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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 great interest has been shown in us by 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 around 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 general potential that exists in our IMMray™ platform.

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

During the spring and summer 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 results that mean we will now continue our efforts aimed at developing a product for patients that are difficult to diagnose in this area.

The main focus, as usual, was on IMMray™ PanCan-d. Work has proceeded according to plan in the second quarter. In August, however, new data emerged showing that the sample-collection procedure, which will be applicable commercially and for our final validation studies, affects our product’s algorithms. We have therefore decided that a necessary stage is to optimize IMMray™ PanCan-d to safeguard the quality of the test results prior to release. This will delay the start of sales to the latter part of 2019.

 

IMMray PanCan-d 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 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; The University of Liverpool, UKRamon y Cajal Institute for Health Research Madrid, SpainUniversity Hospital of Santiago de Compostela, SpainClínica Universidad de Navarra, Spain; and Karolinska Institutet, Stockholm, Linköping University Hospital and Sahlgrenska University Hospital, Gothenburg  in 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 by end 2018.  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, 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, 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.

 

Market introduction of IMMray™ PanCan-d

During the second quarter of 2018, the main focus of the organization was on performing the activities necessary for the release of IMMray™ PanCan-D. This involves a series of studies where the signature and algorithms are finally determined, then verified by independent known samples and finally validated by blind samples. Parallel to this, a variety of other parameters are tested, particulary related to verifiying the robustness of the IMMray™ platform. This includes technical varations, storage times and transport conditions for the product and its components, quality controls and their limits, detailed method instructions and many other activities.

The work proceeded according to plan during the quarter and all IMMray™ platform related results came out positive, specifically regarding low technical variations which confirms the robustness of the IMMray™ platform. However, after the end of the quarter we have obtained results from one of the in-depth studies, where it emerged that due to variations in the collection procedures from different biobanks, optimization of the signature must be performed before release of the product. This means that after optimization, performed with the IMMray’s complete development antibody array (expected to be completed in the first quarter 2019), a number of the tests and studies referred to above must be conducted with the optimized signature, which overall is expected to delay the launch of IMMray™ PanCan-d to the later part of 2019.

We will now fully focus on the optimization of IMMray™ PanCan-d and do all that is possible to minimize the delay while maintaining our high quality, but at the same time we feel strengthened by the fact that all tests of the IMMray™ platform show that IMMray™ is 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.

 

Mats Grahn

CEO, Immunovia AB

November 2018

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