SOPHiA GENETICS Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

Rhea-AI Summary

SOPHiA GENETICS (Nasdaq: SOPH) announced an update on its collaboration with Boundless Bio and Precision for Medicine to develop and deploy an extrachromosomal DNA (ecDNA) detection algorithm for clinical trials. The ecDNA Solution (ECS) algorithm, designed as an Investigational Use Only Clinical Trial Assay, identifies patients with ecDNA amplified tumors using routine clinical next-generation sequencing data. This technology is being utilized in Boundless Bio's POTENTIATE Phase 1/2 study of BBI-355, an ecDNA-directed therapy.

The collaboration leverages SOPHiA GENETICS' SOPHiA DDM™ Platform for data analysis and Precision for Medicine's laboratory services. This innovative approach aims to expedite clinical diagnostics and streamline market entry for pharmaceutical companies targeting oncogene amplified cancers, which affect over 14% of cancer patients.

Positive

• Development of the first ecDNA clinical trial assay (ECS) in alignment with FDA guidelines
• Collaboration with Boundless Bio for the POTENTIATE Phase 1/2 clinical trial of BBI-355
• Integration of SOPHiA DDM™ Platform with Precision for Medicine's laboratory services for efficient clinical trial enrollment
• Potential to address a significant market with over 14% of cancer patients affected by ecDNA-driven oncogene amplification

Negative

• None.

Medical Research Analyst

This collaboration marks a significant advancement in precision oncology. The development of the ecDNA Solution (ECS) algorithm to detect extrachromosomal DNA using routine NGS data is a groundbreaking approach. It addresses a critical gap in cancer treatment, targeting the 14% of cancer patients with ecDNA-driven oncogene amplification who typically don't benefit from existing targeted therapies.

The validation of this novel clinical trial assay could accelerate patient enrollment and potentially lead to more effective treatments for these hard-to-treat cancers. However, it's important to note that while promising, this is still in the early stages of clinical trials and efficacy and safety of BBI-355 remain to be proven.

Biotech Industry Analyst

This partnership between SOPHiA GENETICS, Boundless Bio and Precision for Medicine showcases a trend towards integrated, data-driven approaches in drug development. SOPHiA's cloud-native platform enables global reach and standardization, potentially reducing time and costs in clinical trials. The collaboration also highlights the growing importance of companion diagnostics in oncology drug development.

For SOPHiA GENETICS, this partnership could strengthen its position in the biopharma market, diversifying its revenue streams beyond clinical diagnostics. However, the success of this venture heavily depends on the clinical trial outcomes of BBI-355, which carries inherent risks typical of early-stage oncology drugs.

Financial Analyst

While this news doesn't provide immediate financial impact, it positions SOPHiA GENETICS favorably in the growing precision medicine market. The company's ability to develop FDA-aligned clinical trial assays and support global trials could attract more biopharma partnerships, potentially leading to new revenue streams.

However, investors should note that the financial benefits are likely long-term and contingent on successful clinical outcomes. The oncology drug development landscape is highly competitive and risky. SOPHiA's diversified approach, serving both clinical diagnostics and biopharma, helps mitigate some of this risk, but the company's path to profitability remains a key consideration for investors.

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 DDM^TM 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:
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 press release speak only as of the date hereof. 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.

 

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SOURCE SOPHiA GENETICS

FAQ

What is the purpose of SOPHiA GENETICS' collaboration with Boundless Bio?

The collaboration aims to develop and deploy an extrachromosomal DNA (ecDNA) detection algorithm as a clinical trial device to identify patients with ecDNA amplified tumors for Boundless Bio's POTENTIATE Phase 1/2 clinical trial of BBI-355.

How does the ecDNA Solution (ECS) algorithm work?

The ECS algorithm detects the presence of ecDNA using routine clinical next-generation sequencing (NGS) data, designed as an Investigational Use Only Clinical Trial Assay (IUO CTA) in alignment with FDA guidelines.

What is the significance of targeting ecDNA in cancer treatment?

ecDNA is a root cause of oncogene amplification in over 14% of cancer patients. Targeting ecDNA represents a novel therapeutic approach for oncogene amplified cancers, which typically do not respond well to existing targeted therapies.

How is Precision for Medicine involved in the SOPH collaboration?

Precision for Medicine provides state-of-the-art, CAP-accredited, CLIA-certified laboratory services for Boundless Bio's POTENTIATE clinical trial, adapting its diagnostic workflow to integrate with SOPHiA GENETICS' DDM™ Platform.