Signatera™ to evaluate molecular response to investigational dendritic cell therapy as part of Diakonos’ Phase I/II trial

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company developing immunotherapies to treat challenging and aggressive cancers. As part of the collaboration, Signatera will be used to longitudinally assess molecular response in patients with refractory melanoma enrolled in Diakonos’ DOC-RM Phase I/II investigational immunotherapy trial.

The DOC-RM trial, which began enrollment in May, is evaluating DOC1021 (dubodencel), a first-in-class, personalized dendritic cell investigational therapy that recently received Fast Track designation by the U.S. Food and Drug Administration (FDA) in unresectable or metastatic cutaneous melanoma. With Signatera, Natera will conduct analyses of circulating tumor DNA (ctDNA) at multiple timepoints during and following treatment.

Refractory melanoma is an area of significant unmet need. Although immunotherapy has transformed the treatment landscape for advanced melanoma, many patients either do not respond or eventually develop resistance, underscoring the need for novel therapeutic approaches. Because radiographic response assessment can be challenging in immunotherapy-treated patients, serial ctDNA monitoring may provide earlier insight into molecular response and disease dynamics during treatment.¹

"With an FDA Fast Track designation in hand, DOC1021’s path forward in refractory melanoma will benefit from early, high-quality evidence of activity,” said Jay Hartenbach, president and COO of Diakonos Oncology. “Natera’s Signatera test is the most trusted tumor-informed MRD platform in oncology, making them a natural partner to help evaluate molecular response in a population where imaging often lags the biology.”

“Signatera is uniquely positioned to help biopharma partners evaluate molecular response throughout the course of therapy, and we are thrilled to partner with Diakonos on this exciting program,” said Eric Matthews, general manager, BioPharma, Natera. “By assessing MRD status across multiple timepoints, this collaboration has the potential to provide deep insight into treatment response dynamics and support future development efforts for patients with difficult-to-treat cancers.”

Resources

1. Ribas A, et al. Search for effective treatments in patients with advanced refractory melanoma. Journal for ImmunoTherapy of Cancer. 2021;9:e002820. doi:10.1136/jitc-2021-002820.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our or our partners’ efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

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