Pancreatic Intraductal Neoplasms

The prevalence of cholangiocarcinoma has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cholangiocarcinoma and the growing research and development activities to develop novel therapies to treat cholangiocarcinoma to drive the market. The companies developing the potential therapies in the last stage of development include Eisai, Janssen Research & Development, 3D Medicines, and several others. LAS VEGAS, June 7, 2023 /PRNewswire/ -- ' Cholangiocarcinoma Pipeline Insight – 2023 ' report provides comprehensive global coverage of pipeline cholangiocarcinoma therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space and future growth potential of the cholangiocarcinoma pipeline domain. Key Takeaways from the Cholangiocarcinoma Pipeline Report DelveInsight's cholangiocarcinoma pipeline report depicts a robust space with 65+ active players working to develop 70+ pipeline therapies for cholangiocarcinoma treatment. Key cholangiocarcinoma companies such as Merck KGaA, Eisai Inc., Janssen Research & Development, LLC, 3D Medicines, Basilea Pharmaceutica, Hutchison Medipharma Limited, Jiangsu HengRui Medicine, TransThera Sciences, RedHill Biopharma, Eli Lilly and Company, Elevation oncology, Senhwa Biosciences, InnoCare Pharma, Genoscience Pharma, Intensity therapeutics, Elucida Oncology, GlaxoSmithKline, Verismo Therapeutics, Sirnaomics, Toray Industries, Inc, Kinnate Biopharma, Boehringer Ingelheim, Wellmarker Bio, Arbele Limited, NGM Biopharmaceuticals, Inc., Elicio Therapeutics, Xencor, Inc., Celon Pharma SA, and others are evaluating new cholangiocarcinoma drugs to improve the treatment landscape. Promising cholangiocarcinoma pipeline therapies in various stages of development include Camrelizumab, Niraparib, Irinotecan Liposome, ABC294640, Bintrafusp alfa, TT-00420, Erdafitinib, E7090, 3D185, HMPL-453, Derazantinib, Abemaciclib, Seribantumab, CX-4945, ICP-192, GNS561, INT230-6, SynKIR-110, STP705, LY3410738, TRK-950, KIN-3248, BI 905711, WM-S1-030, ARB202, NGM831, ELI-002 2P, XmAb20717, CPL304110, and others. In May 2023, Richard Kim discussed the investigation of RLY-4008 for the treatment of patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement. RLY-4008 is a highly selective, irreversible FGFR2 inhibitor currently under evaluation in the phase 1/2 REFOCUS trial (NCT04526106). Preliminary data reported at the 2022 ESMO Congress showed that patients with FGFR inhibitor–naïve cholangiocarcinoma who had an FGFR2 fusion or rearrangement (n = 17) experienced an overall response rate of 88.2%. In April 2023, Nuvectis Pharma provided highlights from the poster presentation of NXP800 at the American Association for Cancer Research ("AACR") Annual Meeting 2023 in Orlando, FL. The robust preclinical activity demonstrated by NXP8000 in these CCA PDX models was believed to be served as good indicators for potential clinical benefit. CCA is a very difficult-to-treat disease with poor outcomes and today's results provide promise for patients in the future. In April 2023, Verismo Therapeutics received fast-track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110.SynKIR-110 is an investigational drug to treat serious diseases and life-threatening conditions, specifically mesothelin-expressing mesothelioma, ovarian cancer, and cholangiocarcinoma. In January 2023, Taiho Oncology, Inc. announced the publication of results from the pivotal Phase 2 FOENIX*-CCA2 clinical trial of futibatinib in the January 19, 2023 issue of The New England Journal of Medicine (NEJM). In the FOENIX-CCA2 trial, futibatinib showed clinically meaningful benefit in previously treated patients with FGFR2 fusion/rearrangement-positive iCCA, including an objective response rate of 42%, as assessed by independent review, and a median response duration of 9.7 months. Treatment with futibatinib resulted in durable responses and survival that surpassed historical data with chemotherapy in patients with previously treated iCCA. In October 2022, Invitae announced a partnership with AstraZeneca to use Invitae's Ciitizen natural history data in a retrospective and prospective study of patients diagnosed with cholangiocarcinoma, a rare bile duct cancer. This partnership will enable sharing of high-quality, patient-consented data from the patient community of the Cholangiocarcinoma Foundation (CCF), a leading patient advocacy group whose mission is to find a cure and improve the quality of life for