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History

 

YearMilestones
2007Immunovia AB is founded in 2007 by researchers at the Department of Immunology at Lund University and CREATE Health – Center for Translational Cancer Research, in Lund, Sweden.

The purpose is to commercialize discoveries and patents held in human antibodies, biomarkers and antibody arrays – and to develop a diagnostic antibody test platform based on these discoveries.

2007-2013The antibody technology platform is further developed and a number of important patents are submitted.

Clinical trials and multicenter studies in Spain regarding pancreatic cancer diagnosis are conducted.

2014 -2015Immunovia carries out a new issue of approximately 43 MSEK and receives Horizon 2020 allocations of approximately 43 MSEK over two years.

Several important clinical studies are conducted, including a study in China showing that the pancreatic signature works in populations with a different genetic background. In addition, the clinical studies report encouraging, initial data on the early diagnosis of asymptomatic stage I and II pancreatic cancer.

Immunovia is listed on Nasdaq First North and in connection with this; approximately 60 MSEK is generated, excluding transaction costs.

Between 2014-2015, the number of employees at Immunovia grows from 3 to 11 co-workers.

2016The company carries out a rights issue and a directed issue of approximately 29 MSEK and 190 MSEK excluding transaction costs.

Collaboration agreements on prospective studies in PanFAM-1 are signed with various selected research centers, including Mount Sinai, New York, USA and the Ramon y Cajal Institute for Health Research, Madrid.

Immunovia receives the “2016 Stars of Innovation Prize” for most Innovative SME in Europe.

A Letter of Intent is signed with the National Cancer Institute (NCI) in the United States stating that Immunovia will be part of NCI’s program for the pancreatic cancer risk group New Onset Diabetes type II (NOD) over 50 years of age.

In 2016, the number of employees at Immunovia grows from 11 to 16 co-workers.

2017

 

The NCI project in NOD-associated pancreatic cancer is delayed due to budget problems at NCI.

The world’s largest prospective study (PanDIA-1) of the largest risk group for pancreatic cancer is initiated: people over 50 years getting their first diagnosis of diabetes type II.

The prospective study for familial/hereditary pancreatic cancer (PanFAM-1) is expanded to include the Mount Sinai in New York, the Knight Cancer Institute at Oregon Health and Sciences University, Portland, USA, University of Liverpool, UK, Ramon y Cajal Institute for Health Research, Madrid, Spain, Sahlgrenska University Hospital, Gothenburg, and University of Pittsburgh, USA.

Immunovia’s study in autoimmunity shows that SLE can be distinguished from three other common autoimmune diseases with similar symptoms, including rheumatoid arthritis (RA).

Start of prospective patient sample collection from patients with early symptoms that may be associated with pancreatic cancer at the University College London Hospital. Work is led by Professor Steve Pereira, one of the world’s leading Key Opinion Leaders in this risk group (PanSYM-1).

Immunovia receives a contribution of SEK 4.9 million from SWElife.

Excellent results from a study regarding differential diagnosis of autoimmune diseases including SLE, RA, Vasculitis and Sjögren’s syndrome are obtained. A collaboration agreement is signed with Linköping University Hospital that gives Immunovia access to biobanks for follow-up studies and supplementary retrospective studies.

Immunovia establishes a US office for the subsidiary Immunovia Inc. in Marlborough. The facility rooms an own reference laboratory.

By the end of the year, the number of employees at Immunovia consists of 30 co-workers.

2018

 

Immunovia is approved for listing on Nasdaq Stockholm and completes a directed share issue of approximately SEK 324 million.

Journal of Clinical Oncology publishes that IMMray™ PanCan-d serum biomarker test is able to detect early pancreatic cancer with 96% accuracy.

10 more leading research centers join Immunovia’s global, prospective, vaidation study PanFAM-1, making it the largest clinical study for the early detection of pancreatic cancer in this risk group. The study is designed to validate early diagnosis of Familial Pancreatic Cancer (FPC) using IMMray™ PanCan-d.

