Résultats de la recherche

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. 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. » 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. HEPPAPIG80 Prediction of Early Recurrence of Hepatocellular Carcinoma After Liver Surgery Liver cancer is the sixth most common cancer and the third most common cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) accounts for approximatively 90% of primary liver cancers. Surgery, comprising liver transplantation and liver resections, stands as the primary treatment modality for HCC. However, the recurrence rate is a main issue, being as high as 20% one year after resection and reaching 70% after 5 years. Preliminary data demonstrated that higher levels of hPG80 are associated with significantly lower survival, thus suggesting a prognostic value in this tumor type (Dupuy et al., Cancers, 2022). In addition, the hPG80 levels has not shown any significant difference among HCC patients with different BCLC stages, which may indicate a potential role of this biomarker in the early detection of relapse following liver surgery. HEPPAPIG80 is an Italian, prospective, observational, monocentric study with longitudinal follow-up, in which patients with hepatocellular carcinoma that are planned to receive liver surgery (resection and/or transplantation) will be included. Blood samples will be taken during their treatment follow-up to evaluate plasma concentrations of hPG80 . Study in partnership with the Niguarda hospital of Milan (Italia). HEPPAPIG80 received a favorable opinion from the Italian Ethics Committee (Ethics Committee Milan Area 3, #404-09062022) Current Status: Enrolling and Follow-up

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) as a blood biomarker for high-grade glial tumors: A pilot study January 2023 + Journals - Frontiers, January 11th 2023 Abstract Background: Currently, the long-term prognosis and survival rate of patients with high-grade glial tumors remains poor and there are no biomarkers. hPG80 (circulating progastrin) secreted into the blood by tumor cells has been widely studied in colorectal cancer. Its involvement in tumorigenesis has been demonstrated in the literature. Moreover, according to a recent study, hPG80 is expressed in the blood of cancer patients at a significantly higher concentration than in the control group composed of healthy blood donors. Methods: The PROGLIO study is a pilot, single-center, longitudinal study that primarily seeks to evaluate circulating plasma hPG80 concentrations over time in patients with high-grade glial tumors. A fasting blood sample will be taken on the start and end day of radiotherapy and during the adjuvant chemotherapy (every 3 cycles). Follow-up monitoring will be performed for 9 months, with a blood sample taken every 3 months on the day of the follow-up MRI. The study plans to recruit 30 patients and recruitment started in February 2022. Trial registration: ClinicalTrials.gov , ID NCT05157594; registered on October 27, 2021. Mélanie Casile; Judith Passildas; Bérengère Vire; Ioana Molnar; Xavier Durando.

