• Combination of DNA biomarkers with microbiome biomarkers has potential to enhance technical profile of novel pancreatic cancer screening test

• Joint research project to discover disease specific microbiome biomarkers

BERKELEY, Calif. and MAINZ, Germany, May 10, 2023 (GLOBE NEWSWIRE) -- 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 a research collaboration with Microba Life Sciences (ASX: MAP) (“Microba”), a precision microbiome company leveraging a world-leading technology platform for measuring the human gut microbiome to discover and develop novel therapeutics for major diseases. As part of the agreement, Microba and Mainz Biomed will conduct a pilot research project utilizing Microba’s proprietary metagenomic sequencing technology and bioinformatic tools to potentially discover novel microbiome biomarkers for pancreatic cancer detection.

Pancreatic cancer is a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.¹ It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.² and 9% globally.³ However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher.

“We are excited by the opportunity to collaborate with Microba as PancAlert is being developed for early-stage disease detection with the goal of being a first-in-class screening test for this deadly form of cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Given the growing understanding of the microbiome’s role in pancreatic cancer, we believe it’s of paramount importance to explore integrating diagnostic microbiome biomarkers into the test as it advances to the clinical stage of development and as such, are delighted to align with a global leader in sourcing and analyzing microbiome generated species and datasets.”

The project is expected to run through late 2023 and will deploy Microba’s Community Profiler (MCP), Microba’s unique metagenomic platform technology. MCP has been established as a best-in-class research tool with the ability to produce comprehensive and accurate species profiles of human gastrointestinal samples. Mainz Biomed is currently commercializing its flagship product ColoAlert^®, a highly efficacious and easy-to-use detection test for colorectal cancer (CRC) in select international territories and in December of 2022, initiated a U.S. Pivotal Clinical Study (ReconAAsense) for a CRC screening test that may integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. These biomarkers have demonstrated potential to identify advanced adenomas, a type of curable pre-cancerous polyp often attributed to CRC that are being evaluated in European and U.S. studies (ColoFuture/eAArly DETECT). Results from eAArly DETECT are expected in mid-2023 and Mainz anticipates enrollment in ReconAAsense to commence in the second half of 2023.

References

1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. The online GLOBOCAN 2020 database is accessible at https://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
2. National Cancer Institute, Surveillance, Epidemiology and End Results Program (SEER). Cancer Stat Facts: Pancreatic Cancer. July 2021. https://seer.cancer.gov/statfacts/html/pancreas.html
3. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019;10(1):10-27. doi:10.14740/wjon1166
   
   

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 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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Forward-Looking Statements

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 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.