EW-001 / Shanghai Cell Therapy Group, AdAlta - LARVOL DELTA

AdAlta…co-development partner Shanghai Cell Therapy Group has received approval to provide BZDS1901 first-in-class, armored CAR-T cell therapy to eligible patients with advanced mesothelioma (Small Caps) - "The approval, which falls under a special access scheme in China’s Hainan Boao Lecheng international medical tourism pilot zone, was granted after Hainan’s provincial health and medicines authorities independently assessed BZDS1901’s safety and efficacy evidence. The therapy will be available at Ruijin Hospital to qualifying patients with mesothelin-positive advanced malignant mesothelioma, who currently face a median survival of up to 10 months on recurrence of the disease....BZDS1901 qualified on the strength of investigator-initiated trials into advanced mesothelioma in China and follows the regulator’s approval for the therapy to enter formal Phase I/II clinical trials."

China approval • Mesothelioma

Non-viral mesothelin-targeted CAR-T cells armored with IFNg-induced secretion of PD-1 nanobody in treatment of malignant mesothelioma in phase I clinical trial (AACR 2023) - P1 | "After apheresis and lymphodepletion with cyclophosphamide and fludarabine... PD-1 nanobody secreted and MSLN targeting CAR-T cells have demonstrated promising efficacy on MPM patients. Besides CAR-T direct tumor killing activity, secreted PD-1 nanobodies may provide additional clinical benefit by invigorating CAR-T from PD-L1 inhibition, activating TILs and relieving local immunosuppression."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Solid Tumor • IFNG • IL6 • MSLN

BZDS1901 delivers rare complete responses in mesothelioma and is advancing toward global trials (TradingView) - "BZDS1901, a CAR T-cell therapy for mesothelioma, has shown unprecedented complete response rates in advanced patients and is positioned for global expansion via an East to West strategy. Manufacturing and clinical milestones are progressing, with a phase I Australian trial targeted for late 2027"

New P1 trial • P1 data • Mesothelioma

Study of αPD1-MSLN-CAR T Cells to Evaluate the Safety, Tolerability, and Effectiveness for Patients With MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Shanghai Cell Therapy Group Co.,Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2023 ➔ Jan 2025 | Trial primary completion date: Dec 2022 ➔ Jul 2024

Enrollment open • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PD-L1

Phase I/II Study of αPD1-MSLN-CAR T Cells in MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Shanghai Cell Therapy Group Co.,Ltd

CAR T-Cell Therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor • MSLN • PD-L1

Shanghai Cell Therapy Group’s self-developed innovative CAR-T cell drug BZD1901 has been designated as an orphan drug in the United States [Google translation] (Shanghai Cell Therapy Group Press Release) - "On the evening of May 16, Beijing time, good news came from the United States. The self-developed autocrine PD1 nano-antibody armored cell drug BZD1901 project independently developed by Shanghai Cell Therapy Group successfully obtained FDA Orphan Drug Designation (ODD) for the treatment of mesothelioma."

Orphan drug • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer

"3) Building on observation 👆that PD1 May be resistance mech to CARTmeso. BZDS1901 adds PD1 nanobody. 11 MPM pts: 1 CR, 6 PR, 4 SD. Longest PFS 26 mo. @curemeso https://t.co/ymYVxS5aJ3" (,@MMarmarelis)

Clinical • PD-1

China’s self-developed new CAR-T cell drug approved [Google translation] (Sina Corp) - "The reporter learned on the 25th that the autocrine nanobody CAR-T cell drug (BZD1901) independently developed by Shanghai Cell Therapy Group was approved by the Drug Evaluation Center of the State Food and Drug Administration for use in Treatment of mesothelin-positive advanced solid tumors."

Non-US regulatory • Oncology • Solid Tumor

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Shanghai Mengchao Cancer Hospital | Trial completion date: Sep 2022 ➔ Aug 2023 | Trial primary completion date: Jun 2022 ➔ Feb 2023

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL10 • IL2 • IL6 • MSLN • PD-1 • PD-L1

Phase I clinical safety and efficacy observation of αPD-1-mesoCAR-T cells in the treatment of advanced gynecologic cancer. (ASCO 2022) - "The preliminary clinical study showed that the aPD-1-mesoCAR-T cells are safe for the treatment of gynecologic cancer and stabilized the diseases. More data of the treatment is warrantied to continually follow up these patients."

CAR T-Cell Therapy • Clinical • P1 data • Dermatology • Fatigue • Gynecologic Cancers • Oncology • Ovarian Cancer • Pruritus • IL2 • IL6 • MSLN

αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Shanghai Mengchao Cancer Hospital

CAR T-Cell Therapy • New P1 trial • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL10 • IL2 • IL6 • MSLN • PD-1 • PD-L1 • TNFA

Study of αPD1-MSLN-CAR T Cells to Evaluate the Safety, Tolerability, and Effectiveness for Patients With MSLN-positive Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Shanghai Cell Therapy Group Co.,Ltd

CAR T-Cell Therapy • Clinical • New P1 trial • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PD-L1