Mainz Biomed Enrolls First Patient in ColoFuture Study Evaluating Integration of Novel mRNA Biomarkers into ColoAlert
June 28 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 enrolled the first
patient in ColoFuture, an international clinical study assessing
the potential to integrate a portfolio of novel gene expression
(mRNA) biomarkers into ColoAlert, the Company’s highly efficacious,
and easy-to-use detection test for colorectal cancer (CRC) which is
being commercialized across Europe.
The mRNA biomarkers were acquired from the Université de
Sherbrooke in January 2022 and are the result of the institution’s
pioneering work in the field, where researchers tested multiple
novel transcriptional biomarkers using colon cancer samples and
precancerous lesions. The results from these studies demonstrated
that the mRNA targets chosen by Mainz provided the greatest
sensitivity and specificity of detection. (Herring et al 2021). The
ColoFuture study 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 first patient in milestone marks the conclusion of several
months of intensive preparatory work to ensure the trial is
optimally managed and signifies the formal commencement of the
study,” commented Guido Baechler, Chief Executive Officer of Mainz
Biomed. “This is a particularly exciting clinical trial for the
Company and of course, the patient and medical communities as the
outcome could potentially position ColoAlert as the gold standard
at home screening test for this deadly form of cancer.”
Mainz is currently marketing ColoAlert as a top-tier
discretionary diagnostic option 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. In addition, the Company is preparing for
ColoAlert’s U.S. pivotal trial, and Mainz’s clinical team is in the
process of preparing the protocols for this multi-center study
which is on track to commence in late 2022. If the ColoFuture study
reports positive results, ColoAlert’s technical profile will be
upgraded to include the novel mRNA biomarkers and the U.S. trial
will be amended to enable the updated ColoAlert product to be
utilized in the 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 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 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 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
estimated that in 2021 there were 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
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 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.
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