Mainz Biomed Completes Successful Pre-Submission Process with the U.S FDA for ColoAlert’s Pivotal Clinical Trial

Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) received positive feedback from the FDA on the trial design for its colorectal cancer detection test, ColoAlert. As preparations for a pivotal clinical trial commence, the company initiated its reimbursement process with CMS. This trial aims to evaluate the effectiveness of ColoAlert, which detects CRC through a non-invasive test utilizing DNA analysis. The study, involving over 600 patients, is set to complete enrollment in late 2022, with results expected in early 2023. The U.S. market opportunity for CRC screening is estimated at $3.7 billion annually.

Positive

• FDA's supportive feedback on ColoAlert's pivotal trial design.
• Commencement of reimbursement process with CMS.
• Partnership with Precision for Medicine to enhance regulatory strategy.
• Potential U.S. market opportunity of approximately $3.7 billion.

Negative

• Pivotal clinical trial set to begin later than anticipated.
• Enrollment completion pushed to the second half of 2022.

• Multi-Center Study on Track to Commence in Late 2022
• Initiated Reimbursement Process with The Centers for Medicare and Medicaid Services

BERKELEY, Calif. and MAINZ, Germany, March 31, 2022 (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 that it has received supportive feedback from the U.S. Food & Drug Administration (FDA) on the Company’s pre-submission package profiling the potential pivotal clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). As Mainz prepares to launch ColoAlert’s pivotal clinical trial, the Company is also pleased to announce the formal commencement of its reimbursement process for ColoAlert by scheduling an initial meeting with The Centers for Medicare and Medicaid Services (CMS) in April 2022. The CMS is a federal agency in the U.S. Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program (CHIP), and health insurance portability standards.

“We are encouraged by the FDA’s supportive commentary on our proposed pivotal clinical trial design for ColoAlert and will now work with our clinical team to finalize the study’s protocols and make the necessary preparations to ensure premier trial execution,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “In concert with final pivotal clinical trial preparations, we are excited to pursue reimbursement for ColoAlert and are looking forward to commencing formal discussions with the CMS.”

An integral part of Mainz’s clinical execution and medical reimbursement strategies is its partnership with Precision for Medicine, a leading global Clinical Research Organization. Precision for Medicine will continue to work with Mainz’s management team to implement the U.S. focused regulatory and market access strategy for ColoAlert by finalizing ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient.  The Company is planning to integrate CMS guidelines into ColoAlert’s pivotal trial design, utilizing currently marketed CRC screening tests as benchmarks to provide the test with an optimal product profile for regulatory approval and success in the marketplace.

Mainz is marketing ColoAlert across Europe 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 late 2022.

About ColoAlert
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
*Dollinger MM et al. (2018)

About the ColoFuture Study
The ColoFuture study is an international clinical trial evaluating over 600 patients (women or men) in the age range of 40-85 at two participating centers in Norway and two in Germany. Subjects are invited to potentially participate in the trial when referred for a colonoscopy (pre-inclusion) to screen for CRC or an overall diagnostic analysis. Those who agree to provide a stool sample in advance of the procedure will be eligible for participation. Inclusion criteria are based on one of the following diagnostic outcomes: CRC, advanced precancerous lesions in colon, or normal colon. Then, each patient outcome will compare the observations recorded from the colonoscopy to the results from the ColoAlert test that incorporates the novel biomarkers. The primary endpoints of the study are to determine sensitivity and specificity rates for CRC with ColoAlert plus the new mRNA biomarkers. There are multiple secondary endpoints for evaluating the modified ColoAlert test, including, determining sensitivity for AA lesions in colon, specificity for advanced precancerous lesions in colon and, specificity for no colorectal finding (normal colon). The Company is expecting to complete enrollment during the second half of 2022 and is targeting reporting study results in early 2023.

About Colorectal Cancer
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 estimates that in 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions 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. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

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. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio 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, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

For more information, please visit www.mainzbiomed.com

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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 F-1 filed on January 21, 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 ColoAlert and how does it work?

ColoAlert is a non-invasive colorectal cancer detection test that analyzes DNA from stool samples to identify tumor markers, boasting high sensitivity and specificity.

What is the significance of the FDA's feedback on ColoAlert?

The FDA's supportive feedback on the trial design marks a crucial step towards regulatory approval and validates the clinical approach of ColoAlert.

What are the next steps for Mainz Biomed regarding ColoAlert?

Mainz Biomed will finalize the clinical trial protocols and proceed with the trial, which is planned to start in late 2022.

What is the market potential for ColoAlert in the U.S.?

The annual market opportunity for colorectal cancer screening in the U.S. is estimated at around $3.7 billion.

When are the results of the ColoFuture study expected?

Results from the ColoFuture study are targeted for release in early 2023, after patient enrollment is completed in the second half of 2022.