Helio Genomics presented CLiMB trial data — HelioLiver passed its co-primary and secondary endpoints versus ultrasound — and its cfDNA methylation prognostic score at the 2024 AASLD Annual Meeting and a virtual KOL event.
Nov. 26, 2024 (GLOBE NEWSWIRE) — Helio Genomics (“Helio” or “the Company”) 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 AASLD Annual Meeting (November 18, 2024) and a virtual KOL event (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.
“Dr. Van Etten highlighted HelioLiver’s superior performance over ultrasound, especially in identifying HCC lesions < 2 cm. 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.”
“I was thrilled to present the promising findings from Helio’s CLiMB trial, demonstrating reliable early detection for HCC. 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
- HelioLiver Dx is a multi-analyte blood-based test employing a proprietary algorithm that uses cfDNA methylation, serum proteins and patient demographic information to detect HCC in cirrhotic patients.
- The CLiMB trial enrolled 1,968 subjects at 42 U.S. clinical sites; 1,556 comprised the validation cohort, with 1,268 evaluable patients. 46 subjects (3.6%) were diagnosed with HCC, confirmed by MRI (80% of lesions ≤ 4 cm, 46% < 2 cm, 59% T1-stage).
- Both CLiMB primary and secondary endpoints were developed with FDA guidance as part of a PMA approval pathway. The test met the prespecified coprimary endpoints (overall superior sensitivity ≥ 5% and non-inferior specificity > –10% vs ultrasound) and the secondary endpoint (superior sensitivity for lesions ≤ 4 cm).
- HelioLiver Dx outperformed ultrasound for sensitivity in cirrhotic patients:
- All HCC lesions: 47.8% vs. 28.3%
- Lesions ≤ 4 cm: 37.8% vs. 13.5%
- Lesions < 2 cm: 28.6% vs. 0% (ultrasound failed to detect any lesions < 2 cm)
- T1 HCC lesions: 44.4% vs. 11.1%
- HelioLiver Dx was 20% more sensitive and 6% less specific than ultrasound alone (p<0.001), and had higher sensitivity and specificity than the combination of ultrasound + AFP (10 ng/mL).
- HelioLiver Dx addresses key ultrasound weaknesses: accessibility, operator skill and training, lesion size and location, and patient BMI.
- HelioLiver Dx is available as an LDT under CPT 0333U, covered with prior authorization by most health plans. A cost-effectiveness analysis vs ultrasound is being conducted by Stanford; the main cost benefits are in treatment savings (early-stage HCC treatment $30–50K vs late-stage $200K+).
- In the longitudinal Ochsner Health collaboration (n=108), Helio’s HL-ONC methylation model score from pre-treatment specimens outperformed the ALBI, GALAD, MELD and Child-Pugh scores, cumulative lesion size, and AFP/AFP-L3/DCP in predicting outcomes; responders showed a significantly larger decline in methylation score.
- Current HCC pipeline: HelioLiver in HCC surveillance (potential FDA approval Q3 2025); HelioLiver 2.0 (preliminary data Q2 2026); HL-ONC in precision oncology (2nd data readout Q4 2025); HL-MRD1 in MRD (preliminary data Q4 2025); HL-MONITOR1 in monitoring (preliminary data Q4 2025).
About Richard A. Van Etten, MD, PhD
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. A board-certified, fellowship-trained hematologist and oncologist, he leads a team of more than 250 physicians and scientists conducting cancer research at UC Irvine. He earned his MD and a PhD in biophysics from the Stanford University School of Medicine, completed his residency and hematology fellowship at Harvard Medical School and Brigham & Women’s Hospital, and was a visiting scientist in the lab of Nobel laureate David Baltimore at MIT’s Whitehead Institute. He is the author of more than 150 scientific articles, reviews and book chapters.
Recent News
Helio recently presented a poster on its Ochsner Health collaboration at the 2024 San Antonio Liver Cancer Symposium (a top-three abstract) — read more — and presented CLiMB trial data at the EASL Congress 2024.
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. Its primary goals were to evaluate the sensitivity and specificity of HelioLiver Dx compared to ultrasound for the detection of HCC in a population at high risk due to liver cirrhosis.
About Helio Genomics
Helio Genomics, founded in 2016 and headquartered in Irvine, CA, is a commercial-stage, AI-driven diagnostics platform company focused on early cancer detection, precision oncology, recurrence and treatment monitoring, using liquid biopsy and DNA methylation analysis.
Investor Contact
Jeremy Feffer
Managing Director, LifeSci Advisors
jfeffer@lifesciadvisors.com
SOURCE Helio Genomics. View source version on GLOBE NEWSWIRE.