Grant in honour of Dr. Barbara T. Murphy, Verici Dx co-founder and former Board member
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has signed an agreement with the American Society of Transplantation (“AST”) to establish a Career Development Research Grant, commemorating Dr. Barbara T. Murphy, the Company’s late co-founder and Board member.
The grant will be awarded annually to a talented researcher in the fields of transplant science and immunology, enabling them to expand on preliminary research findings that have the potential to further the knowledge base in these areas.
Dr. Barbara T. Murphy, who passed away on 30 June 2021, was a leading nephrologist and specialist in kidney transplant immunology, with her research focusing on predicting and diagnosing the outcomes of kidney transplants.
The value of the initial grant is $50,000. The AST will be collecting the applications, with members of the AST Research Network Scientific Review Committee (SRC) choosing the recipient based on a scoring system reviewing the quality of the research. The grant recipient will be recognised during the 2022 American Transplant Congress, held from June 4-7, 2022, in Boston, MA, USA.
The AST is an organisation dedicated to advancing the field of transplantation and improving patient care by promoting research, education, advocacy, organ donation, and service to the community through a lens of equity and inclusion.
For more information on the grant and on how to apply: www.myast.org/research-grants
Sara Barrington, Chief Executive Officer of Verici Dx, said:
“I am honoured to launch this research grant with the AST in memory of Barbara. She was an innovator, an entrepreneur and a mentor, and it is only befitting that this grant will enable promising, innovative researchers to further the research base within the transplant and immunology fields, within which Barbara was a leading voice. She was a valued colleague and a good friend, and she is missed greatly by all of us at Verici Dx.”
John Gill, President of the American Society of Transplantation, said:
“The AST is honored to partner with Verici on this award in tribute to Dr. Barbara T. Murphy. Dr. Murphy was a passionate supporter and inspiration to so many new investigators in the field of transplantation and it is particularly fitting that this generous award will be used to support the career development of a promising new investigator. As a past AST President, Dr. Murphy also understood the importance of our industry partners such as Verici in advancing innovation and I wish to thank Verici for their tremendous support.”
About Dr. Barbara T. Murphy
Dr. Murphy was the Murray M. Rosenberg Professor of Medicine, Chair of the Department of Medicine for the Mount Sinai Health System, and Dean for Clinical Integration and Population Health at the Icahn School of Medicine at Mount Sinai.
Dr. Murphy earned her M.B. B.A.O. B.Ch. from The Royal College of Surgeons in Ireland and went on to do an internship at Beaumont Hospital in Dublin. She completed a residency rotation at Beaumont Hospital followed by a fellowship in Clinical Nephrology also at Beaumont Hospital. Dr. Murphy completed her postdoctoral training with a fellowship in Nephrology at Brigham and Women’s Hospital, Harvard Medical School. As part of this she trained in transplant immunology at the Laboratory of Immunogenetics and Transplantation, Renal Division, Brigham and Women’s Hospital, Harvard Medical School. Dr. Murphy was recruited to Icahn Mount Sinai in 1997 as the Director of Transplant Nephrology and, just six years later, was named the Division’s Chief, becoming one of the youngest division chiefs in the United States as well as one of the few women at the time to hold the role. Among her many honours, Dr. Murphy was awarded the Young Investigator Award in Basic Science by the American Society of Transplantation in 2003. In 2005, Dr. Murphy became the Irene and Dr. Arthur M. Fishberg Professor of Medicine at the Mount Sinai School of Medicine. Then, in 2011, she was named Nephrologist of the Year by the American Kidney Fund. In 2012, she was named Chair of the Department of Medicine; at the time, she was only the second female chair of any department of medicine at a top 20 medical school in the United States. She received the distinguished Jacobi Medallion in 2014. She also received an honorary degree from University College, Dublin, Ireland. In 2016, Dr. Murphy was honoured by The Annual Irish America Healthcare & Life Science 50. She was named in June 2021 as the recipient of the ASN’s first Lifetime Achievement Award.
