Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study

Rhea-AI Summary

Mainz Biomed has received approval for its pivotal study, ReconAAsense, aimed at evaluating the clinical performance of its colorectal cancer detection test. The study will enroll approximately 15,000 subjects across 150 sites in the U.S., with results expected in 2025. This study is crucial for obtaining FDA marketing authorization and enhancing the technical profile of Mainz Biomed's tests for detecting advanced adenomas, which can lead to colorectal cancer. The eAArly DETECT study aims to integrate novel biomarker technology to improve diagnostic sensitivity.

Positive

• Approval obtained for ReconAAsense pivotal study to evaluate colorectal cancer detection test.
• Study will include 15,000 subjects, enhancing chances for FDA marketing authorization.
• Potential to upgrade the technical profile of tests, increasing sensitivity and specificity.

Negative

• Results of the study will not be available until 2025, delaying market entry.
• Dependence on the eAArly DETECT study outcomes for integration of biomarkers.

• ReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025
• Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)
• Study will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization

BERKELEY, Calif. and MAINZ, Germany, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense, the Company’s U.S. pivotal study to evaluate the clinical performance of its highly efficacious and easy-to-use detection test for colorectal cancer (CRC). Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.

ReconAAsense is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and advanced adenomas (AA). 

Integral to the Company’s development strategy concerning the evolution of the product’s specifications is the potential to upgrade its technical profile to achieve a transformational advancement in self-administered CRC screening. To this end, Mainz Biomed recently initiated eAArly DETECT, its U.S. extension of ColoFuture, the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into its next-generation product. These biomarkers have demonstrated a unique ability to identify precancerous colonic polyps and early-stage CRC (Herring et al., 2021). The eAArly DETECT study was initiated in November of 2022 and is evaluating the effectiveness of these biomarkers to enhance product specifications to extend its capability to include the detection of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for colorectal cancer. Mainz Biomed expects to complete eAArly DETECT enrollment in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, Mainz Biomed will decide on the integration of the biomarkers evaluated in ColoFuture’s eAArly DETECT into the ReconAAsense study.

“Given that colorectal cancer continues to be one of the deadliest forms of cancer, early detection plays a critical role in disease prevention and treatment,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to commencing the U.S. regulatory approval process for our next-generation product and are passionate about bringing this easy-to-administer test to the U.S. In addition, we eagerly await results from the ColoFuture feasibility study, as the potential to include novel biomarkers to detect advanced adenomas will be a game changer for at-home CRC screenings.”

Once enrollment commences, ReconAAsense will continue until at least 73 evaluable subjects are diagnosed with colorectal cancer, and at least 138 evaluable subjects are diagnosed with advanced adenoma. Details about the ReconAAsense study will soon be online at clinicaltrials.gov. The Company anticipates reporting results in 2025.

About Colorectal Cancer 
According to the Centers for Disease Control and Prevention (CDC), 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 US, with 52,980 resulting in death. Recent decisions by the US Food and Drug Administration (FDA) 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 and a US market opportunity of approximately $3.7 billion per year.

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 currently marketed across Europe and the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 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.

For media inquiries -
In Europe: 
MC Services AG 
Anne Hennecke/Caroline Bergmann 
+49 211 529252 20 
mainzbiomed@mc-services.eu

In the US: 
Spectrum Science 
Melissa Laverty/Valerie Enes 
+1 540 272 6465 
mainz@spectrumscience.com

For investor inquiries, please contact ir@mainzbiomed.com 

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 annual report 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. 

FAQ

What is the purpose of the ReconAAsense study?

The ReconAAsense study aims to evaluate the clinical performance of Mainz Biomed's colorectal cancer detection test.

How many subjects will be enrolled in the ReconAAsense study?

Approximately 15,000 subjects will be enrolled across 150 sites in the United States.

When are the results of the ReconAAsense study expected?

Results from the ReconAAsense study are expected in 2025.

How does the eAArly DETECT study relate to ReconAAsense?

The eAArly DETECT study is assessing novel biomarkers that may enhance the sensitivity of the ReconAAsense test.

What regulatory approval is Mainz Biomed seeking?

Mainz Biomed is seeking FDA marketing authorization based on the results from the ReconAAsense study.