MiRXES strengthens global fight against cancer

SINGAPORE – MiRXES Pte Ltd, a Singapore-headquartered biotechnology company, whose mission is to save and improve lives through early, actionable, and personalized diagnoses with its innovative RNA-powered cancer early detection solutions, announced today the signing of a Memorandum of Understanding (MOU) that launched Project CADENCE (CAncer Detected Early caN be CurEd). Project CADENCE is the world’s first large-scale clinical research project for the discovery and validation of novel combinations blood-borne circulating microRNA (miRNA) and DNA methylation biomarkers that will lead to the development of a multi-cancer early detection test for up to nine high incidence and high mortality cancers, including lung, breast, colorectal, liver, stomach (gastric), esophageal, ovarian, pancreatic, and prostate cancers.

Witnessed by Guest-of-Honor, Mr. Ong Ye Kung, Minister for Health, MiRXES signed this MOU together with the National Cancer Centre Singapore, Nanyang Technological University, Singapore, (NTU Singapore), National University Hospital, Singapore General Hospital, Singapore Translational Cancer Consortium, Tan Tock Seng Hospital and Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine). This MOU represents a new public-private partnership where Project CADENCE, a global effort championed by clinician-scientists from Singapore’s institutes of higher learning (IHLs) and public healthcare institutions (PHIs) represented by all three healthcare clusters, and powered by MiRXES, aims to address the rising cancer incidence rate and economic impact in Singapore and globally through early detection.

Project CADENCE will receive an investment of an estimated S$50 million and more by MiRXES over a three-year period, with substantial in-kind contributions from the IHLs and PHIs. This research is expected to recruit more than 12,000 individuals including healthy average-risk individuals, high-risk individuals, patients with benign conditions, and newly diagnosed, treatment native cancer patients, and produce a significant number of intellectual property rights created on single- and multi-cancer biomarkers and test kits. The initiative will fortify Singapore’s leadership position in molecular cancer early detection solutions. The intellectual property rights will be shared by MiRXES, IHLs and PHIs, and the resulting blood test kits will be prototyped, manufactured, and commercialized by MiRXES.

Project CADENCE will also see the creation of more than 80 new positions in research, manufacturing, and data science over the next three years.

Dr. Zhou Lihan, Co-founder and CEO for MiRXES, said, “Since MiRXES was founded in 2014, we have been focused on being a global leading miRNA technology innovator and cancer early detection test developer. Following our 2019 launch of GASTROClear, the world’s first miRNA-based blood cancer early detection test, Project CADENCE is our most ambitious effort to date, where we leverage our proprietary technologies, a decade long RNA clinical test development experience, and Singapore’s strong clinical research and translation infrastructure, to develop a novel blood test that offers physicians and at-risk individuals the earliest possible signs of multiple solid cancers through a wholistic analysis of miRNA and DNA biomarkers. MiRXES’s investment in Project CADENCE is timely as we continue to accelerate the development and commercialization of miRNA-powered in vitro diagnostic (IVD) blood tests in oncology as well as pulmonary and cardiovascular disease areas.”

A two-phased approach to solve unmet needs

Project CADENCE comprises two phases. First, the biomarker discovery and test development phase between 2022 to 2024 will seek to surpass existing blood-based cancer biomarkers with more superior clinical performance in sensitivity and specificity. To identify novel combinations of miRNA and DNA methylation biomarkers to achieve better performance than existing tests, this phase will involve high-throughput, in-depth multi-omics analysis of the blood miRNA and DNA signatures of 12,000 individuals. The resulting cancer biomarkers will then be prototyped into a blood based multi-cancer early detection (MCED) test, manufactured in MiRXES’s newly opened Industry 4.0 (i4.0) IVD Manufacturing Facility in Singapore, under strict analytical and clinical validations by laboratory partners from A*STAR and the PHIs.

Implementation and clinical utility will take place in the second phase from 2024, with the goal of optimizing large-scale clinical implementation workflow and to demonstrate the utility of a MCED test in shifting today’s late stage cancer diagnosis to earlier stages. The second phase could see a longitudinal population cohort of more than 100,000 participants, including both average-risk and high-risk cancer individuals.

Project CADENCE and Singapore’s healthcare

Professor Yeoh Khay Guan, Lead Principal Investigator for the project said, “Project CADENCE combines the efforts of cancer experts from all three healthcare clusters in Singapore with MiRXES’ cutting edge nucleic acid technology in a national effort to address an unmet need. Success in this venture would produce a game changer and a major breakthrough, a first of its kind blood test that can accurately detect early cancers and save many lives.” He is also Irene Tan Liang Kheng Professor in Medicine and Oncology, Department of Medicine, NUS Medicine, and Senior Consultant, Division of Gastroenterology & Hepatology, National University Hospital.

