Mainz Biomed Presented Industry Leading Results of its Pooled Study at ASCO 2024

Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, presented pivotal data from its largest cohort to date during a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois, and online. This data combines results from the ColoFuture and eAArly DETECT studies including additional patients collected since the first reported study results, demonstrating the significance of its innovative screening approach.

The combined analysis involves 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the United States, including previously unexamined and unreported samples, highlighting the remarkable efficacy of Mainz Biomed's multimodal screening test. This test integrates the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm. This combination enables precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.

Presentation DetailsTitle: “A Novel, Non-Invasive, Multimodal Screening Test for Early Detection of Precancerous Lesions and Colorectal Cancer Using an Artificial Intelligence-Based Algorithm.”Presenter: Dr. D. Kim TurgeonAbstract #: 3627Poster Bd #: 290Citation: J Clin Oncol 42, 2024 (suppl 16; abstr 3627)

Key Findings

• Sensitivity for Colorectal Cancer: 92.3% (95% confidence interval: 84.0-97.1)
• Specificity: 90.1% (95% confidence interval: 87.1-92.7)
• Sensitivity for Advanced Precancerous Lesions: 82.2% (95% confidence interval: 75.0-88.0)
• High-Grade Dysplasia Detection Rate: 95.8%

This study highlighted the significant advantage of the multimodal screening test over existing methods, particularly in detecting advanced precancerous lesions. For example, the sensitivity for detecting high-grade dysplasia, which have an increased risk of turning into cancer, with the multimodal approach was 95.8%, significantly higher than other non-invasive tests currently available.

“These results offer the unique promise of a self-administered screening tool with highly effective detection of adenomas (AA), a type of pre-cancerous polyp often attributed to this deadly disease,” commented Dr. Kim Turgeon, M.D., Professor of Gastroenterology and Internal Medicine at University of Michigan Health. “Patients with advanced adenomas have an increased risk of developing colorectal cancer. The significant improvement in AA sensitivity compared to other non-invasive tests currently available, allows for the screening paradigm to shift from cancer detection to prevention. I believe that these results are very promising for the GI community.”

Dr. Moritz Eidens, Chief Scientific Officer at Mainz Biomed, commented, “Combining data from two different studies to achieve these outstanding results is highly unusual and demonstrates the robustness of our multimodal screening test. It is also the third consecutive read-out of scientific data that confirms the ability of our innovative test: the significant improvement in sensitivity for advanced adenomas, combined with high sensitivity and specificity for CRC, supports our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”

For more detailed results, visit https://mainzbiomed.com/wp-content/uploads/2024/05/ASCO_MBM_poster.pdf to access the poster with the detailed results.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About eAArly DETECT and ColoFutureeAArly DETECT and ColoFuture studies were designed to integrate novel mRNA biomarkers into Mainz Biomed’s pivotal FDA PMA clinical trial ReconAAsense. The studies included 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe. The two cohorts included patients (US cohort aged 45 and older and European cohort aged 40 and older) that provided a stool sample before undergoing a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.

About Colorectal CancerColorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is planning to run 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. To learn more, visit mainzbiomed.com.   

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