Natera, Diakonos Oncology Pair to Test Molecular Response in Refractory Melanoma Patients

Editor’s Take: Refractory melanoma is a significant unmet need; though immunotherapy has transformed the treatment landscape, novel approaches are needed.

Natera and Diakonos Oncology are collaborating to assess molecular response in patients with refractory melanoma. The partnership uses Natera’s Signatera test to longitudinally evaluate patients enrolled in Diakonos’ Phase I/II investigational immunotherapy trial (DOC-RM).

Natera is a global company specializing in cell-free DNA and precision medicine, particularly for oncology, women’s health, and organ health. Diakonos, a clinical-stage biotechnology company, develops immunotherapies to treat challenging and/or aggressive cancers.

New Approaches Needed for Melanoma

The DOC-RM trial, which began enrolling earlier in May, is evaluating DOC1021 (dubodencel), a first-in-class personalized dendritic cell investigational therapy. The U.S. FDA recently gave Fast Track designation to DOC1021 in unresectable or metastatic cutaneous melanoma.

According to Natera and Diakonos, refractory melanoma is an area of significant unmet need. Immunotherapy has helped transform the advanced melanoma treatment landscape. However, a need persists for novel therapeutic approaches. This is because many patients either do not respond to the available treatments or develop eventual resistance.

Natera, Diakonos Oncology Work in Tandem

The Signatera test enables Natera to conduct analyses of circulating tumor DNA (ctDNA) at multiple timepoints during and following treatment. With radiographic response assessment presenting challenges in patients treated with immunotherapy, serial ctDNA monitoring may provide insights earlier during treatment.

Diakonos Oncology President and Chief Operating Officer Jay Hartenbach said imaging for minimal residual disease (MRD) often lags biology.

“DOC1021’s path forward in refractory melanoma will benefit from early, high-quality evidence of activity,” Hartenbach said. “Natera’s Signatera test is the most trusted tumor-informed MRD platform in oncology, making them a natural partner.”

“Signatera is uniquely positioned to help biopharma partners evaluate molecular response throughout therapy,” Eric Matthews, general manager, BioPharma, Natera, said. “By assessing MRD status across multiple timepoints, this collaboration has the potential to provide deep insight into treatment response dynamics.”