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BERKELEY, Calif. and MAINZ, Germany, Dec. 20, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the first patient has been enrolled in eAArly DETECT, Mainz’s U.S. extension of ColoFuture, its European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert. Currently, Mainz is commercializing ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) across Europe and in select international territories. ColoFuture/eAArly DETECT are multi-center studies assessing the potential of these biomarkers to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC.
“Given the transformational impact that integrating advanced adenoma detection will have on ColoAlert’s technical profile and ultimate role in helping CRC prevention and treatment, today’s milestone is important as we embark on the execution phase of this feasibility study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “All of us involved with Mainz are excited by the prospect of incorporating these biomarkers into ReconAAsense, our U.S. pivotal study to evaluate the clinical performance of ColoAlert which we anticipate commencing patient enrollment in H1 2023.”
The five novel gene expression (mRNA) biomarkers being evaluated in the eAArly DETECT/ColoFuture studies were in-licensed from the Université de Sherbrooke, Quebec, Canada (January 2022). In the institution’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using colon cancer samples and precancerous lesions. The five mRNA targets chosen by Mainz Biomed provided the greatest sensitivity and specificity of detection (Herring et al. 2021) and demonstrated a unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC. The eAArly DETECT study will evaluate the effectiveness of these biomarkers to enhance ColoAlert’s product specifications to extend its capability to include the identification of advanced adenomas while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
Mainz expects to complete enrollment for the eAArly DETECT in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, the Company will determine which of the biomarkers are eligible for inclusion in the Company’s U.S. pivotal trial (ReconAAsense), which is on schedule to begin enrolling patients in 2023 with results expected in 2025.
ColoAlert detects CRC via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with a fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements). The product is commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. 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
According to the Centers for Disease Control and Prevention (CDC), colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC, which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the US, with 52,980 resulting in death. Recent decisions by the US Food and Drug Administration (FDA) suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently, there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years and a US market opportunity of approximately $3.7 billion per year.
About Mainz Biomed NV
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. ColoAlert is currently marketed across Europe and the United Arab Emirates. The Company is currently 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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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 May 5, 2022. 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.