IDH1

SOMERVILLE, Mass., Oct. 30, 2024 /PRNewswire/ -- Aitia, a biotech company pioneering the use of causal AI and Digital Twins in drug discovery and development, is expanding its collaboration with Servier, a global and independent pharmaceutical company, to tackle gliomas, a broad group of brain cancers. This collaboration aims to use Aitia's breakthrough technology which is powered by millions of data points from patient cancer tissues to find new treatments for this deadly disease. Under the terms of the collaboration, Aitia and Servier will work together to discover and, validate novel drug targets and develop novel drug candidates for glioma using Aitia's Gemini Digital Twins and Servier's therapeutic discovery and clinical development expertise in oncology. This collaboration will include exploration of the heterogeneous biology of these brain cancers, mechanisms of resistance, and drug response at the individual patient level. In a recent breakthrough in another form of glioma, specifically Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection in adult and pediatric patients 12 years and older, Servier recently announced approval of the brain cancer drug, VORANIGO, the first approved drug for this disease area in almost 25 years. Gliomas, tumors that originate in the brain or spinal cord from glial cells, affects more than 190,000 people worldwide annually. The most aggressive form of glioma, glioblastoma, has an average survival time after diagnosis of approximately 15 months, with less than 7% of patients surviving beyond five years, according to the National Brain Tumor Society. Despite standard treatments like surgery, radiation and chemotherapy, glioblastoma has a high rate of recurrence and there are currently no curative therapies. "We are excited to expand our collaboration with Aitia into gliomas as we continue to prioritize brain cancer after our recent positive results and approval of VORANIGO in the US and in growing number of territories," said Fabien Schmidlin, Global Head of Translational Medicine at Servier. "At Servier, we are committed to advancing therapies for cancer patients with high unmet medical needs, and we believe that integrating Aitia's Gemini Digital Twins with our expertise in oncology, particularly in targeting molecular mutations, could open new avenues for more effective treatments." "Glioma is the among the deadliest forms of cancer, and the lack of broadly effective treatments highlights the urgent need for new approaches that leverage the growth of genetic and multi-omic patient data and breakthroughs in AI," said Colin Hill, CEO and co-founder of Aitia. "We believe that our Gemini Digital Twins, along with Servier's drug discovery and clinical development expertise in hard-to-treat cancers can lead to new breakthrough therapies for this disease." This collaboration represents the fourth area of research Aitia and Servier are collaborating on. The companies began their partnership in 2022, to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma, then expanding in 2023 to include drug discovery and development for pancreatic cancer, and again in January 2024 to discover patient responders for Servier's LRRK2 inhibitor in Parkinson's disease. Aitia's approach centers on two key innovations: causal AI and Gemini Digital Twins. Causal AI goes beyond correlative associations to identify which genetic or molecular changes drive diseases and patient response to therapies. Gemini Digital Twins are virtual models that are reverse-engineered from huge quantities of genetic, multi-omic, and clinical data from patients that reveal how genes, proteins, and other molecules interact within cells and tissues to drive clinical outcomes. These Gemini Digital Twins of a specific disease allow researchers to rapidly test billions of experiments such as gene and protein knockdowns or application of a drug candidate in a human patient context versus animal models or cells in petri dishes. These high-throughput "virtual experiments" in patient-derived Gemini Digital Twins leads to discovering and selecting drug candidates that are more likely to succeed in clinical trials in specific patient populations. About Aitia Aitia is an AI-enabled biotechnology company deploying causal AI and creating Gemini Digital Twins to discover the next generation of breakthrough drugs in neurodegenerative diseases and oncology, including a lead program in Huntington's disease. By leveraging the convergence of multi-omic patient data, high-performance computing, and causal AI, Aitia's Gemini Digital Twins reveal the hidden biological mechanisms of disease to transform the discovery and development of new therapeutics. To date, Gemini Digital Twins have been used to accelerate R&D in oncology, neurodegeneration, cardiometabolic, and immunology. Media Contact: Isabelle Caffry Senior Director, Strategy & Corporate Development [email protected] +1-617-374-2300 Ryan Flinn In Like Flinn Communications [email protected] +1 510-207-7616 SOURCE Aitia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