Denmark’s Diabetes Center for Strategic Research in type 2 diabetes (DD2) joins Immunovia’s prospective pancreatic cancer study of new onset diabetics (NOD) PanDIA- 1, to accelerate the investigation of the prevalence of pancreatic cancer in diabetes type II patients over 50 years.

IMMray™ PanCan-d biomarker signature for the diagnosis of pancreatic cancer is patented in Japan.

A collaborative study shows that Immunovia’s IMMray™ platform provides highly accurate diagnosis of non-small cell lung cancer (NSCLC). A blood-based IMMray™ biomarker array provides an accuracy of 95%, distinguishing between 50 NSCLC and 50 controls.

Immunovia announces a breakthrough in autoimmune testing – an IMMrayTM based biomarker signature can identify rheumatoid arthritis (RA) with over 90% accuracy. More over IMMrayTM can detect RA in patients testing sero-negative for rheumatoid factor (RF) and anti-CCP, according to a discovery study in collaboration with the University of Linköping.

Immunovia announces new strategic focus centered on devloping a IMMray™ blood-based biomarker signature for rheumatoid arthritis (RA) within autoimmunity.

Immunovias prospective study for familiar/hereditary pancreatic cancer (PanFAM-1) is registrered on ClinicalTrials.gov, the world’s largest database for clinical studies.

The expansion of the new production facility and clinical laboratory – IMMray Dx Laboratories Lund (Sweden) is completed. Together with IMMray Dx Laboratories Marlborough (MA, USA), the state-of-the-art facility has the capacity to satisfy the foreseeable market need for testing, both commercially and in our ongoing studies.

By the end of the year, Immunovia employs 39 co-workers.

2019

 

Immunoiva completes IMMray™ PanCan-d optimization, and announces excellent results across all symptomatic risk groups.

To further optmize validation of IMMray™ PanCan-d for early diagnosis in high-risk individuals with Familial Pancreatic Cancer (FPC), the research centers in Sweden and Spain expand their sample collection to increase ethnical and genetical variation.

University College of London (UCL) expands prospective collection of blood samples for the PanSYM-1 pilot study, designed to validate IMMray™ PanCan-d’s use for detection of pancreatic cancer in patiens with early related signs and symptoms.

Two new cancer centers in New York and Chicago join PanFAM-1, which is now the most comprehensive prospective study in pancreatic cancer to date.

Immunovia signs a collaboration agreement with the University Hospital Erlangen (Germany) for the collection of blood samples from pancreatic cancer patients in order to complete development of IMMray™ PanCan-d.

Results of the IMMray™ PanCan-d optimization study are presented at PancreasFest 2019 by Immunovia’s US Medical Director, Thomas King. The results show that IMMray™ PanCan-d (in combination with CA19-9) is able to differentiate between PDAC, similar symptoms, healthy controls, and type 2 diabetes. Similar results are obtained for all stages of PDAC with ROC AUC values of 0.97, 0.98 and 0.96 respectively.

Immunovia launches a campaign in collaboration with the Greg and Cathy Griffith Family Foundation’s initiative called Sideline Cancer® to raise awareness of pancreatic cancer that is on display in Times Square, New York City.

2020

 

Immunovia issues a COVID-19 pandemic announcement to protect society, but maintains the plan to launch IMMray™ PanCan-d in the fall of 2020. The initial addressable market in the US and Europe is estimated at USD 4.4 billion.

Immunovia ends lung cancer collaboration with a global pharmaceutical company, but continues own program as planned with the goal of completing the study by the second quarter of 2020.

Immunovia™ Dx Laboratories in Marlborough, Massachusetts, resumes operations after the shutdown caused by the new coronavirus.

Immunovia carries out a targeted new issue that provides a capital injection of approximately SEK 400 million – one of the largest capital acquisitions for a diagnostic company based outside the United States. The aim is to further accelerate the market introduction of the first test for early detection of pancreatic cancer, IMMray™ PanCan-d.

Immunovia announces Q4 2020 launch of the IMMray™ based test tor early detection of pancreatic cancer in Marlborough USA.

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