Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
December 01 2021 - 8:13AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN
PRIVATE 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 its
charter)
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:
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-IV
Multimodal Clinical Study
Study to leverage deep learning-enabled analysis
of the aggregation of real-world multimodal data to validate predictive signatures associated with response to immunotherapy and prognosis
of patients with stage IV non-small cell lung cancer
Large-scale, multicentric real-world study aims
to enroll 4,000 patients from approximately 30 sites across North America, Europe, and Latin America
BOSTON and LAUSANNE, Switzerland, December
1, 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.
SOPHiA
GENETICS products are for Research Use Only and not for use in diagnostic procedures, unless specified otherwise. The information included
in this press release is about products that may or may not be available in different countries and, if applicable, may or may not have
received 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 for
your country of residence.
SOPHiA GENETICS Forward-Looking Statements:
This press release contains statements
that 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, as
well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based
on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject
to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements
due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be
given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date
of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this
press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements
are based, unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy
of 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.
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SOPHiA GENETICS SA
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Date: December 01, 2021
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By:
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/s/ Daan van Well
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Name:
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Daan van Well
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Title:
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Chief Legal Officer
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