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

• Immunovia reports positive results of the blinded clinical validation of IMMray™ PanCan-d blood test for Stage I/II pancreatic cancers in familial/hereditary risk groups in USA – and improved test performance in detecting early stage pancreatic cancer in high risk symptomatic patients
• 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. Link to the complete poster.

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 for early detection of pancreatic cancer in familial/hereditary risk group

• Locked signature and algorithms with blinded samples, in total 591 samples. The blinded validation study data demonstrated that Immunovia’s IMMray™ PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/hereditary controls (reference PanFAM clinicaltrials.gov) and with a specificity/sensitivity of 99%/85% vs healthy controls. All stages of PDAC were detected with a specificity of 98% and a sensitivity of 87% against familial/hereditary controls. The blinded validation study, performed by Immunovia Dx Laboratory in Marlborough USA, analysed 591 samples including 167 PDACs whereof 56 PDAC stage I&II, 203 high risk individuals, and 221 healthy controls. These samples have been freshly collected from 11 sites in the US and Europe. Press release, March 29 2021. Webcasted telephone conference, March 30 2021: Immunovia reports historical breakthrough in early detection of pancreatic cancer in high risk groups. IMMray.com

IMMray™ PanCan-d clinical study for early detection of pancreatic cancer in symptomatic patients risk group with unspecific but concerning symptoms

• Immunovia reports improved test performance of IMMray™ PanCan-d in detecting early stage pancreatic cancer in high risk symptomatic patients. The study data demonstrate that Immunovia’s test  now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe. Press release, March 29 2021. Webcasted telephone conference, March 30 2021: Immunovia reports historical breakthrough in early detection of pancreatic cancer in high risk groups. IMMray.com

IMMray™ PanCan-d Launch

• The final validation study was completed in Q1 2021. Commercial testing will begin in Q2 2021 after the accreditation of Immunovia Dx Laboratory in Marlborough, Massachusetts, USA.

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.