Mainz Biomed Completes Successful Pre-Submission Process with the U.S FDA for ColoAlert’s Pivotal Clinical Trial
March 31 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 that it has received
supportive feedback from the U.S. Food & Drug Administration
(FDA) on the Company’s pre-submission package profiling the
potential pivotal clinical trial design for ColoAlert, its highly
efficacious, and easy-to-use detection test for colorectal cancer
(CRC). As Mainz prepares to launch ColoAlert’s pivotal clinical
trial, the Company is also pleased to announce the formal
commencement of its reimbursement process for ColoAlert by
scheduling an initial meeting with The Centers for Medicare and
Medicaid Services (CMS) in April 2022. The CMS is a federal agency
in the U.S. Department of Health and Human Services (HHS) that
administers the Medicare program and works in partnership with
state governments to administer Medicaid, the Children's Health
Insurance Program (CHIP), and health insurance portability
standards.
“We are encouraged by the FDA’s supportive commentary on our
proposed pivotal clinical trial design for ColoAlert and will now
work with our clinical team to finalize the study’s protocols and
make the necessary preparations to ensure premier trial execution,”
commented Guido Baechler, Chief Executive Officer of Mainz Biomed.
“In concert with final pivotal clinical trial preparations, we are
excited to pursue reimbursement for ColoAlert and are looking
forward to commencing formal discussions with the CMS.”
An integral part of Mainz’s clinical execution and medical
reimbursement strategies is its partnership with Precision for
Medicine, a leading global Clinical Research Organization.
Precision for Medicine will continue to work with Mainz’s
management team to implement the U.S. focused regulatory and market
access strategy for ColoAlert by finalizing ColoAlert’s clinical
development plan to ensure the trial design is cost-effective,
robust, and efficient. The Company is planning to integrate
CMS guidelines into ColoAlert’s pivotal trial design, utilizing
currently marketed CRC screening tests as benchmarks to provide the
test with an optimal product profile for regulatory approval and
success in the marketplace.
Mainz is marketing ColoAlert across 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 running ColoFuture, an
international clinical study evaluating the potential to integrate
a portfolio of in-licensed novel mRNA biomarkers into the product
which have previously demonstrated the unique ability to identify
curable precancerous colonic polyps, as well as treatable
early-stage CRC (Herring et al 2021). ColoFuture 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 results of the study will
ultimately impact the configuration of ColoAlert prior to
commencing the U.S. pivotal study which is on track to begin in
late 2022.
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 the ColoFuture StudyThe 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 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 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.
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