Mainz Biomed appoints Dr T Wang to medical advisory board

Mainz Biomed N.V., 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.
MB Bureau