Mainz Biomed Partners with Microba Life Sciences for the Development of PancAlert

• 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, US and MAINZ, Germany – [May 10, 2023] -- (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 , 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. 
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 or follow us on , and .

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