Mainz Biomed acquires the exclusive rights to a new mRNA


Potential for ColoAlert to become the most robust and accurate home screening test for colorectal cancer

Biomarkers have demonstrated a unique ability to identify curable precancerous colonic polyps as well as curable early-stage colorectal cancer

BERKELEY, Calif. And MAINZ, Germany, January 5, 2022 (GLOBE NEWSWIRE) – Mainz Biomed NV (NASDAQ: MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetic diagnostics company specializing in the early detection of cancer , today announced that it has entered into a technological rights agreement with Socpra Sciences Santé Et Humaines SEC (“TTS”) to access a portfolio of new mRNA biomarkers for possible future integration into ColoAlert, the highly efficient and easy to use. use the colorectal cancer test (“CRC”). Mainz is currently marketing ColoAlert in Europe through its unique business model of partnering with third-party laboratories for processing test kits versus the traditional methodology of operating a single facility. The Company is also preparing to launch the regulatory pathway for ColoAlert for approval in the United States.

Under the terms of the Technology Rights Agreement, the Company has the unilateral option to license exclusive worldwide rights to five gene expression biomarkers that have demonstrated a high degree of efficacy in detecting CRC lesions, including advanced adenomas (“AA”), a type of precancerous polyp often attributed to this fatal disease. In a study evaluating these biomarkers published in the online peer-review journal platform MDPI (March 11, 2021), the study results reached overall sensitivities of 75% for AA and 95% for the CCR, respectively, for a specificity result of 96%. If these statistical results are duplicated when biomarkers are integrated into ColoAlert, we believe this will ultimately position the company’s CRC test as the most robust and accurate home diagnostic screening test on the market. It will not only detect cancerous polyps with a high degree of accuracy, but has the potential to prevent CRC through the early detection of precancerous adenomas.

“Obtaining the exclusive license rights to this family of new biomarkers is a fantastic step for the company as it offers an extraordinary opportunity to potentially improve the technical profile of ColoAlert, making it perhaps the screening test for most efficient home for CRC that has ever been marketed. », Commented Guido Baechler, CEO of Mainz Biomed. “The Mainz team’s mission is to develop benchmark molecular diagnostic screening solutions for cancer indications and obtaining the rights to these biomarkers demonstrates our continued commitment to developing cutting-edge products because they have shown a Superior sensitivity even to fluid biopsy products in development in terms of identifying advanced adenomas.

The Company will now begin a clinical study in Europe to assess the efficacy of these biomarkers to improve the utility of ColoAlert in terms of expanding its ability to include the identification of advanced adenomas, while increasing the rates of diagnostic sensitivity and specificity. As ColoAlert in its current form has already been CE-IVD marked (in accordance with EU safety, health and environment requirements), the timeline and process to initiate this ‘follow-up’ study is speeded up. , and the Company is targeting the first half of 2022 to launch the clinical study. Additionally, the data generated by the study may potentially be incorporated into the company’s U.S. clinical trial design of ColoAlert for FDA review.

About ColoAlert
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity almost as high as an invasive colonoscopy *. The test uses proprietary methods to analyze cellular DNA for specific tumor markers combined with the fecal immunochemistry (FIT) test and is designed to detect tumor DNA and early-stage CRC cases. The product is CE-IVD marked (complies with EU safety, health and environmental requirements) and is in transition to IVDR compliance. The product is commercially available in several countries of the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical subsidiaries. Once approved in the United States, the Company’s business strategy is to establish scalable distribution through a collaborative partnership program with regional and national laboratory service providers across the country.
*Dollinger MM et al. (2018)

About colorectal cancer
Colorectal cancer (CRC) is the second deadliest cancer in the United States and Europe, but also the most preventable with early detection offering survival rates over 90%. Annual testing costs per patient are minimal, especially compared to advanced stage CRC treatments which cost patients an average of $ 38,469 per year. The American Cancer Society estimates that by 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the United States, of which 52,980 will result in death. Recent decisions from the FDA suggest that screening with stool DNA tests such as ColoAlert in the United States should be done once every three years starting at age 45. There are currently 112 million Americans aged 50 and over, a total expected to rise to 157 million in 10 years. Appropriately testing these 50+ US-based populations every three years, as directed, equates to 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 diseases. 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 in Europe with a clinical study and FDA submission process slated to launch in the first half of 2022 for regulatory approval in the United States. Mainz Biomed’s product candidate portfolio includes PancAlert, an early stage pancreatic cancer screening test based on real-time multiplex polymerase chain reaction (PCR) -based detection of molecular genetic biomarkers in samples. stool, and GenoStick technology, a platform under development to detect pathogens on a molecular genetic basis.

About TransferTech Sherbrooke
TransferTech Sherbrooke has been working since 2007 to forge links between high-tech companies and the 1,200 professors and professors of the University of Sherbrooke and its affiliated research centers. Entrepreneurs and a few small and medium-sized businesses, including some Top Fortune 500s, have benefited from his expertise and know-how. TransferTech Sherbrooke has largely contributed to the development and promotion of many university technologies, to the improvement of the competitiveness of innovative companies, and above all to the enrichment of the world of tomorrow.

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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 which predict or indicate future events or trends or which are not statements of historical questions. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. Therefore, caution should 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) failure to achieve projected development and related objectives; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or anticipated markets; and (iv) the other risks and uncertainties described herein, as well as the risks and uncertainties discussed from time to time in other reports and other public documents filed with the Securities and Exchange Commission (the “SEC”) by the Society. Additional information regarding these and other factors that may affect the Company’s expectations and projections can be found in its initial documents with the SEC, including its prospectus filed on November 12, 2021. The documents filed by the Company with the SEC are publicly available on the SEC’s website at www. sec.gov. Any forward-looking statement we make in this press release is based solely on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed assumes no obligation to publicly update any forward-looking statements, 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. required.


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