AB011 / CARsgen - LARVOL DELTA

Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: CARsgen Therapeutics Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Sep 2023

Trial completion • Trial completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

CARsgen’s CLDN18.2 mAb AB011 Achieves IND Clearance from the NMPA for the First-line Combination Treatment of Gastric Cancer (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announced that AB011 in combination with atezolizumab monoclonal antibody, Roche's PD-L1 checkpoint inhibitor, along with chemotherapy (capecitabine and oxaliplatin) achieved IND clearance from the CDE for first-line treatment Claudin18.2 (CLDN18.2) positive unresectable locally advanced, recurrent or metastatic gastric cancer/gastroesophageal junction cancer."

New trial • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

AB011 Plus CAPOX Demonstrates Preliminary Safety, Efficacy in Advanced Gastric/GEJ Cancer (OncLive) - P1 | N=62 | NCT04400383 | Sponsor: CARsgen Therapeutics Co., Ltd. | "Among 23 evaluable patients who received the combination and had at least 1 post-treatment tumor assessment, the confirmed overall response rate (ORR) was 52.2%. The ORR was 53.8% in the patients treated with 20 mg/kg of AB011 (n = 13) and 50% in those treated with 30 mg/kg of the agent (n = 11). Notably, the disease control rate was 100% in this population. Regarding safety, 37.5% experienced serious treatment-emergent adverse effects (TEAEs); however, no dose-limiting toxicities (DLTs) or treatment-related AEs leading to death occurred....Additionally, of the 35 patients with advanced solid tumors who received AB011 monotherapy across different lines of treatment, 2.9% achieved a complete response (CR), 22.9% had stable disease, and 8.6% had non-CR/non­-progressive disease."

P1 data • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A multicenter, phase 1 study of AB011, a recombinant humanized anti-CLDN18.2 monoclonal antibody, as monotherapy and combined with capecitabine and oxaliplatin (CAPOX) in patients with advanced solid tumors. (ASCO-GI 2023) - P1 | "These results indicate that AB011, either in monotherapy or combined with chemotherapy, had a manageable safety profile and encouraging efficacy in CLDND18.2 positive advanced GC/GEJA and PC. Clinical trial information: NCT04400383."

Clinical • Metastases • Monotherapy • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • CLDN8

CARsgen Announces Collaboration Agreement to Evaluate AB011 in Combination with PD-L1 Checkpoint Inhibitor to Treat Gastric Cancer (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announced CARsgen's execution of a collaboration agreement with F. Hoffmann-La Roche Ltd ('Roche') to evaluate CARsgen's investigational drug AB011, the first humanized monoclonal antibody against Claudin18.2 (CLDN18.2) that received IND clearance globally, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma . Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen's proprietary CLDN18.2 IHC test kit, which has showed excellent specificity and sensitivity profiles, will be applied to evaluate CLDN18.2 expression in the gastric cancer patients."

Licensing / partnership • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

"#CARsgen Presents Results on #AntiClaudin182mAb #AB011 at #ASCOGI23 https://t.co/2AdD9nSLXG" (@1stOncology)

Gastrointestinal Cancer • CLDN18 • CLDN8

CARsgen Presents Results on Anti-Claudin18.2-mAb AB011 at ASCO GI (PRNewswire) - "CARsgen Therapeutics Holdings Limited...announces that a poster presentation highlighting the Phase 1 preliminary results of a recombinant humanized anti-claudin18.2 monoclonal antibody (AB011), as monotherapy and combination therapy, for patients with advanced solid tumors was presented at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium ('ASCO GI'), in San Francisco, California, during January 19-21, 2023."

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

Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=62 | Active, not recruiting | Sponsor: CARsgen Therapeutics Co., Ltd. | Recruiting ➔ Active, not recruiting | N=197 ➔ 62 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Enrollment change • Enrollment closed • Metastases • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

CARsgen 2021 Annual Results: Steady Advancement in Innovative CAR T Products and Technologies (PRNewswire-Asia) - "Rapid progress of pipeline products: (i) CT053: CARsgen plans to make regulatory submissions for marketing approval to the NMPA in the first half of 2022 and plans to submit the BLA to the U.S. FDA in 2023. The company also plans to conduct additional clinical trials to develop CT053 as an earlier line of treatment for multiple myeloma; (ii) CT041: CARsgen plans to submit an NDA to the NMPA in China in the first half of 2024 and also plans to initiate a Phase 2 clinical trial in the second half of 2022 in North America and to submit the BLA to the U.S. FDA in 2024; (iii) AB011: The company plans to consult with the NMPA in the second half of 2022 and to initiate the subsequent Phase II clinical trial."

BLA • New P2 trial • New trial • Non-US regulatory • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=197 | Recruiting | Sponsor: CARsgen Therapeutics Co., Ltd. | N=103 ➔ 197 | Trial primary completion date: May 2022 ➔ Dec 2022

Enrollment change • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18