Mainz Biomed Acquires Exclusive Rights to Novel mRNA Biomarkers
January 05 2022 - 3:01AM
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 it has entered into a
Technology Rights Agreement with Socpra Sciences Santé Et Humaines
S.E.C. (“TTS”) to access a portfolio of novel mRNA biomarkers for
potential future integration into ColoAlert, the Company’s highly
efficacious, and easy-to-use detection test for colorectal cancer
(“CRC”). Mainz is currently marketing ColoAlert in 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
preparing to initiate ColoAlert’s regulatory pathway for approval
in the United States.
Under the terms of the Technology Rights Agreement,
the Company has the unilateral option to license the exclusive
global rights to five gene expression biomarkers which have
demonstrated 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. In a study
evaluating these biomarkers published in the online peer review
journal platform MDPI (March 11, 2021), study results achieved
overall sensitivities of 75% for AA and 95% for CRC, respectively,
for a 96% specificity outcome. If these statistical results are
duplicated when the biomarkers are integrated into ColoAlert, we
believe that it will ultimately position the Company’s CRC test to
be the most robust and accurate at-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
early detection of precancerous adenomas.
“Securing the exclusive rights to license this
family of novel biomarkers is a fantastic milestone for the Company
as it provides an extraordinary opportunity to potentially upgrade
ColoAlert’s technical profile, possibly making it the most
effective at-home screening test for CRC that has ever been
commercialized,” commented Guido Baechler, Chief Executive Officer
of Mainz Biomed. “The Mainz team is on a mission to develop gold
standard molecular diagnostic screening solutions for cancer
indications and obtaining the rights to these biomarkers is a
testament to our on-going commitment to develop cutting-edge
products as they have shown superior sensitivity to even liquid
biopsy products in development in terms of identifying advanced
adenomas.”
The Company will now commence a clinical study in
Europe to evaluate the effectiveness of these biomarkers to enhance
ColoAlert’s utility in terms of extending its capability to include
the identification of advanced adenomas, while increasing rates of
diagnostic sensitivity and specificity. Given ColoAlert in its
present form has already been CE-IVD marked (complying with EU
safety, health and environmental requirements), the timeline and
process to initiate this “add-on” study is expedited, and the
Company is targeting the first half of 2022 to launch the clinical
study. Furthermore, data generated by the study may potentially be
incorporated into the Company’s design of ColoAlert’s U.S. clinical
trial for consideration by the FDA.
About ColoAlertColoAlert 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
immunochemistry 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 several countries in the European Union.
Mainz Biomed currently distributes ColoAlert through a number of
clinical affiliates. Once approved in the United States, 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 Colorectal CancerColorectal
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 United States with 52,980 resulting in death. Recent FDA
decisions suggest that screening with stool DNA tests such as
ColoAlert in the United States 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 in 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.
About TransferTech
SherbrookeTransferTech Sherbrooke has been working since
2007 to build connections between high-tech businesses and the
1,200 professors of the Université de Sherbrooke and its affiliated
research centers. Entrepreneurs and some small and medium-sized
enterprises, including some Top Fortune 500, have been able to
benefit from its expertise and know-how. TransferTech Sherbrooke
has substantially contributed to the development and valorization
of numerous university technologies, the improvement of the
competitiveness of innovative businesses, and especially the
enrichment of the world of tomorrow.
For more information, please visit
www.mainzbiomed.com
For media enquiries, please
contact press@mainzbiomed.com
For investor enquiries, please
contact ir@mainzbiomed.com
Forward-Looking StatementsCertain
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 Prospectus filed on November 12, 2021.
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.
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Mar 2024 to Apr 2024
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Apr 2023 to Apr 2024