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. CANCER DETECTION hPG80 : a Biomarker to Detect Cancers By detecting multiple cancers with a single test, we are streamlining the diagnostic process and paving the way for earlier intervention, even in cancers for witch no blood biomarker is available. hPG80 is Significantly Higher in Cancers Patients Case-control studies have shown that hPG80 is found at significantly higher levels in the plasma of patients with various types of cancer than in healthy donors. Bar plots showing hPG80 levels in healthy subjects (n=1,199) and in patients with different types of cancer (n=4,085). Adapted from You et al. 2020; Kohli et al. 2021, Dupuy et al. 2022; Chauhan et al. 2022; Prieur et al. 2023; Doucet et al. 2023; Hofman et al. ESMO 203, data on file. Tested Across More than 16 Different Cancer Types Adapted from You et al. 2020; Kohli et al. 2021, Dupuy et al. 2022; Chauhan et al. 2022; Prieur et al. 2023; Doucet et al. 2023; Hofman et al. ESMO 203, data on file. Bar plots showing hPG80 levels in healthy subjects (n=1,199) and in patient samples from 16 different types of cancer at various stages: 712 breast, 608 prostate, 829 lung, 386 colorectal, 319 liver, 305 gynecologic, 232 kidney, 140 esophagus/stomach, 133 skin melanoma, 129 neuroendocrine, 108 pancreas, 104 brain, 49 head&neck, 31 uveal melanoma. hPG80 : a Biomarker for Early-Stage Cancer Detection As the global cancer burden continues to rise, with cases projected to exceed 28 million by 2040 (a 47% increase compared to 2020), the importance of early detection becomes critical. Early detection has been shown to greatly enhance cancer survival rates while also increases the chances for successful outcomes. Detection of hPG80 at Early-Stage Non-Small-Cell Lung Cancer Bar plots showing hPG80 levels in healthy subjects (n=1,199) and in patient samples (n=2,629) from 16 different types of cancer with stage I (n=390), stage II (n=374), stage III (n=284) and stage IV (n=1,581). Data on file hPG80 : Detection of Early-Stage Non-Small-Cell Lung Cancer In the United States, only 21% of cases are diagnosed at an early stage (localized – confined to primary site) when the five-year survival rate is much higher (62.8%). Unfortunately, 53% of cases are not detected until a late stage (distant – cancer has metastasized), when the survival rate drops to just 8.2%. Source: SEER 22 (Excluding IL/MA) 2013–201,9 All Races, Both Sexes by SEER Combined Summary Stage Lung cancer is the deadliest cancer worldwide, accounting for 1.8 million deaths in 2022. When lung cancer is caught early enough to be localized, survival rates can improve dramatically. Significantly Higher hPG80 Levels in NSCLC Patients, Even at Early Stages Using a retrospective case-control cohort of 396 patients with non-small-cell-lung cancer (NSCLC) and 330 healthy subjects, we demonstrated that hPG80 levels are significantly higher in NSCLC patients than in healthy subjects. hPG80 levels were already elevated in stage I NSCLC and maintained at high levels with disease progression, with no statistically significant differences between stages, except between stage I and III (p=0.033). Dot plots showing hPG80 levels in healthy subjects (n=330), in all NSCLC patients (n=396) and in NSCLC patients’ subgroups based on cancer stages (stage I, n=100; stage II, n=100; stage III, n=97; stage IV, n=99). Adapted from Hofman et al. ESMO 2023, data on file. Plasma hPG80 levels in NSCLC patients and healthy subjects. IQR: interquartile range High Diagnostic Performance of hPG80 in NSCLC Receiver operating characteristic curves (ROC) of hPG 80 in differentiating patients with NSCLC at various stages from healthy subjects or in differentiating stage I to IV NSCLC patients from healthy subjects. AUC: Area under the curve, 95% CI: 95% confidence interval. All Stages By Stages Adapted from Hofman et al. ESMO 2023, data on file. hPG80 : a Biomarker for Early-Stage Hepatocellular Carcinoma Hepatocellular carcinoma (HCC) is the 7th most common cancer overall and the 3rd leading cause of cancer-related death worldwide. Early detection is crucial because prognosis is closely linked to the tumor stage at diagnosis. However, many HCC patients are still diagnosed at advanced stages when a cure is no longer possible. Source: SEER 22 (Excluding IL/MA) 2014–2020, All Races, Both Sexes by SEER Combined Summary Stage Superior Performance of hPG80 Compared to AFP in Detecting Early-Stage HCC Serum AFP levels are commonly used for monitoring individuals at risk, but its sensitivity for early HCC detection is low, and it is more frequently elevated in advanced stages of the disease. Using a retrospective cohort of 168 hepatocellular carcinoma patients, we demonstrated superior performance of hPG80 in detecting early and intermediate stages compared to AFP. Bar plots showing sensitivities of hPG80 and AFP according to their respective cut-offs values (4.5 pM for hPG80 and 100 ng/mL for AFP) for early, intermediate and advanced hepatocellular carcinoma. Adapted from Dupuy et al. 2022

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. Publications Publications Progastrin: An Overview of Its Crucial Role in the Tumorigenesis of Gastrointestinal Cancers April 2024 Plasma hPG80 (circulating progastrin) as a novel biomarker for detecting gastric cancer: a Japanese multicenter study March 2024 Association between post-operative hPG80 (circulating progastrin) detectable level and worse prognosis in glioblastoma October 2023 Plasma hPG80 (Circulating Progastrin) as a Novel Prognostic Biomarker for early-stage breast cancer in a breast cancer cohort. April 2023 hPG80 (circulating progastrin) as a blood biomarker for high-grade glial tumors: A pilot study January 2023 hPG80 and cancer: A new blood biomarker in development for patient monitoring June 2022 hPG80 (Circulating Progastrin), a Novel Blood-Based Biomarker for Detection of Poorly Differentiated Neuroendocrine Carcinoma and Well Differentiated Neuroendocrine Tumors February 2022 Plasma hPG80 (Circulating Progastrin) as a Novel Prognostic Biomarker for Hepatocellular Carcinoma January 2022 A novel method to detect hPG80 (human circulating progastrin) in the blood September 2021 Prognostic Value of Plasma hPG80 (Circulating Progastrin) in Metastatic Renal Cell Carcinoma January 2021 The oncogenic and druggable hPG80 (Progastrin) is overexpressed in multiple cancers and detected in the blood of patients December 2019 Targeting the Wnt Pathway and Cancer Stem Cells with Anti-progastrin Humanized Antibodies as a Potential Treatment for K-RAS-Mutated Colorectal Cancer September 2017

