NeraCare Announces Publication of Abstract on Clinical Validation of a Prognostic 7-Biomarker Assay for Prediction of Relapse in Patients with Early-Stage Cutaneous Melanoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

• Assay identified 98% of relapses and 100% of cutaneous melanoma-related deaths in stage IB/IIA patients
• Patients with stage IB/IIA melanoma identified as high-risk had a relapse rate comparable to later-stage patients for whom adjuvant therapy is already approved
• The prognostic assay may be useful in selecting early-stage melanoma patients for adjuvant trials
• Assay is being transferred to the Akoya Biosciences’ PhenoImager® HT multiplex platform to enable automation and tissue preservation

FRANKFURT, Germany--(BUSINESS WIRE)-- NeraCare, a leading developer of laboratory tests for personalized survival prediction of melanoma patients, today announced publication of an abstract describing the clinical validation of a prognostic seven biomarker immunohistochemistry (7-IHC; Immunoprint) risk categorization assay that stratifies patients with early-stage (IB/IIA) cutaneous melanoma into high-risk or low-risk groups for recurrence and melanoma-specific survival, on the American Society of Clinical Oncology (ASCO) website.

Results of the Melarisk-001 study demonstrated that use of 7-IHC identified 98% of relapses and 100% of cutaneous melanoma-related deaths in stage IB/IIA patients. Patients with 7-IHC high-risk had a relapse rate comparable to stage IIB-IV patients for whom adjuvant therapy is approved. Results of the study suggest its utility in selecting early-stage melanoma patients for adjuvant trials.

“Anti-PD-1 therapy is a standard of care adjuvant therapy for cutaneous melanoma patients with resected AJCC stages IIB-IV disease.” said Jeffrey Weber, MD, PhD, co-author of the poster and Deputy Director of the Perlmutter Cancer Center and Co-Director of the Melanoma Research Center at NYU Langone Health. “Nonetheless, a smaller subgroup of earlier-stage patients with IB or IIA disease is at high risk of relapse and death, and remains without access to adjuvant therapy. This subgroup accounts for a significant share of overall melanoma-related mortality. While adjuvant clinical trials for these earlier-stage patients that will be destined to relapse may be merited, this subgroup is not detectable via current AJCC staging alone. The ability to identify these patients using 7-IHC may be useful in selecting such high-risk participants for adjuvant trials.”

The multicenter MELARISK-001 archival study enrolled 382 patients diagnosed with stage IB/IIA cutaneous melanoma with available formalin-fixed paraffin-embedded primary melanoma tissue sections; 247 (65%) patients were categorized as stage IB and 135 (35%) were stage IIA, all sentinel node-negative. Tissue specimens were analyzed by the 7-IHC assay and patients classified as either high-risk or low-risk. The assay measures the expression of five risk markers (Bax, Bcl-X, CD20, COX-2, PTEN) and two protective markers (MTAP, β-Catenin). Median follow-up for recurrence-free survival (RFS) was 90 months and for melanoma-specific survival (MSS), 98 months.

• 7-IHC classified 212 patients (55%) as high-risk and 170 (45%) as low-risk
• 7-IHC high-risk patients had significantly worse survival outcomes than 7-IHC low-risk patients

“As the majority of melanoma patients are diagnosed with early-stage disease, there is a critical unmet medical need to identify those at-risk patients to potentially enable earlier access to life-saving therapeutic agents,” said Daniel von Janowski, Co-Founder of NeraCare.

“With clinical validation of 7-IHC and the potential for tens of thousands of early-stage melanoma patients to benefit from the test, we are already in the process of transferring the assay from IHC to the Akoya Biosciences’ PhenoImager HT multiplex platform. In doing so, the assay can be fully automated and will require a much smaller tissue sample than is needed for IHC.” said Friedrich Ackermann, Co-Founder of NeraCare.

Poster Presentation Details:
Title: Clinical validation of a prognostic 7-marker IHC assay (7-IHC) in 382 patients (pts) with stage IB/IIA cutaneous melanoma (CM; MELARISK-001)
Presenter: Teresa Amaral, MD, PhD, Skin Cancer Center, Department of Dermatology, Eberhard Karls University of Tübingen
Abstract: 9572
Poster Board: 356
Session Title: Melanoma/Skin Cancers
Session Location, Date, and Time: Hall A, Saturday, June 1 - 1:30pm CDT

ABOUT NERACARE

NeraCare is a developer of laboratory tests for individualized survival with offices in Frankfurt and New York. In addition to Immunoprint®, the company markets the gene expression-based assay MelaGenix®, which was used in the phase III NivoMela trial, the first clinical trial in melanoma to select patients for adjuvant treatment based on individualized risk for relapse. The company has raised more than $20 million in venture capital funding led by MIG Capital AG, also a founding investor of German biotech giant BioNTech.

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