Renowned Experts to Support ColoAlert’s U.S. Pivotal Clinical Trial and Development of Additional Cancer Diagnostics
Dr. Wang is the GI (Gastrointestinal) Division Chief at Columbia University Vagelos College of Physicians and Surgeons and serves as Co-leader of the Tumor Biology and Microenvironment Program of the Herbert Irving Comprehensive Cancer Center
BERKELEY, US – MAINZ, Germany – JULY 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 the formation of a Medical Advisory Board (MAB), and the appointment of Dr. Timothy Wang as its inaugural member. The MAB will support the Company’s forthcoming U.S. pivotal trial for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) and assist Mainz in evaluating ColoAlert’s potential to address additional oncology indications along with enhancing Mainz’s pipeline of product candidates.
“We are excited to launch this advisory board and particularly pleased to build this consortium around Dr. Wang given his vast experience and domain expertise in the field of gastroenterology cancer research,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to making additional appointments to the MAB and working with these premier advisors to ensure ColoAlert’s planned U.S. pivotal trial is optimally positioned to succeed, and to help facilitate achieving our goal of bringing to market a robust pipeline of cutting-edge tests for early-stage detection of multiple cancers.”
Dr. Wang is a leading expert in gastroenterology cancer research and patient care. His laboratory has for decades investigated the molecular mechanisms of gastrointestinal carcinogenesis and the role of inflammation in promoting gastrointestinal neoplasia, including colon cancer. Dr. Wang is the Dorothy L. and Daniel H. Silverberg Professor of Medicine and GI Division Chief at Columbia University Vagelos College of Physicians and Surgeons and serves as Co-leader of the Tumor Biology and Microenvironment Program of the Herbert Irving Comprehensive Cancer Center.
In addition to his leadership at Columbia, Dr. Wang has served as President of the American Gastroenterology Association (AGA). His work has been recognized with numerous awards, including the Outstanding Investigator Award from the NCI, the Irene and Arthur Fishberg Prize for medical research, the Ruth Leff Siegel Award for pancreatic cancer research, and the William Beaumont Prize in Gastroenterology from the AGA.
Mainz announced in February 2022 that ColoAlert’s U.S. pivotal clinical trial pre-submission was accepted for review by the U.S. Food & Drug Administration (FDA), and in March received supportive feedback on the pre-submission package profiling the potential clinical trial design for ColoAlert. Mainz will continue to bring together experts in gastroenterology and pathology to provide continuing guidance as it navigates through pre-market activities including the FDA submission. Their input will ensure that clinical study endpoint definitions are aligned with current standards and practices, and that a comprehensive adjudication plan is executed to ensure endpoints are categorized accordingly. Furthermore, the MAB will play an active role in the analysis of new tests being contemplated internally for development, and in assessing in-licensing and M&A opportunities.
“I’m thrilled to help build out this advisory board and work as a collective to support Mainz in its mission to become the industry leader in developing and commercializing molecular genetics diagnostic tests for the early detection of cancers,” commented Dr. Wang. “It is an exciting time in the genetic testing field and Mainz represents a unique opportunity for me to provide insight and direction on next-generation technologies that have the potential to have a profound impact in healthcare.”
Mainz is currently marketing ColoAlert 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 running ColoFuture, an international clinical study evaluating the potential to integrate a portfolio of in-licensed novel mRNA biomarkers into the product which have previously demonstrated the unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC (Herring et al 2021). ColoFuture is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. The results of the study will ultimately impact the configuration of ColoAlert prior to commencing the U.S. pivotal study which is on track to begin in 2023.
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 immunochemical 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.
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 estimated that in 2021 there were 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.
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.