CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Advanced Gastroesophageal Junction AdenocarcinomaCLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinoma+ [9]

Inactive Indication

AdenocarcinomaCLDN18.2 Positive Gastrointestinal NeoplasmsEsophageal Carcinoma+ [1]

Originator Organization

Ganymed Pharmaceuticals AG

Active Organization

Astellas Pharma Global Development, Inc.

Astellas Pharma China, Inc.Astellas Pharma US, Inc.

+ [5]

Inactive Organization

Ganymed Pharmaceuticals AG

License Organization

Shanghai Pharmaceutical Co., Ltd.

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (26 Mar 2024),

CLDN18.2 positive Stomach Cancer

RegulationPriority Review (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Accelerated assessment (United States)

Structure/Sequence

Sequence Code 431594752L

Source: *****

Sequence Code 524309292H

Source: *****

Clinical Trials associated with Zolbetuximab

NCT06962137

/ Not yet recruitingPhase 2IIT

Phase II RAINSPOT: a Multicentric Open Label Trial of Zolbetuximab-Paclitaxel-Ramucirumab in Second Line Setting for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma

This study examines whether adding the drug Zolbetuximab to an existing treatment (Paclitaxel and Ramucirumab) can improve patients' survival. The goal is to see if this combination works better for patients whose tumours contain a specific protein (CLDN18.2). The results will be compared to past patient data from those who only received the standard treatment.
Zolbetuximab (Vyloy) is a cancer medicine that is used to treat adults with gastric or gastro-esophageal junction adenocarcinoma (a type of cancer of the stomach or the transition between the stomach and esophagus). Zolbetuximab will be administered via an intravenous infusion in combination with Paclitaxel and Ramucirumab (Cyramza) (two other cancer drugs that are the standard treatment for this condition). Treatment will take place at regular intervals in the hospital. In addition to treatment,patients will undergo a tumour biopsy. While the biopsy procedure may cause some discomfort or pain, it will only be performed if medically justifiable. Patients participation in the study will continue as long as they receive treatment and the disease does not worsen. The overall duration of the study, for all patients, will span several years.

Start Date01 Oct 2025

Sponsor / Collaborator-

NCT06901531

/ RecruitingPhase 3

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Start Date22 May 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06881017

/ Not yet recruitingPhase 2IIT

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

Start Date01 May 2025

Sponsor / Collaborator

China Medical University

100 Clinical Results associated with Zolbetuximab

100 Translational Medicine associated with Zolbetuximab

100 Patents (Medical) associated with Zolbetuximab

124

Literatures (Medical) associated with Zolbetuximab

01 Apr 2026·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

Author: Yoshioka, Tsubasa ; Kimura, Rika ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Okamoto, Risa ; Tachibana, Ayu

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Population pharmacokinetic analysis of fluorouracil and oxaliplatin in the absence or presence of zolbetuximab in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Article

Author: Bonate, Peter L ; Yang, Jianning ; Yamada, Akihiro ; Poondru, Srinivasu ; Heo, Nakyo

PURPOSE:

Zolbetuximab, a monoclonal antibody targeting claudin 18.2 (CLDN18.2), is approved in combination with chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer (in Japan) and in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (in geographies including but not limited to the US, Europe, and China). Noncompartmental analysis (NCA) was previously used to evaluate the effect of zolbetuximab on pharmacokinetics (PK) of 5-fluorouracil (5-FU) and oxaliplatin; however, limitations of NCA confounded the results. This study utilized population pharmacokinetic (PopPK) analysis to address these limitations.

METHODS:

In Cohort 2 of the phase 2 ILUSTRO study (NCT03505320), patients with locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive G/GEJ adenocarcinoma received zolbetuximab with modified folinic acid, 5-FU, and oxaliplatin. PopPK models were developed to evaluate the impact of zolbetuximab on PK of 5-FU and oxaliplatin (including simultaneous analysis of free and total platinum).