those with cholangiocarcinoma. In November 2022, The FDA granted orphan drug designation to ZB131 for treatment of cholangiocarcinoma, according to the agent's manufacturer. ZB131 (ZielBio) is a monoclonal antibody with a high affinity and specificity for cancer-specific plectin. Request a sample and discover the recent advances in cholangiocarcinoma drug treatment @ Cholangiocarcinoma Pipeline Report The cholangiocarcinoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage cholangiocarcinoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the cholangiocarcinoma clinical trial landscape. Cholangiocarcinoma Overview Cholangiocarcinoma is an epithelial cell cancer that arises from several places within the biliary network and exhibits cholangiocyte differentiation markers. The most recent anatomical classifications include intrahepatic, perihilar, and distal cholangiocarcinoma. Many occurrences of cholangiocarcinoma occur without a specific risk factor, but a variety of risk factors have been found, including primary hepatobiliary illness, genetic diseases, toxic exposures, and infections. Like many other cancers, cholangiocarcinoma develops from precursor lesions such as the more common biliary intraepithelial neoplasia and the less common intraductal papillary mucinous neoplasm. Mutations in various oncogenes and tumor suppressor genes cause the normal epithelium to become one of these premalignant lesions. Cholangiocarcinomas have mutations in genes such as RAS, BRAF, p52, SMAD4, and others, but the exact molecular mechanism has not been discovered. Basic laboratory tests for the liver should include aminotransferases, alkaline phosphatase, and total/indirect/direct bilirubin. Cholangiocarcinoma can be treated medically or surgically, although surgery is the only curative option. Find out more about drugs for cholangiocarcinoma @ New Cholangiocarcinoma Drugs A snapshot of the Cholangiocarcinoma Pipeline Drugs mentioned in the report: Learn more about the emerging cholangiocarcinoma pipeline therapies @ Cholangiocarcinoma Clinical Trials Cholangiocarcinoma Therapeutics Assessment The cholangiocarcinoma pipeline report proffers an integral view of cholangiocarcinoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Cholangiocarcinoma Pipeline Report Coverage: Global Cholangiocarcinoma Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Cholangiocarcinoma Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Cholangiocarcinoma Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravitreal, Subretinal, Topical Cholangiocarcinoma Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Cholangiocarcinoma Therapeutics Assessment By Mechanism of Action: Type 1 fibroblast growth factor receptor antagonists, Type 3 fibroblast growth factor receptor antagonists, Type 4 fibroblast growth factor receptor antagonists, Type-2 fibroblast growth factor receptor antagonists, Programmed cell death-1 receptor antagonists, Bcr-abl tyrosine kinase inhibitors, EphA2 receptor antagonists, Platelet-derived growth factor beta receptor antagonists, Proto oncogene protein c-kit inhibitors, Src-Family kinase inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Poly(ADP-ribose) polymerase 1 inhibitors, Poly(ADP-ribose) polymerase 2 inhibitors Key Cholangiocarcinoma Companies: Merck KGaA, Eisai Inc., Janssen Research & Development, LLC, 3D Medicines, Basilea Pharmaceutica, Hutchison Medipharma Limited, Jiangsu HengRui Medicine, TransThera Sciences, RedHill Biopharma, Eli Lilly and Company, Elevation oncology, Senhwa Biosciences, InnoCare Pharma, Genoscience Pharma, Intensity therapeutics, Elucida Oncology, GlaxoSmithKline, Verismo Therapeutics, Sirnaomics, Toray Industries, Inc, Kinnate Biopharma, Boehringer Ingelheim, Wellmarker Bio, Arbele Limited, NGM Biopharmaceuticals, Inc., Elicio Therapeutics, Xencor, Inc., Celon Pharma SA, and others. Key Cholangiocarcinoma Pipeline Therapies: Camrelizumab, Niraparib, Irinotecan Liposome, ABC294640, Bintrafusp alfa, TT-00420, Erdafitinib, E7090, 3D185, HMPL-453, Derazantinib, Abemaciclib, Seribantumab, CX-4945, ICP-192, GNS561, INT230-6, SynKIR-110, STP705, LY3410738, TRK-950, KIN-3248, BI 905711, WM-S1-030, ARB202, NGM831, ELI-002 2P, XmAb20717, CPL304110, and others. Dive deep into rich insights for new drugs for cholangiocarcinoma treatment; visit @ Cholangiocarcinoma Medications Table of Contents For further information on the cholangiocarcinoma pipeline therapeutics, reach out @ Cholangiocarcinoma Drug Treatment Related Reports Cholangiocarcinoma Market Cholangiocarcinoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cholangiocarcinoma companies, including AstraZeneca, Decalth Systems, Basilea Pharmaceutica, Taiho Oncology, Eisai Pharmaceuticals, TransThera Sciences, Incyte Corporation, Roche, among others. Cholangiocarcinoma Epidemiology Forecast Cholangiocarcinoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and cholangiocarcinoma epidemiology trends. Intrahepatic Cholangiocarcinoma Pipeline Intrahepatic Cholangiocarcinoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key intrahepatic cholangiocarcinoma companies, including Basilea Pharmaceutica, AstraZeneca, Delcath Systems Inc., Jiangsu HengRui Medicine Co., Ltd., Syndax Pharmaceuticals, Hutchison Medipharma Limited, Medivir, Newish Technology (Beijing) Co., Ltd., Relay Therapeutics, Inc., among others. Intrahepatic Cholangiocarcinoma Market Intrahepatic Cholangiocarcinoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key intrahepatic cholangiocarcinoma companies, including Kinnate Biopharma, Taiho Oncology, Inc., Sirtex Medical, Virogin Biotech Ltd, TriSalus Life Sciences, among others. Bile Duct Cancer Pipeline Bile Duct Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key bile duct cancer companies, including Merck, BMS, Elicio Therapeutics, among others. Biliary Tract Cancers Pipeline Biliary Tract Cancers Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key biliary tract cancers companies, including companies involved such as Merck, RemeGen, EMD Serono, SMT bio Co., Ltd., among others. Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

SAN DIEGO--( BUSINESS WIRE )--Biological Dynamics, a life sciences company focused on developing and commercializing exosome isolation technology for earlier disease detection, today announced the publication of a case report, “Early detection of pancreatic pre-cancer lesion in multimodal approach with exosome liquid biopsy,” in Frontiers in Oncology , highlighting the successful detection of early-stage pancreatic ductal adenocarcinoma (PDAC) lesions using its exosome liquid biopsy assay, ExoVita TM Pancreas. The case report suggests that the high sensitivity and specificity of the ExoVita Pancreas for early-stage PDAC detection have the potential to improve patient survival outcomes significantly. Pancreatic cancer is currently the third-leading cause of cancer-related death in the United States, 1 with a 5-year survival rate of just 12.5%. 2 The earlier pancreatic cancer is diagnosed and treated, the better the prognosis. Unfortunately, pancreatic cancer usually shows little or no symptoms until it has advanced and spread. As a result, it is often diagnosed in late stages, leaving patients and clinicians with limited treatment options, which lowers the chances of survival. “What is clinically significant about this case report is that the ExoVita Pancreas detected a pancreatic lesion, which has high potential to become malignant very rapidly,” said Harmeet Dhani, M.D., M.Sc., Medical Director of Biological Dynamics. “In this case, our assay, which was initially trained on stage I and II pancreatic cancer patient samples, successfully detected exosomes from an early-stage lesion. This demonstrates the potential to use our assay in conjunction with other diagnostic modalities to help make a diagnosis at very early stages, when treatment is most likely to improve patient outcomes.” The case report profiles a 60-year-old, healthy, non-Hispanic white male who presented with acute pancreatitis. The patient underwent ten months of invasive procedures and testing that failed to detect radiographic evidence of pancreatic lesions or identify disease concerns. However, the ExoVita Pancreas assay resulted in a “high likelihood of PDAC.” Surgical pathology confirmed the diagnosis of high-grade intraductal papillary mucinous neoplasm (IPMN), which was consistent with the ExoVita Pancreas results. Additionally, a post-operative ExoVita Pancreas signature result was not detected, demonstrating that biomarkers had decreased and corroborating the patient’s disease-free clinical picture after a successful surgery. The current standard of care for IPMN patients is a “watch-and-wait” approach that includes invasive, frequent scans and chronic symptom monitoring. Adding ExoVita Pancreas could allow physicians to more confidently direct patient treatment options for both high