination of ultrasound + AFP (10 ng/mL). HelioLiver Dx addresses key ultrasound weaknesses: AccessibilitySkill and training of the operatorSize and location of the lesionBMI of the patient HelioLiver Dx is available as an LDT under CPT 0333U, covered with prior authorization by most health plans, price of test and reimbursement depends on the insurance. A cost-effectiveness analysis on HelioLiver Dx vs ultrasound is currently being conducted by Standford.The main cost benefits come in the form of savings on treatment costs: Early-stage HCC treatment – $30–50KLate-stage HCC treatment – $200K+ Helio pipeline expansion has broad applicability, using its multi-modal multi-omics computational platform of biomarker discovery, cancer diagnostics, treatment response prediction, and MRD and disease monitoring: Precision oncology/treatment guidelines can leverage all of the Helio platforms (ECLIPSE, CHALM, MESA) to assess candidates for certain ICI therapies and other types of therapies. In a longitudinal study cohort (n=108) in a collaboration with Ochsner Health where all enrolled patients were previously diagnosed with liver cirrhosis with varying underlying etiologies, Helio’s HL-ONC methylation model score from pre-treatment blood specimens outperformed other metrics such as the ALBI score, GALAD score, MELD score, Child-Pugh score, cumulative lesion size and biomarkers like AFP, AFP-L3 and DCP in predicting patient outcomes and demonstrating that a methylation score can accurately classify patients with low or high risk of progression. Patients who responded to liver-directed therapy showed a significantly larger decline in their methylation score compared to those who did not respond and progressed to advance-stage disease.Current pipeline in HCC for Helio Genomics includes: HelioLiver in HCC surveillance test – potential FDA approval in Q3 2025HelioLiver 2.0 in HCC surveillance test – preliminary data readout in Q2 2026HL-ONC in HCC precision oncology – 2nd data readout in Q4 2025HL-MRD1 in HCC MRD – preliminary data readout in Q4 2025HL-MONITOR1 in HCC monitoring - preliminary data readout in Q4 2025 Richard A. Van Etten, MD, PhD, is Chief Medical Advisor for Helio Genomics and Director of the Chao Family Comprehensive Cancer Center at UCI Health. He is a board-certified, fellowship-trained UCI Health hematologist and oncologist who specializes in the treatment of leukemia and other blood cancers. His clinical focus also includes hematopoetic stem cell transplantation. As Director of the UC Irvine Chao Family Comprehensive Cancer Center, he leads a team of more than 250 physicians, basic and translational scientists conducting cancer research at UC Irvine. Dr. Van Etten received a medical degree and a PhD in biophysics from the Stanford University School of Medicine, where he worked with biochemist David F. Clayton, PhD, on the molecular genetics of mammalian mitochondrial DNA and brain development. He went on to complete a residency in internal medicine and a fellowship in hematology at Harvard School of Medicine and Brigham & Women's Hospital in Boston. Next he worked as a visiting scientist in the lab of Nobel laureate David Baltimore at the Massachusetts Institute of Technology's Whitehead Institute in Boston. He joined the Harvard Medical School and Brigham & Women's Hospital as a faculty member of the departments of Medicine and Genetics. In 2003, he became a professor of Medicine at Tufts Medical Center and director of the Hematologic Malignancies Program at Tufts Cancer Center, eventually becoming chief of the Division of Hematology/Oncology. In 2009, he was named director of the Tufts Cancer Center. Dr. Van Etten became director of the Chao Family Comprehensive Cancer Center on Oct. 1, 2013 and a professor of Medicine and Biochemistry in the UCI School of Medicine. Under his leadership, the cancer center's comprehensive cancer center designation has been renewed twice by the National Cancer Institute. He is the author of more than 150 scientific articles, reviews and book chapters. His research lab, which is funded by grants from the National Cancer Institute, investigates the molecular pathogenesis of leukemia and myeloproliferative neoplasms with an emphasis on dysregulated tyrosine kinases and mouse model systems. Recent News: Helio recently presented a poster on their latest collaboration with Ochsner Health, demonstrating the utility of cell-free DNA (cfDNA) methylation-based biomarkers for assessing biological aggressiveness and prognosis in patients with hepatocellular carcinoma (HCC) on Friday, October 11, 2024 at the 2024 San Antonio Liver Cancer Symposium in San Antonio, Texas. Additionally, Helio’s abstract was awarded as one of the top three abstracts by the Symposium Committee. The full press release, including data highlights, can be found here. Helio presented CLiMB trial data at the EASL Congress 2024. Full press release details can be found here. About the CLiMB Trial The CLiMB study enrolled 1,968 subjects at high-risk for liver cancer, making it the largest completed prospective, multi-center clinical trial for a liver cancer detection liquid biopsy test conducted in the United States. The primary goals of the study were to evaluate the sensitivity and specificity of HelioLiver Dx compared to ultrasound for the detection of HCC within a population at high risk of HCC due to liver cirrhosis. Subjects were diagnosed with liver cirrhosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index > 0.5), ultrasound and elastrography (> 12.5 kPa), diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report) or liver biopsy (liver cirrhosis indicated on pathology report), and those who were eligible for HCC surveillance as determined by the subject’s physician. About HelioLiver Dx HelioLiver Dx is a multi-analyte blood test that analyzes methylation patterns through cfDNA, serum protein markers and demographic information to detect early-stage HCC for patients at risk due to liver cirrhosis or Hepatitis B. HelioLiver Dx achieved superior sensitivity and non-inferior specificity compared to ultrasound, the current standard of care for HCC surveillance, as demonstrated by the results of the ENCORE and CLiMB clinical trials. HelioLiver has received a Category I Current Procedural Terminology Proprietary Laboratory Analyses, or CPT PLA, code from the American Medical Association, effective October 1, 2022, which establishes a reimbursement pathway and facilitates expected Medicare coverage for increased access and potential broader adoption of HelioLiver in the United States. Based on the results of the CLiMB trial, Helio submitted its PMA application for HelioLiver to the FDA in the second quarter of 2024 for authorization as a Class III medical device. Prior to FDA approval, HelioLiver will be commercially available in the United States in a CLIA laboratory as a laboratory developed test, or LDT. About Helio Genomics Helio Genomics, founded in 2016 and headquartered in Irvine, CA, is a commercial-stage, AI-driven diagnostics platform company focused on developing pioneering tests for early cancer detection, precision oncology, recurrence and treatment monitoring. Committed to improving global cancer survival rates, Helio Genomics specializes in blood-based technologies, utilizing advanced approaches liquid biopsy and DNA methylation analysis to detect cancer at its earliest stages. For more information, please visit our website at www.heliogenomics.com or www.linkedin.com/company/heliogenomics; information that may be important to investors will be routinely posted in both locations. Investor Contact: Jeremy Feffer Managing Director LifeSci Advisors jfeffer@lifesciadvisors.com