PRESS RELEASE - 23/10/2024, 07:00 CEST Biocartis announces six Idylla™ abstracts to be presented at AMP 2024 Annual Meeting Mechelen, Belgium, 23 October 2024 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that six abstracts highlighting the benefits of Idylla™ will be presented at the Association for Molecular Pathology (AMP) Annual Meeting, taking place November 19th to November 23rd, 2024 in Vancouver, Canada. In addition, Biocartis will host a free corporate workshop. Six Idylla™ abstracts from renowned institutions will be presented at this year's AMP conference, showcasing the strong collaborations Biocartis has built with leading research and academic partners. 1. Performance Assessment and Clinical Validation of the Idylla™ IDH1-2 Mutation Assay Kit in Rapid Detection of IDH Mutations in Acute Myeloid Leukemia Ashutosh Vashisht, Ashis K Mondal, Lora Walczak, Vishakha Vashisht, Shubha Sharma, Pankaj Ahluwalia, Jana Woodall, Harmanpreet Singh, Ravindra Kolhe - Department of Pathology, Medical College of Georgia, Augusta University, GA, USA. By using 36 samples from 18 unique AML cases, the authors were able to demonstrate perfect concordance (100%) of the Idylla™ IDH1-2 Mutation Assay Kit with NGS. Directly using bone marrow aspirate in the Cartridge significantly reduced turnaround time, making this technique an ideal solution for developing assays for AML diagnosis, prognosis, and treatment evaluation. 2. The Idylla™ Platform Enables Rapid and Accurate EGFR Mutation Assessment in NSCLC with Minimal Sample InputKatherine Drews-Elger, Rodrigo Santoscoy-Valencia, Catherine Garcia-Serje, Silvia Gonzalez-Leiva, Mayra Rodriguez, Orlando Bracho-Rincon, and Roberto Ruiz-Cordero - Department of Pathology and Laboratory Medicine, University of Miami, Miami, FL - Jackson Memorial Hospital, Miami, FL - Clinical OncoMolecular Lab, Department of Pathology and Laboratory Medicine, University of Miami, Miami, FL. This new prospective study demonstrated how the Idylla™ EGFR Mutation Assay offered rapid and accurate detection of EGFR mutations in non-small cell lung cancer (NSCLC), with 95% concordance with NGS. The Assay successfully identified mutations in cases where NGS could not be performed (10% of the cohort) and reduced turnaround time from 12.1 to 1.7 days. With minimal sample requirements and hands-on time, Idylla™ provided a faster option for obtaining EGFR mutation status in NSCLC. 3. Re-verification and Report Ruling Revision of NTRK Fusion Results of Idylla™ GeneFusion Assay after Manufacturer Algorithm UpdatePatricia Caffes, Gang Zheng M.D. Ph.D., Ying-Chun Lo M.D. Ph.D. - Division of Laboratory Genetics and Genomics, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN - Division of Anatomic Pathology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN. This recent re-verification study of the Idylla™ GeneFusion Assay demonstrated improved sensitivity for detecting NTRK2 fusions, due to a software update. Although sensitivity for NTRK3 decreased slightly, updates to the laboratory’s standard operating procedure have enhanced accuracy by requiring confirmation testing for certain equivocal results. The study showed no changes to the detection of ALK, ROS1, RET, and MET fusions, maintaining 100% sensitivity and specificity. 4. Rapid Determination of IDH1 and IDH2 Mutation Status in AML and Glioma Using Microfluidic Detection SystemCatalina Esguerra, Anthony Magliocco - Protean BioDiagnostics This study showed 97% accuracy, 100% sensitivity and 95% specificity for detecting IDH1 and IDH2 mutations in glioma and AML samples with the Idylla™ IDH1-2 Mutation Assay Kit. The Assay delivered rapid results within 95 minutes, with only one discordant case under investigation, potentially due to a higher sensitivity than the reference test. The Idylla™ System was praised for its ease of use and reliability, making it a valuable tool for determining IDH mutation status in various malignancies. 5. The Idylla™ POLE Mutation Assay, a New Tool for Direct Mutation Detection from FFPE TissueSofie Metsu - Biocartis Based on a literature review, the diagnostic sensitivity of the (under development) Idylla™ POLE Mutation Assay for detecting POLE mutations with evidence to support clinical utility, was 98% in endometrial cancer and 90% colorectal cancer. The new assay is currently undergoing evaluation at multiple selected sites across Europe and the US, using clinical endometrial carcinoma FFPE specimens. The conclusive results will be shared at the AMP conference. 