Phase I trial in Germany will support treatment response monitoring for Kupando Therapeutics’ investigational immunotherapy using Latitude MRD testing

Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, today announced a new collaboration regarding a Phase 1 clinical trial, sponsored by Kupando Therapeutics.

Under the agreement, Natera’s Latitude tissue-free assay for molecular residual disease (MRD) detection will be used in Kupando’s clinical trial of its lead immunotherapy candidate, KUP-101. The trial will assess serial circulating tumor DNA (ctDNA) dynamics as part of treatment response monitoring. Patients with advanced tumors across multiple skin cancers will be treated with KUP-101 and Latitude MRD testing will be performed at multiple timepoints.

Following the successful dosing of the first patient, Kupando’s safety committee has approved the ongoing enrollment of further patients across the activated clinical sites, including leading oncology centers in Germany.

KUP-101 is designed to activate the innate immune system and induce trained immunity. It has potential as a tissue-agnostic treatment across multiple solid tumor types, both as a standalone therapy and in combination with other agents. To evaluate molecular response in this setting, the Latitude test is well suited to assess treatment response in the trial.

"Dosing our first patient is a defining inflection point in Kupando’s history," said Johanna Holldack, M.D., founder and chief executive officer, Kupando Therapeutics. "By leveraging the power of innate immune stimulation and the induction of trained immunity, KUP-101 represents a fundamentally different way of approaching hard-to-treat cancers. Natera’s Latitude test can provide valuable insights into treatment response dynamics, helping us better understand the molecular activity of this novel therapeutic approach and advance our clinical development program for patients with advanced solid tumors."

"We are pleased to work with Kupando as they advance this promising first-in-class approach to innate immune activation," said Eric Matthews, general manager, biopharma, Natera. "Latitude’s capabilities make it ideally suited to evaluate ctDNA dynamics across diverse solid tumor types, and we look forward to generating molecular insights that can support Kupando’s development of KUP-101 and ultimately help patients with difficult-to-treat cancers."

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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Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com