On June 2, 2022 InterVenn Biosciences, a clinical technology company leveraging glycoproteomics to transform the future of healthcare, reported new data showing that its new DAWN IO Melanoma test accurately assesses and classifies advanced melanoma patients as likely or unlikely to benefit from immune checkpoint inhibitor therapies: either pembrolizumab alone or ipilimumab in combination with nivolumab (Press release, InterVenn Biosciences, JUN 2, 2022, View Source [SID1234615461]). This test was developed on InterVenn’s perspectIV platform, which can directly interrogate the blood glycoproteome, for its own development or on behalf of partners.

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InterVenn conducted the validation study of the new DAWN IO Melanoma test in collaboration with Mass General Hospital (MGH), on a cohort of 205 advanced melanoma patients. The company was able to develop a signature based on the blood glycoproteome. The test is designed to guide clinicians in accurately assessing individual likelihood of benefit to the commonly used therapies nivolumab and ipilimumab, given in combination, or pembrolizumab. The test showed strong discriminatory power with a hazard ratio of 4.93 and high statistical significance.

DAWN IO Melanoma is the first in a series of liquid biopsy-based assays that InterVenn plans to develop under the DAWN IO brand to address a variety of cancers. InterVenn is building a robust pipeline of liquid biopsy tests to unlock the untapped, rich layer of biology called the glycoproteome, which is, in simple terms, the entire set of sugars on proteins. Because of the essential roles glycoproteins play in physiological functions, the glycoproteome has the potential to be highly significant for real-time clinical decision-making.

"Immune checkpoint inhibitors simply don’t work on everyone. The launch of DAWN IO Melanoma helps physicians and patients with advanced melanoma plan the best treatment path based on their likelihood to benefit from these therapies," said Aldo Carrascoso, CEO of InterVenn. "The DAWN IO Melanoma validation study confirms that the perspectIV platform can identify glycoproteomic biomarkers that perform consistently and accurately, with the potential to support oncologists treating patients with advanced melanoma and other complex cancers."

The Problem that DAWN IO Melanoma Solves

Approximately 100,000 cases of melanoma are diagnosed a year in the United States, with 5% of those diagnosed at a late stage. While cancer immune therapies are powerful treatments for many types of cancer, including melanoma, they are effective only in subsets of patients. Reliable tests to assess a patient’s likelihood of benefit before starting immunotherapy are limited, which can lead to sub-optimal clinical decisions.

Patients who gain no health benefit miss out on alternative options for treatment, losing valuable time. As a result, there is a significant unmet medical need for tests that can guide physician selection of the appropriate treatment, including the recommendation to enroll in an appropriate clinical trial.

Built to meet clinical requirements, DAWN IO Melanoma interrogates the blood glycoproteome at an unprecedented speed and scale. Unlike other non-invasive methods, it does not depend on detecting material shed by tumors, and it requires a significantly lower blood sample volume than conventional methods. In addition, the groundbreaking ability to process significantly large amounts of highly complex post-translational information enables clinical applications of glycosylation in ways that clinicians have not previously seen.

The Validation Study

Results of the retrospective validation study demonstrated a glycoproteomic biomarker signature successfully identified metastatic melanoma patients as likely or not to benefit from ICIs, where the "Unlikely to Benefit" group displayed a median progression-free survival of 2.5 months versus 17.34 months for the Likely to Benefit group, p<1.29 x 10-5. The study’s results confirm that DAWN IO Melanoma determined 12% of patients were "Unlikely to Respond" while 10% were classified as "Indeterminate."

"Our validation study is an important milestone in InterVenn’s ongoing efforts to build high-quality clinical tests and the supporting clinical evidence that its innovative glycoproteomic biomarkers can enable," said Tillman Pearce, M.D., Chief Medical Officer at InterVenn.

InterVenn’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The DAWN IO Melanoma test was developed, and its performance characteristics were determined by InterVenn. The DAWN IO Melanoma test has not been cleared or approved by the U.S. Food and Drug Administration. InterVenn’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The DAWN IO Melanoma test is intended for clinical purposes.

Lung Registry: Enrollment Begins

To further support clinical evidence for DAWN IO, InterVenn is starting recruitment for its HEaLth through I/O therapy Success Registry (HELIOS-001), focused on individuals diagnosed with advanced malignancies who will begin ICI treatment. The HELIOS-001 Registry will support current and future discovery of InterVenn’s DAWN IO product portfolio. Individuals who consent to participate will be asked to provide an initial blood sample, as well as clinical data pertaining to their diagnosis and treatment. For more information about the Registry, please contact [email protected].

Poster Presentation at ASCO (Free ASCO Whitepaper) 2022

The validation results will be presented in a poster session on June 6 at 1:15-4:15 p.m. CT in Hall A, Abstract # 9545, Poster #138 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting at McCormick Place in Chicago.

Additional Information

For more information about DAWN IO Melanoma, go to www.intervennoncology.com. InterVenn will also have a stand at the ASCO (Free ASCO Whitepaper) conference and will be available for in-person meetings during the event.