RESULTS:

PK of 5-FU was adequately described by a 1-compartment model with zero-order input and first-order elimination. PK of free and total platinum was simultaneously described by a 3-compartment model with zero-order input, first-order elimination, and time-dependent free fraction. No impact of zolbetuximab on 5-FU PK or on systemic clearance or free fraction of oxaliplatin in plasma was observed. The effect of zolbetuximab on oxaliplatin distribution volume (12.3% decrease) was statistically significant but not considered clinically relevant.

CONCLUSION:

PopPK analysis suggests no effect of zolbetuximab on 5-FU or oxaliplatin PK.

01 Dec 2025·MODERN PATHOLOGY

Analytical and Clinical Performance of the VENTANA CLDN18 (43-14A) RxDx Assay in Gastric and Gastroesophageal Junction Adenocarcinoma Tissue Samples in SPOTLIGHT and GLOW

Article

Author: Guerruero, Abraham ; Moran, Sean ; Kouzova, Margarita ; Lawrence-Glaze, Rebecka ; Moran, Diarmuid ; Stratton, Steven P ; Pang, Lizhen ; Pugh, Judith ; Baldwin, Drew ; McDonald, Jannine

New therapies are needed to treat patients with human epidermal growth factor receptor 2 (HER2)-negative, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. Zolbetuximab is a monoclonal antibody that targets the tight junction protein claudin 18 isoform 2 (CLDN18.2) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma cells. We describe the analytical and clinical performance of the VENTANA CLDN18 (43-14A) RxDx Assay (Roche Diagnostics Solutions) as a companion diagnostic immunohistochemistry assay for treatment with zolbetuximab. Analytical performance was assessed in commercially available G/GEJ adenocarcinoma samples. Clinical performance was assessed in the context of 2 phase 3 trials (SPOTLIGHT, NCT03504397; GLOW, NCT03653507) of first-line zolbetuximab plus chemotherapy in patients with HER2-negative, LA unresectable or mG/GEJ adenocarcinoma, whose tumors were CLDN18.2 positive (≥75% of viable tumor cells demonstrating moderate-to-strong membrane CLDN18 staining). Staining acceptability rates were assessed in patients whose tumors were tested for CLDN18.2 status using the VENTANA CLDN18 (43-14A) RxDx Assay and who met enrollment eligibility criteria not related to CLDN18.2 status. Progression-free survival and overall survival were evaluated in the enrolled patients. Analytical performance: positive and negative percent agreement compared with immunohistochemistry reference scoring was 100% for between-antibody, between-detection kit, between-instrument, between-day, and within-run precision studies. Interlaboratory reproducibility exceeded 90% average positive and negative agreement between sites and 94% average positive and negative agreement between readers across 3 sites. Clinical performance: among 3783 patient tumor samples, staining acceptability rates exceeded 94%. Patients identified for eligibility using the VENTANA CLDN18 (43-14A) RxDx Assay demonstrated statistically significant improvement in progression-free survival and overall survival with zolbetuximab plus chemotherapy in both phase 3 trials. The VENTANA CLDN18 (43-14A) RxDx Assay demonstrated robust, reproducible analytical performance and clinical utility as a companion diagnostic for first-line zolbetuximab plus chemotherapy in patients with HER2-negative, LA unresectable or mG/GEJ adenocarcinoma, whose tumors were CLDN18.2 positive.

112

News (Medical) associated with Zolbetuximab

23 Jul 2025

·www.prnewswire.com

Claudin 18.2-Directed Oncology Therapeutics--A Fast-Growing Market with Blockbuster Potential | DelveInsight

