Boston An independent LDT provider

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.

Click on image below for larger size.

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 goals of PanFAM-1 were to diagnose pancreatic cancer early and to provide clinical performance data for IMMray™ PanCan-d from a prospective cohort of high-risk asymptomatic individuals compared with currently used surveillance methods i.e. imaging technologies.

The study has gathered over 3000 patient samples from 1265 subjects from 23 different familial/hereditary pancreatic cancer high-risk surveillance programs in the USA and Europe, making it the largest prospective study of pancreatic cancer to date. The last blood samples were collected in April 2021. All blood samples will be analyzed by the second half of 2021.

There are 23 participating partners in PanFAM-1:

  • 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 is an ongoing prospective validation study for the early diagnosis of pancreatic cancer in patients with non-specific but concerning symptoms and other risk factors. The study has been designed to provide clinical performance data for IMMray™ PanCan-d in this risk group together with leading Key Opinion Leaders (KOL) in the area. Immunovia is also working actively on a global basis with Key Opinion Leaders (KOL) in an attempt to influence medical practice and national guidelines.

The goal is to help clinicians to diagnose the cancer while it is still resectable by surgery, thereby dramatically improving survival rates, and at the same time lowering healthcare costs, and to achieve routine testing of patients with vague but concerning symptom profiles where the clinician suspects, or wants to rule out, pancreatic cancer.

The prospective collection of serum samples from high risk patients with vague but concerning symptoms attending secondary care centers and endoscopy / gastrointestinal units started in 2018, in close collaboration with the University College London Hospital (UCLH) and Professor Stephen Pereira. Professor Pereira is one of the world’s most renowned experts in pancreatic cancer and a member of Immunovia’s advisory board since 2017.

The samples collected up to 2020 have been part of the development stages of IMMray™ PanCan-d: the optimization study, the commercial test model study, verification and validation study.

Investigator initiated studies are under discussion with UCLH and several other rapid diagnostic centers across UK analysing patients with non-specific but concerning symptom profiles to assess utility of Immunovia’s test in identifying the high risk patients earlier than the current standard.

PanSYM-1 prospective study is part of the UCL ADEPTS Study (Accelerated Diagnosis of neuroEndocrine and Pancreatic TumourS) and associated Early Diagnosis Research Alliance (EDRA) funded by Pancreatic Cancer UK to support significant elements of the NHS (National Healthcare System) Long Term Plan set in 2019 with one main goal being cancer diagnosis at a resectable stage. (Press release April 10, 2019)

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 is an ongoing prospective observational study for the early diagnosis of pancreatic cancer in high-risk individuals within the risk group of New Onset Diabetes type 2 (NOD).

In 2017 Immunovia launched PanDIA-1, the world’s most comprehensive prospective study for the early diagnosis of pancreatic cancer within the NOD risk group. The study was started in collaboration with Lund University, Uppsala University, Lund University’s Diabetes Center (LUDC), Region Skåne and Region Uppsala.

The goal of PanDIA-1 is to validate the clinical utility of IMMray™ PanCan-d in this risk group, proving the overall healthcare benefits and economics involved in testing for pancreatic cancer in NOD.

A 7.6 million SEK grant from SWElife, the Swedish government’s strategic innovation program, was given to support the study. The SWElife program has supported the creation of one of the world’s largest biobank of recently diagnosed diabetes patients (21,000 diabetes patients from two Swedish regions via ANDIS (All New Diabetics in Skåne) and ANDIU (All New Diabetics in Uppsala) studies. Through this collaboration, Immunovia will gain access to up to 6,000 diabetic patients over 50 years of age for prospective tests using IMMray™ PanCan-d, over a period of 3 years.

Interim analysis expected during the second half of 2021.

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.