Dr. Murphy belonged to a number of professional societies including the American Society of Transplantation and the American Society of Nephrology. Among her numerous achievements, she has held many leadership roles at a national level, including being a member of the board of the American Society of Transplantation, the executive committee of the American Transplant Congress, and chair of Education Committee of the American Society of Transplantation. In 2009 Dr. Murphy was the president of the American Society of Transplantation, and she was the president-elect of the American Society of Nephrology at the time of her death.
Her area of interest was transplant immunology, focusing on the use of high throughput genomic technologies as a means to understand the immune mechanisms that lead to graft injury and loss, with the aim of identifying gene expression profiles and or genetic variants that may be used to predict those at greatest risk.
Verici Dx was founded on intellectual property developed at Icahn Mount Sinai by Dr. Murphy and her colleagues. Icahn Mount Sinai and Mount Sinai faculty have financial interests in Verici Dx.
Enquiries:
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the appointment of Lorenzo Gallon, MD, as Chair of the Company’s Science Advisory Board (SAB). Dr. Gallon was appointed to the Company’s Board as a Non-executive Director on 19 August 2021.
A Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation), Dr. Gallon is currently the Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University. He is an alumnus of the University of Padua Medical School, Italy and Harvard Medical School.
An expert in nephrology and hypertension as well as organ transplantation, Dr. Gallon’s primary research interests include:
- The role of immunosuppressive medications in modulating the immune system,
- Genomics of chronic renal allograft rejection,
- Prednisone-free and calcineurin inhibitors-free immunosuppressive protocols,
- New immunosuppressive strategies,
- Focal segmental glomerulosclerosis (FSGS), and
- Aging and impact of physical exercise after kidney transplantation.
With nearly 20 years’ experience in the life sciences industry, focusing largely on nephrology and organ transplantation, Dr. Gallon is excellently placed to provide insight and guidance in the development of Verici’s two lead products, Clarava™ and Tuteva™. He was a collaborator and co-author with Verici’s previous SAB Chair, Dr. Barbara Murphy, in the GoCar study1 which was foundational in the development of Verici’s products. He has also been a member of the Editorial Board at the journal Nephron since 2019.
In 2012, Dr Gallon was part the Northwestern Medicine transplant team that conducted the first successful removal and implantation of a kidney from one patient to another after the organ failed in the first recipient. The findings of the case were published in the New England Journal of Medicine.
Julian Baines, MBE, Non-executive Chairman of Verici Dx, said:
“I am delighted to welcome Lorenzo as the new Chair of Verici Dx’s Science Advisory Board. As a leading expert in nephrology and organ transplantation, he has been hugely valuable on the Board so far, and I’m sure will become even more so in this additional role, helping us accelerate development of our two lead products, Clarava™ and Tuteva™.”
Dr Lorenzo Gallon, Non-executive Director of Verici Dx, said:
“I am pleased to take on this additional role with Verici Dx, as Chair of the Science Advisory Board. I have been impressed with the progress of its product portfolio, which has the potential to really improve outcomes for kidney transplant patients, and look forward to working more closely with the team to provide advice and some experience to help advance the products.”
1 – https://pubmed.ncbi.nlm.nih.gov/27452608/
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Strong progress made with key milestones towards commercialisation met ahead of schedule
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its unaudited interim results for the six months ended 30 June 2021.
Strategic and Operational highlights for the period
- Partnered with five leading US centres to collaborate on clinical validation trial for lead products Clarava™ and Tuteva™.
- Expanded scope of licence agreement with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) in January 2021, to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and graft rejection.
- Entered into a Material Transfer Agreement (“MTA”) with Mount Sinai to allow access to CTOT-19 (Clinical Trials in Organ Transplant) samples, providing Verici Dx, in combination with the Company’s clinical validation study, with a large, well-characterised sample group.