Claudin 18.2-directed therapies are on track to become foundational in the treatment of gastrointestinal and select solid tumors. Fueled by innovation in antibody engineering, combination strategies, and biomarker testing, this therapeutic class is set to play a transformative role in the next generation of precision oncology. LAS VEGAS, July 23, 2025 /PRNewswire/ -- DelveInsight's Claudin 18.2 Directed Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging Claudin 18.2-directed therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Claudin 18.2 Directed Therapies Market Report As per DelveInsight's analysis, the total market size of Claudin 18.2-directed therapies in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors Leading Claudin 18.2-directed therapies companies, such as AskGene, Innovent, AstraZeneca, Antegene, Antennova, Kelun, Phanes, and others, are developing novel Claudin 18.2-directed therapies that can be available in the Claudin 18.2-directed therapies market in the coming years. Some of the key Claudin 18.2-directed therapies in the pipeline include ASKB589, IBI-343, AZD0901, ATG022/ATN022, SKB315, Spevatamig (PT886), and others. In May 2025, Astellas entered an exclusive license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2. Discover which indication is expected to grab the major Claudin 18.2-directed therapies market share @ Claudin 18.2 Directed Therapies Market Report Claudin 18.2 Directed Therapies Market Dynamics The Claudin 18.2-directed therapies market has been witnessing significant momentum driven by advancements in targeted oncology therapies. Claudin 18.2 is a tight junction protein selectively expressed in certain cancers, such as gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer, making it an attractive therapeutic target. The approval of zolbetuximab (VYLOY) by Astellas has validated the clinical potential of Claudin 18.2-targeting monoclonal antibodies, positioning the pathway as a critical frontier in precision oncology. Other players, including domestic and international pharmaceutical companies, are actively developing monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies directed against Claudin 18.2, further intensifying the competitive dynamics. The market is characterized by a robust pipeline across various modalities. Monoclonal antibodies such as zolbetuximab lead the segment, but the pipeline also features novel ADCs and bispecifics, aiming to improve efficacy and overcome resistance mechanisms. Several companies are exploring combination regimens with checkpoint inhibitors and chemotherapy to enhance treatment outcomes. Additionally, there is a growing interest in expanding the therapeutic scope beyond gastric and gastroesophageal junction cancers to include pancreatic, lung, and other solid tumors where Claudin 18.2 expression is evident, potentially broadening the patient pool. Despite the growth prospects, the Claudin 18.2-directed therapies market faces several challenges. These include the need for reliable diagnostic tools to identify Claudin 18.2 expression, patient heterogeneity in expression levels, and potential off-target effects leading to safety concerns. Moreover, market penetration may be impacted by the high cost of biologics and the evolving reimbursement landscape, particularly in emerging markets. Nonetheless, the strong clinical efficacy signals, favorable regulatory momentum, and increasing physician awareness position Claudin 18.2 therapies for substantial growth over the next decade. Looking ahead, the Claudin 18.2-directed therapy landscape is expected to diversify with the introduction of next-generation modalities such as CAR-T therapies and vaccines targeting the protein. The competitive intensity is likely to increase as additional players enter late-stage development and as combination regimens redefine the treatment paradigm. Continued biomarker-driven patient selection and companion diagnostic development will be critical to optimizing outcomes and driving adoption. Overall, the Claudin 18.2 market represents a dynamic and evolving segment of the oncology therapeutics space, poised for continued innovation and expansion. Claudin 18.2 Directed Therapies Treatment Market Therapies targeting Claudin 18.2 have shown activity across several cancers, such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. Astellas' VYLOY (zolbetuximab) is currently the first and only approved therapy directed against Claudin 18.2 for advanced gastric and gastroesophageal junction adenocarcinoma. It was first approved in Japan in March 2024, followed by regulatory clearance in the UK in August 2024, and later by the US FDA in October 2024. VYLOY is a cytolytic monoclonal antibody that targets claudin 18.2 and is approved for use alongside fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. This treatment is specifically intended for patients whose tumors express claudin 18.2, as confirmed by an FDA-approved diagnostic test. As a claudin 18.2-targeting cytolytic antibody, VYLOY destroys CLDN18.2-positive cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Preclinical models have shown that combining VYLOY with chemotherapy enhances antitumor activity in CLDN18.2-positive tumors compared to the use of either treatment alone. Learn more about the Claudin 18.2-directed therapies @ Claudin 18.2 Directed Therapies Analysis Key Emerging Claudin 18.2 