Collaboration to utilize cutting-edge AI analysis platform for clinical trials and cancer screening test processing
BERKELEY, US – MAINZ, Germany – NOVEMBER 9, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a strategic partnership with Liquid Biosciences, a bio-analytics company leveraging its proprietary AI analysis technology platform (EMERGE) to serve the biopharma and diagnostics industries along with academic institutions.
The collaboration builds upon Mainz Biomed’s initial utilization of EMERGE to analyze the Company’s ColoFuture study, which recently reported groundbreaking results including sensitivity for colorectal cancer of 94% with a specificity of 97% and a sensitivity for advanced adenoma of 80%. ColoFuture is an international multi-center clinical trial which assessed the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert®, Mainz Biomed’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. This proprietary family of mRNA biomarkers represents a potentially game-changing innovation in CRC screening as the portfolio has previously demonstrated the ability to detect CRC lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease.
Under the terms of the partnership, the utility of EMERGE in Mainz Biomed’s product development pipeline will be extended to include analysis of its eAArly DETECT study (the U.S. arm of the ColoFuture clinical trial), and the forthcoming U.S. pivotal FDA PMA trial (ReconAAsense) which, if successful, will enable Mainz Biomed to further advance its current test’s capabilities and commercialize a next-generation, gold standard, self-administered CRC screening tool. The eAArly DETECT clinical trial, a multi-center feasibility study is enrolling 265 subjects across 22 sites and remains on track to report results in Q4 2023. The goal at completion will result in a single fixed machine learning/AI-based algorithm, developed utilizing the evolutionary EMERGE platform, integrated into the next-generation product’s test report.
“As artificial intelligence continues to disrupt every aspect of the healthcare sector, we are excited to establish a robust partnership with a genuine leader in the field as we head into the final development stage of our next-generation CRC screening test,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to continuing our highly productive partnership with the Liquid Biosciences team as we execute on our mission to bring the most effective self-administered cancer detection products to the market.”
Since launching the EMERGE bio-analytics platform, Liquid Biosciences is widely considered to be the premier analytical partner to the life sciences industry. Its technology has been deployed in over 170 projects for Big Pharma and emerging therapeutic and diagnostic companies covering biomarker discovery, clinical trial screening and post-FDA approval services such as patient treatment selection and optimal dosing regiments. Key attributes of EMERGE that make it superior to mainstream AI and machine learning analytical solutions include its computational speed, ability to handle millions of variables and operate agnostically, without any assumptions or constraints. It was designed as a scalable, unbiased methodology to produce transparent algorithms from complex data, without any prior assumptions. This enables the identification of variables with relatively low expression, but which may be functionally important because of the non-linear interactions pervasive in complex biologic systems.
“We are excited to extend our relationship with Mainz Biomed into a formal partnership as we take great pride in working with companies who represent disruptive innovation that will impact disease prevention and treatment,” commented Patrick Lilley, Chief Executive Officer of Liquid Biosciences. “The work Mainz Biomed is doing will be crucial to saving lives from a disease where mortality is driven by late detection. As such, we are very pleased to have the opportunity to play an integral role in helping it develop the next generation of its pioneering products.”
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ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.
About Mainz Biomed N.V.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.
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About Liquid Biosciences
Liquid Biosciences radically reduces diagnostic and drug development risk, time, and cost, from pre-clinical research through regulatory approval. Our Emerge bio-analytics platform agnostically discovers and models the nonlinear dynamics of how biology, behavior, and circumstances interact to drive patient outcomes. Our mathematical evolution technology goes beyond artificial intelligence’s capabilities, and has produced superior accuracy, novel insights, and explainability in every head-to-head comparison with other analytic methods. Liquid Biosciences’ clients are major biopharma firms, diagnostic companies, and world-class research institutions. We’ve completed over 165 major analytic projects across 44 diseases, using the full spectrum of clinical trial, real-world, and multi-omics biomarker data. For more information about Liquid Biosciences, visit www.liquidbiosciences.com.
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.