Financial highlights
- Adjusted EBITDA1 loss of $2.52m.
- Cash balance at 30 June 2021 of $14.5m (31 December 2020: $17.8m).
- Strong cash position to expand the Verici Dx platform over time with additional innovative licensing opportunities that complement the existing offering.
- Engage and build new alliances with patient groups and foundations alike focused on kidney research.
Post-period end
- Obtained CLIA2 Certification of Registration for the Company’s newly established US clinical laboratory in Tennessee ahead of schedule, authorising the Company to initiate commercial operations as a diagnostic laboratory, a key milestone towards the commercial launch of Clarava™ and Tuteva™.
- Expanded multi-centre clinical validation trial to a total of twelve US and EU sites.
- Completion of patient enrolment to the clinical validation trial for lead products, ahead of schedule.
- Appointment of Lorenzo Gallon, MD, as Non-Executive Director.
Julian Baines, Non-Executive Chairman, said: “The Company has made strong progress over the past six months, with some key milestones reached ahead of schedule as we look to commercialise our innovative organ transplant products.
“We initially partnered with five leading US centres in our collaborative, multi-centre observational clinical validation study. We have since expanded to partner with a total of twelve US and European centres for the validation study and completed patient enrolment for Clarava™ and Tuteva™ ahead of schedule We remain on target for the validation study to be completed by the end of 2021 for lead products, in line with expectations set out at IPO, with the data to be submitted for publication in Q1 2022.
“Post-period end, we obtained a CLIA Certification of Registration for our US clinical laboratory in Tennessee. Having a CLIA-certified lab will enable us to launch our two lead products commercially, subject to the successful conclusion of our analytical validation studies. I’d like to thank all of our employees and shareholders for their ongoing hard work and support over the past six months and into the next phases of commercialisation.”
Notes:
- Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items and foreign exchange loss
- The CLIA (Clinical Laboratory Improvement Amendments) regime is used by the Center for Medicare and Medicaid Services (CMS) to regulate laboratory testing in the US, and requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing
Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Final Results via the Investor Meet Company platform on 13 September 2021 at 16:30hrs BST.
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9.00 a.m. the day before the meeting or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and add to meet VERICI DX PLC via:
https://www.investormeetcompany.com/verici-dx-plc/register-investor
Investors who already follow Verici Dx plc on the Investor Meet Company platform will automatically be invited.
Enquiries:
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it will release its unaudited results for the six-month period to 30 June 2021 on Monday 13 September 2021.
Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Half Year Results via the Investor Meet Company platform on Monday 13 September 2021 at 16:30hrs BST.
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 09:00hrs the day before the meeting or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and add to meet VERICI DX PLC via:
https://www.investormeetcompany.com/verici-dx-plc/register-investor
Investors who already follow Verici Dx plc on the Investor Meet Company platform will automatically be invited.
Enquiries:
About Verici Dx plc
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.
Verici Dx remains on track for completion of study end points by the end of 2021 for lead products
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that patient enrolment for a multi-centre observational clinical validation study for the Company’s lead products has concluded ahead of management expectations. Early completion of enrolment supports that the Company remains on track to complete the validation study for these products by the end of 2021, in line with expectations set out in the Company’s admission document.
Verici Dx has partnered with eleven leading US and EU centres to date to run a global, non-randomised study for the clinical validation of Verici Dx’s lead products, ClaravaTM and TutevaTM.
The study uses next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx signature tests.
Over the longer term, the study will also provide validation for the Company’s fibrosis test, called Protega™. Patient enrolment continues for validation of Protega and is expected to complete by Q3 2022. The end points of the validation study for this product are expected to be reached up to two years after the completion of enrolment, with data expected shortly thereafter around year-end 2024.
Sara Barrington, CEO of Verici Dx, said: “I am delighted to have reached this key milestone ahead of our original expectations. Since IPO our primary focus has been on the successful prosecution of these clinical trials, as the first key step in commercialising our innovative transplant products.