Directed Therapies and Companies Several companies, including AskGene (ASKB589), Innovent (IBI-343), Antegene (ATG022/ATN022), Kelun (SKB315), AstraZeneca (AZD0901), Phanes (Spevatamig), and others, are currently engaged in the development and production of CLDN 18.2 therapies, which have the potential to significantly impact and enhance the MCR therapies market. ASKB589 is a humanized IgG1 monoclonal antibody targeting CLDN1, specifically designed to enhance antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In combination with CAPOX chemotherapy and a PD-1 inhibitor as a first-line therapy for patients with gastric/gastroesophageal junction (G/GEJ) cancer, ASKB589 showed a favorable safety and tolerability profile. The addition of a PD-1 inhibitor to the ASKB589 plus CAPOX regimen in patients expressing moderate to high levels of CLDN18.2 led to promising anti-tumor effects, characterized by strong and lasting responses. IBI-343 is a recombinant human monoclonal antibody targeting Claudin 18.2, linked to a topoisomerase I inhibitor payload (Exatecan). Engineered with an Fc-silenced backbone to reduce unwanted immune activation, it features a cleavable linker for targeted drug release within tumor cells, enabling a bystander killing effect that affects neighboring tumor cells with low antigen expression. IBI-343 has been granted Fast Track Designation by the U.S. FDA and is currently being investigated in the Phase III G-HOPE trial (NCT06238843). The anticipated launch of these emerging therapies are poised to transform the Claudin 18.2-directed therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Claudin 18.2-directed therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about Claudin 18.2-directed therapies clinical trials, visit @ Claudin 18.2 Directed Therapies Treatment Claudin 18.2 Directed Therapies Overview Claudin 18.2 is a tight junction protein essential for preserving the integrity of the stomach lining. It is one of the two isoforms produced by the CLDN18 gene and is normally found only in differentiated epithelial cells of the gastric mucosa. In healthy tissues, Claudin 18.2 is hidden within tight junctions, making it inaccessible to drugs. However, during the development of cancers like gastric, gastroesophageal junction (GEJ), and pancreatic cancer, Claudin 18.2 becomes abnormally exposed on the surface of tumor cells, while its expression in normal tissues remains limited. This distinct expression profile makes Claudin 18.2 a promising and highly specific therapeutic target. The most advanced treatment targeting this protein is VYLOY, a monoclonal antibody that binds to Claudin 18.2 and induces immune-mediated killing of tumor cells. VYLOY has demonstrated encouraging results in late-stage clinical trials and is now approved for treating CLDN18.2-positive gastric and GEJ cancers. Additional therapies under investigation include CAR-T cell therapies, bispecific antibodies, and antibody-drug conjugates. Testing for CLDN18.2 expression using immunohistochemistry (IHC) helps identify patients who may benefit from these targeted treatments, highlighting the dual role of CLDN18.2 as both a biomarker and a therapeutic target in precision cancer therapy. Claudin 18.2 Directed Therapies Epidemiology Segmentation The Claudin 18.2-directed therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for Claudin 18.2-directed Therapies Total Eligible Patients of the Selected Indications of Claudin 18.2-directed Therapies Total Treated Cases in Selected Indications for Claudin 18.2-directed Therapies Scope of the Claudin 18.2 Directed Therapies Market Report Claudin 18.2 Directed Therapies Therapeutic Assessment: Claudin 18.2 Directed Therapies current marketed and emerging therapies Claudin 18.2 Directed Therapies Market Dynamics: Conjoint Analysis of Emerging Claudin 18.2 Directed Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Claudin 18.2 Directed Therapies Market Access and Reimbursement Discover more about Claudin 18.2-directed therapies in development @ Claudin 18.2 Directed Therapies Clinical Trials Table of Contents Related Reports Gastric Cancer Market Gastric Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, Bristol Myers Squibb, BioLineRx, Alligator Bioscience, Bellicum Pharmaceuticals, OSE Immunotherapeutics, Actuate Therapeutics, FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, Merus, Mirati Therapeutics, Rexahn Pharmaceuticals, Ocuphire Pharma, Processa Pharmaceuticals, ImmunityBio, Berg, Panbela Therapeutics, GlaxoSmithKline, Eleison Pharmaceuticals, Molecular Templates, Lokon Pharma AB, Cantargia AB, Bristol-Myers Squibb, among others. Gastroesophageal Junction Adenocarcinoma Market Gastroesophageal Junction Adenocarcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gastroesophageal junction adenocarcinoma companies, including Astellas Pharmaceuticals, AstraZeneca, Bayer, Beigene, Bristol-Myers Squibb, Daichii Sankyo, Elevar Therapeutics, Eli Lilly, FivePrime Therapeutics, Incyte Corporation, Macrogenics, Merck Co., Ono Pharmaceuticals, Roche, Taiho Pharmaceuticals, Zai Labs, ZymeWorks, among others. Pancreatic Ductal Adenocarcinoma Market Pancreatic Ductal Adenocarcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PDAC companies, including Cardiff Oncology, Cantargia, RenovoRx, Jeil Pharmaceutical, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inImmunotherapyPhase 3Phase 1

