Microbiome-based stratification of immune-oncology cancer patients for optimal treatment.

Recent advancements in microbiome science suggest it holds the key to revolutionizing medicine, offering insights into health and solutions for complex diseases. Despite this potential, existing technologies have fallen short of translating discoveries into practical medical tools, such as reliable microbiome tests to guide treatments and clinical decisions. Bio-Me has bridged this gap with its Precision Microbiome Profiling (PMP™), a purpose-built platform enabling reproducible routine microbiome testing. PMP™ is driving the development of biomarkers and diagnostics with broad applications, from improving cancer treatment responses and addressing recurring infections to advancing fertility treatments in women’s health. Esteemed institutions like Gustave Roussy, MIT, and Harvard, as well as pioneering companies like Microbiotica and Gedea, are leveraging PMP™ to enhance therapies and develop microbiome-based drugs. Notably, Bio-Me's collaboration in the EU Prevalung consortium demonstrated PMP™'s capacity to improve immune-oncology outcomes, with findings published in Cell this year. Supported by Norwegian Research Council funding, Bio-Me has validated testing methods for critical microbes and analyzed thousands of clinical samples, positioning Norway as a leader in the global microbiome revolution. Today, PMP™ is used worldwide to develop products that advance human health, unlocking the microbiome's vast potential in modern medicine.

Outcomes 1. Advancements in Microbiome Research and Diagnostics The project has established PMP™ as a groundbreaking technology for biomarker and diagnostic development in microbiome research. A key outcome is Bio-Me’s inclusion in the EU PREVALUNG Consortium, an influential initiative aiming to develop the first diagnostic signature for immune checkpoint inhibitor (ICI) treatment response. This collaboration highlights the trust placed in PMP™ as a robust and innovative platform. Additionally, Bio-Me’s partnership with Microbiotica has supported the development of a functional microbiome test for use alongside their live biotherapeutic product. 2. Expanded Collaboration and Knowledge Sharing Through partnerships with research institutions, clinical centers, and pharmaceutical companies, Bio-Me has significantly increased international collaboration. Data and resources, such as the HUNT4 microbiome dataset, have been made widely accessible, enabling further research and publications. Key collaborations with Ultimovacs, Microbiotica, and leading consortia have reinforced Bio-Me’s role as a catalyst for microbiome R&D. Technological Innovation and Capability Building Core advancements in assay design, workflow optimization, and data analysis have enhanced Bio-Me’s ability to rapidly expand its product portfolio. The project enabled the launch of RUO testing services for gut, skin, and vaginal microbiomes, establishing Bio-Me as a global leader in microbiome diagnostics. 3. Enhanced Competency and Regulatory Readiness By aligning its development processes with ISO 15189 guidelines and contributing to international regulatory discussions, Bio-Me has strengthened its capacity to meet the stringent requirements for clinical diagnostics. Impacts 1. Advancing Microbiome-based Precision Medicine The project’s impact is exemplified by the EU PREVALUNG Consortium’s decision to use PMP™ to translate a highly cited microbiome biomarker into a reproducible diagnostic test. The publication of this work in Cell (DOI: 10.1016/j.cell.2024.05.029) demonstrates how PMP™ can bridge the gap between discovery and clinical application, setting a precedent for microbiome-based diagnostics in precision medicine. 2. Fostering Innovation Ecosystems Bio-Me’s collaborations with key opinion leaders and institutions have strengthened the innovation ecosystem, ensuring that microbiome profiling becomes a central tool in healthcare. The company’s leadership in the EU Human Microbiome Action and other initiatives continues to shape the future of the field. 3. Driving Economic Growth The project has catalyzed Bio-Me’s business expansion, with service lab revenue growing at a CAGR of over 60% between 2022 and 2024. This growth reflects the increasing market demand for microbiome profiling and positions Bio-Me as a major player in the biotech sector.

Bio-Me will deliver the first fecal-microbiome-based effective precision medicine approach to immune checkpoint inhibitor cancer therapy with the potential of lifting patient response rates from 30% to 80%+, dramatically improving patient outcomes. Bio-Me has developed a gut microbiome analysis platform in collaboration with Thermo Fisher Scientific (TFS) called Precision Microbiome Profiling (PMP™). PMP™ is based on a targeted approach to microbiome analysis using qPCR/TaqMan assays in an OpenArray format. It enables the analysis of close to 200 samples in about 2 hours. This technology allows Bio-Me to deliver a microbiome-based test that is very well positioned to meetings requirements for clinical diagnostic applications. In this project, Bio-Me will further the development of PMP into a stratification tool that can assist medical doctors in determining optimal IO treatments. This will be done by developing specific assays for selected target bacteria known to interfere with IO medications. In order to accomplish this, Bio-Me will collaborate with leading doctors and scientists in Norway and abroad.