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L'équipe R&D de Biodena Care découvre le rôle essentiel de la protéine hPG80 dans l’évolution du cancer. De cette découverte, issue de la recherche française, nous avons développé un test sanguin pratique et abordable : DxPG80. A new test to help detect and monitor cancers «We are bringing a new diagnostic solution to improve cancer detection and management throughout the patient care pathway.» A simple and accessible test Our R&D team found that hPG80 protein was present at high levels in the blood of patients with 16 different types of cancer, regardless of the stage of the disease. Building on this groundbreaking French research, we developed a practical and cost-effective blood test: DxPG80.Lab. DxPG80.Lab: a new device to lead the fight against cancer Through a simple blood test, the DxPG80.Lab test detects the presence of hPG 80 , a biomarker associated with cancer activity. Commercialized with CE marking View product Easy Rapid execution (<3 hours) Reliability Affordable CE-marked hPG80 is detected in all cancers tested, including those for which no markers are available. Tested on > 4,000 cancer patients and 1,200 healthy subjects. Detected across all stages of 16 different types of cancer. View Clinical Data Proposing a more efficient support A biomarker to support decision-making throughout the patient care pathway. DxPG80.Lab provides valuable insights to help clinicians optimise patient care. DETECTION DIAGNOSIS PROGNOSIS TREATMENT OUTCOME PREDICTION TREATMENT MONITORING/ FOLLOW-UP Despite significant progress over the last decade, the burden of cancer continues to rise. 20 million new cases per year, expected to rise to 31M in 2040. > 50% late diagnosis Over half of cancers in the US are diagnosed at stages III and IV. 79% vs 11% 79% vs 11% mortality 5-year cancer s pecific mortality when diagnosed late vs early stage. Sources: WHO and Cancer Atlas Strong unmet medical need To detect cancer earlier and monitor treatment with a low-cost blood test. It's time to take concrete action

Biodena Care develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. DxPG80.Lab is a blood-based assay designed for the quantitative measurement of hPG 80 (circulating progastrin), a biomarker associated with cancer. Commercialized with CE marking Easy Rapid execution (<3 hours) Reliability Affordable CE-marked What is DxPG80.Lab test? A simple blood-based test for quantitative measurement of hPG 80 . Easy, accurate, fast and non-invasive, results can be obtained within 3 hours, allowing for timely clinical decision-making. Registered as CE-IVD. How does DxPG80.Lab test work? The DxPG80.Lab test accurately measures hPG 80 (circulating progastrin), which is differentially expressed in blood samples from patients with various types of cancer compared to healthy individuals. Our test is based on the principle of a sandwich ELISA to measure the concentration of hPG 80 in plasma samples collected in EDTA tubes. The ELISA-based method ensures that the test provides accurate and reproducible results, which are critical for effective patient management. Additional information regarding the analytical performance characteristics of the DxPG80.Lab test can be accessed here: View Manuscript Eligible population DxPG80.Lab test is indicated for adults aged 18 years or older. It is not intended for pregnant women. DxPG80.Lab Workflow DxPG80.Lab request The physician prescribes the DxPG80.Lab assay Blood sample DxPG80.Lab analysis DxPG80.Lab report A blood sample is taken by the diagnostic laboratory The sample is analyzed in an analytical laboratory The results are reported to the physician who informs the patient Services facility The test is intended for professional laboratory use only. DxPG80.Lab test is currently performed in a state-of-the-art analysis laboratory, ensuring consistent and reliable results. Ask for our Instruction for Use View Munuscript

< Back François Fabre Chief Financial and Operational Officer 8 years as managing director or general manager of companies. 5 years in cash and investment management. Fundraising actions up to 26 M €. Drastic cost management to ensure the sustainability of this company.

< Back Alix De Jacquelot BD Director & Medical Partnerships 15 years' experience in pharmaceutical industry, including over 10 years in medical affairs, at regional, national and international levels. Cross-functional collaboration to ensure pre-launch and launch of innovative drugs in various therapeutic areas, including immuno-oncology. Good knowledge of clinical research, regulatory issues and market access. Strategic vision, field experience, good listening and analytical skills.

