Mainz Biomed Appoints Dr. D. Kim Turgeon of University of Michigan Health to its Medical Advisory Board
August 23 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 the appointment of Dr. D. Kim
Turgeon of University of Michigan Health to its Medical Advisory
Board (MAB).
The MAB is supporting the Company’s forthcoming U.S. pivotal
trial for ColoAlert, its highly efficacious, and easy-to-use
detection test for colorectal cancer (CRC) and assist Mainz in
evaluating ColoAlert’s potential to address additional oncology
indications along with enhancing Mainz’s pipeline of product
candidates.
An esteemed Clinical Professor at University of Michigan Health
and clinical translational researcher, Dr. Turgeon has been a
Co-Iead on BETRNet, a multi-disciplinary, multi-institutional
collaboration co-sponsored by the National Cancer Institute’s
(NCI’s) Division of Cancer Prevention and Division of Cancer
Biology (2011-2022), a Co-I on the Network for Translational
Research (NTR) (2008-2013), and a Co-Iead on the Great Lakes-New
England Clinical Epidemiology and Validation Center of the
NCI-funded Early Detection Research Network (2000-2015). Dr.
Turgeon has an established and extensive record of protocol
development, protocol implementation, subject recruitment, subject
retention, and extensive clinical data management skills and has
provided practical knowledge about clinical gastroenterology and
endoscopy to support clinical research endeavors. She received her
medical degree from the University of Rochester in New York and did
her internal medicine residency at Strong Memorial Hospital at the
University of Rochester. Her special research interests include
colon cancer, chemoprevention, and drug metabolism.
“We’re thrilled to be assembling an MAB which will bring
together a highly distinguished group of multi-disciplinary experts
such as Dr. Turgeon,” commented Guido Baechler, Chief Executive
Officer of Mainz Biomed. “Having access to rich expertise from
across gastroenterology, clinical research and diagnostics as we
establish our pivotal U.S. trial, will ensure the process is as
effective and seamless as possible and that ColoAlert can be made
accessible to more people across the world and help turn the tide
against the devastating impacts of CRC.”
Mainz announced in February 2022 that ColoAlert’s U.S. pivotal
clinical trial pre-submission was accepted for review by the U.S.
Food & Drug Administration (FDA), and in March received
supportive feedback on the pre-submission package profiling the
potential clinical trial design for ColoAlert. Mainz will continue
to bring together experts in gastroenterology and pathology to
provide continuing guidance as it navigates through pre-market
activities including the FDA submission. Their input will ensure
that clinical study endpoint definitions are aligned with current
standards and practices, and that a comprehensive adjudication plan
is executed to ensure endpoints are categorized accordingly.
Furthermore, the MAB will play an active role in the analysis of
new tests being contemplated internally for development, and in
assessing in-licensing and M&A opportunities.
Mainz is currently marketing ColoAlert 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
2023.
About ColoAlert
ColoAlert 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-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 in the United Arab Emirates.
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 and in the United Arab Emirates
with the intention of beginning its pivotal FDA clinical study in
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 Aug 2024 to Sep 2024
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Sep 2023 to Sep 2024