arcotatug tavatecan (IBI-343) / Innovent Biologics - LARVOL DELTA

VBC108: a first-in-class CDH17/CLDN18.2 targeted bispecific antibody drug conjugate (ADC) to overcome tumor heterogeneity of gastrointestinal cancers (GC, PADC, CRC, etc.) (AACR 2025) - "However, these therapies face challenges due to the heterogeneous expression of CLDN18.2, leading to inconsistent efficacy and the need of patient stratification, as observed with Zolbetuximab, AZD0901 and IBI343. VBC108 also exhibited excellent developability in a comprehensive developability assessment (DA) test, making it a strong candidate for further CMC development. In summary, VBC108, with its unique design, shows the potential as a first-in-class ADC for GI cancer and supports the advancement to clinical trials."

Heterogeneity • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH17 • CLDN18

Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): Results from a phase I dose expansion cohort evaluating IBI343. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05458219 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • P1 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CLDN18

Seven Oral Presentations: Innovent to Present Breakthrough Clinical Data of IBI363（PD-1/IL-2α-bias）and Other Novel Drug Candidates at the 2025 ASCO Annual Meeting (PRNewswire) - "Innovent Biologics...announces that clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S."

Clinical data • Trial status • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Mucosal Melanoma • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

IBI343 Combined with Chemotherapy in Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Zhejiang University

New P2 trial • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer (PRNewswire) - "Innovent Biologics...announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment. The BTD for IBI343 was granted based on data from an ongoing Phase 1 study conducted in China, Australia and the U.S. (NCT05458219), which demonstrated favorable safety and tolerability, as well as promising antitumor activity of IBI343 monotherapy in advanced PDAC patients."

Breakthrough therapy • Evidence highlight • Oncology • Pancreatic Ductal Adenocarcinoma • CLDN18

Domestic new drugs have a breakthrough!…Class I new drugs have been included in the breakthrough therapy [Google translation] (Sohu.com) - "On January 8, the official website of the China Food and Drug Administration (CDE) announced that four domestically produced Class I new drugs were to be included in the breakthrough therapy category, which attracted widespread attention...drugs are...YL201 (Yilian Biopharma), IBI343 (Innovent Biologics)...YL201, developed by Yilian Bio, is an antibody-drug conjugate (ADC) targeting B7-H3, mainly used to treat recurrent or metastatic nasopharyngeal carcinoma...Innovent Biologics' IBI343 is an ADC targeting CLDN18.2, developed specifically for advanced pancreatic ductal adenocarcinoma."

Breakthrough therapy • Nasopharyngeal Carcinoma • Pancreatic Ductal Adenocarcinoma

Innovent Presents Updated Data From Innovative Anti-CLDN18.2 ADC (IBI343) Phase 1 Study in Patients with Advanced Pancreatic Cancer at the ESMO Asia Congress 2024 (PRNewswire) - P1 | N=470 | NCT05458219 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics... announced updated Phase 1 study results of IBI343...for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024....As of September 6, 2024, a total of 43 patients with CLDN18.2-positive (≥60% tumor cells with membranous staining intensity ≥1+ by IHC) advanced PDAC received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least 1 line of prior therapy, and 60.5% had received 2 or more lines of anticancer treatment. 43 patients were efficacy evaluable with overall objective response rate (ORR) of 32.6%, confirmed objective response rate (cORR) of 23.3%, and confirmed disease control rate (cDCR) of 81.4%. As the data cutoff date, 4 out of 10 cORR patients had progressed, the median duration of response (mDoR) was 7.0 (4.0-NC) months, and the 6-month DoR rate was 63%."

P1 data • Pancreatic Ductal Adenocarcinoma

Innovent to Present Clinical Data of Multiple Novel Molecules at ESMO Asia 2024 (PRNewswire) - "Innovent Biologics...announces that nearly 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore."

Clinical data • Cholangiocarcinoma • Colorectal Cancer • Hepatocellular Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Pancreatic Cancer

Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with advanced pancreatic ductal adenocarcinoma (PDAC): Updated results from a phase I study (ESMO Asia 2024) - P1 | "Results As of July 6, 2024, 43 pts were enrolled from China and Australia (median age: 60.0 years, males: 55.8%, prior treatments ≥2L: 53.5%, prior irinotecan therapy: 46.5%, prior immunotherapy: 22.0%). Conclusions IBI343 was well tolerated and continued to show favorable safety profiles and encouraging efficacy in CLDN18.2-positive PDAC. The trial continues to enroll and more data will be presented at the meeting."

