6-K
SOPHiA GENETICS SA (SOPH)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGNPRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2021.
Commission File Number: 001-40627
SOPHiA GENETICS SA
(Exact name of registrant as specified in itscharter)
Rue du Centre 172
CH-1025 Saint-Sulpice
Switzerland
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
| Form 20-F | ☒ | Form 40-F |
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
SOPHiA GENETICS Announces Launch of DEEP-Lung-IVMultimodal Clinical Study
Study to leverage deep learning-enabled analysisof the aggregation of real-world multimodal data to validate predictive signatures associated with response to immunotherapy and prognosisof patients with stage IV non-small cell lung cancer
Large-scale, multicentric real-world study aimsto enroll 4,000 patients from approximately 30 sites across North America, Europe, and Latin America
BOSTON and LAUSANNE, Switzerland, December1, 2021— SOPHiA GENETICS SA (Nasdaq: SOPH), the creator of a global data pooling and knowledge sharing platform that advances data-driven medicine, announced today the launch of their DEEP-Lung-IV clinical study (NCT04994795). The study leverages deep learning-enabled analysis of the aggregation of multimodal clinical, biological, genomic and radiomics data to identify and validate predictive signatures associated with response to immunotherapy and prognosis of patients with metastatic non-small cell lung cancer (NSCLC).
Over the last decade, immunotherapy has revolutionized the treatment landscape for patients diagnosed with stage IV NSCLC and has become the standard of care in the frontline setting for patients without oncogene-activating mutations. Despite the clinical promise of immunotherapy, significant challenges remain as the majority of NSCLC patients fail to respond to immune checkpoint inhibitors. Today, PD-L1 is the only standard predictive biomarker for immune checkpoint inhibitor efficacy. However, it remains a very suboptimal biomarker with several well-characterized issues limiting its clinical utility. Thus, an urgent need exists to discover new predictive biomarkers of response to immunotherapy.
SOPHiA GENETICS’ DEEP-Lung-IV clinical study aims to predict immunotherapy treatment response at first evaluation at the individual patient level using data across multiple modalities including genomics, radiomics, clinical and biological data. The study also aims to validate an algorithm that will allow the prediction of outcomes at the individual patient such as progression-free survival (PFS) and overall survival (OS). This predictive model will help identify patients that are likely to benefit from immunotherapy versus those that are not, as well as stratify patients according to risk, helping clinicians make more informed therapeutic decisions for their patients and supporting biopharma to ensure the right patients are selected for clinical trials.
“We are very excited about the opportunity to validate multimodal predictive models through such an innovative large-scale, multicentric, real-world clinical study. We aim to generate entirely novel actionable insights to improve clinical outcomes for patients with stage IV NSCLC treated with immunotherapy and develop next-generation patient stratification strategies to support the selection of the right patients for clinical trials” said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS. “The analytical power of the multimodal SOPHiA GENETICS platform applied to this important clinical question illustrates the potential benefit for patients in embracing a future of Data-Driven Medicine.”
To learn more about the DEEP-Lung-IV clinical study, please visit https://clinicaltrials.gov/ct2/show/NCT04994795.
About SOPHiA GENETICS:
SOPHiA GENETICS is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 780 hospital, laboratory, and biopharma institutions globally.
More info: SOPHiAGENETICS.COM; follow @SOPHiAGENETICS on Twitter.
SOPHiAGENETICS products are for Research Use Only and not for use in diagnostic procedures, unless specified otherwise. The information includedin this press release is about products that may or may not be available in different countries and, if applicable, may or may not havereceived approval or market clearance by a governmental regulatory body for different indications for use. Please contact support@sophiagenertics.com to obtain the appropriate product information foryour country of residence.
SOPHiA GENETICS Forward-Looking Statements:
This press release contains statementsthat constitute forward-looking statements. All statements other than statements of historical facts contained in this press release,including statements regarding our future results of operations and financial position, business strategy, products and technology, aswell as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are basedon our management’s beliefs and assumptions and on information currently available to our management. Such statements are subjectto risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statementsdue to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can begiven that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the dateof this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in thispress release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statementsare based, unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracyof any such forward-looking statements.
Media Contact:
Eliza Bamonti
ebamonti@sophiagenetics.com
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| SOPHiA GENETICS SA | ||
|---|---|---|
| Date: December 01, 2021 | ||
| By: | /s/ Daan van Well | |
| Name: | Daan van Well | |
| Title: | Chief Legal Officer |