Professor Chng Wee Joo, Executive Director of Singapore Translational Cancer Consortium, said, “Project CADENCE brings together institutional leaders in cancer care, that will further enhance Singapore’s early detection in cancer capabilities and advances STCC’s efforts towards the development of a National Early Detection and Screening Research Program, which ultimately aims to benefit patients. We are honored to promote institutional-industry collaborations, and partner with MiRXES to create early cancer detection solutions that will have positive effects on the healthcare system of Singapore.”

Professor Joseph Sung, NTU Senior Vice President (Health & Life Sciences) and Lee Kong Chian School of Medicine Dean, said, “We are delighted to partner with MiRXES in developing and validating a first-of-its-kind blood-based Multi-Cancer Screening Test. Early detection of these nine high mortality cancers will help to save lives and strengthen Singapore’s public health. NTU is well-placed to bring together experts collaborating across disciplines, leveraging LKCMedicine’s research strengths, to achieve these outcomes.”

Building infrastructure for the future

Together with the signing of the MOU, MiRXES also opened doors to two key laboratories at Biopolis, built through the COVID-19 pandemic – MiRXES Lab which is an ultra-high-throughput RNA research laboratory, and M Diagnostics a state-of-the-art molecular diagnostic laboratory. Both MiRXES laboratories will provide the crucial infrastructures to the development, validation and implementation of the MCED test. The co-location of more than 60 research institutes and biomedical research and development (R&D) companies within Biopolis promotes collaboration between private companies and public scientific or educational institutes. Its proximity to the IHLs, PHIs and private biomedical companies provides greater access to a close-knit community of global talents and cutting-edge R&D infrastructure, as well as create new partnerships and business opportunities.

Dr. Zhou said, “Throughout the pandemic, MiRXES with our partners in local IHLs and PHIs, continued to build technologies, know-hows and next-generation research and clinical infrastructures aligned with Singapore’s and an inevitable global shift towards preventive healthcare solutions. The MiRXES Lab enables us with a global leading throughput in miRNA biomarker analysis and discovery, while M Diagnostics serves as a reference clinical laboratory to work with our regional and global clinical laboratory partners for validation and implementation of novel molecular tests such as the MCED developed from Project CADENCE. Together with our i4.0 IVD Manufacturing Facility, MiRXES has further strengthened our technology and development capabilities in Singapore from research to manufacturing and clinical testing locally, with the goal to serve both our internal development needs and to provide support to the local ecosystem.”

Witnessed by Guest-of-Honor, Mr. Ong Ye Kung, Minister for Health, MiRXES signed this MOU together with the National Cancer Centre Singapore, Nanyang Technological University, Singapore, (NTU Singapore), National University Hospital, Singapore General Hospital, Singapore Translational Cancer Consortium, Tan Tock Seng Hospital and Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine). This MOU represents a new public-private partnership where Project CADENCE, a global effort championed by clinician-scientists from Singapore’s institutes of higher learning (IHLs) and public healthcare institutions (PHIs) represented by all three healthcare clusters, and powered by MiRXES, aims to address the rising cancer incidence rate and economic impact in Singapore and globally through early detection.

Project CADENCE will receive an investment of an estimated S$50 million and more by MiRXES over a three-year period, with substantial in-kind contributions from the IHLs and PHIs. This research is expected to recruit more than 12,000 individuals including healthy average-risk individuals, high-risk individuals, patients with benign conditions, and newly diagnosed, treatment native cancer patients, and produce a significant number of intellectual property rights created on single- and multi-cancer biomarkers and test kits. The initiative will fortify Singapore’s leadership position in molecular cancer early detection solutions. The intellectual property rights will be shared by MiRXES, IHLs and PHIs, and the resulting blood test kits will be prototyped, manufactured, and commercialized by MiRXES.

Project CADENCE will also see the creation of more than 80 new positions in research, manufacturing, and data science over the next three years.

Dr. Zhou Lihan, Co-founder and CEO for MiRXES, said, “Since MiRXES was founded in 2014, we have been focused on being a global leading miRNA technology innovator and cancer early detection test developer. Following our 2019 launch of GASTROClear, the world’s first miRNA-based blood cancer early detection test, Project CADENCE is our most ambitious effort to date, where we leverage our proprietary technologies, a decade long RNA clinical test development experience, and Singapore’s strong clinical research and translation infrastructure, to develop a novel blood test that offers physicians and at-risk individuals the earliest possible signs of multiple solid cancers through a wholistic analysis of miRNA and DNA biomarkers. MiRXES’s investment in Project CADENCE is timely as we continue to accelerate the development and commercialization of miRNA-powered in vitro diagnostic (IVD) blood tests in oncology as well as pulmonary and cardiovascular disease areas.”

