Results of European study potentially incorporated into U.S. regulatory strategy for FDA approval
Opportunity for ColoAlert to become the gold standard at-home screening test for colorectal cancer
BERKELEY, Calif. and MAINZ, Germany, Jan. 19, 2022 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has formally contracted with DCN Dx, a leading international developer of point-of-care diagnostics, and provider of comprehensive product development services. An integral part of the engagement will be the role of Emily Friedland, Vice President of Clinical Research at DCN Dx, who will spearhead the preparation and initiation of Mainz’s European centric clinical study to evaluate the potential to integrate a portfolio of recently acquired novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer. This suite of biomarkers which were in-licensed from Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) in early January 2022, have demonstrated the unique ability to detect pre-cancerous lesions including advanced adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC). The study is on track to commence in the first half of 2022.
“We are excited to work with the DCN Dx team and in particular, Emily Friedland who brings tremendous expertise in designing and managing clinical trials for molecular genetic diagnostic tests in development,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “If this study proves statistically significant, it will position ColoAlert as the most comprehensive and accurate CRC self-administered screening test on the market, as its enhanced technical profile will detect cancerous polyps with a high degree of accuracy and potentially eliminate CRC via its ability to detect lesions associated with contracting this deadly disease.”
Under the terms of the engagement, DCN Dx will be responsible for the selection of additional clinical research organizations (CRO) and assist Mainz’s management with the development of robust study protocols and associated clinical processes. Emily brings to the project over 20 years of clinical research experience as a scientist and executive. She spent over a decade at Roche Molecular Systems focused on clinical studies for regulatory approval of PCR-based molecular devices, primarily in infectious diseases and STDs. Prior to joining DCN Dx, Emily served as the Director of Global Clinical Operations for Teleflex, Inc., a manufacturer of traditional medical devices where her team was responsible for all sponsored and investigator-initiated research across Teleflex’s five business units including Clinical Operations, Biostatistics and Data Management. Emily holds a BS in Biology (concentration in Microbiology) from Virginia Tech.
Mainz is currently marketing ColoAlert across Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The Company is also preparing to initiate ColoAlert’s regulatory pathway for approval in the U.S., and results from the European biomarker study will potentially be incorporated into the design of the U.S. clinical study.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemistry test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., 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.
*Dollinger MM et al. (2018)
About Colorectal Cancer
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 estimates that in 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions 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. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.
About DCN Dx
DCN Dx’s globally-recognized products and services enable today’s leading rapid diagnostics tests. DCN Dx provides end-to-end support for rapid diagnostic test development and production in an array of applications. With DCN Dx, clients receive the products and development, design, manufacturing, and commercialization expertise they need to meet their rapid diagnostic milestones. Learn more at dcndx.com
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. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio 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, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.
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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 Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021. 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.