Wellmarker Bio Co., Ltd.

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

Wellmarker Bio is pleased to sign a clinical collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate a first-in-class treatment with a novel mechanism in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy. SEOUL, South Korea , Feb. 7, 2023 /PRNewswire/ -- Wellmarker Bio Co., Ltd (WMBIO) (CEO: Dong-Hoon Jin, Department of Convergence Medicine, Ulsan College of Medicine and Asan Medical Center,), a predictive biomarker-driven biotech company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, today announced the company has entered a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) on 7th Feb. Under the agreement, WMBIO will sponsor the Phase 1 (or Phase 1b) clinical trial for WM-A1-3389, a novel therapeutic antibody for Non-Small Cell Lung Cancer (NSCLC) patients with low or no PD-L1 expression, in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy. Some NSCLC patients with low or no PD-L1 expression have shown limited response to treatment with immunotherapies alone and there is a high unmet need in these patient populations. WMBIO is also planning to expand the target patient group to other solid tumor indications. WM-A1-3389 is a novel therapeutic antibody targeting a new immune checkpoint protein discovered by Wellmarker Bio and has demonstrated efficacy across different PBMC humanized models. An additive benefit of WM-A1-3389 and anti-PD-1 antibody was evidenced in preclinical mouse models including PD-1-resistant CT26 and LLC-1 mouse models. "This clinical trial collaboration with MSD holds great significance for WMBIO as it allows us to evaluate a first-in-class drug with a novel mechanism in combination with KEYTRUDA," said Dong-Hoon Jin, CEO of Wellmarker Bio. "Now that we have seen WM-A1-3389 demonstrates a favorable safety margin in combination with immunotherapies in preclinical studies, we are excited to collaborate with MSD to further investigate the therapeutic potential of an additive benefit when combining WM-A1-3389 with KEYTRUDA." WM-A1-3389 development was funded by Korea Drug Development Fund (KDDF). In eary 2022, this study was selected by the follow-up project of Korea Drug Development Fund (KDDF, Director. Muk, Hyunsang) in the preclinical stage.In addition, Wellmarker Bio is co-developing liquid biopsy companion diagnostics (CDx) with Cytogen. PharmaVentures Ltd., a UK-based premier transaction advisory firm, acted as the exclusive advisor for this collaboration and the ongoing partnering efforts for WM-A1-3389. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. For further information, please contact: Jai-Hee Moon Strategy planning manager (email: [email protected]) About Wellmarker Bio Wellmarker Bio Co., Ltd (WMBIO) is the first company to be spun out from the renowned Asan Medical Center, Korea's largest hospital. It focuses on the development of novel anticancer drugs derived from comprehensive biomarker analysis. Since it was founded in 2016, WMBIO has developed 9 first-in-class drugs for solid tumor indications. Having access to a wide array of patient samples from Asia and using predictive biomarkers to guide therapeutic development in innovative ways have allowed WMBIO to rapidly move its assets from exploratory to preclinical and then into early clinical stages. WMBIO's R&D strategy is to focus mainly on drug discovery and early-stage development of lead compounds to build a deep and wide pipeline of products, with the most advanced assets in phase 1 clinical trials. Once a drug candidate is at that stage, WMBIO would seek to find global pharmaceutical companies to partner with for co-development or licensing. For further information, visit: About WM-A1-3389 WM-A1-3389 is a novel therapeutic antibody targeting a new immune checkpoint protein discovered by Wellmarker Bio. WM-A1-3389's novel target is abundantly expressed in a variety of cancer types and has demonstrated efficacy across different PBMC humanized models. An additive benefit of WM-A1-3389 and anti-PD-1 antibody was evidenced in preclinical mouse models including PD-1-resistant CT26 and LLC-1 mouse models. About PharmaVentures PharmaVentures is a premier transaction advisory firm and a leading international company in partnering, M&A deals and strategic alliances. For the past 30 years, PharmaVentures has acted as advisor on over 1,000 deal related projects covering licensing, mergers, acquisitions, divestments, and joint venture activities for companies worldwide. We are regulated through PharmaVentures Capital Ltd. Find out more SOURCE Wellmarker Bio

SEOUL, South Korea, March 3, 2021 /PRNewswire/ -- Wellmarker Bio( ) announced that on February 23, 2021 the company received approval from the Australian Therapeutic Goods Administration (TGA) for a Phase I clinical trial using WM-S1-030, a targeted anti-cancer drug for colorectal cancer and progressive cancer. Under the approval, Wellmarker Bio will seek to recruit a total of 100 advanced cancer patients in multiple centers, including sites in Australia such as the Linear Clinical Center and Monash Hospital, to conduct clinical trials in two stages: Phase Ia (dose escalation) and Phase Ib (dose expansion). "We plan to study the drug's safety at various doses in Phase Ia, and in Phase Ib, we will conduct studies for indication expansion as well as combination therapy with chemotherapy, other targeted or cancer immunotherapy drugs along with validation of our predictive biomarker," said Dong-Hoon Jin, CEO of WMBIO. WM-S1-030 has demonstrated significant tumor growth inhibition in colorectal cancer models that are resistant to Erbitux (generic name: cetuximab), an anti-cancer drug commonly used as a targeted therapy in solid cancers including colorectal cancer. Wellmarker's WM-S1-030 has so far shown outstanding therapeutic efficacy in extensive preclinical studies, including Patient-Derived tumor Cell (PDC) and Patient-Derived tumor Xenograft (PDX) animal models. This deep understanding of the mechanism of action of WM-S1-030 means that the drug is expected to demonstrate efficacy in patients with colorectal cancer across both KRAS wild-type and KRAS mutant genotypes. Currently there is a significant unmet need for patients displaying primary and secondary resistance to Erbitux, which could allow WM-S1-030 to be positioned as a first-in-class drug. By using predictive biomarkers to enable efficient development of an effective precision medicine for patients who lack alternative options, WMBIO has rapidly moved its asset from exploratory research through preclinical studies and now into early clinical development in less than four years. Since its inception in 2016, Wellmarker Bio has developed 9 first-in-class pipeline drugs, as well as predictive biomarkers for each drug candidate. By utilizing a bed-to-bench discovery strategy, selecting the right patient groups with high unmet needs and building a wealth of data around the safety and efficacy of its novel drug candidates, Wellmarker Bio is moving closer to delivering individualized, effective and affordable options to patients.