A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A Cancer-Specific Plectin (CSP)-Targeting Functional Antibody in Solid Tumors That Are Likely to Express CSP

This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where prevalence of CSP expression is high. Approximately 12 to 24 patients will be enrolled in the Dose Escalation Stage; the total number of patients will depend on the dose level at which the RP2D is defined. Patients who meet the eligibility criteria during Screening will enter the treatment period. ZB131 will be given via IV every week. Patients will be treated until disease progression or unacceptable toxicities occur.

Start Date14 Jan 2022

Sponsor / Collaborator

Zielbio, Inc.

100 Clinical Results associated with Ibentatug

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News (Medical) associated with Ibentatug

07 Jun 2023

·www.prnewswire.com

Cholangiocarcinoma Clinical Trial Pipeline Analysis Demonstrates 65+ Key Companies at the Horizon Expected to Transform the Treatment Paradigm, Assesses DelveInsight

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

Clinical ResultFast TrackOrphan DrugPhase 2Phase 1

02 Jun 2023

·www.prnewswire.com

ZielBio to Present Interim Findings from its Phase 1/2, First-in-Human Trial of ZB131 at 2023 ASCO Annual Meeting

ZB131 is a first-in-class humanized monoclonal antibody targeting cancer-specific plectin (CSP), which is expressed on the surface of cancer cells in solid tumors Interim data demonstrates safety and tolerability of ZB131 while providing evidence of clinical activity in a proportion of patients with difficult-to-treat tumors CHARLOTTESVILLE, Va., June 2, 2023 /PRNewswire/ -- ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases, will present the first set of clinical data from its lead asset, ZB131, directed against cancer-specific plectin (CSP), during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In an interim analysis (n=32) of the Phase 1/2 trial, ZB131 demonstrated a favorable safety and tolerability profile, evidence of clinical activity and dose-proportional pharmacokinetics. Dr. David Sommerhalder, principal investigator at NEXT Oncology in San Antonio, Texas, will present the data in a poster session (board 281) on Saturday, June 3 from 9:00 am to 12:30 pm in poster Hall A at Chicago's McCormick Place. The ZB131 clinical trial (trial identifier NCT05074472) is a Phase 1/2, first-in-human, open-label, dose escalation study of ZB131 in tumors likely to express CSP. The primary objective of the dose escalation phase was to evaluate the safety and tolerability of ZB131 as a monotherapy. Having established safe dosing levels, the study began enrolling expansion cohorts treating patients with either ZB131 at 30 mg/kg as a monotherapy or ZB131 at 15 mg/kg in combination with gemcitabine. "The initial safety, pharmacokinetics and clinical activity from the Phase 1/2 trial, combined with preclinical evidence that ZB131 binds selectively to CSP, rapidly internalizes, and can be conjugated to cytotoxic payloads, validates our efforts to further develop ZB131, including as an antibody-drug conjugate (ADC)," said Alan Bash, CEO of ZielBio. "CSP is a highly promising target given its cell surface expression in malignant tissue and lack of presence in healthy tissue across multiple solid tumors, and ZielBio is leading the field of research into this target." About ZielBio ZielBio is a clinical stage biotechnology company that identifies novel disease targets and develops therapeutic interventions to improve patient outcomes. Its proprietary drug discovery platform ZielFind combines the power of functional, high throughput screening with large content data analytics to identify high value targets. ZielBio has a promising pipeline of therapies and targets, including novel lead asset ZB131 (proposed international nonproprietary name Ibentatug), a proprietary humanized monoclonal antibody against cancer-specific plectin. The company's clinical trial of ZB131 is open and enrolling with additional study details available at clinicaltrials.gov (NCT05074472). SOURCE ZielBio, Inc.

ASCOPhase 1Clinical Result

18 Apr 2023

·www.prnewswire.com

ZielBio to Present New Research on the Utility of Cancer-Specific Plectin (CSP) and ZB131 in Antibody-Drug Conjugates at AACR Annual Meeting 2023

ZB131 is a first-in-class humanized monoclonal antibody targeting cancer-specific plectin (CSP), which is expressed on the surface of cancer cells in many solid tumors New, preclinical research suggests that CSP is a promising target and ZB131 is an ideal candidate for antibody-drug conjugate approaches CHARLOTTESVILLE, Va., April 17, 2023 /PRNewswire/ -- ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases, will present new, preclinical data showing that its lead asset, ZB131, directed against cancer-specific plectin (CSP), represents a promising approach for antibody-drug conjugates (ADCs) at the American Association for Cancer Research (AACR) Annual Meeting 2023. The AACR Annual Meeting is taking place April 14-19, 2023 in Orlando and virtually. ZielBio's Dr. Lindsey Brinton, Principal Scientist and Head of Research, and Dr. Samantha Perez, Senior Scientist, will present the data in a poster session on Wednesday, April 19 from 9:00 am to 12:30 pm in Section 21 of the poster hall. Major advances in payload and linker technology are increasing the clinical adoption of ADCs, leaving an unmet need for the identification of new targets that differentiate cancer cells from healthy cells across multiple tumor types. ZielBio has validated CSP, a pro-tumorigenic protein expressed on the surface of cancer cells, as a high-value drug target and developed ZB131 as a first-in-class anti-CSP monoclonal antibody. ZB131 is currently being evaluated in a Phase 1/2 clinical trial (NCT05074472) across multiple solid tumors. Research presented at AACR will focus on CSP as a target for ADCs, demonstrating its abundance on the surface of cancer cells (and not healthy tissue), its bioavailability in humans, and its application across multiple cancer indications. ZB131 demonstrates favorable pharmacokinetics, is rapidly internalized by CSP-expressing tumor cells in mouse models, and can be conjugated to multiple cytotoxic payloads. "These findings underscore our enthusiasm for CSP as a therapeutic target and ZB131 as an excellent candidate for conjugation to payloads," said Alan Bash, CEO of ZielBio. "We are excited to share this data with the AACR community and are committed to exploring new avenues for deploying ZB131 against difficult-to-treat cancers." About ZielBio ZielBio is a clinical stage biotechnology company that identifies novel disease targets and develops therapeutic interventions to improve patient outcomes. Its proprietary drug discovery platform ZielFind combines the power of functional, high throughput screening with large content data analytics to identify high value targets. ZielBio has a promising pipeline of therapies and targets, including novel lead asset ZB131 (proposed international nonproprietary name Ibentatug), a proprietary humanized monoclonal antibody against cancer-specific plectin. The company's clinical trial of ZB131 is open and enrolling with additional study details available at clinicaltrials.gov (NCT05074472). SOURCE ZielBio, Inc.

AACR

100 Deals associated with Ibentatug

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Biliary Tract Neoplasms	Phase 2	US	Zielbio, Inc.	14 Jan 2022
Ovarian Serous Adenocarcinoma	Phase 2	US	Zielbio, Inc.	14 Jan 2022
Pancreatic Ductal Adenocarcinoma	Phase 2	US	Zielbio, Inc.	14 Jan 2022
Serous Cystadenocarcinoma	Phase 2	US	Zielbio, Inc.	14 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05074472 (ASCO2023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	24	ZB131	(kcrixcaiwr) = Except for one episode of Gr 3 neutropenia at the 30 mg/kg dose, no other drug-related grade 3/4 TRAE’s were reported. hyvegsmzrp (vnnzfmgthu ) View more	Positive	26 May 2023

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