SOPHiA GENETICS Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024
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.
SOPHiA GENETICS (Nasdaq: SOPH) ha annunciato un aggiornamento sulla sua collaborazione con Boundless Bio e Precision for Medicine per sviluppare e implementare un algoritmo per la rilevazione del DNA extracromosomico (ecDNA) per studi clinici. L'algoritmo ecDNA Solution (ECS), progettato come un test clinico ad uso investigativo, identifica i pazienti con tumori amplificati da ecDNA utilizzando dati di sequenziamento di nuova generazione. Questa tecnologia è attualmente utilizzata nello studio di fase 1/2 POTENTIATE di Boundless Bio, relativo alla terapia BBI-355, indirizzata all'ecDNA.
La collaborazione sfrutta la SOPHiA DDM™ Platform di SOPHiA GENETICS per l'analisi dei dati e i servizi di laboratorio di Precision for Medicine. Questo approccio innovativo mira ad accelerare le diagnosi cliniche e semplificare l'ingresso nel mercato delle aziende farmaceutiche che mirano a trattare i tumori amplificati da oncogeni, che interessano oltre il 14% dei pazienti oncologici.
SOPHiA GENETICS (Nasdaq: SOPH) anunció una actualización sobre su colaboración con Boundless Bio y Precision for Medicine para desarrollar e implementar un algoritmo de detección de DNA extracromosómico (ecDNA) para ensayos clínicos. El algoritmo ecDNA Solution (ECS), diseñado como una prueba clínica solo para uso investigativo, identifica a los pacientes con tumores amplificados por ecDNA utilizando datos de secuenciación de nueva generación. Esta tecnología se está utilizando en el estudio de fase 1/2 POTENTIATE de Boundless Bio, relacionado con la terapia BBI-355 dirigida al ecDNA.
La colaboración aprovecha la SOPHiA DDM™ Platform de SOPHiA GENETICS para el análisis de datos y los servicios de laboratorio de Precision for Medicine. Este enfoque innovador tiene como objetivo acelerar los diagnósticos clínicos y simplificar la entrada al mercado de las compañías farmacéuticas que se enfocan en cánceres amplificados por oncogenes, que afectan a más del 14% de los pacientes con cáncer.
SOPHiA GENETICS (Nasdaq: SOPH)는 Boundless Bio 및 Precision for Medicine과 협력하여 임상 시험을 위한 비염색체 DNA (ecDNA) 탐지 알고리즘을 개발하고 배포하기 위한 업데이트를 발표했습니다. ecDNA Solution (ECS) 알고리즘은 연구용으로만 사용되는 임상 시험 분석법으로, 일반적인 임상 차세대 염기서열 분석 데이터를 사용하여 ecDNA가 증폭된 종양을 가진 환자를 식별합니다. 이 기술은 Boundless Bio의 POTENTIATE 1/2 단계 연구에서 ecDNA 지향 치료제인 BBI-355에 활용되고 있습니다.
이 협업은 데이터 분석을 위해 SOPHiA GENETICS의 SOPHiA DDM™ Platform과 Precision for Medicine의 실험실 서비스를 활용합니다. 이 혁신적인 접근 방식은 임상 진단을 신속하게 하고, 14% 이상을 차지하는 온코겐 증폭 암을 목표로 하는 제약 회사의 시장 진입을 간소화하는 것을 목표로 합니다.
SOPHiA GENETICS (Nasdaq: SOPH) a annoncé une mise à jour concernant sa collaboration avec Boundless Bio et Precision for Medicine pour développer et déployer un algorithme de détection de l'ADN extracromosomique (ecDNA) pour les essais cliniques. L'algorithme ecDNA Solution (ECS), conçu comme un test clinique à usage uniquement investigatif, identifie les patients atteints de tumeurs amplifiées par ecDNA en utilisant des données de séquençage nouvelle génération routinières. Cette technologie est utilisée dans l'étude de phase 1/2 POTENTIATE de Boundless Bio, qui porte sur la thérapie dirigée par ecDNA BBI-355.
La collaboration tire parti de la SOPHiA DDM™ Platform de SOPHiA GENETICS pour l'analyse des données et des services de laboratoire de Precision for Medicine. Cette approche innovante vise à accélérer les diagnostics cliniques et à simplifier l'entrée sur le marché des entreprises pharmaceutiques ciblant les cancers amplifiés par oncogènes, qui touchent plus de 14 % des patients atteints de cancer.
SOPHiA GENETICS (Nasdaq: SOPH) hat ein Update zu seiner Zusammenarbeit mit Boundless Bio und Precision for Medicine bekannt gegeben, um einen Algorithmus zur Erkennung von extrachromosomalem DNA (ecDNA) für klinische Studien zu entwickeln und bereitzustellen. Der ecDNA Solution (ECS) Algorithmus, der als klinischer Test nur für Forschungszwecke konzipiert ist, identifiziert Patienten mit ecDNA-amplifizierten Tumoren anhand von Routinedaten der klinischen Next-Generation-Sequenzierung. Diese Technologie wird derzeit in der Phase 1/2 Studie POTENTIATE von Boundless Bio für die ecDNA-gesteuerte Therapie BBI-355 eingesetzt.
Die Zusammenarbeit nutzt die SOPHiA DDM™ Platform von SOPHiA GENETICS für die Datenanalyse und die Labordienstleistungen von Precision for Medicine. Dieser innovative Ansatz soll die klinische Diagnostik beschleunigen und den Markteintritt von Pharmaunternehmen erleichtern, die auf amplifizierte Onkogen-Krebsarten abzielen, die über 14% der Krebspatienten betreffen.
- 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
- None.
Insights
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.
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.
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
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
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
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FAQ
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