Biodena Care develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. hPG80 (Circulating Progastrin), a Novel Blood-Based Biomarker for Detection of Poorly Differentiated Neuroendocrine Carcinoma and Well Differentiated Neuroendocrine Tumors February 2022 + Journals - Cancers 2022, 14, 863 Simple Summary Current blood-based biomarkers for neuroendocrine neoplasms (NENs) lack both sensitivity and specificity. Human circulating progastrin (hPG80) can be easily measured in plasma by ELISA. This study is the first to examine hPG80 in NENs. The study demonstrated increased levels of hPG80 in all sub-types of NENs, with a high sensitivity and specificity demonstrated. Plasma hPG80 in NENs may be a diagnostic blood biomarker for both low- and high-grade NENs; further study is warranted. A prospective multi-center trial is ongoing in NET to evaluate hPG80 as a means of monitoring disease (NCT04750954). Abstract Current blood-based biomarkers for neuroendocrine neoplasms (NENs) lack both sensitivity and specificity. Human circulating progastrin (hPG80) is a novel biomarker that can be easily measured in plasma by ELISA. This study is the first to examine hPG80 in NENs. Plasma hPG80 was quantified from 95 stage IV NEN patients, using DxPG80technology (ECS Progastrin, Switzerland) and compared with hPG80 concentrations in two cohorts of healthy donor controls aged 50–80 (n = 252) and 18–25 (n = 137). Median hPG80 in NENs patients was 5.54 pM compared to 1.5 pM for the 50–80 controls and 0.29 pM the 18–25 cohort (p < 0.0001). Subgroup analysis revealed median hPG80 levels significantly higher than for either control cohort in neuroendocrine carcinoma (NEC; n = 25) and neuroendocrine tumors (NET; n = 70) including the small-cell lung cancer (SCLC) sub-cohort (n = 13). Diagnostic accuracy, estimated by AUCs, was high for NENs, as well as both sub-groups (NEC/NET) when compared to the younger and older control groups. Plasma hPG80 in NENs may be a diagnostic blood biomarker for both low- and high-grade NENs; further study is warranted. A prospective multi-center trial is ongoing in NET to evaluate hPG80 as a means of monitoring disease (NCT04750954). Aman Chauhan, Alexandre Prieur, Jill Kolesar, Susanne Arnold, Léa Payen, Younes Mahi, Berengere Vire, Madison Sands, B. Mark Evers, Dominique Joubert and Lowell Anthony.

Biodena Care develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. Association between post-operative hPG80 (circulating progastrin) detectable level and worse prognosis in glioblastoma October 2023 + Journals - ESMO OPEN October 08th, 2023 Abstract Background Patients with glioblastomas have a dismal prognosis, and there is no circulating predictive or prognostic biomarker. Circulating progastrin, hPG80, is a tumor-promoting peptide present in the blood of patients with various cancers that has been shown to have prognostic value. We evaluated the prognostic value of plasma hPG80 in patients with isocitrate dehydrogenase-wild type glioblastoma after surgery. Patients and methods A multicentric retrospective study in glioblastoma patients treated with standard radio-chemotherapy was conducted. The hPG80 levels were measured in plasma EDTA samples collected after surgery with an ELISA DxPG80.lab kit (Biodena Care, Montpellier, France), which has a detection threshold of 1.2 pM. The relationship between post-operative hPG80 plasma levels, in combination with other known prognostic factors, and patients’ progression-free survival (PFS) and overall survival (OS) was evaluated. Results Sixty-nine patients were assessable. Plasma samples were collected after tumor biopsy (B), partial resection (PR), and complete resection (CR) for 22, 25, and 22 patients, respectively. At a median concentration of 5.37 pM (interquartile range 0.00-13.90 pM), hPG80 was detected in 48 (70%) patients (hPG80+). CR was associated with significant lower values of hPG80 levels: the median value was 0.7 versus 9.1 pM for PR (P = 0.02) and 8.3 pM for B (P = 0.004). The hPG80 detection rate was also significantly lower: 50% (CR) versus 72% (PR) versus 86% (B) (P = 0.005). The median follow-up was 39 months [22.4 months-not reached]. hPG80 post-operative detection was associated with numerically shorter PFS (6.4 versus 9.4 months, P = 0.13) and OS (14.5 versus 20.9 months, P = 0.11). In multivariate analysis, hPG80 was a prognostic factor for OS (P = 0.034). Conclusions Circulating hPG80 could serve as a new prognostic biomarker after surgery in patients with glioblastoma treated with radio-chemotherapy. L. Doucet, A. Cailleteau, L. Vaugier, C. Gourmelon, M. Bureau, C. Salaud, V. Roualdes, E. Samarut, M. Aumont, M. Zenatri, D. Loussouarn, V. Quillien, F. Bocquet, L. Payen-Gay, D. Joubert, A. Prieur, M. Robert, J.-S. Frenel

