Mainz Biomed Appoints Dr. Timothy Wang to Newly Formed Medical Advisory Board
July 19 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 formation of a Medical
Advisory Board (MAB), and the appointment of Dr. Timothy Wang as
its inaugural member. The MAB will support 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.
“We are excited to launch this advisory board and particularly
pleased to build this consortium around Dr. Wang given his vast
experience and domain expertise in the field of gastroenterology
cancer research,” commented Guido Baechler, Chief Executive Officer
of Mainz Biomed. “We look forward to making additional appointments
to the MAB and working with these premier advisors to ensure
ColoAlert’s planned U.S. pivotal trial is optimally positioned to
succeed, and to help facilitate achieving our goal of bringing to
market a robust pipeline of cutting-edge tests for early-stage
detection of multiple cancers.”
Dr. Wang is a leading expert in gastroenterology cancer research
and patient care. His laboratory has for decades investigated the
molecular mechanisms of gastrointestinal carcinogenesis and the
role of inflammation in promoting gastrointestinal neoplasia,
including colon cancer. Dr. Wang is the Dorothy L. and Daniel H.
Silverberg Professor of Medicine and GI Division Chief at Columbia
University Vagelos College of Physicians and Surgeons and serves as
Co-leader of the Tumor Biology and Microenvironment Program of the
Herbert Irving Comprehensive Cancer Center.
In addition to his leadership at Columbia, Dr. Wang has served
as President of the American Gastroenterology Association (AGA).
His work has been recognized with numerous awards, including the
Outstanding Investigator Award from the NCI, the Irene and Arthur
Fishberg Prize for medical research, the Ruth Leff Siegel Award for
pancreatic cancer research, and the William Beaumont Prize in
Gastroenterology from the AGA.
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.
“I’m thrilled to help build out this advisory board and work as
a collective to support Mainz in its mission to become the industry
leader in developing and commercializing molecular genetics
diagnostic tests for the early detection of cancers,” commented Dr.
Wang. “It is an exciting time in the genetic testing field and
Mainz represents a unique opportunity for me to provide insight and
direction on next-generation technologies that have the potential
to have a profound impact in healthcare.”
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 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
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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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