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Clinical prospective study program

Immunovia has developed since 2016 a clinical prospective study program in the three main risk groups for pancreatic cancer as follows:

  • PanFAM- 1 is the clinical study for individuals with familial/hereditary pancreatic cancer
  • PanSYM-1 for patients with early non-specific symptoms suggestive of pancreatic cancer
  • PanDIA-1 designed for individuals at risk due to the diagnosis of new onset diabetes after the age of 50

These three large clinical studies cover today more than 10 000 subjects recruited at >30 sites in the US and Europe.

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PanFAM-1 study: Familial/hereditary pancreatic cancer high risk group

PanFAM-1 is a multicenter prospective study for early detection of pancreatic cancer in individuals presenting hereditary/familial risk factors that has been designed in close collaboration with global Key Opinion Leaders in familial/hereditary pancreatic cancer.

The main goal of the study is to provide actionable information to the clinicians regarding diagnosis of pancreatic cancer. Furthermore, the study will deliver clinical performance data for IMMray™ PanCan-d from a cohort of highrisk asymptomatic individuals compared with currently used surveillance methods i.e. imaging technologies.

We have concluded sample collection across the 23 global study sites (starting December 2017 and ending April 2021) with a total of over 3 000 samples from 1 265 subjects. Currently, these samples are being analyzed at our CLIA laboratory in Marlborough and the results will be made public in mid 2022.

The 23 participating partners in PanFAM-1 are:

  • United States: New York University Hospital, NY; Columbia University, NY; Mount Sinai Hospital, NY; Stanford Gastroenterology and Hepatology, CA; Yale University, CT; University of Chicago Medical Center, IL; Massachusetts General Hospital, MA; University of Massachusetts, MA; The Ohio State University, OH; Oregon Health & Science University, OR; University of Pennsylvania, PA; University of Pittsburgh Medical Center, PA and University of Utah, UT.
  • Canada: The Research Institute of the McGill University Health Centre.
  • Sweden: Karolinska University Hospital; Sahlgrenska University Hospital; Umeå University Hospital and Linköping University Hospital.
  • Spain: University Hospital Ramon y Cajal; University Hospital Santiago de Compostela and Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL).
  • United Kingdom: University College London Hospital and The University of Liverpool.

References:

  1. American Society of Clinical Oncology, ’Pancreatic Cancer: Risk Factors’, cancer.net/cancer-types/pancreatic-cancer/risk-factors.
  2. Mouad E, Guido E, ’Risk factors for pancreatic cancer: underlying mechanisms and potential targets’, Front Physiol. 2014; 5: 490.
  3. Theodore B, Anna Mae Diehl, ’Advanced Therapy in Gastroenterology and Liver Disease’, PMPH-USA, 2005, s. 825.

PanSYM-1 study: Risk group with vague symptom profiles associated to pancreatic cancer

PanSYM-1 started in November 2018 as a prospective validation study for the early diagnosis of pancreatic cancer in patients with nonspecific but concerning symptoms and other risk factors. The sample collection was conducted at the University College Hospital, London, and The Royal Free Hospital. The study was intended to demonstrate that IMMray™ PanCan-d was equal or better than the standard of care diagnostic pathway. The target sample collection size was 2 000, which was not achieved due to the impact of Covid-19 on patient attendance at the hospitals enrolled in the study. Due to the shortage of samples, the primary endpoints, sensitivity, and specificity of the IMMray™ PanCan-d assay as compared to the standard of care could not be evaluated as intended. Study samples were instead included in the Commercial Test Model and other studies of IMMray™ PanCan-d. In particular more than 200 patient samples from PanSYM-1 were used in the performance study announced on 29th of March 2021 that showed 92 percent specificity and 80 percent sensitivity in discriminating early stage I/II pancreatic cancer from high-risk symptomatic patients. This underscores the promising potential IMMray™ PanCan-d has in this patient group. We are currently investigating our options to fully validate the promising results for IMMray™ PanCan-d in the symptomatic risk group. At the same time, we continue to work with our Key Opinion Leader-network to focus on pancreatic cancer detection in symptomatic patients.

References:

  1. Suresh T. Chari et al. Summative Review: “Early Detection of Sporadic Pancreatic Cancer”, 2015
  2. Fiona M Walter et al.  Symptoms and patient factors associated with diagnostic intervals for pancreatic cancer (SYMPTOM pancreatic study): a prospective cohort study, Lancet Gastroenterol Hepatol 2016.
  3. ACE Cancer Decision Support Tools Cluster “Using Cancer Decision Support Tools to support the early diagnosis of cancer”, May 2017
  4. Keane MG et al. A case–control study comparing the incidence of early symptoms in pancreatic and biliary tract cancer. BMJ Open 2014;4:e005720. doi:10.1136/bmjopen-2014-005720
  5. NHS Long Term Plan: https://www.longtermplan.nhs.uk/areas-of-work/cancer/

PanDIA-1 study: New onset diabetes at 50+ years of age

PanDIA-1 started in January 2018 as the world’s most comprehensive prospective sample collection for early detection of pancreatic cancer in the new onset diabetes type 2 high risk group. In December 2021, 6 000 samples had been collected from new onset diabetes patients, of which approx. 5 100 are above the age of 50 years. The samples were collected from new onset diabetic patients starting at the time of diabetes diagnosis over a 3-year period, the time span during which patients with new-onset diabetes type 2 have up to 6-8 times higher risk of developing pancreatic cancer than the normal population. In collaboration with ANDIS (All New Diabetics in Skåne) and ANDIU (All New Diabetics in Uppsala) the team is currently obtaining the associated clinical records related to the collected samples. An update will be provided during Q2 2022.

References:

  1. Mikael Öman et al. ’Nationellt vårdprogram för pankreascancer och periampullär cancer’, Regionala cancercentrum i samverkan, 2012, s. 56.
  2. Damiano J, Bordier L, Le Berre JP, et al. ‘Should pancreas imaging be recommended in patients over 50 years when diabetes is discovered because of acute symptoms?’ Diabetes Metab 2004; 30: 203–07.
  3. Rahul Pannala, Ananda Basu, Gloria M Petersen et al. ‘New-onset diabetes: a potential clue to the early diagnosis of pancreatic cancer’, Lancet Oncol 2009; 10: 88–95, 2009., s. 89.