Mainz Biomed Enrolls First Patient in eAArly DETECT Study Evaluating Integration of Novel mRNA Biomarkers into ColoAlert
December 20 2022 - 3:01AM
Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a
molecular genetics diagnostic company specializing in the early
detection of cancer, announced today the first patient has been
enrolled in eAArly DETECT, Mainz’s U.S. extension of ColoFuture,
its European feasibility study evaluating the integration of a
portfolio of novel gene expression (mRNA) biomarkers into
ColoAlert. Currently, Mainz is commercializing ColoAlert, its
highly efficacious, and easy-to-use detection test for colorectal
cancer (CRC) across Europe and in select international territories.
ColoFuture/eAArly DETECT are multi-center studies assessing the
potential of these biomarkers to identify advanced adenomas, a type
of pre-cancerous polyp often attributed to CRC.
“Given the transformational impact that integrating advanced
adenoma detection will have on ColoAlert’s technical profile and
ultimate role in helping CRC prevention and treatment, today’s
milestone is important as we embark on the execution phase of this
feasibility study,” commented Guido Baechler, Chief Executive
Officer of Mainz Biomed. “All of us involved with Mainz are excited
by the prospect of incorporating these biomarkers into
ReconAAsense, our U.S. pivotal study to evaluate the clinical
performance of ColoAlert which we anticipate commencing patient
enrollment in H1 2023.”
The five novel gene expression (mRNA) biomarkers being evaluated
in the eAArly DETECT/ColoFuture studies were in-licensed from the
Université de Sherbrooke, Quebec, Canada (January 2022). In the
institution’s pioneering work, researchers tested a battery of
novel transcriptional biomarkers using colon cancer samples and
precancerous lesions. The five mRNA targets chosen by Mainz Biomed
provided the greatest sensitivity and specificity of detection
(Herring et al. 2021) and demonstrated a unique ability to identify
curable precancerous colonic polyps, as well as treatable
early-stage CRC. The eAArly DETECT study will evaluate the
effectiveness of these biomarkers to enhance ColoAlert’s product
specifications to extend its capability to include the
identification of advanced adenomas while increasing ColoAlert’s
rates of diagnostic sensitivity and specificity.
Mainz expects to complete enrollment for the eAArly DETECT in Q1
2023 and targets reporting topline results in 1H 2023. Based on the
study’s outcome, the Company will determine which of the biomarkers
are eligible for inclusion in the Company’s U.S. pivotal trial
(ReconAAsense), which is on schedule to begin enrolling patients in
2023 with results expected in 2025.
About ColoAlert ColoAlert detects CRC via
a simple-to-administer test with a sensitivity and specificity
nearly as high as the invasive colonoscopy (Dollinger MM et al.,
2018). The test utilizes proprietary methods to analyze cell DNA
for specific tumor markers combined with a fecal immunochemical
test (FIT). It is designed to detect tumor DNA and CRC cases in
their earliest stages. The product is CE-IVDR marked (complying
with EU safety, health and environmental requirements). The product
is commercially available in a selection of countries in the
European Union and the United Arab Emirates. Mainz Biomed currently
distributes ColoAlert through a number of clinical affiliates. 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 According to the
Centers for Disease Control and Prevention (CDC), colorectal 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 US, with 52,980 resulting
in death. Recent decisions by the US Food and Drug
Administration (FDA) 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 and 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 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 and the United Arab Emirates. The
Company is currently 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 based on real-time Polymerase Chain Reaction-based (PCR)
multiplex detection of molecular-genetic biomarkers in stool
samples. To learn more, visit mainzbiomed.com or follow us on
LinkedIn, Twitter and Facebook.
For media inquiries, please
contact press@mainzbiomed.com
In Europe:
MC Services AG Anne Hennecke/Caroline Bergmann +49 211 529252 20
mainzbiomed@mc-services.eu
In the US:
Spectrum Science Melissa Laverty/Valerie Enes +1 540 272 6465
mainz@spectrumscience.com
For investor inquiries, please
contact info@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 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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