The companies share how their collaboration
enables clinical trial enrollment for a novel cancer therapy for
oncogene amplified cancers in development by Boundless Bio
BOSTON and ROLLE, Switzerland, Sept. 5,
2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq:
SOPH), a cloud-native healthcare technology company and a global
leader in data-driven medicine, today announced an update from the
Company's work with biopharma company Boundless Bio. SOPHiA
GENETICS first partnered with Boundless Bio in 2022 to develop and
deploy Boundless Bio's extrachromosomal DNA (ecDNA) detection
algorithm as a clinical trial device, to identify patients with
ecDNA amplified tumors using the SOPHiA DDM™ Platform. The two
companies collaborated with precision medicine clinical research
organization (CRO) Precision for Medicine, which contributes its
state-of-the-art, CAP-accredited, CLIA-certified laboratory
services to Boundless Bio's POTENTIATE Phase 1/2 clinical trial by
successfully validating a proprietary workflow to process patient
samples.
It is well established that oncogenic alterations, such as
mutations and fusions, can lead to malignant cellular growth that
results in cancer. While approved targeted agents are available to
treat several types of oncogenic mutations, patients whose cancers
harbor oncogene amplification typically do not derive the same
benefit. Oncogenes can be amplified not only on chromosomes but
also on ecDNA, which are cancer-specific, circular fragments of DNA
that are a root cause of oncogene amplification in over 14 percent
of patients with cancer. Boundless Bio targets ecDNA as a novel
therapeutic axis in oncogene amplified cancers.
Together, SOPHiA GENETICS and Boundless Bio pioneered the ecDNA
Solution (ECS) algorithm to detect the presence of ecDNA using
routine clinical next-generation sequencing (NGS) data. ECS is the
first ecDNA clinical trial assay and was designed by SOPHiA
GENETICS in alignment with FDA guidelines as an Investigational Use
Only Clinical Trial Assay (IUO CTA). SOPHiA GENETICS provides data
and analytical support for the device usage in Boundless Bio's
ongoing, first-in-human POTENTIATE Phase 1/2 study of its lead
ecDNA-directed therapy (ecDTx), BBI-355.
"The work we've done with SOPHiA GENETICS over the last two
years to develop ECS is vital to identify patients with ecDNA
amplified tumors for our POTENTIATE clinical trial of BBI-355,"
said Peter Krein, Ph.D., Senior Vice
President of Precision Medicine at Boundless Bio. "The capabilities
that SOPHiA GENETICS provides, from assay development to clinical
trial use, help enable this first-in-human precision medicine
clinical trial."
"We are excited to see our SOPHiA DDMTM Platform's
capabilities continue to be delivered across the clinical trial
continuum through our ground-breaking collaboration with Boundless
Bio. We are very excited at the prospect of contributing to
meaningful clinical advances for patients with ecDNA-driven
oncogene amplified cancers," said Philippe Menu, M.D., PhD., Chief
Medical Officer and Chief Product Officer, SOPHiA GENETICS.
SOPHiA GENETICS provides a technology-agnostic cloud-native
platform for the computing, standardization and analysis of genomic
data, allowing inputs from any leading NGS technology. The
decentralized SOPHiA DDM™ Platform breaks barriers
inherent to the traditional lab approach, allowing for global reach
into major hospitals and academic centers. This technology will
expedite the implementation of clinical diagnostics and streamline
market entry for pharmaceutical companies.
Precision for Medicine incorporates scientific expertise
and clinical trial excellence to deliver critical insights into
patient biology. Precision is supporting the POTENTIATE clinical
trial by adapting its diagnostic workflow to ensure a seamless
connection with the SOPHiA DDM™ Platform. Results from testing of
POTENTIATE trial participants' biopsy samples will be used to
further analyze clinical activity of the investigational drug
BBI-355 in specific patient populations.
"Working side-by-side with Boundless Bio and SOPHiA GENETICS,
Precision for Medicine has generated a novel and seamless platform
unlike any other that enables a new model for clinical trial
testing," said Darren Davis, PhD,
Senior Vice President, Precision for Medicine. "By expediting a
more accurate patient selection process, we can exceed the industry
standard for clinical trial enrollment and support the potential
for new ecDNA-directed therapies to reach patients in a timely
manner."
More information about this collaboration will be provided
during the World Clinical Biomarkers & CDx event in
Boston on September 5, 2024. Learn more about the event
here and learn more about the Company's BioPharma solutions here.
About SOPHiA GENETICS
SOPHiA GENETICS (Nasdaq: SOPH)
is a cloud-native healthcare technology company on a mission to
expand access to data-driven medicine by using AI to unlock
insights to deliver world-class care to patients across the globe.
It is the creator of SOPHiA DDM™, a platform that analyzes complex
genomic and multimodal data and generates real-time, actionable
insights for a broad global network of hospital, laboratory, and
biopharma institutions. For more information,
visit SOPHiAGENETICS.COM and connect with us
on LinkedIn.
About Precision for Medicine
Precision for Medicine is the first biomarker-driven clinical
research and development services organization supporting life
sciences companies in the use of biomarkers essential to targeting
patient treatments more precisely and effectively. Precision
applies a transformational approach to clinical research that
integrates clinical trial design and execution with deep scientific
knowledge, laboratory expertise, data sciences and advanced
manufacturing solutions. This convergence is driving faster
clinical development and approval. Precision for Medicine is part
of Precision Medicine Group, with 3,400 people in 40 locations
globally across North America,
Europe and Asia-Pacific. For more information, visit
PrecisionForMedicine.com.
SOPHiA GENETICS products are for Research Use Only and not
for use in diagnostic procedures, unless specified otherwise. The
information 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@sophiagenetics.com to
obtain the appropriate product information for your country of
residence.
SOPHiA GENETICS Forward-Looking
Statements:
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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 press release speak only as of the date hereof. We
expressly disclaim any obligation or undertaking to update these
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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
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