Clinical • IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CLDN18

Technical, preclinical, and clinical developments of Fc-glycan-specific antibody-drug conjugates. (PubMed, RSC Med Chem) - "Notably, JSKN003 and IBI343 have demonstrated promising results in phase 1 trials and are advancing into phase 3 studies. This review discusses the advantages of Fc-glycan-conjugation, various glycan-specific conjugation techniques, and the preclinical and clinical development of gsADCs. While challenges such as increased manufacturing cost for large-scale production need continuous innovation to overcome and there are different opinions regarding the pros and cons of reduced/diminished affinities to Fc gamma receptors, ongoing research and clinical progress underscore the potential of gsADCs to renovate ADC cancer therapy."

Journal • Preclinical • Review • Oncology

CIBI343A101: A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=470 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=210 ➔ 470 | Trial completion date: Oct 2024 ➔ Dec 2025 | Trial primary completion date: May 2024 ➔ Dec 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review). (PubMed, Int J Mol Med) - "The human/humanized anti‑CLDN18.2 mAb osemitamab, and ADCs AZD0901, IBI343 and LM‑302, with single‑agent ORRs of 28‑60%, have been tested in phase III clinical trials. In addition, bsAbs, CAR T cells and their derivatives targeting CLDN4, 6 or 18.2 are in phase I and/or II clinical trials. AZD0901, IBI343, zolbetuximab and the anti‑CLDN1 mAb ALE.C04 have been granted fast track designation or priority review designation by the US Food and Drug Administration."

Journal • Review • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • CLDN1 • CLDN18 • CLDN4 • CLDN6

Targeting Claudin-18.2 for cancer therapy: updates from 2024 ASCO annual meeting. (PubMed, J Hematol Oncol) - "At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, the final results of the phase 3 SPOTLIGHT trial were presented, demonstrating a significant survival benefit from the addition of the CLDN18.2-specific antibody zolbetuximab to chemotherapy in the first-line treatment of advanced gastroesophageal adenocarcinomas with ≥ 75% CLDN18.2 expression...In addition, several early-phase trials presented at ASCO 2024 investigate other CLDN18.2-targeting approaches in CLDN18.2-positive refractory advanced solid tumors, including the CLDN18.2-targeting antibody-drug conjugates LM-302 and IBI343, the bispecific anti-CLDN18.2/CD3 antibody IBI38, and the chimeric antigen receptor T cell therapy satricabtagene autoleucel. These novel approaches could potentially expand the benefit of CLDN18.2-targeting therapies to a broader range of tumor types and to tumors expressing lower levels of CLDN18.2."

Journal • Review • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

G-HOPE-001: A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=450 | Enrolling by invitation | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial primary completion date: Jun 2027 ➔ Dec 2026

Metastases • Monotherapy • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

G-HOPE-001: A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=450 | Enrolling by invitation | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Enrolling by invitation | Trial completion date: Jun 2027 ➔ Dec 2027 | Initiation date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: May 2026 ➔ Jun 2027

Enrollment open • Metastases • Monotherapy • Trial completion date • Trial initiation date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Innovent Announces Oral Presentation at the ESMO Gastrointestinal Cancers Congress 2024 on Latest Clinical Data of Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (PRNewswire) - P1 | N=210 | NCT05458219 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced oral presentation of the latest Phase 1 clinical data of an innovative anti-CLDN18.2 ADC (IBI343) for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) at the...ESMO GI Congress 2024 (NCT05458219). The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2....In participants with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC) at the 6 mg/Kg dose (N=30), the ORR and DCR were 36.7% and 93.3%, respectively. At the 8 mg/kg dose (N=17), the ORR was 47.1% and the DCR was 88.2%. With a median follow-up time of 7.2 months in the 6 mg/kg dose group, the median progression-free survival (mPFS) of participants with high CLDN18.2 expression was up to 6.8 months."

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Innovent Reports Oncology Pipeline Updates at Investor Meeting (PRNewswire) - P1a/b | N=210 | NCT05458219 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "The world's first ADC single agent to show breakthrough efficacy in pancreatic cancer: Preliminary Phase 1 data of IBI343 in pancreatic cancer patients who had received at least one line of treatment showed that the objective response rate (ORR) was 40% in CLDN18.2 IHC1/2/3+≥60% pancreatic cancer patients (n=10) who received 6 mg/kg IBI343....Based on the unique advantages of IBI343 and IBI389 demonstrated in early clinical trials, Innovent is advancing the development of IBI343 for the MRCT Phase 3 clinical trial in gastric cancer. Additionally, the Company is moving forward with proof-of-concept clinical studies of both IBI343 and IBI389 in the difficulty-to-treat pancreatic cancer."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase I study (ESMO-GI 2024) - P1 | "IBI343 was well tolerated in all pts with encouraging efficacy in CLDN18.2-postive G/GEJ AC."