“We remain on track to have our two lead products fully tested by the end of the year and look forward to reporting the data in Q1 2022.”
Enquiries:
About Verici Dx plc
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the appointment to the Board of Lorenzo Gallon, MD, as Non-executive Director with immediate effect.
Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation), Dr. Gallon is currently the Medical Director of the Translational Medicine Program, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University, He is an alumnus of the University of Padua Medical School, Italy.
Dr. Gallon has extensive experience in nephrology and hypertension as well as organ transplantation. He was a collaborator and co-author with Dr. Barbara Murphy in the GoCar study1, which was foundational in the development of Verici’s products. He has acted as an advisor / consultant for multiple pharmaceutical and biotechnology companies, such as Alexion Pharmaceuticals, Inc., Horizon Therapeutics, Inc., and Argenx Pharma. He is also a member of the Editorial Board at the journal Nephron since 2019. In 2012, Dr Gallon was part the Northwestern Medicine transplant team that conducted the first successful removal and implantation of a kidney from one patient to another after the organ failed in the first recipient. The findings of the case were published in the New England Journal of Medicine.
In March 2021, Verici Dx unveiled that it has partnered with Dr Lorenzo Gallon, together with Dr Milagros Samaniego at Henry Ford Health System and Dr Daniel G. Maluf at the University of Maryland, Baltimore, in order to initiate the first US clinical trials for its two lead products, Clarava™ and Tuteva™. The trial will use next generation sequencing in the Verici laboratory to create transcriptomic profiles to validate performance characteristics of Clarava™ and Tuteva™. In the longer term, Verici is also seeking to work on the validation of its fibrosis test.
Julian Baines, MBE, Non-executive Chairman of Verici Dx, said:
“On behalf of the Board, I am delighted to welcome Lorenzo to Verici Dx. He brings extensive experience counselling boards and executives and will be an integral advisor helping us accelerate innovation in kidney disease and transplantation, especially on validation of our two lead products, Clarava™ and Tuteva™. The wealth of clinical acumen Lorenzo brings will definitely add value to the work we do every day on behalf of the millions of patients who had or waiting for kidney transplant. We look forward to embarking on our next phase of growth with our strengthened Board.”
Dr Lorenzo Gallon, Non-executive Director of Verici Dx, said:
“I’m honoured to join the Verici Dx Board of Directors and share my perspective as advisor with nearly 20 years of experience in the life sciences industry, particularly in nephrology and organ transplantation. I am glad to see the continuing development of relationships between academics and biotechnology companies, and I want to do all that I can to use my knowledge and experiences I’ve obtained to help advance innovation in the treatment as well as diagnostic testing of those who have kidney disease.”
Regulatory Disclosures
Dr Lorenzo Giovanni Gallon, aged 56, currently has no shareholding in the Company and there is no further information required to be disclosed under Rule 17 or paragraph (g) of Schedule 2 of the AIM Rules for Companies.
1 – https://pubmed.ncbi.nlm.nih.gov/27452608/
Enquiries:
About Verici Dx plc
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.
Major milestone in the commercial launch of Verici Dx’s lead products, ClaravaTM and TutevaTM
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has obtained a Clinical Laboratory Improvement Amendments (CLIA) Certification of Registration under the Centers for Medicare & Medicaid Services (CMS) for the Company’s newly established US clinical laboratory at the Innovation Park in Franklin, Tennessee, on which it took a lease in late April this year.
The Certificate of Registration authorises the Company to initiate commercial operations as a diagnostic laboratory in Tennessee. The location was selected for the high-quality premises within a healthcare hub to facilitate ease of logistics and hiring in the Palmetto region. Verici Dx expects to commercially launch its two flagship commercial products, Clarava™ and Tuteva™, in 2022.
