Q-1802 / Viva Biotech - LARVOL DELTA

A phaseⅠ/Ⅱ clinical trial of anti-CLDN18.2/PD-L1 recombinant humanized bispecific antibody Q-1802 combined with XELOX chemotherapy in untreated advanced GC/GEJ patients (SITC 2025) - P1/2 | "Survival indicators are under following-up and 20 mg/kg cohort is still enrolling.Trial Registration ClinicalTrials.gov ID: NCT05964543.Ethics Approval This study has been approved by Medical Ethics Committee of Peking University Cancer Hospital with approval number 2023YW14-ZY01; and written informed consent was obtained from the patients before taking part in the trial.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CLDN18

QureBio raises CNY 100 M in series C1 for accelerating core pipelines (Biospectrumasia) - "China-based startup Qure Biotechnology (Shanghai) has completed a Series C1 financing round. The financing raised nearly CNY 100 million (approximately $14 million) and was led exclusively by Efung Capital. This infusion of capital will be used to accelerate QureBio's clinical trials and advance its pipeline of novel antibody therapeutics....Key pipeline developments include: Q-1802 (Claudin18.2/PD-L1 bispecific antibody)...Q-1801 (SIRPα/PD-L1 bispecific antibody)...PD-1 Antibody-Cytokine Fusion Candidate."

Financing • Gastric Cancer • Pancreatic Cancer

A phase II trial of bispecific antibody Q-1802 in patients with relapsed or refractory solid tumors (SITC 2024) - P1 | "The expansion of phase II study is still in progress, and the survival effects are under follow up. Ethics Approval This study has been approved by Medical Ethics Committee of Peking University Cancer Hospital with approval number 2023YW14-ZY01; and written informed consent was obtained from the patients before taking part in the trial."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

QureBio Ltd. to Present its Q-1802 Clinical PhaseⅡ Data at 2024 SITC 39th Annual Meeting (PRNewswire) - P2 | N=72 | NCT05964543 | Sponsor: QureBio Ltd. | "QureBio Ltd...announced that Phase Ⅱ Clinical Data of its Q-1802 program will be presented at SITC 39th annual meeting hold at Houston on November 8–9, 2024....A phase II trial of bispecific antibody Q-1802 in patients with relapsed or refractory solid tumors...The objective response rate (ORR) is approximately 70.0% (14/20) in the 10 mg/kg group. The proportion of Grade 3 and above adverse events in the 10 mg/kg group is approximately 55%, with good safety profile. There is no adverse events above Grade 3 and Q-1802 related death. Clinical Data shows that Q-1802 has significant anti-tumor activity."

P2 data • Oncology • Solid Tumor

Development and validation of ELISA method for quantification of Q-1802 in serum and its application to pharmacokinetic study in ICR Mouse. (PubMed, J Pharm Biomed Anal) - "In conclusion, we have developed and validated a highly sensitive and selective method for measuring Q-1802 in ICR mouse serum. The development and validation steps of assays met the required criteria for validation, which suggested that these can be applied to quantify Q-1802, as well as in PK studies."

Journal • PK/PD data • Preclinical • Oncology • CLDN18

A Study of Q-1802 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: QureBio Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2023 ➔ Jul 2024 | Trial primary completion date: Aug 2022 ➔ Apr 2024

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Immune Modulation • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: QureBio Ltd.

New P1/2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • CLDN18 • HER-2

Interim results of a first-in-human phase 1 study of Q-1802, a CLDN18.2/PD-L1 bsABs, in patients with relapsed or refractory solid tumors. (ASCO-GI 2023) - P1 | "Interim data from the present phase 1 study, demonstrate that Q-1802 has excellent preliminary safety, tolerability and preliminary anti-tumor activity up to doses of 20 mg/kg. The dose extension is still ongoing. Clinical trial information: NCT04856150."

