Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, today announced the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"⁽¹⁾ in Clinical Cancer Research, a journal published by the American Association for Cancer Research.

The study details the development of the Personalis Neoantigen Presentation Score (NEOPS™), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden. Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

“Given the varied response to immunotherapy as well as the potential toxicities associated with treatment, there is a need for improved biomarker approaches to better predict which patients will respond to therapy,” said Richard Chen, MD, Personalis CMO. “Our findings suggest that integrative, multi-omic biomarkers like NEOPS can be stronger predictors of response than simpler, single-analyte approaches, especially in the setting of new cancer therapies where the underlying biological mechanisms governing response are highly complex. We feel that NEOPS and other composite biomarkers will be important, sharper tools for enabling precision oncology.”

NEOPS utilizes technology that Personalis has been developing since 2015 to better predict neoantigens and identify associated escape mechanisms such as HLA LOH. Our ImmunoID NeXT, and clinical NeXT Dx tests make this advanced capability, including NEOPS, available to pharmaceutical researchers and clinicians for clinical trials and investigational use, and additional clinical studies with other tumor types are planned.

About Personalis, Inc.

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform™ is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, The Personalis Clinical Laboratory is built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA’88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

Forward-Looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to attributes or advantages of NEOPS or the Personalis NeXT Platform, Personalis’ business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

⁽¹⁾ Clin Cancer Res August 1 2021 (27) (15) 4265-4276; DOI: 10.1158/1078-0432.CCR-20-4314

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