Mainz Biomed Appoints Vice President of Clinical Affairs to Lead US Clinical Studies in Support of FDA Submission
Jane Edwards, CCRA, RAC brings over 20 years of senior experience developing optimal product and clinical trial strategies in diagnostics and medical devices
Will manage the design and logistical operations of Mainz Biomed’s clinical trials in the US and Europe to support FDA submission
BERKELEY, Calif. and MAINZ, Germany, June 14, 2022 (GLOBE NEWSWIRE) — 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 Jane Edwards, CCRA, RAC, as VP of Clinical Affairs.
As an integral part of her role, Ms. Edwards will manage the design and logistical operations of the Company’s multifaceted clinical trials – to include subjects in the US and EU – which support key stages of the FDA submission process for ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). She will also develop and liaise closely with Key Opinion Leaders responsible for carrying out, or contributing to, both the European and US clinical studies and supporting related publications.
“The strength of the design and execution of our clinical trials in Europe and the US is integral to the efficiency and effectiveness of our FDA submission and approval process for ColoAlert,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We’re thrilled to welcome Jane to our team and know that having such a highly respected and proven leader in the field of clinical trial strategies in diagnostics and medical devices in charge of our initiatives in this area will ensure that our FDA approval process is as seamless as it can be.”
Ms. Edwards has over 20 years of senior level experience in clinical program strategies including global clinical research and operations, regulatory, technical services and clinical training. She has successfully led clinical operations, and authored and executed studies involving various disease areas including cardiovascular, diabetes, nephrology, toxicology and coagulation. She joins Mainz Biomed from L3 Healthcare, a full-service contract research organization, where, as VP of Clinical Research, she led clinical research and operations.
Prior to joining L3 Healthcare, she held the role of Senior Director, Clinical Research at Beaufort CRO, a global contract research organization that partners with IVD, medical device and biopharmaceutical developers. While at Beaufort CRO she led the clinical team executing many large, multi-center trials for various indications. She also held the position of Associate Director, Clinical Operations at Alere, a global leader in point of care diagnostics which was acquired by Abbott in 2016. At Alere, she successfully led the active U.S. and global clinical operations teams, helping to devise optimal strategies for FDA pre-submissions of new diagnostic products and managing the department’s multi-million dollar global trial budgets.
“I’ve been highly impressed by the sophistication of the ColoAlert test in its current form and am also keenly aware of the immense future potential that comes with the integration of the portfolio of novel gene expression (mRNA) biomarkers,” said Jane Edwards. “ColoAlert is an impressive solution with the potential to positively impact an enormous number of lives and I’m very excited to be playing a role in ensuring it’s able to meet its full potential.”
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-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 Study
The 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 Cancer
Colorectal 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.
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Forward-Looking Statements
Certain 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.
