Mainz Biomed Acquires Entire Intellectual Property Portfolio for its Colorectal Cancer Diagnostic Test Program
February 21 2023 - 03:01AM
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 execution of its option
from Uni Targeting Research AS to acquire all of the previously
licensed scientific intellectual property (“IP”) for its flagship
product ColoAlert, a highly efficacious, and easy-to-use detection
test for colorectal cancer (“CRC”) being commercialized across
Europe. Simultaneously, the Company also exercised its exclusive
option with SOCPRA Sciences Sante et Humaines S.E.C. (“SOCPRA”), to
outright purchase IP, including a pending patent, associated with a
portfolio of novel gene expression (mRNA) biomarkers that have
demonstrated ability to detect CRC lesions, including advanced
adenomas (“AA”), a type of pre-cancerous polyp often attributed to
this deadly disease.
“This is an important value generation milestone for us as we
continue executing our commercial strategy and product development
plan to ultimately bring to market the gold-standard CRC
self-administered diagnostic test,” commented Guido Baechler, Chief
Executive Officer of Mainz Biomed. “Securing complete IP ownership
is integral to our growth strategy as it streamlines
administration, reduces per-test expenses, and provides us the
opportunity to ramp-up corporate development activities,” added
Baechler.
Mainz Biomed is commercializing ColoAlert across Europe and in
select international markets through a differentiated business
model of partnering with third-party laboratories for test kit
processing versus the traditional methodology of operating a single
facility. Under the standard terms of all partnerships, Mainz
Biomed is providing ColoAlert to the respective labs, including
co-branding with key accounts, whereby each facility purchases
Mainz Biomed’s customized polymerase chain reaction (“PCR”) assay
kits on an on-demand basis and provides their respective network of
physicians and patients with a comprehensive solution for advanced
CRC detection.
The Company is in the process of evaluating the mRNA biomarkers
it is has acquired from SOCPRA in ColoFuture and eAArly DETECT, an
international multi-center clinical study (US and Europe) assessing
the potential for the integration of the mRNA biomarkers into
ColoAlert. This particular portfolio of mRNA biomarkers selected by
Mainz Biomed was based on work in the field by the University of
Sherbrooke, where researchers tested multiple novel transcriptional
biomarkers using colorectal cancer and precancerous lesion samples.
The results from these studies demonstrated that the mRNA targets
chosen by the Company provided a dynamic combination of sensitivity
and specificity of detection (Herring et al. 2021). The ColoFuture
study (extended into the US as eAArly DETECT) is evaluating the
effectiveness of these biomarkers to enhance ColoAlert’s technical
profile to expand its capability to identify AA while increasing
ColoAlert’s rates of diagnostic sensitivity and specificity.
ColoFuture’s eAArly DETECT study is on track to complete
enrollment in the first quarter of 2023, with results reported in
the first half of 2023. Based on the study’s outcome, Mainz Biomed
will decide on integrating the biomarkers into the ReconAAsense
study, which is on track to enroll patients in the summer of 2023,
with results reported in 2025.
The ReconAAsense study (ClinicalTrials.gov Identifier:
NCT05636085) will form the basis of the data package for review by
the US Food and Drug Administration (FDA) to achieve marketing
authorization. It is a prospective clinical study that will include
approximately 15,000 subjects from 150 sites across the United
States. The study objectives include calculating sensitivity,
specificity, positive predictive value (PPV) and negative
predictive value (NPV) in average-risk subjects for CRC and AA. If
successful, the Company’s mRNA and DNA-based CRC screening test
will be positioned as the most robust and accurate at-home
diagnostic screening test on the market, as it will not only detect
cancerous polyps with a high degree of accuracy but has the
potential to prevent CRC through early detection of precancerous
adenomas.
About ColoAlertColoAlert detects colorectal
cancer (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 the 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)
and 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. If
approved in the United States, 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 CancerAccording to the Centers
for Disease Control and Prevention (“CDC”), CRC is the second most
lethal cancer in the United States and Europe, but also the most
preventable, with early detection providing survival rates above
90%. 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
U.S. Food and Drug Administration (FDA) suggest that screening with
stool DNA tests such as ColoAlert in the United States 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 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 CRC. ColoAlert is currently
marketed across Europe and in select international territories. The
Company is currently running a pivotal FDA clinical study for U.S.
regulatory approval. Mainz Biomed’s product candidate portfolio
also includes PancAlert, an early-stage pancreatic cancer screening
test based on real-time 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 AGAnne Hennecke/Caroline Bergmann+49 211 529252
20mainzbiomed@mc-services.eu
In the US:
Spectrum ScienceMelissa Laverty/Valerie Enes+1 540 272
6465mainz@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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