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Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effectiveTwo mRNA biomarkers found to be particularly valuable in detecting disease signals in advanced adenoma sampleseAArly DETECT clinical trial evaluating these biomarkers with fresh samples reporting results mid-year 2023Results of eAArly DETECT will inform possible inclusion in U.S. Pivotal Clinical Trial (ReconAAsense) assessing Company’s CRC detection testReconAAsense represents an opportunity to achieve gold standard status for self-administered colorectal cancer (CRC) screening
BERKELEY, Calif. and MAINZ, Germany, March 29, 2023 (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 results of an independent feasibility study conducted in collaboration with members of the Early Detection Research Network (EDRN) to evaluate the Company’s portfolio of five novel gene expression (mRNA) biomarkers acquired from Université de Sherbrooke in January, 2022.
Data results highlights from this feasibility study include:
Mainz’s proprietary nucleic acid extraction process and PCR process is robust and highly reliable – able to consistently obtain DNA and mRNA from patient specimens that were stored for greater than 15 yearsTwo mRNA biomarkers proved powerful in detecting disease signals from these aged specimens Able to detect signals from samples of known colorectal cancer (CRC) patients deemed to have higher levels of CRC-specific transcripts, and from specimens of AA patients where disease is in the early stage and thus CRC-specific transcripts are fewer and harder to detectIn univariate analysis, demonstrated statistically significant differences between: CRC specimens and controls p=0.0002 and p=0.001, respectively and more importantly,Advanced adenoma (AA) specimens and controls p=0.0005 and p=0.07 (trend), respectively
“I am extremely pleased with the study’s result as this outcome is exactly what the Mainz team envisioned when acquiring this portfolio of biomarkers, as it is well documented in the medical community that accurate and early detection of CRC and precancerous adenomas plays an integral role in saving lives,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We now await the mid-year 2023 results of our eAArly DETECT clinical trial evaluating these biomarkers prospectively with fresh, stabilized samples from enrolled patients versus frozen stool samples from up to 15 years ago. We are keen to review the composite of results from both studies to determine which biomarkers are finally selected for integration into our ReconAAsense U.S. pivotal trial for PMA approval. With a way to diagnose both CRC and AA, Mainz has the potential to transform self-administered CRC screening by bringing to market the best-in-class diagnostic test.”
In Sherbrooke’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using samples obtained from patients diagnosed with CRC or as having an advanced adenoma (“AA”), a type of precancerous polyp, and identified a subset of mRNA biomarkers that provided the greatest sensitivity and specificity of detection (Herring et al. 2021). Mainz specifically selected those RNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with AA. The power to detect a disease signal in samples from patents with AA can change the entire CRC diagnosis landscape because AA often progresses to CRC, but if treated at the appropriate time AA is curable, CRC can be prevented.
Knowing how fragile mRNA can be, all of Sherbrooke’s research on the mRNA biomarkers was performed using fresh and retrospective stool samples allowing for high quality mRNA extraction, and best-in-class RT-PCR. However, real world CRC testing is often performed with suboptimal patient specimens. Therefore, as part of this feasibility analysis of the “Sherbrooke biomarkers,” the Company utilized banked frozen stool samples provided by the Great Lakes-New England Clinical and Validation Center (GLNE CVC) of the Early Detection Research Network (EDRN). The GLNE includes investigators at several top-tier medical centers including MD Anderson Cancer Center, Dana Farber Cancer Institute, the University of Michigan, NYU Langone Health, the University of Minnesota and others, and is part of the renowned research consortium funded by the Division of Cancer Prevention at the National Cancer Institute (NIH) comprising over 300 academic and industry investigators. The Sherbrooke feasibility protocol involved evaluating 150 samples (50 disease free controls, 51 diagnosed with AA, and 49 from subjects diagnosed with CRC). These banked raw stool specimens were stored for over 15 years at -70°C without any additional stabilization and were exclusively preserved by the surrounding deep freeze temperature. Researchers at the Company first extracted nucleic Acid (DNA and mRNA) and proteins from these samples using their proprietary extraction protocols. Next each extracted mRNA sample was analyzed with the newly acquired RNA biomarkers. The mRNA results were compared with results from fecal immunochemical test (FIT) analysis, hDNA, and mutational status of KRAS and BRAF genes, that together comprise ColoAlert® the Company’s CE-marked, easy-to-use detection test for CRC which is being marketed across Europe and in select international territories. One fascinating outcome from the study was the effectiveness of Mainz’s proprietary extraction technology as it achieved 100% accuracy in detecting nucleic acids from stool samples that have been without stabilization for over 15 years.
The Company now awaits results from the eAArly DETECT clinical trial which commenced enrollment in December of 2022 and remains on track to report results in mid-year 2023. This multi-center feasibility study is enrolling 250 subjects across 25 sites in the U.S. To participate in the study, subjects must be of either average risk for colon cancer or be suspected/known to have an advanced adenoma or CRC. Once eAArly DETECT is completed and the data analyzed, Mainz will compare outcomes from both feasibility studies and select biomarkers for inclusion in the ReconAAsense pivotal trial which will form the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization for the Company’s next generation CRC test. ReconAAsense, is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. It will examine the clinical performance of the Mainz Biomed Colorectal Cancer Screening Test. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AAs. Once enrollment commences, ReconAAsense will continue until at least 73 evaluable subjects are enrolled that are diagnosed with colorectal cancer. To learn more about ReconAAsense please visit clinicaltrials.gov (Identifier: NCT05636085)
ColoAlert, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Gies et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs, and via direct sales. To receive marketing approval in the US, ColoAlert will be evaluated in the FDA-registration trial ‘ReconAAsense’. Once approved in the US, 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.
About Colorectal Cancer
Colorectal 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 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 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 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. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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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.
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