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. TREATMENT OUTCOME PREDICTION hPG80 : a Biomarker for Treatment Outcome Prediction An early and accurate treatment outcome prediction in cancer is crucial because it helps tailor therapies to individual patients, improving overall survival rates and quality of life of patients. hPG80: a Biomarker for Treatment Outcome Prediction Interim data from our ongoing ONCOPRO prospective clinical study support the clinical utility of hPG80 as a potential new biomarker for immunotherapy outcome prediction in metastatic non-small cell lung cancer (NSCLC) patients. Key data were presented at the 2024 European Society for Medical Oncology Congress (Barcelona, Spain). Poster title: “Circulating hPG80 (WNT pathway activation) as a potential new prognostic/predictive factor of immunotherapy (ICI) efficacy: ONCOPRO prospective study ”. In this study, the predictive value of hPG80 was assessed in a cohort of 45 patients with advanced NSCLC receiving either 1st line immunotherapy, alone or in combination with chemotherapy (n=21), or chemotherapy, alone or in combination with immunotherapy, regardless of the line of treatment (n=24). For these patients, hPG80 titers were determined at the initiation of treatment and at each treatment cycle. Patients were stratified into two groups: < or ≥ median at baseline and after 2 cycles of treatment and progression-free survival (PFS) was analyzed using the Kaplan-Meier method. As shown below, after 2 treatment cycles, for patients treated without immunotherapy in 1st line, hPG80 levels were not associated with improved PFS. However, in the cohort of patients receiving 1st line immunotherapy, patients with low hPG80 levels had a significantly longer PFS. Potential predictive value of hPG80 t iters for PFS in NSCLC patients treated with ICI. Kaplan-Meier analysis of progression-free survival (PFS) in 45 metastatic NSCLC patients treated with chemotherapy with (n=21) or without immune checkpoint inhibitors (ICI) (n=24) in 1st line setting. Patients were stratified into two groups depending on hPG80 levels at baseline and after 2 cycles of treatment (< or ≥ median). Patients treated without ICI Patients treated with ICI Adapted from You et al. ESMO 2024.

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. hPG 80 : a new blood biomarker What is hPG80 ? Progastrin is an intracellular protein that is, or not, maturated into gastrin. Non-Pathological Condition Progastrin is not detected in the blood of healthy subjects. Pathological Condition hPG80 (circulating progastrin) is detected in the blood of cancer patients. The ROCHE laboratory markets a test for the detection of Progastrin-releasing peptide (Pro-GRP) to differentiate between 2 types of lung cancer. hPG80 (Progastrin) and Progastrin-releasing peptide (Pro-GRP) are two completely different proteins even though they share the word "Progastrin / Pro-Gastrin” with the same phonetics. hPG80 : a biomarker significantly higher in the blood of cancer patients Meta-analysis of all retrospective and prospective studies, published and unpublished data. N=4,085 patients with cancers & N=1,199 healthy subjects. View Clinical Data Adapted from You et al, 2020; Kholi et al, 2021; Chauhan et al, 2022; Dupuy et al, 2022, Prieur et al, 2023; Doucet et al, 2023, You et al, 2023 and Hofman et al, 2023 and unpublished data hPG80: a biomarker of cancer activity Tumoral mass Peripheral tissue The biomarker hPG80 is detectable in the tumor/bloodstream of cancer patients at every stage of tumor progression, from the primary tumor to metastasis. This figure illustrates the high expression of hPG 80 by tumor cells from pancreatic and liver cancer (A) and (B), respectively. The tissues peripheral to the tumor masses were devoid of hPG 80 -immunoreactive cells (C) and (D). Scale bars: 25 µm. Immunomarking of cancer biopsy hPG 80 : red, Heparan sulfates: green, Cell nuclei: blue You et al. EBioMedicine 2020 Close link between Wnt pathway, Cancer and hPG80 The Wnt signaling pathway is dysregulated in cancer. Zhong et al, Cancer Metastatic review (2020) The Wnt signaling pathway regulates a wide range of cellular functions during development and adulthood, including cell proliferation, cell fate determination, apoptosis, cell migration and cell polarity during development and stem cell maintenance in adults. It is dysregulated in most cancers. It plays a important role in the development of cancer and is involved in key features of cancer. The GAST gene and progastrin are overexpressed via the Wnt oncogenic pathway. The GAST gene, which encodes progastrin, is a target of the Wnt/ß-catenin/ Tcf4 oncogenic pathway. GAST and consequently hPG80 are overexpressed in tumor tissues. Once secreted, hPG80 will trigger a positive feedback loop that will activate the Wnt signaling pathway, further amplifying hPG80 secretion. Joubert et al, under submission hPG 80 is a pro-oncogenic factor. It has been shown that hPG80 plays a major role in tumor promotion and progression: Pro-angiogenic factor Anti-apoptotic factor Regulation of cell-cell junctions Cancer stem cells survival hPG80 neutralization: Inhibits Wnt-dependent tumorigenicity in vivo. Induces differentiation of cancer cells and then their death by apoptosis. Reduces tumor neovascularization in xenograft cells in nude mice. Joubert et al, under submission

Team Members Philippe Pourquier CEO Founder and Chief Executive Officer of several companies in Diagnostic in vitro Read More Alexandre Prieur Chief Scientific Officer Scientific Director since 2012 with 20 years in cancer research Read More Nassima Mimoun Managing Director MD with strong experience in Pharmaceutical Business. Read More François Fabre Chief Financial and Operational Officer Administrator of the group entities, Specialist in business management Read More Alix De Jacquelot BD Director & Medical Partnerships PharmD, specialized in new product launch Read More Monica Cappellini Development and production manager PhD in Neuroscience with 7 years of experience in R&D and production specific to hPG80 Read More