and low-risk patients. Early data demonstrate the ability to use Biological Dynamics’ ExoVerita exosome isolation platform to detect cancer earlier using a new generation of biomarkers and technology, which is especially important for high-risk patients. The ExoVita Pancreas test, which targets and isolates exosomes found in patient blood samples, detected cancer at stages I and II with high sensitivity and specificity in prior studies, and now has the potential to detect precancerous lesions as well. About Biological Dynamics Biological Dynamics, Inc. is committed to improving global health outcomes by detecting diseases at the earliest stages. Its proprietary exosome-isolation ExoVerita™ platform, currently used by the company and research customers, simplifies isolation of extracellular vesicles, enabling multiomic applications. Biological Dynamics recently initiated its ExoLuminate study to demonstrate the effectiveness of its ExoVita™ Pancreas assay for early-stage detection of pancreatic cancer. The assay is a lab-developed test (LDT) validated and performed in the Company’s College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego. All clinical decision making remains with patient and their physicians. Learn more at www.ExoLuminate.com . References: American Cancer Society: Cancer Facts & Statistics. American Cancer Society | Cancer Facts & Statistics . https://cancerstatisticscenter.cancer.org . Accessed May 17, 2023. Cancer Stat Facts: of the pancreas – Pancreatic Cancer. National Cancer Institute. SEER. https://seer.cancer.gov/statfacts/html/pancreas.html . Accessed May 17, 2023.

SAN DIEGO, May 8, 2023 /PRNewswire/ -- Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, today announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease. Pancreatic adenocarcinoma (PDAC) is one of the most deadly forms of cancer, in part due to the majority of diagnoses being late-stage; the five-year survival rate for PDAC is less than 10%. The PDACatch assay is based on Singlera's MethylTitan platform, which utilizes a proprietary library construction approach and methylation haplotypes to achieve unparalleled conversion rates and cancer detection sensitivity. This technology was previously demonstrated to allow early detection of five types of cancer four years prior to conventional diagnosis (Nature Communications). The PDACatch assay detects methylation patterns in circulating tumor DNA in blood that originate from early stage pancreatic adenocarcinomas and precancerous pancreatic lesions such as intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN), potentially allowing earlier detection and intervention for high-risk PDAC patients. To qualify for Breakthrough Device Designation, a device must address an unmet medical need and show that it has the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval. With Breakthrough Device Designation, the PDACatch assay could become available as a screening option for patients at high risk for pancreatic cancer sooner. "We are very excited that the FDA has recognized the PDACatch assay as a Breakthrough Device. This is a big milestone for Singlera. PDACatch is the first ever liquid biopsy tool to detect and monitor pancreatic adenocarcinoma; early detection and monitoring of patients at high-risk for pancreatic cancer will make a significant impact on these individuals' quality of life," said Qiang Liu, COO of Singlera Genomics. "We look forward to working with the FDA as part of the Breakthrough program to obtain continued guidance and prioritized reviews of our clinical trials and pre-market approval processes." Singlera Genomics is in the process of launching a prospective study and clinical trial to further evaluate and obtain pre-market approval for the PDACatch assay. About Singlera Genomics Inc. () Founded in 2014, Singlera Genomics Inc. is a world leader in liquid biopsy and cancer early detection. By leveraging our deep expertise and broad experience in genome technology，Singlera offers a wide range of products and solutions covering Early Cancer Screening, Diagnostics, and Prognosis Monitoring for multiple types of cancers including lung, colorectal, liver, gastric, esophageal, pancreatic, thyroid, and more. The company has established Research & Development centers in Shanghai and San Diego, manufacturing facilities in Shanghai and Yangzhou, and commercial clinical labs in Shanghai, Taizhou, and Chengdu. SOURCE Singlera Genomics, Inc