06 Jun 2025

·www.fiercepharma.com

Fierce Pharma Asia—Bispecific field's roller coaster week; Enhertu's first-line win; Regeneron-Hansoh obesity deal

Summit Therapeutics' unsatisfactory global phase 3 readout, Bristol Myers Squibb's big bet on PD-L1/VEGF, Enhertu's first-line breast cancer data and Regeneron's obesity deal with Hansoh Pharma made our news this week. The PD-(L)1xVEGF field had a roller coaster week marked by an imperfect readout and a potentially $11 billion deal. AstraZeneca and Daiichi Sankyo trotted out Enhertu's detailed data in first-line breast cancer. Regeneron signed on a GLP-1/GIP candidate from China's Hansoh Pharma. And more.1. Akeso, Summit's ivonescimab delayed progression of certain lung cancers in first global phase 3 readoutBristol Myers inks $11B BioNTech deal to join bispecific gold rush, leaping ahead of Merck and PfizerSummit Therapeutics unveiled the first global phase 3 readout from Akeso’s PD-1xVEGF bispecific ivonescimab, saying the drug reduced the risk of progression or death by 48% in previously treated EGFR-mutated nonsquamous non-small cell lung cancer. But, because the HARMONi trial did not meet the overall survival endpoint at the current analysis, the company’s stock price tanked.But the PD-(L)1xVEGF field quickly got an injection of confidence when Bristol Myers Squibb announced a potentially $11.1 billion deal to co-develop and co-commercialize BioNTech’s PD-L1xVEGF candidate BNT327. The deal includes $1.5 billion upfront and $2 billion in unconditional anniversary payments through 2028. BioNTech got the drug recently from purchasing its then-partner, Chinese biotech Biotheus, for $800 million upfront.2. ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer dataAstraZeneca and Daiichi Sankyo’s Enhertu, used in combination with Roche’s Perjeta, significantly reduced the risk of progression or death by 44% versus the standard THP regimen in first-line HER2-positive breast cancer. Experts suggested that the result, from the Destiny-Breast09 trial, makes the Enhertu combo a new first-line standard treatment option, although some questions such as treatment duration remained.3. Regeneron pens $2B pact for Hansoh's potential obesity rival to Lilly's ZepboundRegeneron is paying China’s Hansoh Pharma $80 million upfront for ex-China rights to a GLP-1/GIP receptor agonist coded HS-20094. The deal includes up to $1.93 billion in potential milestone payments. The drug is currently undergoing a phase 2b in diabetes and a phase 3 in obesity in China.4. Astellas aspires to strike CLDN18.2 gold again with ADC licensing deal worth up to $1.34BAstellas has doubled down on the Claudin18.2 field by in-licensing an antibody-drug conjugate from Chinese biotech Evopoint Biosciences in a deal potentially worth up to $1.34 billion. Evopoint is testing the agent, XNW27011, in a phase 1/2 solid tumor trial covering gastric, pancreatic, colorectal, ovarian and other cancers. Astellas already has the first FDA-approved Claudin18.2 agent, Vyloy.5. Cullinan pens $700M pact for BCMA bispecific to pair with another autoimmune T-cell engagerCullinan Therapeutics, which is already working on a CD19 bispecific for autoimmune diseases, is getting a BCMA T-cell engager. For $20 million upfront and nearly $700 million in potential milestones, Cullinan is getting ex-China rights to Genrix Bio’s BCMAxCD3 candidate velinotamig. Last year, researchers reported a deep remission in a woman with aggressive refractory systemic lupus erythematosus who received Johnson & Johnson’s BCMA bispecific Tecvayli.6. Kelun-Biotech raises $250M with 6M share placement (release)After its Hong Kong IPO in 2023, China's Kelun-Biotech has raised about $250 million in a new share placement. The company sold about 5.92 million shares at HK$331.80 per share, according to a press release. Kelun said the placement was "multiple times oversubscribed" with support from various types of investors, leading the biotech to expand a previous fundraising target of $200 million. Kelun plans to use the money to fund R&D operations, regulatory interactions, manufacturing infrastructure and more. Other News of Note:7. Ascletis scores phase 3 win for daily acne pill, prepares push to Chinese regulators8. ASCO: Kura, Kyowa reveal 23% remission rate behind oral leukemia drug's phase 2 win9. BioAge inks option agreement for Chinese biotech's obesity asset on heels of earlier APJ agonist setback10. Astellas organizes action week to connect patients to advocacy groups11. Fujifilm, Coherus, ViGeneron unveil rebrands to better reflect ongoing work