Clinical • IO biomarker • P1 data • Anemia • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor • CLDN18

Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer (PRNewswire) - "Innovent Biologics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC (R&D code: IBI343), for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. Previously, IBI343 has already received FDA approval of its IND application for the treatment of PDAC. At the ASCO 2024 Annual Meeting, Innovent reported the preliminary Phase 1 results of IBI343 in advanced PDAC patients who have received at least one prior line of treatment."

Fast track • IND • P1 data • Pancreatic Ductal Adenocarcinoma

Safety and efficacy of IBI343 (anti-claudin18.2 antibody-drug conjugate) in patients with advanced pancreatic ductal adenocarcinoma or biliary tract cancer: Preliminary results from a phase 1 study. (ASCO 2024) - P1 | "IBI343 was well tolerated with favorable safety profiles and encouraging efficacy in CLDN18.2-positive PDAC and BTC."

Clinical • Metastases • P1 data • Anemia • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Innovent Presents at the 2024 ASCO Annual Meeting on Clinical Data of anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Pancreatic Cancer or Biliary Tract Cancer (PRNewswire) - P1a/b | N=210 | NCT05458219 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...presented Phase 1 clinical data of IBI343 (TOPOi anti-CLDN18.2 ADC) for the treatment of advanced pancreatic ductal adenocarcinoma or biliary tract cancer at the 2024...ASCO Annual Meeting....Clinical data...from this Phase 1 trial will be published in oral presentation at the ESMO Gastrointestinal Cancers Congress 2024 this month....As of January 15, 2024, 25 subjects had performed at least one post-baseline tumor evaluation. 7 subjects achieved partial response (PR), 5 of which were PDAC patients, 2 were BTC patients. The objective response rate (ORR) was 28.0% (95% CI: 12.1-49.4), and the disease control rate (DCR) was 80.0% (95% CI: 59.3-93.2). In the 6 mg/kg dose group, 13 subjects with CLDN18.2 1/2/3+≥60% had at least one post-baseline tumor assessment, of which 5 achieved PR with an ORR of 38.5% (95%CI: 13.9-68.4) and a DCR of 84.6% (95% CI：54.6-98.1)."

P1 data • Biliary Tract Cancer • Pancreatic Ductal Adenocarcinoma

Innovent Announces Oral Presentations at ESMO Plenary and ESMO GI Congress on Clinical Data of IBI363 (PD-1/IL-2) and IBI343 (CLDN18.2 ADC) (PRNewswire) - "Innovent Biologics...announces that the company will deliver oral presentations on clinical data of its first-in-class PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) and novel Topoi anti-Claudin18.2 ADC (R&D code: IBI343) at the upcoming medical conferences in June, including ESMO Virtual Plenary and ESMO Gastrointestinal Cancers Congress (ESMO GI) 2024."

P1 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Innovent Receives NMPA Breakthrough Therapy Designation for IBI343（Anti-Claudin18.2 ADC）as Monotherapy for Advanced Gastric Cancer (PRNewswire) - "Innovent Biologics...announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343 as monotherapy for the treatment of claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least 2 lines of prior systematic treatments. The BTD for IBI343 was based on the data from an ongoing Phase 1 study (NCT05458219), in which favorable safety and tolerability and promising antitumor activity of IBI343 monotherapy in advanced GC patients were observed. The study results will be published at an upcoming medical conference later in 2024."

Non-US regulatory • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Innovent Biologics' Claudin 18.2 ADC is planned to be included in breakthrough therapy [Google translation] (163.com) - "Recently, Innovent Biologics' IBI343 is planned to be included as a breakthrough therapy by CDE for the treatment of Claudin (CLDN) 18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma that has received at least two systemic therapies....At the upcoming ASCO conference, Innovent will also announce the preliminary results of the Phase I safety and efficacy trial of IBI343 in patients with advanced pancreatic duct adenocarcinoma or biliary tract cancer. In February this year, Innovent registered a registration phase III trial of IBI343 for Claudin 18.2-positive, HER2-negative gastric cancer on the clinicaltrials website. The study is expected to recruit 450 subjects and is expected to be completed in May 2026."

Non-US regulatory • P1 data • Trial completion date • Biliary Tract Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Innovent Announces 2023 Annual Results and Business Updates (PRNewswire) - "Encouraging progress in the next wave innovation of 'IO+ADC': TYVYT (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors; IBI310 (CTLA-4): plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer; IBI343 (CLDN18.2 ADC): preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications....IBI363 (PD-1/IL-2): preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S."

Licensing / partnership • New P3 trial • Trial status • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor