Mainz Biomed Provides Product Development Update on PancAlert
May 05 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 PancAlert, its screening
test candidate for pancreatic cancer has achieved multiple
pre-clinical milestones that support the development of this
potential first-in-class diagnostic for a deadly cancer indication.
The PancAlert project commenced in 2020 with a grant from the
German Federal Ministry of Education and Research to develop a
non-invasive early detection test for pancreatic cancer, a
malignant neoplasm of the pancreas with one of the highest
mortality rates of all major cancers. Each year, about 466,000
lives are taken globally, and it’s the seventh leading cause of
cancer-related death worldwide.1 It has one of the lowest survival
rates of any cancer, with typically late detection and poor
outcomes with standard of care treatment(s). The 5-year overall
survival rate is approximately 11% in the U.S.2 and 9%
globally.3 However, if diagnosis occurs in the early stages of the
disease, the survival rate is significantly higher, hence the
rationale behind launching the PancAlert initiative.
Mainz Biomed is pleased to report the achievement of multiple
predefined milestones for the PancAlert project, including
achievement of specificity target, collection of a set of
characterized clinical samples, selection of potential biomarker
candidates, and the development of prototype biomarker tests. The
Company will now allocate resources over the next 12 months to
determine if the product candidate warrants clinical evaluation.
It's possible that PancAlert’s technical profile will include
functioning as a stool-based test, mirroring the Company’s flagship
product ColoAlert, a highly efficacious and easy to use at-home
detection test for colorectal cancer. However, given the growing
understanding of the role of the microbiome in pancreatic cancer,
Mainz Biomed will evaluate Real-Time Polymerase Chain Reaction
(“PCR”)-based multiplex detection of molecular-genetic biomarkers
and other testing methods in stool samples, and will also evaluate
other collection methodologies including saliva, urine and
blood.
“The composite of PancAlert’s project accomplishments is an
important value inflection point for the test’s development as the
data and material generated meet the threshold required to deploy
resources to define the technical profile of this potentially
game-changing diagnostic test for this deadly form of cancer where
early detection plays an integral role in survival,” commented
Guido Baechler, Chief Executive Officer of Mainz Biomed. “All of us
at Mainz are excited by the possibility to enhance our product
pipeline with another cutting-edge diagnostic solution, and we
extend our gratitude to the German government for their support in
incubating this important project.”
Mainz is marketing ColoAlert across Europe via its
differentiated commercial plan of partnering with third-party
laboratories for test kit processing versus the traditional
methodology of operating a single facility. The Company has also
formally commenced ColoAlert’s U.S. regulatory activities and
remains on track to initiate its multi-center pivotal study in late
2022. In February 2022, Mainz initiated ColoFuture, a clinical
study to evaluate a portfolio of five acquired gene expression
biomarkers (January 2022). The results from a published study
demonstrated that these specific biomarkers a high degree of
effectiveness in detecting CRC lesions including advanced adenomas
(“AA”), a type of pre-cancerous polyp often attributed to this
deadly disease.4 As such, the ColoFuture study will determine if
the biomarkers enhance ColoAlert’s technical profile to extend its
capability to include the identification of AA while increasing
ColoAlert’s rates of diagnostic sensitivity and specificity.
References
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I,
Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates
of Incidence and Mortality Worldwide for 36 Cancers in 185
Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi:
10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. The online
GLOBOCAN 2020 database is accessible at http://gco.iarc.fr/, as
part of IARC’s Global Cancer Observatory.
- National Cancer Institute, Surveillance, Epidemiology and End
Results Program (SEER). Cancer Stat Facts: Pancreatic Cancer. July
2021. https://seer.cancer.gov/statfacts/html/pancreas.html
- Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic
Cancer: Global Trends, Etiology and Risk Factors. World J
Oncol. 2019;10(1):10-27. doi:10.14740/wjon1166
- Herring E, Tremblay É, McFadden N, Kanaoka S, Beaulieu J-F.
Multitarget Stool mRNA Test for Detecting Colorectal Cancer Lesions
Including Advanced Adenomas. Cancers. 2021; 13(6):1228.
https://doi.org/10.3390/cancers13061228
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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