CEO Mats Grahn presents Immunovia
Immunovia was founded on the hypothesis that blood contains enough information to detect any disease – even at the earliest stages. However, turning this insight into useful tools for the clinician, we believe requires not only new technology, but a whole new approach to assay development, an approach based on cutting-edge bioinformatics and machine learning.
We are delighted to see that our commitment to these original ideas is starting to bear fruit. Firstly we are seeing encouraging results from both our retrospective and prospective pancreatic cancer studies for our first diagnostic test IMMray™ PanCan-d. These are backed up by equally encouraging results from our discovery studies in other types of cancer and in autoimmunity; especially the ongoing retrospective studies in autoimmune diseases such as SLE (Systemic Lupus Erythematosus) and related diseases.
At corporate level, we have made major progress in 2017 and in the beginning of 2018, all these efforts lead to the introduction of Immunovia on the main list of Nasdaq Stockholm, after a positive decision by NASDAQ on March 26, 2018, setting the date for first trading day on the main list to April 3rd, 2018.
Prospective studies prepare the way for cost reimbursement
Returning to our clinical study program, over the past 3 years, we have run 6 retrospective clinical studies based on 2,500 patient blood samples with the aim of finding a unique biomarker signature for all stages of pancreatic cancer, but with the main focus on early stages (I-II). We have now embarked on a comprehensive prospective study program to validate blood-based IMMray™ PanCan-d test in all three risk patient target groups. The program will provide the data required for statistically relevant sample cohorts that meet the criteria for reimbursement from health insurance systems while also enabling the test for national guidelines inclusions.
- PanFAM-1 – for the familial/hereditary risk group
- PanDIA-1 – for patients with new onset type II diabetes after 50 years of age
- PanSYM-1 – for patients with vague symptoms profiles associated with pancreatic cancer clinical risk factors.
Our prospective study for familial and hereditary risk groups, PanFAM-1, is a global multicenter prospective study that started at the end of 2016. During 2018 we are continuing to sign up cancer centers, both in the US and the EU. In December 2017, we announced that Sahlgrenska University Hospital in Gothenburg, had become the first Swedish site to join the study, and that the University of Pittsburgh, one of the most renowned centers of pancreatic cancer expertise in the US, had also become part of the study. In 2018 we have welcomed NYU School of Medicine Pancreatic Cancer Center, lead by Professor Diane M. Simeone (one of the leading experts in pancreatic cancer and an authority surgeon in the field), the renowned Clínica Universidad de Navarra in Spain and Linköping University Hospital in Sweden. Their participation expands the patient base giving the study greater breadth and legitimacy. Broadening the study also have market advantages as the participating centers will most likely also be the first customers of the commercial test. Other participating partners are: Mount Sinai in New York, Knight Cancer Institute at Oregon Health and Sciences University, Massachusetts General Hospital, Boston. The European partners are IRYCIS in Madrid, the University of Liverpool in the UK, Santiago de Compostela University Hospital and Sahlgrenska University Hospital in Sweden.
PanDIA-1, our prospective study for the new onset type II diabetes risk groups focuses on patients diagnosed after 50 years of age, one of the largest risk groups for pancreatic cancer. We have a collaboration with Lund University Diabetes Centre (LUDC). LUDC has historically collected samples from virtually all newly diagnosed diabetes patients since 2008 in the Skåne region of Sweden, a total of over 17,000 patients.
In December 2017, we initiated PanDIA-1, the world’s most comprehensive prospective study of this risk group, through a consortium that includes Lund University and Uppsala University, Lund University Diabetes Center, Region Skåne and Region Uppsala. This consortium will receive a SEK 7.6 million grant from SWElife, the Swedish government’s strategic innovation program, for the project “Improved diagnostics and treatment of diabetes-related comorbidities”. Through this project, Immunovia will be able to access up to 6,000 new-onset diabetics, over 50 years of age, for prospective testing with the IMMray™ PanCan-d biomarker signature assay. In January 2018, the Danish Center for Strategic Research into Type 2 Diabetes (DD2) signed a letter of intent to join PanDIA-1 study, adding up to 3,500 patients in what is planned to be a global collaborative study.
PanSYM-1, our prospective study for early and vague symptoms risk groups, started with the collection of samples in a pilot study in collaboration with University College London Hospital and the Multidisciplinary Diagnostic Center London, under the leadership of Professor Steve Pereira, one of the world’s most prominent key opinion leaders in this field.
The results of the pilot study, which covers up to 360 patients, are due in 2018. PanSYM-1 will be expanded to cover thousands of patients if the results of the pilot study are positive.
On track for self-pay sales in 2018
Already in 2016, Immunovia also started implementing commercialization plans for IMMray™ PanCan-d aimed at obtaining reimbursement of costs from various insurance systems and achieving national guideline status on each market. In 2018, we expect to reach our goal of starting sales of IMMray™ PanCan-d commercially by offering the test to customers, both as private individuals or healthcare institutions – so-called self-pay customers. To achieve this, we worked intensively during 2017 to industrialize IMMray™ PanCan-d. This work will be completed in 2018 and has involved development and documentation, preparations for ISO 13485 certification, ISO 17025 accreditation of the clinical laboratory in Lund, CLIA/CAP accreditation of the laboratories in the US, and CE marking of the product. Preparations ahead of the market launch also include scaling up production and laboratory processes with the same robustness and reproducibility maintained through the retrospective validation studies. We are making good progress, including, for example, reducing turnaround times in the laboratory from five to two days, and expect to complete it as planned in the latter part of 2018. The company will then start generating its first sales revenue.
Major potential in autoimmunity
In the long term Immunovia sees great potential in the development of tests for other unsolved problems within the cancer and autoimmunity fields via its IMMray™ technology. Tests will next be carried out for SLE and RA, based on the very positive results announced in early 2017. During the year we announced a major collaboration with Linköping University, which has expertise and valuable biobanks in RA, SLE, Vasculitis and Sjögren’s Syndrome. The goal is to develop the next generation of diagnostics for autoimmune diseases based on our IMMray™ platform.
In November 2017, we were honoured by a visit from His Majesty King Carl XVI Gustaf of Sweden and a delegation of industrial leaders that included AstraZeneca chairman Leif Johansson, and Swedish public officials. The visit was part of a program of visits to Sweden’s most innovative companies. Being chosen was a great honor and very welcome confirmation that our business involves a high level of innovation. Another, more concrete confirmation that we are not alone in seeing the potential in our blood-based test, was the award during the final quarter of the year of an SEK 4.9 million grant from SWElife, the Swedish government’s strategic innovation program, to be used in collaboration with CREATE Health at Lund University in our pancreatic work.
Move to main Nasdaq Stockholm list
Listing on Nasdaq First North has served the company well. Since the introduction in 2015 we have had access to capital and an investor base that has given us the opportunity to make the necessary preparations for taking the company to a commercial phase.
On the 26th of March, 2018, Immunovia has been approved for listing on Nasdaq Stockholm. First day of trading on Nasdaq Stockholm is scheduled for 3 April 2018, and the last day of trading on Nasdaq First North is scheduled for 29 March 2018.
I now look forward to starting the sales of our test to help the patients and their families!
Thank you for your continuing support.
CEO, Immunovia AB