A two-phased approach to solve unmet needs

Project CADENCE comprises two phases. First, the biomarker discovery and test development phase between 2022 to 2024 will seek to surpass existing blood-based cancer biomarkers with more superior clinical performance in sensitivity and specificity. To identify novel combinations of miRNA and DNA methylation biomarkers to achieve better performance than existing tests, this phase will involve high-throughput, in-depth multi-omics analysis of the blood miRNA and DNA signatures of 12,000 individuals. The resulting cancer biomarkers will then be prototyped into a blood based multi-cancer early detection (MCED) test, manufactured in MiRXES’s newly opened Industry 4.0 (i4.0) IVD Manufacturing Facility in Singapore, under strict analytical and clinical validations by laboratory partners from A*STAR and the PHIs.

Implementation and clinical utility will take place in the second phase from 2024, with the goal of optimizing large-scale clinical implementation workflow and to demonstrate the utility of a MCED test in shifting today’s late stage cancer diagnosis to earlier stages. The second phase could see a longitudinal population cohort of more than 100,000 participants, including both average-risk and high-risk cancer individuals.

Project CADENCE and Singapore’s healthcare

Professor Yeoh Khay Guan, Lead Principal Investigator for the project said, “Project CADENCE combines the efforts of cancer experts from all three healthcare clusters in Singapore with MiRXES’ cutting edge nucleic acid technology in a national effort to address an unmet need. Success in this venture would produce a game changer and a major breakthrough, a first of its kind blood test that can accurately detect early cancers and save many lives.” He is also Irene Tan Liang Kheng Professor in Medicine and Oncology, Department of Medicine, NUS Medicine, and Senior Consultant, Division of Gastroenterology & Hepatology, National University Hospital.

Professor Chng Wee Joo, Executive Director of Singapore Translational Cancer Consortium, said, “Project CADENCE brings together institutional leaders in cancer care, that will further enhance Singapore’s early detection in cancer capabilities and advances STCC’s efforts towards the development of a National Early Detection and Screening Research Program, which ultimately aims to benefit patients. We are honored to promote institutional-industry collaborations, and partner with MiRXES to create early cancer detection solutions that will have positive effects on the healthcare system of Singapore.”

Professor Joseph Sung, NTU Senior Vice President (Health & Life Sciences) and Lee Kong Chian School of Medicine Dean, said, “We are delighted to partner with MiRXES in developing and validating a first-of-its-kind blood-based Multi-Cancer Screening Test. Early detection of these nine high mortality cancers will help to save lives and strengthen Singapore’s public health. NTU is well-placed to bring together experts collaborating across disciplines, leveraging LKCMedicine’s research strengths, to achieve these outcomes.”

Building infrastructure for the future

Together with the signing of the MOU, MiRXES also opened doors to two key laboratories at Biopolis, built through the COVID-19 pandemic – MiRXES Lab which is an ultra-high-throughput RNA research laboratory, and M Diagnostics a state-of-the-art molecular diagnostic laboratory. Both MiRXES laboratories will provide the crucial infrastructures to the development, validation and implementation of the MCED test. The co-location of more than 60 research institutes and biomedical research and development (R&D) companies within Biopolis promotes collaboration between private companies and public scientific or educational institutes. Its proximity to the IHLs, PHIs and private biomedical companies provides greater access to a close-knit community of global talents and cutting-edge R&D infrastructure, as well as create new partnerships and business opportunities.

Dr. Zhou said, “Throughout the pandemic, MiRXES with our partners in local IHLs and PHIs, continued to build technologies, know-hows and next-generation research and clinical infrastructures aligned with Singapore’s and an inevitable global shift towards preventive healthcare solutions. The MiRXES Lab enables us with a global leading throughput in miRNA biomarker analysis and discovery, while M Diagnostics serves as a reference clinical laboratory to work with our regional and global clinical laboratory partners for validation and implementation of novel molecular tests such as the MCED developed from Project CADENCE. Together with our i4.0 IVD Manufacturing Facility, MiRXES has further strengthened our technology and development capabilities in Singapore from research to manufacturing and clinical testing locally, with the goal to serve both our internal development needs and to provide support to the local ecosystem.”