Pancreatic cancer

Clinical need

Pancreatic cancer is a disease in which malignant (cancer) cells appear in the pancreas.

Symptoms of pancreatic cancer appear late, and the disease often goes undetected until it is no longer resectable by surgical procedures. Because of this, the survival rate 5 years from diagnosis is only about 5%, making pancreatic cancer the third deadliest form of cancer. A test for the early detection of pancreatic cancer (stage I and II) when more effective treatment is available has the potential to dramatically increase patient survival rates.

Such a test would be able to address several unmet clinical needs:

1. Screening of high-risk groups i.e. familial/hereditary pancreatic cancer
2. Testing of new onset diabetes type II patients over 50 years who suffer a 6-8 times increased risk of developing pancreatic cancer within 1-3 years
3. Testing of patients with vague symptom profiles where the clinicans suspects, or wants to rule out, pancreatic cancer

Early diagnosis of pancreatic cancer based on the IMMray™ platform

Immunovia is currently developing a blood test called IMMray™ PanCan-d based on the IMMray™ platform for the early diagnosis of pancreatic cancer, with a focus on early stages (stage I and II).

IMMray™ PanCan-d can be performed, using a regular blood sample, on risk groups within familiar pancreatic cancer, new onset diabetes type II patients over 50 years and selected patients with vague symptoms profiles in combination with other risk factors.

Current status

• Our retrospective studies show that the test is able to detect stage I and stage II pancreatic cancer with 96% accuracy
• Undergoing prospective validation for hereditary risk group in the clinical study called PanFAM-1
• Undergoing prospective validation for new onset diabetes type II over 50 years of age in the clinical study called PanDIA-1
• Under evaluation for the patients with vague symptoms profiles in the clinical study called PanSYM-1

Steps to market

IMMray™ PanCan-d Discovery and Development Studies

• Danish and US studies published in JCO.
• Link to the article in JCO: Mellby et al. Serum biomarker signature-based liquid biopsy for diagnosis of early-stage pancreatic cancer.
• Flyer for download

IMMray™ PanCan-d Optimization study

• Study successfully completed with accuracy >90% for PDAC vs symptomatic, diabetic and healthy controls. Press release, June 3, 2019. Link to update call, June 3, 2019.
• Results on the IMMray™ PanCan-d optimization study presented at PancreasFest 2019. Press release, July 11, 2019. Link to the complete poster.

IMMray™ PanCan-d Commercial Test Model study

• Study successfully completed for IMMray™ PanCan-d in combination with CA 19-9 resulted in accuracy of 96% for PDAC stages I-IV vs symptomatic and healthy controls, and 95% for PDAC stages I-II vs symptomatic and healthy controls, respectively. Press release, December 19, 2019  
  Webinar Commercial Test Model Study & Update on Launch Activities, Sept 2, 2020.

IMMray™ PanCan-d Verification study

• Locked signature and algorithms with known samples, in total 519 samples. The verification results showed accuracy of 94% in differentiating early stage I/II PDAC patients from healthy controls. The test showed a specificity of 99% and a sensitivity of 78% for this comparison, yielding a high NPV of 0.993. Early stages I/II PDAC were differentiated from all the controls with an accuracy of 91%, with a now reported specificity of 93% and a sensitivity of 78%, yielding an NPV of 0.993. Press release, Nov 2, 2020. Immunovia Webinar Introducing New CEO, Patrik Dahlen with Chairman, Carl Borrebaeck, Nov 3, 2020.

IMMray™ PanCan-d Validation study

• Locked signature and algorithms with blinded samples, up to 600 samples.

IMMray™ PanCan-d Launch

• Sales Start Immunovia Dx Lab Marlborough USA, at the end of Q1 2021 with subsequent commercial testing in Q2.

References:

1. Pancreatic registry in Japan – 20 years of experience, 2004.
2. Ingvarsson J et al.Proteomics 2008 8(11):2211-9.
3. Wingren et al. Cancer Res. 2012 15;72(10):2481-90.
4. Gerdtsson et al. Int Journal of Proteomics 2015;2015:587250.
5. Gerdtsson et al. J Mol Oncol, 2016. 10, 1305-1316.
6. Mellby et al. Serum biomarker signature-based liquid biopsy for diagnosis of early-stage pancreatic cancer. J Clin Oncol. 2018 Aug 14. doi: 10.1200/JCO.2017.77.6658.