In addition, the issuance of the CLIA Certification of Registration in Tennessee represents a milestone in the steps toward seeking a coverage determination through the MolDx Program administered by Palmetto GBA, the regional Medicare Administrative Contractor (MAC) of CMS which is responsible for services performed in laboratories located in the State of Tennessee and is also one of the largest MACs in the US.
Verici Dx’s two leading commercial clinical offerings, Clarava™ and Tuteva™, are designed to support clinician management and short and long-term graft health in kidney transplant patients. These leading-edge technologies are underpinned by extensive patented and published scientific research from Mount Sinai Medical Center for which Verici Dx holds an exclusive worldwide licence.
Michael J. Donovan, Chief Medical Officer of Verici Dx, said: “CLIA certification is the keystone of our strategy that serves to broaden diagnostic testing in the near term for kidney transplant patients. This Certificate of Registration is a key milestone in the CLIA approval pathway essential for commercial launch of the Company’s two lead products. Subject to successful conclusion of our validation studies, having a CLIA-certified lab will allow us to aid clinicians by using accurate, data-driven and non-invasive detection, to support their clinical decisions and ultimately improve kidney graft health for the tens of thousands of patients who undergo kidney transplant each year. We look forward to publishing validation study data on our first two products in early 2022.”
Enquiries:
About Verici Dx plc
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.
Multi-centre validation trial for leading products on track for completion by the end of the year including participation from European sites.
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has initiated its first European clinical validation trial site with Prof. Gaetano La Manna, Director of the Specialization School in Nephrology and the Dialysis and Transplant Unit, at the Sant’Orsola Polyclinic Hospital in Bologna, Italy.
The trial is a global, non-randomised, observational study for the clinical validation of Verici Dx’s lead products, ClaravaTM to predict risk of early acute rejection in the first six months post-transplant and TutevaTM for the diagnosis of acute cell-mediated rejection, and over the longer term, for the validation of the Company’s fibrosis test, now called Protega™.
Prof. Gaetano La Manna is the Director of the Nephrology, Dialysis and Transplantation Unit at the IRCCS-Sant’Orsola Polyclinic Hospital; he is Director of the School of Specialization in Nephrology of the University of Bologna; Full Professor of Nephrology at the University of Bologna, as well as Deputy Coordinator and member of the Board of Professors of the Research Doctorate in Cardio-Nephro-Thoracic Sciences. Prof. La Manna holds a PhD in Nephrology and Post-Doctorate in Medical Sciences. He has extensive experience in both clinical and experimental nephrology, dialysis and kidney transplantation, and also in the medical management of kidney transplant and its complications. The Kidney Transplant Center of the University of Bologna, inside the IRCCS Sant’Orsola Polyclinic Hospital, is one of the most important in Europe for number, quality and complexity of transplants, with more than 3,000 to its credit, including donation after brainstem death (DBD), donation after circulatory death (DCD), marginal donor, double transplants, ABO incompatible, hyperimmunized patients, combined kidney-liver, kidney-heart transplants and other special programs.
Angela Rose, Senior Director of Clinical Trial Operations of Verici Dx, said:
“The team has worked incredibly hard on this project, from designing and developing the approach to implementing the trial. In our effort to expand our clinical development and validation beyond North America, we are pleased to be working with Prof. Gaetano La Manna, a highly respected and experienced primary investigator, to lead our trial in Bologna, Italy. The diversification of our patient sample is a strategically important initiative for Verici, as we seek to leverage our clinical expertise and demonstrate our commitment to the development of globally validated transplant diagnostics.”
Verici Dx announced the collaboration with three leading US centres for clinical validation trial of its lead products in March 2021 and has subsequently opened 2 more US centres. Enrolment is on target for completion of the Clarava™ and Tuteva™ validation study by the end of 2021. Data is expected to be published as soon as practicably possible in 2022.
Enquiries:
About Verici Dx plc
Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.