Biodena Care develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. PRO-NEM1 Diagnostic value to discriminate MEN1 Patients With or Without Neuroendocrine Tumors MEN1 (Multiple Endocrine Neoplasia type 1) is a genetic disorder that predisposes individuals to develop tumors in various endocrine glands, including the pancreas, parathyroid, and pituitary glands. One of the significant concerns for individuals with MEN1 is the development of neuroendocrine tumors (NETs), which can occur in multiple organs. MEN1 patients currently undergo regular biological and morphological screening, at least annually, in order to screen the development of NETs. However, despite these diagnostic tools, there are still unmet needs in effectively diagnosing NETs in this population who has a high risk of developing cancer. The study will enroll 297 patients with multiple encocrine neoplasia type 1 (MEN1) with or without neuroendocrine tumors. Blood samples will be taken in both patients to evaluate plasma concentrations of hPG80 . Study in partnership with the CHU Dijon (France). PRO-NEM1 is registered at ClinicalTrials.gov (NCT06430021) Current Status: Enrolling

Biodena Care develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. ETCTN 10558 Metastatic Neuroendocrine Tumors Therapeutic Follow-up ETCTN 10558 phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors. We currently lack reliable blood biomarkers for the therapeutic follow-up of neuroendocrine tumors, making it challenging to monitor treatment efficacy and disease progression. This limitation hampers personalized treatment strategies and timely adjustments in patient care. In this study, we will evaluate, as an exploratory objective, whether hPG80 could be used to monitor treatment response in these patients. The study will enroll 94 patients with metastatic neuroendocrine tumors. Blood samples will be taken before and during their treatment follow-up to evaluate plasma concentrations of hPG80 . Study in partnership with the National Cancer Institute (USA). ETCTN 10558 is registered at ClinicalTrials.gov (NCT05724108) Current Status: Enrolling

Biodena Care develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. About Us Our Mission In the battle against cancer, BIODENA CARE considers its mission as a succession of relays between Fundamental Scientific Knowledge on the one hand and "the Art and Science of Medicine" on the other. The final relay, undoubtedly the most important, is the one that the Physician must carry out alone with his Patient, against the disease. This is why, in order to never forget the Patient, we carry out our mission by exclusively serving Physicians with a single objective: « To ensure that demonstrations of basic science become effective, reliable and accessible solutions, handed over to physicians for the benefit of their patients. » Executive Team Philippe Pourquier CEO Skills AgroParisTech - Institut des Sciences et Industries du Vivant et de l'Environnement Bachelor of Engineering (B.E.), Microbiology and Genetics of Microorganisms Professional strength More than 38 years of professional experience in the field of in vitro diagnostics. Founder and Chief Executive Officer of Innovative Diagnotics, company who develops and produces ELISA and PCR reagents for the diagnosis of infectious zoonotic and veterinary diseases. ID employs over 170 staff members in its 5000 m² headquarters in Montpellier, France. Chief Executive Officer of AFYIA Diagnostics, it aims to provide easy-to-use and affordable multiplex diagnostics for human syndromic infectious diseases. Chief Executive Officer of ADELIS Technologies, a company developing an ultrasensitve and easy-to-use automat for size profiling of circulating DNA. Nassima Mimoun Managing Director Skills Medical Doctor MBA from an international Business school in Paris ESCP Business School Harvard Business School: Executive Leadership Program Professional strength 25 years of experience in Pharma Industry. Broad range of experiences across various therapeutic areas at regional and local level in multiple markets and mainly in oncology. Solid experience in launching and successfully commercializing innovative products and identifying life cycle management opportunities. Ability to work successfully with external stakeholders by integrating their insights. Strong learning agility and a good track record in coming into new and challenging situations in both, strategic and operational roles using strong communication and interpersonal skills. Diversity & Inclusion as a DNA to build right teams and talents working cross functionally. Acting & leading by example. Supporting and driving transformations with flexibility and adaptability. Alix De Jacquelot Director of Business Development and Medical Partnerships Skills PharmD Specialized in health product development Professional strength 15 years' experience in pharmaceutical industry, including over 10 years in medical affairs, at regional, national and international levels. Cross-functional collaboration to ensure pre-launch and launch of innovative drugs in various therapeutic areas, including immuno-oncology. Good knowledge of clinical research, regulatory issues and market access. Strategic vision, field experience, good listening and analytical skills. Alexandre Prieur Chief Scientific Officer Skills Scientific Director since 2012 20 years in cancer research 8 years of R&D specific to hPG80 (extra-cellular circulating progastrin) PhD in Oncology since 2005 (Paris XI University) Master - Innovation, Valorization, Partnerships (Montpellier University) in 2013 Professional strength 12 years of fundamental research as a researcher in cancer research institutes in Europe. 8 years of R&D in biotechnology companies as Chief Scientific Officer (diagnostic and therapy). Results Listed as inventor for 8 patent applications, including 7 on interaction between hPG80 and cancer. Author of 10+ publications in peer-reviewed journals in the field of cancer. Co-editor at Frontiers in Oncology on the Research Topic “Therapeutic Targeting of Cancer Stem Cells- The Current State of the Art “ in 2019. François Fabre Chief Financial and Operational Officer Skills Administrator of the group entities Fundraising lead Specialist in business management Master's degree in international business Professional strength 8 years as managing director or general manager of companies. 5 years in cash and investment management. Results Fundraising actions up to 26 M €. Drastic cost management to ensure the sustainability of this company. Monica Cappellini Development and production manager Skills 7 years of experience in R&D and production specific to hPG80 PhD in Neuroscience (University of Montpellier) Professional strength 19 years of experience in start-up companies as in vivo and/or laboratory manager. Strong team management and project management. Implementation and maintenance of quality system according to ISO 13485. Results Co-author in several articles related to hPG80. Successful launch of the DxPG80.Lab kit. Our History Our History The dream of a scientist, the fight of a woman Dominique Joubert Senior Scientist Consultant Dominique Joubert is a scientist with a PhD in biology and over 40 years of experience in academic and fundamental research. Between 1991 and 2011, she served as Director of Research at Inserm (France) and Director of the Oncology Department at the IGF, a Joint Research Unit of CNRS, INSERM, and the University of Montpellier. Throughout her career, Dominique Joubert has challenged the prevailing scientific dogma by maintaining her belief that cancer follows the "laws of the living" and is therefore reversible. This conviction led her to search for a "key" to this reversion. In 2003, a groundbreaking observation was made in her lab on a protein that needed to exit the tumor cell and re-interact with it to exert its effect on the tumor. Dominique Joubert hypothesized that this protein, linked to disruptions in the Wnt signaling pathway (a major contributor to tumorigenesis), could be the key to reversing the tumor process. Her bold approach was met with skepticism. She proposed that neutralizing this protein could regulate the very pathway that produced it—an idea her team found far-fetched. Despite the doubts, Dominique Joubert proceeded with the experiment. To the surprise of many, the results were conclusive, providing the first demonstration that a tumor mechanism could be reversed in solid tumors. The protein in question is progastrin, the precursor of gastrin, which is found in the G cells of the stomach in healthy individuals and is absent from the bloodstream. However, in cancer patients, progastrin is secreted by tumor cells and is referred to as hPG80 . Her research has shown that hPG80 is present in the blood of 83% of cancer patients, and that 100% of tumors produce this protein. Dominique Joubert believes that this discovery will revolutionize cancer treatment. However, she recognizes the challenges ahead: the need to mobilize the necessary resources, expertise, and energy to ensure that this breakthrough in basic research translates into practical solutions for physicians and ultimately benefits patients.

