- Cutting Edge IVD Developer Sentinel Chosen to Provide Automated FIT Analysis System
- Leading Clinical Research Organization Alcedis Selected to Manage the Study
ColoFuture on track to complete enrollment in 2H 2022
BERKELEY, Calif. and MAINZ, Germany, March 17, 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 partnerships with Sentinel Diagnostics and Alcedis GmbH to support ColoFuture, its clinical study evaluating the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC).
Sentinel Diagnostics is a global leader in the development and production of in vitro diagnostics (IVD). Under the terms of the partnership, Mainz will have access to the SENTiFIT® 270 Analyzer, Sentinel’s leading automated Fecal Immunochemical Test (FIT) processing system for the ColoFuture study. An essential component of ColoAlert is the utilization of a FIT which provides a complete review of blood in the stool, a condition often associated with cancerous polyps and colorectal carcinoma. It is the combination of ColoAlert and FIT results that provide the diagnostic outcome. This partnership enables Mainz to transition from deploying a manual FIT processing methodology to a state-of-the-art automated system for potential future use in the EU commercial setting and in the Company’s forthcoming U.S. clinical trial.
“We pride ourselves on aligning with companies spearheading diagnostic innovation so it’s a pleasure to provide support for this ground-breaking clinical study,” commented Marco Buonaguidi, Head of Sales and Marketing for Sentinel Diagnostics. “We are particularly excited to play a key role in ColoFuture because if the trial proves successful, it will position ColoAlert as the most robust and effective at-home diagnostic and preventive tool for one of the deadliest forms of cancer.”
In addition to the Sentinel appointment, Mainz is pleased to partner with Alcedis GmbH, a full-service state-of-the-art contract research organization (CRO) providing clinical trial management for biotechnology and medical device companies across the globe. Under the terms of the engagement, Alcedis will provide Mainz with the full range of services and responsibilities associated with executing ColoFuture, including patient recruitment, overseeing study protocol compliance, and the documentation and reporting of patient results.
“Establishing partnerships with industry leaders such as Sentinel and Alcedis is a testament to our dedication to operating the most sophisticated and streamlined product development system for bringing to market next-generation molecular diagnostic tools to improve early detection and prevention of serious cancer indications such as CRC,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “As we embark on the ColoFuture study, we are thrilled to engage with world-class partners in every aspect of the patient experience, and we look forward to enrolling our first patient into the study in due course.”
The ColoFuture study is evaluating over 600 patients including both male and female genders in the age range of 40-85 at two participating centers in Norway and two in Germany. Subjects will be invited to potentially participate in the trial when referred for a colonoscopy (pre-inclusion) to screen for CRC or an overall diagnostic analysis. Those who agree to provide a stool sample in advance of the procedure will be eligible for participation. Inclusion criteria are based on one of the following diagnostic outcomes: CRC, advanced precancerous lesions in colon, or normal colon. Then, each patient outcome will be compared to the observations recorded from the colonoscopy to the results from the ColoAlert test that incorporates the novel biomarkers. The primary endpoints of the study are to determine sensitivity and specificity rates for CRC with ColoAlert plus the new mRNA biomarkers. There are multiple secondary endpoints for evaluating the modified ColoAlert test, including, determining sensitivity for advanced adenomas (AA) lesions in colon, specificity for advanced precancerous lesions in colon and, specificity for no colorectal finding (normal colon). The Company expects to complete enrollment during the second half of 2022 and is targeting reporting study results in early 2023. Mainz is also preparing to initiate ColoAlert’s regulatory pathway for approval in the U.S., and results from ColoFuture 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 partners. 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.
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 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.
About Sentinel Diagnostics (Sentinel CH. S.p.A.)
Sentinel Diagnostics (Sentinel CH. S.p.A) is an Italian company based in Milan focused on the development and production of In Vitro Diagnostics for the most advanced Clinical Chemistry, Immunochemistry and Molecular Diagnostics platforms. Besides the wide product portfolio in Clinical Chemistry, the FOB Gold® line is Sentinel’s complete solution for colorectal cancer screening, which includes patented sampling devices and analytical systems. In the field of Molecular Biology, the STAT-NAT® portfolio is the company’s answer to the market need for sensitive, ready to use and eco-friendly Molecular Diagnostics, which now includes a RT-PCR test for the detection of SARS-CoV-2 infection (COVID-19). For more information, visit www.sentineldiagnostics.com.
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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 registration statement on Form F-1 filed on January 21, 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.