Novel Screening Test for Pancreatic Cancer Funded by the German Government
Achieved Key Project Milestones; Next Phase of Development Launched
BERKELEY, Calif. and MAINZ, Germany, May 5, 2022 — 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 PancAlert, its screening test candidate for pancreatic cancer has achieved multiple pre-clinical milestones that support the development of this potential first-in-class diagnostic for a deadly cancer indication.
The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.1 It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.2 and 9% globally.3 However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher, hence the rationale behind launching the PancAlert initiative.
Mainz Biomed is pleased to report the achievement of multiple predefined milestones for the PancAlert project, including achievement of specificity target, collection of a set of characterized clinical samples, selection of potential biomarker candidates, and the development of prototype biomarker tests. The Company will now allocate resources over the next 12 months to determine if the product candidate warrants clinical evaluation. It’s possible that PancAlert’s technical profile will include functioning as a stool-based test, mirroring the Company’s flagship product ColoAlert, a highly efficacious and easy to use at-home detection test for colorectal cancer. However, given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz Biomed will evaluate Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples, and will also evaluate other collection methodologies including saliva, urine and blood.
“The composite of PancAlert’s project accomplishments is an important value inflection point for the test’s development as the data and material generated meet the threshold required to deploy resources to define the technical profile of this potentially game-changing diagnostic test for this deadly form of cancer where early detection plays an integral role in survival,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “All of us at Mainz are excited by the possibility to enhance our product pipeline with another cutting-edge diagnostic solution, and we extend our gratitude to the German government for their support in incubating this important project.”
Mainz is marketing ColoAlert across Europe via its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The Company has also formally commenced ColoAlert’s U.S. regulatory activities and remains on track to initiate its multi-center pivotal study in late 2022. In February 2022, Mainz initiated ColoFuture, a clinical study to evaluate a portfolio of five acquired gene expression biomarkers (January 2022). The results from a published study demonstrated that these specific biomarkers a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease.4 As such, the ColoFuture study will determine if the biomarkers enhance ColoAlert’s technical profile to extend its capability to include the identification of AA while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. The online GLOBOCAN 2020 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
- National Cancer Institute, Surveillance, Epidemiology and End Results Program (SEER). Cancer Stat Facts: Pancreatic Cancer. July 2021. https://seer.cancer.gov/statfacts/html/pancreas.html
- Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019;10(1):10-27. doi:10.14740/wjon1166
- Herring E, Tremblay É, McFadden N, Kanaoka S, Beaulieu J-F. Multitarget Stool mRNA Test for Detecting Colorectal Cancer Lesions Including Advanced Adenomas. Cancers. 2021; 13(6):1228. https://doi.org/10.3390/cancers13061228
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.
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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 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.