ECS progastrin develops and markets an IVD test and innovative solutions against cancer, based on the presence of hPG80 (Circulating Progastrin) in blood for monitoring, diagnosis from a simple blood test and therapy in the near future thanks to an antibody. Plasma hPG80 (circulating progastrin) as a novel biomarker for detecting gastric cancer: a Japanese multicenter study March 2024 + Journals - J-STAGE March 1st, 2024 Abstract Purpose: Early detection and treatment of cancer are important for prolonging life expectancy. hPG80 (circulating progastrin) is an 80-amino acid protein that could prove useful for detecting and following up cancer patients. However, no studies have clarified hPG80 levels in Japanese populations. Patients and Methods: From 2018 to 2022, we prospectively measured hPG80 levels in 40 cancer patients and 18 healthy volunteers. A receiver operating characteristic (ROC) curve was used to assess the optimal cut-off for hPG80. According to this cut-off, we divided participants into a high-hPG80 group (n=30) and a low-hPG80 group (n=10) and compared clinical characteristics between groups. Results: Levels of hPG80 were higher in cancer patients (5.9 pM) than in healthy volunteers (2.3 pM; p=0.036), especially for gastric cancer (7.2 pM). We identified an optimal cut-off for hPG80 at 3.42 pM. At this cut-off, the sensitivity was 93.3% and specificity 83.3% for gastric cancer. The proportion of gastric cancer patients (46.7% vs. 10.0%; p=0.040) was higher in the high-hPG80 group. Among gastric cancer patients, 7 of 8 patients (87.5%) with early-stage cancer showed high hPG80 levels. Conclusion: Plasma hPG80 levels appear useful for early detection of cancer patients, especially gastric cancer. Keiko Hamasaki, Tetsuro Tominaga, Shigekazu Hidaka, Yasumasa Hashimoto, Jun-ichi Arai, Takashi Nonaka, Yuki Sonoda, Kazuto Ashizawa, Mitsuko Masutani, Naoki Uno, Katsunori Yanagihara, Michio Yasunami, Yasuhiro Terasaki, Kengo Shirahane, Ko Igami, Kumiko Tokieda, Alexandre Prieur, Dominique Joubert, Takeshi Nagayasu