Phase 3Phase 2Drug ApprovalClinical ResultLicense out/in

30 May 2025

·firstwordpharma.com

Astellas strikes $1.34B deal with Evopoint for CLDN18.2-directed ADC

Looking to bulk up its oncology pipeline, Astellas Pharma signed a licensing deal worth nearly $1.4 billion with Evopoint Biosciences for rights to the latter’s investigational antibody-drug conjugate (ADC) targeting CLDN18.2, dubbed XNW27011.The agreement announced Thursday, grants Astellas exclusive development and commercialisation rights to XNW27011 worldwide, with the exception of mainland China, Hong Kong, Macao and Taiwan. Evopoint will receive $130 million upfront, up to $70 million in near-term payments and additional milestone payments totalling up to $1.34 billion, plus sales royalties.The ADC — which utilises topoisomerase I inhibitor payload and linker technology — is currently undergoing Phase I/II trials for CLDN18.2-expressing solid tumours in China, including gastric, gastroesophageal and pancreatic cancers. “We look forward to harnessing our expertise in targeting CLDN18.2 and specialised knowledge in [gastrointestinal] cancers to advance XNW27011 and deliver meaningful outcomes to patients," Adam Pearson, chief strategy officer at Astellas.XNW27011 represents a strategic addition to Astellas' portfolio, which already includes Vyloy (zolbetuximab), the world's first approved CLDN18.2-targeted therapy approved for first-line gastric cancer in Japan, the EU and US. The Japanese drugmaker recently touted “greater-than-expected sales growth" of Vyloy.

