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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.

On 3rd April 2018, Immunovia moved from First North to NASDAQ Stockholm’s main market. We are listed in the Mid Cap segment and have seen great interest from investors. The change in listing strengthened Immunovia’s brand as expected, significantly increasing awareness of the company, and in the second quarter we completed a directed share issue worth approximately SEK 324 million. This share issue generated strong interest from reputable institutions in Sweden as well as internationally, including Swedbank Robur, Handelsbanken Fonder, Alfred Berg Kapitalförvaltning AB, Nyenburgh Investment Partners, Apus Capital and Bonit Capital. We are very pleased and grateful for the confidence shown in us by our investors to now utilize the great potential that exists in our IMMray™ platform.

Very exciting results have been achieved in two major application areas, lung cancer and rheumatoid arthritis, which demonstrates the versatility of the general application of the IMMray™ platform opening up great opportunities for Immunovia.

During the spring and summer of 2018, we completed a lung cancer study with very good results. This was our first collaboration with a global, top-ten pharmaceutical business and the aim was to assess the technical performance of the IMMray™ platform within lung cancer.

In the autoimmune field, we have made significant progress within rheumatoid arthritis. In August, we published compelling results and will continue our efforts aimed at developing a product for patients that are difficult to diagnose in this area.

The main focus in 2018 was on IMMray™ PanCan-d. As Immunovia announced in August 2018, the combination of retrospective samples from different biobanks, with varying sample collection procedures and storage time, introduced unforeseen variability in the test algorithm performance. Because of that, additional work was done. We confirmed in early 2019 that the distorting effect caused by the variability in blood sampling procedures was eliminated by consistent and optimal protocols. Additionally, for optimal performance of the test, the samples should be collected within 24 months to avoid potential storage distortions.

During 2018, we have been extremely successful in expanding our three large clinical studies, PanFAM-1, PanSYM-1 and PanDIA-1. These prospective studies designed to validate Immunovia’s test for early detection of pancreatic cancer IMMray™ PanCan-d, cover currently 24 sites from USA and Europe and will enroll more than 10.000 patients from the 3 high risk groups of pancreatic cancer: hereditary/familial (PanFAM-1), early symptoms suggestive of pancreatic cancer (PanSYM-1) and new onset diabetes type II after the age of 50 (PanDIA-1).

 

IMMray™ PanCan-d prospective studies prepare the way for cost reimbursement

Regarding 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). Since 2016, we have been building a comprehensive prospective study program to validate the 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.

Study High risk group No. of subjects
PanSYM-1 Non-specific but concerning symptoms >2 000
PanFAM-1 Asymptomatic familiar/hereditary >2 000
PanDIA-1 New onset diabetes type II after the age of 50   6 000

 

PanFAM-1 overview

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. The PanFAM-1 partners to date are: Mount Sinai, New YorkKnight Cancer Institute at Oregon Health and Sciences University, Portland, OR; The University of Pittsburgh Medical Center Pittsburgh, PAThe Massachusetts General Hospital, Boston, MANYU School of Medicine, New YorkResearch Institute of the McGill University Health Centre (RI-MUHC), Montreal Canada; The Trustees of the University of Pennsylvania; University of Massachusetts; Yale University MA; University of Chicago Medical Center, IL; Columbia University, New York; The University of Liverpool, UKUniversity College London (UCL), UKRamon y Cajal Institute for Health Research Madrid, SpainUniversity Hospital of Santiago de Compostela, Spain, Clínica Universidad de Navarra, Spain, Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL) in Barcelona, SpainKarolinska Institutet, Stockholm, SwedenSahlgrenska University Hospital, Gothenburg, Sweden, Umeå University Hospital, Swedenand Linköping University Hospital, Sweden.

Advanced discussions over potential participation continue with several other European and US centers running high risk surveillance programs. The goal is to close the recruitment of new centers spring of 2019.  More information about PanFAM-1 trial can be found on: www.clinicaltrials.gov.

 

PanDIA-1 overview

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 overview

In October 2017, 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 data of the pilot study will be analyzed as soon as the optimization of the IMMray™ PanCan-d signature has been completed. PanSYM-1 is planned to cover thousands of patients with pancreatic cancer suggestive symptoms.

 

Collaboration on lung cancer with a global pharmaceutical company

During the spring in 2018, a dedicated Immunovia team carried out a lung cancer study in our first collaboration with a global top-ten pharmaceutical company. The study included 100 serum samples – 50 NSCLC (non-small cell lung cancer) and 50 controls – and was performed to assess the technical performance of the IMMray™ platform in tests for lung cancer. The result, that we could differentiate healthy controls from NSCLC samples with a 95% accuracy, give us good opportunities to proceed with larger studies in order to confirm the preliminary findings. There is a need for early detection in the lung cancer field, which in addition to being one of the three largest forms of cancer in terms of numbers affected each year, also has the highest mortality, i.e. numbers of deaths per year. Lung cancer is therefore one of the biggest markets for new and effective diagnostic solutions.

 

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 have been 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. We have performed additional studies to establish information for our product strategy.

As reported in August 2018, this work primarily centered on a large study of rheumatoid arthritis (RA). Here, one of the biggest clinical problems is that over 25% of those who develop RA test negatively in the two standard tests, thus making them very difficult to diagnose. Health providers want to detect and treat RA as early as possible so they can limit or prevent damage to joints and other parts of the body that result from the disease and which mean sickness leave from work and lower quality of life for patients. In the early stages of RA, over 50% of patients test negative, using the current two standard tests, which is a further strong reason for being able to offer a solution that enables an increase in the share of patients diagnosed at an early stage of RA.

In the study, we performed in the first half of the year and finished in August, we were able to report exceptionally good results in the detection of so-called double-negative patients from healthy controls. We will now proceed with further studies aimed at developing an optimized product for early detection of RA in patients who are difficult to diagnose.

We remain encouraged by the results from the tests of IMMray™’s platform which demonstrated robust and reproducible with low technical variations at all levels while being capable of finding solutions to clinical problems in addition to pancreatic cancer. This has been shown in the results for lung cancer and for the autoimmune disease, rheumatoid arthritis. All of this opens great opportunities for Immunovia. We are always grateful for our shareholders’ continued support.

 

Market introduction of IMMray™ PanCan-d

The main focus of 2018 was on performing the activities necessary for the commercialization of IMMray™ PanCan-d. Through our large and growing network of influential key opinion leaders, we were able to secure the relevant samples needed to complete the optimization work. Acquiring these freshly collected samples for the optimization work has pushed out the previously communicated timeline to complete the optimization work by about 8 weeks, which will impact the commencement of sales accordingly. Going forward, the verification and validation process of IMMray™ PanCan-d will be conducted solely with samples collected that best conforms to real-life, commercial conditions.

The steps to market remain the same and once the optimization work is complete, we will begin the commercial test model study, followed by verification and validation studies. Details on timing of these milestones will be communicated at the end of May/beginning of June 2019.

In conjunction with the preparations for the commercialization of IMMray™ PanCan-d, Immunovia completed the expansion of our production and sample testing facilities, IMMray™ Dx Laboratories, at our headquarters in Lund, Sweden. This new state-of-the-art facility, together, with our IMMray™ Dx Laboratories at our subsidiary in Marlborough, MA, allows us the capacity and capability to produce slides to meet the current foreseen demands for commercial testing as well as meet the demands of more than 10.000 patients that are ongoing enrollment in the three large prospective studies that will be performed in parallel the coming years.

We worked intensely throughout 2018 on the preparations for our sales launch targeted for the beginning of 2020. We focus all our efforts to reach this pivotal milestone in the continued development of our company. At Immunovia, we remain fully committed and focused on the commercialization of IMMray™ PanCan-d and continue to do everything possible to maximize efficiency while maintaining our high quality.

 

Mats Grahn
CEO, Immunovia AB
May 2019

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