6. Same-Day Molecular Testing Results from Cytology Specimens: The Next Frontier of the Rapid On-site Evaluation?Dr. Gloria Sura - Cytology, MDACC This MDACC study demonstrated the feasibility of Idylla™ for rapid and accurate molecular testing of NSCLC and thyroid cancer biomarkers from cytology samples. Results were available in 2-3 hours, with high accuracy across KRAS, EGFR, BRAF and GeneFusion Assays, showing concordance rates of 94-100%. The Biocartis corporate workshop will take place on November 20th, 2024 at 3 PM PST and is focused on optimizing Fine Needle Aspiration (FNA) workflows using the Idylla™ Platform. Gloria Sura, MD (MD Anderson Cancer Center) will present a comprehensive feasibility and performance study showcasing the rapid assessment of EGFR, KRAS, BRAF and GeneFusion in cytopathology. Dr. Sura will highlight the integration of cytology and small biopsy specimens, particularly in lung and thyroid cancers, within a large cancer center. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: “The research results that will be presented at the AMP Annual Meeting, highlight our commitment to expanding rapid and high-quality testing options for patients with hematological and solid malignancies. Our Idylla™ System allows for the analysis of small biological samples, including cytological specimens, providing healthcare providers with critical information for timely treatment decisions within hours.” ----- END ----- More information: www.biocartis.com info@biocartis.com About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, convenient, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house access to accurate molecular information in a minimum amount of time for faster, informed treatment decisions. Idylla™'s continuously expanding menu of molecular diagnostic tests addresses key unmet clinical needs, with a focus in oncology. This is the fastest growing segment of the molecular diagnostics market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain, blood and liver cancer. More information: www.biocartis.com. Follow us on X (Twitter): @Biocartis. Idylla™ IDH1-2 Mutation Assay Kit, Idylla™ EGFR & POLE-POLD1 Mutation Assay, and Idylla™ GeneFusion Assay are for Research Use Only (RUO), not for use in diagnostic procedures. Idylla™ POLE-POLD1 Mutation Assay is currently under development. Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. © October 2024, Biocartis NV. All rights reserved.

The Ion Torrent Oncomine Dx Target Test is the first FDA-approved next generation sequencing-based diagnostic. Credits: JHVEPhoto / Shutterstock. Thermo Fisher Scientific has announced that its in vitro diagnostic test, Oncomine, has won US Food and Drug Administration (FDA) approval for use as a companion diagnostic in grade 2 IDH-mutant glioma. As per the 21 October press announcement, Oncomine is now approved to be used to identify patients who are eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, which gained FDA approval in August 2024, is the first and only targeted therapy available for patients with grade 2 IDH-mutant glioma. The French drugmaker gained control over the asset in 2020 after purchasing Agios’ oncology pipeline for $1.8bn in 2020. Agios has since sold its royalty stake in Voranigo to Royalty Pharma for $905m. Under the terms of the agreement, Royalty Pharma will gain a 12% royalty on annual US sales up to $1bn and a 12% royalty on net US sales over $1bn. As a once-daily oral inhibitor of IDH1 and IDH2 enzymes, Voranigo is indicated for use in grade 2 IDH-mutant glioma patients following surgery, including biopsy or gross total resection. The Ion Torrent Oncomine Dx Target Test is the first FDA-approved sequencing-based diagnostic. Oncomine received its first approval as a companion diagnostic in 2017 and subsequently gained approval in August 2022 as a companion diagnostic for identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with Daiichi Sankyo ’s Enhertu (fam-trastuzumab deruxtecan-nxki). See Also: FDA approves Astellas’ VYLOY for gastric cancer treatment Intercept’s liver disease drug Ocaliva faces FDA approval delay Oncomine is also approved for use in cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). Daiichi and AstraZeneca ’s Enhertu has seen several wins this year. The drug gained conditional approval in China earlier this month and a breakthrough therapy designation for a specific type of breast cancer in August 2024. Additionally, in April, the treatment was granted accelerated approval for the treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive [immunohistochemistry (IHC) 3+] solid tumours. According to GlobalData’s consensus forecasts, Voranigo is expected to generate sales of $37m in 2030. Enhertu is projected to generate total sales of $13bn in 2030. GlobalData is the parent company of Pharmaceutical Technology .