ADCLicense out/inDrug ApprovalPhase 1

100 Deals associated with Zolbetuximab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Zolbetuximab	-	DB15118

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Canada	Astellas Pharma Canada, Inc.	09 Jan 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive stomach adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive Stomach Cancer	Japan	Astellas Pharma, Inc.	26 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Japan	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Argentina	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Canada	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Croatia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Greece	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Ireland	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Malaysia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Netherlands	Astellas Pharma Global Development, Inc.	28 Nov 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	CLDN18.2 positive Stomach Cancer CLDN18.2-positive	-	Zolbetuximab + Chemotherapy	dpaimchpfy(dsdgvtvdba) = 8% chmvyopsbb (ivvpfsczvb ) View more	Positive	30 May 2025
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	Phase 3	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	lhifriwjnk(ayujcxdzif) = iibsnxylfq wlypqoxkjh (cbobtcpnlm, imxqaeachg - klsdcbqvte) View more	-	26 Feb 2025
NCT03653507 (GLOW, CTgov)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	xbbtfvsvvl(hhvqjxyooz) = fvlysnxnwa sjsjvclljc (vecpscmleb, snbkveffhn - lqkhsjhacn) View more	-	27 Jan 2025
				Placebo (CAPOX+ Placebo)	xbbtfvsvvl(hhvqjxyooz) = xjkhbhzwgh sjsjvclljc (vecpscmleb, uosbjzmsxn - ittalhkjhq) View more
NCT03504397 (SPOTLIGHT, NEWS) Manual	Phase 3	Gastroesophageal junction adenocarcinoma First line CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	diitpeqfre(esxzxxluke) = vahevwxpsl pyjeouzdok (nzbglfxzht, 6.7 - 16.7) View more	Positive	28 Sep 2024
				安慰剂+mFOLFOX6	diitpeqfre(esxzxxluke) = krtzuhquwm pyjeouzdok (nzbglfxzht, 6.0 - 8.4) View more
NCT03653507 (GLOW, NEWS) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	qhznvhfoxb(oynqkuapcp) = idcydfqzej jcxynpsusg (hvlndlcvvo, 6.1 - 9.1) View more	Positive	28 Sep 2024
				安慰剂联合CAPOX	qhznvhfoxb(oynqkuapcp) = yfzuetdclt jcxynpsusg (hvlndlcvvo, 5.0 - 8.0) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	jvkhsamjyb(qydmtikaja) = jmvdzcekxu hgxtofgtfi (rylrcyhvon, 8.4 - 10.4) View more	Positive	16 Sep 2024
				Placebo + chemotherapy	jvkhsamjyb(qydmtikaja) = qatzryjefp hgxtofgtfi (rylrcyhvon, 7.6 - 8.4) View more
NCT03504397 (SPOTLIGHT, ASCO2024) Manual	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	ledxvjymja(pnsfpamurp) = bpxbqrbnyb rorvntiewk (owqkmwatdf ) View more	Positive	24 May 2024
				Placebo + mFOLFOX6	ledxvjymja(pnsfpamurp) = ypgnccyitz rorvntiewk (owqkmwatdf ) View more
NCT03653507 \| NCT03504397 (Pubmed \| Future Oncol)	Phase 3	Gastrooesophageal junction cancer CLDN18.2-positive \| HER2-negative	-	Zolbetuximab plus chemotherapy	pefehkhcrv(ndepdkkvqd) = nyrocqcjiu giyzmbmkqt (brjwnvvrtr ) View more	Positive	24 May 2024
				Placebo plus chemotherapy	pefehkhcrv(ndepdkkvqd) = gcswazcwgu giyzmbmkqt (brjwnvvrtr ) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT, ASCO_GI2024) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	-	Zolbetuximab + mFOLFOX6	wlsfksvsjy(phhtoiaxtr) = ydidnkfrhp mrsvcswtpi (pjcryjsvow ) View more	Positive	18 Jan 2024
				Zolbetuximab + CAPOX	wlsfksvsjy(phhtoiaxtr) = dwyxjyblfg mrsvcswtpi (pjcryjsvow ) View more
NCT04086758 \| NCT03653507 \| NCT00909025 \| NCT03504397 \| NCT03505320 \| NCT01630083 \| NCT01197885 \| NCT03528629 \| NCT01671774 (ASCO_GI2024) Manual	Not Applicable	Adenocarcinoma of Esophagus \| CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2 Positive	-	Zolbetuximab (First Dose (800 mg/m2))	aapewhrgfn(wttrfwevpc) = jilloptfll qufhfkevzm (xtjstwkpdo, 96) View more	Positive	18 Jan 2024
				Zolbetuximab (Steady State (600 mg/m2 Q3W))	aapewhrgfn(wttrfwevpc) = safswzteah qufhfkevzm (xtjstwkpdo, 91) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis