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GemciTest: An innovative In Vitro Diagnostic for the decision-making process of pancreatic cancer treatment

Periodic Reporting for period 1 - ImOPac (GemciTest: An innovative In Vitro Diagnostic for the decision-making process of pancreatic cancer treatment)

Reporting period: 2019-12-01 to 2021-01-31

What is the problem/issue being addressed?

Pancreatic adenocarcinoma is predicted to be the 2nd cause of death by cancer in Western Countries in 2023. For nearly 80% of patients (~51,000 and ~150K in USA and EU patients in 2017), diagnosis occurs at an advanced, non-surgical stage, making them incurable. The high mortality rate, with more than 95% of patients dead at 5 years, versus 13% for breast cancer, is partly due to the difficulty to diagnose, but also because of the lack of stratification of patients and a limited choice for treatments in the current decision-making process.
The treatment paradigm for pancreatic cancer is predominantly composed of chemotherapies, most notably gemcitabine-based and Folfirinox therapies, which are considered to be gold standard for pancreatic cancer. Up until now, the algorithm of decision-making (treatment choice) in metastatic pancreatic ductal adenocarcinoma (PDAC) management does not mention pharmacogenomics biomarkers, needed to stratify patient populations and to choose the best treatment with the best clinical effectiveness for a given patient. These regimens have very different toxicities profiles which factors in to which regimen is recommended.
Through ImOPac project, Acobiom aims to implement an innovative approach to improve personalized pancreatic cancer management in the decision-making process of PDAC, by using biomarkers to help in the patient stratification. This approach is the GemciTest®, a non-invasive test based on a nine gene predictive signature for gemcitabine-based therapies sensitivity.

B. Why is it important for society?

On one side, the Global Pancreatic Cancer market accounted for $1,904.20 million in 2017 and is expected to reach $4,728.19 million by 2026 growing at a CAGR of 10.6% during the forecast period. Advancement of technology in therapeutic devices and expanding prevalence of cancer growth are the factors driving the market. However, accessibility of costly treatment and poor repayment strategies in the emerging regions of the world are some of the factors which may hamper the market growth during the forecast period.

On the other side, Goldstein DA and coll. (Medical Oncol., 2016) described a complete cost description of chemotherapy regimens for the treatment of pancreatic cancer. They described the monthly costs and the overall treatment costs for gemcitabine-based and Folfirinox therapies. In addition to the cost of drugs, they included administration expenditures and costs of toxicities, including growth factor support, blood product transfusion and re-hospitalization. This complete medico-economic study is unique and has shown the explosive cost of inappropriate treatments for Hospital and Payer, and deadly side-effects for patient.
Thus, GemciTest® justifies its unique and innovative potential because it can:
1. facilitate precision medicine by guiding clinicians towards the measured choice of optimal therapy,
2. reduce and control overall healthcare costs in pancreatic cancer,
3. improve the quality of life of the patient.

C. What are the overall objectives?

Combining innovative strategy and medical needs, ACOBIOM is intended to open up new opportunities in "PDAC" treatment. Acobiom’s IVD is able to be integrated into daily practice and incorporated into the treatment decision-making process to optimize patient outcomes including performance, nutritional and psychological status, patient's age, pain, and other comorbidities.

Thanks to this innovation, Acobiom has an opportunity to create an EU new market. Acobiom needs to strengthen its competencies and to develop senior positions in Medical Affairs, Sales and Marketing, and Global Alliances.
Acobiom has hired in-house a pharmacist (October 2018 – December 2018) to analyze the public medico-economic data associated with pancreatic cancer. His work answered the question "How can GemciTest add value in the treatment of patients with metastatic pancreatic cancer?"

The results obtained by the pharmacist should be extended in order to assess in a very cost-effective view the impact of pancreatic cancer.

Thus, Acobiom filed a study “Panorama of therapeutic management of pancreatic cancer in France (PaPriCap study)”.
This study required:
- filing of a declaration with the National Institute for Health Data (INDS), March 2020,
- obtaining a favorable opinion from the Ethical and Scientific Committee for Research, Studies and Evaluations in the field of Health (CESREES), September 2020,
- the filing of an authorization request for research, study or evaluation treatment with the CNIL on September 2020,
- obtaining a favorable opinion from the CNIL to access data from the INDS (National Institute for Health Data) and the SNDS database, on December 2020
- Final file filed with the CNAM Assurance Maladie, January 2021.
If ACOBIOM planed original schedule, it has been postponed several times by the different organisms in charge of validation. Of course, this delay is mainly due to an overburden of the partners in charge of the data extraction within the Covid-19 outbreak. Indeed, Covid-19 lockdown generates a huge number of inquiries/demands from industrials to deal with health data especially for the e-health and e-solutions able to bring some support to tackle the Covid-19 pandemic outbreak.

ACOBIOM presented the 6-7 September, the GemciTest® results and device to the sixth American Association for Cancer Research (AACR, the world's largest professional association) Special Conference on pancreatic cancer.

ACOBIOM published on October 2020 “Predictive Values of Blood-Based RNA Signatures for the Gemcitabine Response in Advanced Pancreatic Cancer” in Cancers (doi:10.3390/cancers12113204).
ACOBIOM is waiting the file access to data from the partners in charge of the data extraction. The aim of the study will be to perform the first French (and European) economic analysis to identify the clinical and cost determinants of pancreatic cancer to centralise existing real-world patient data.
State of art overview of GemciTest Environment in mPDAC
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