Clinical • IO biomarker • P1 data • Biliary Cancer • Biliary Tract Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-L1

"#GI23 ➡️And there are6⃣other Ph 1 trials of Cldn 18.2🎯💊: ✅AB011➕CAPEOX 👁️J Li, Abs 391 ✅MIL93 👁️J Huang, Abs 798 ✅ADC CMG901 👁️RH Xu, Abs 352 ✅ASKB589 👁️BD Hickingbottom, Abs 397 ✅A Claudin 18.2-CAR-T 👁️DB Zhen, Abs TPS480 ✅Q-1802, a CLDN18.2/PD-L1 bsABs 👁️XQu, Abs 382" (@TumorBoardTues)

Gastrointestinal Cancer • CLDN18 • PD-L1

QureBio Ltd. to Present its Q-1802 Clinical Phase Ⅰ Data at 2023 ASCO-GI Meetings (PRNewswire) - "QureBio...announced that Phase Ⅰ Clinical Data of its Q-1802 program will be presented at ASCO Gastrointestinal Cancers Symposium (ASCO-GI) hold at the San Francisco and online on January 19–21, 2023. The abstract will be found in 2023 ASCO Gastrointestinal Cancers Symposium–Meeting Abstracts (#382) and a brief of the abstract information is shown as below: Interim results of a first-in-human phase 1 study of Q-1802, a CLDN18.2/PD-L1 bsABs in patients with relapsed or refractory solid tumors....Q-1802 is a humanized bispecific antibody targets both the tumor -specific antigen CLDN18.2 and the immune checkpoint PD-L1 Q-1802 has excellent safety, tolerability Q-1802 has excellent anti-tumor activity in CLDN18.2 positive GI patients."

P1 data • Oncology • Solid Tumor

Safety results of Q-1802, a Claudin18.2/PD-L1 bsABs, in patients with relapsed or refractory solid tumors in a phase 1 study. (ASCO 2022) - P1 | "Q-1802 bsABs has presented safe and well-tolerated profile up to doses of 10 mg/kg. The dose escalation is still in progress."

Clinical • IO biomarker • P1 data • Dermatology • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Immune Modulation • Inflammation • Oncology • Pain • Solid Tumor • CLDN18 • CLDN8 • PD-L1

QureBio Ltd. to Showcase its Q-1802 Clinical Advances at 2022 ASCO Annual Meetings (PRNewswire) - "Professor Lin Shen...leads this study. The key data from the mono-therapy of Q-1802 in both dose-escalation and dose-expansion studies demonstrate excellent safety, tolerability, and preliminary anti-tumor activities of Q-1802 at the dose up to 10 mpk."

QureBio Ltd. to Showcase its Q-1802 Clinical Advances at 2022 ASCO Annual Meetings (PRNewswire) - P1 | N=66 | NCT04856150 | Sponsor: QureBio Ltd. | "The presentation will showcase the preliminary results of a first-in-human Phase 1a/1b, multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity Q-1802, a Claudin18.2/PD-L1 bi-specific therapeutic in patients with relapsed or refractory solid tumors after standard therapies....The key data from the mono-therapy of Q-1802 in both dose-escalation and dose-expansion studies demonstrate excellent safety, tolerability, and preliminary anti-tumor activities of Q-1802 at the dose up to 10 mpk."

P1 data • Oncology • Solid Tumor

[VIRTUAL] Immunotherapy directed to tumor antigen by multi-specific antibody (AACR 2021) - "Though some agents, Trastuzumab, Ramucirumab, Pembrolizumab as well as Apatinib has been approved for clinical use, chemotherapy is still the first line treatment, demonstrating the need for more effective treatment with less toxicity.For the purpose of enhancing therapeutic index, we designed a bispecific antibody Q-1802 to target checkpoint inhibitors to Claudin 18.2, a membrane protein positive for most gastric tumor cells. In preliminary toxicology study, no animals in the dose exploration experiment showed abnormality in the body weight, body temperature, hematology examination etc in each dose group. Further studies are on-going to explore details of mechanism for efficacy toxicity and PK for this compound."

Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor • CLDN18 • CTLA4 • FCGR3A

A Study of Q-1802 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=66; Not yet recruiting; Sponsor: QureBio Ltd.

Clinical • New P1 trial • Gastric Cancer • Immune Modulation • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

IND Approval of Q-1802 from QureBio by FDA (PRNewswire) - "Feb 27th, 2021, the U.S. Food and Drug Administration granted IND approval for Q-1802 from QureBio.Ltd. Q-1802 is a bispecific antibody which can target PD-L1 and Claudin18.2 simultaneously. This is the first FDA-approved bispecific antibody against PD-L1 and Claudin18.2....It has completed three batches of pilot production and is expected to complete the dual IND filings in both China and the United States this year. The Q-1801 project is a bispecific antibody drug targeting the tumor microenvironment signaling pathway. It is expected to complete the clinical declaration in 2021."

Clinical • IND • Non-US regulatory • Oncology