LY007 / China Biotech Services - LARVOL DELTA

HIGH EFFICACY AND SAFETY OF A NOVEL ANTI-CD20 CAR-T CELL THERAPY, LY007 IN RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (EHA 2025) - P1 | "LY007 demonstrated a favorable safety profile, promising efficacy, and robust PK characteristics at doses up to DL3, with no DLTs or neurotoxicity or Grade 3+ CRS observed. LY007 achieved a 91.7% BOR, including pts with high tumor burden, prior CD19-targeted CAR T therapy and ASCT."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • MYC

China Biotech Services (08037): Present updated clinical trial results of LY007 cell injection at the 2024 American Society of Hematology Annual Meeting [Google translation] (Sina Corp) - P1 | N=18 | NCT06279611 | Sponsor: Shanghai Longyao Biotechnology Inc., Ltd. | "China Biotech Services...announced that Shanghai Longyao has presented updated clinical trial results of a Phase I study of LY007 cell injection...Among all patients participating in the study, the best confirmed objective response rate (ORR) was 92% (11 of 12 patients), while the ORR at the recommended dose (RP2D) of the Phase 2 trial of 5.0×106 cells/kg was 100% (all 5 patients). The best complete response (CR) rate was 67% (8 of 12 patients). The ORR at month 3 was 73% (8 of 11 patients) and the CR rate was 55% (6 of 11 patients). One patient who had relapsed after previous CD19-CAR-T cell therapy and autologous stem cell transplantation (ASCT) had a CR in the tumor assessment at month 3."

P1 data • B Cell Non-Hodgkin Lymphoma

LY007, a Novel Anti-CD20 CAR-T Cell Therapy for Relapsed or Refractory B Cell Non-Hodgkin Lymphoma (R/R B-NHL): Results from a Phase 1 Study (ASH 2024) - "Methods In this phase 1 study, eligible pts with CD20-positive R/R B-NHL received lymphodepletion with fludarabine (30 mg/m2 Day -5 to -3) and cyclophosphamide (300 mg/m2 Day -5 to -3) before a single CAR-T cell infusion. LY007 showed a favorable safety profile, promising efficacy and good PK characteristics at all tested dose levels with 92% best ORR including pts with a high tumor burden, such as extranodal involvement, maximum tumor length of ≥5 cm, aged ≥ 65 years and prior CD19-directed CAR T therapy and ASCT. Follow-up of enrolled pts is on-going and the planned phase 2 study will start for enrollment shortly."

CAR T-Cell Therapy • IO biomarker • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • MYC

China Biotech Services presents clinical results of new anti-cancer drug LY007 in the US [Google translation] (Sohu.com) - P=NA | N=NA | "Recently, at the annual meeting of the American Society of Hematology, Shanghai Longyao Biotechnology Co., Ltd., a subsidiary of China Biotechnology Service Company, brought exciting news - their independently developed LY007 cell injection has made positive progress in the treatment of patients with relapsed and refractory B-cell non-Hodgkin's lymphoma....In short, the successful appearance of LY007 cell injection at the annual meeting of the American Society of Hematology not only demonstrated the outstanding achievements of Chinese companies in the field of life science research, but also injected strong impetus into the global fight against cancer."

Clinical data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A phase 1 study of LY007, a novel anti-CD20 CAR-T cell therapy in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. (ASCO 2024) - P1 | " In this open-label, single-arm phase 1 trial, r/r B-NHL pts were infused with LY007 in 3 dose levels (DLs) (DL1, 0.5 x 10 6 cells/ kg; DL2, 1.5 x 10 6 cells/ kg; DL3, 5.0 x 10 6 cells/ kg) based on a standard 3+3 dose escalation design after cyclophosphamide/fludarabine lymphodepletion. This phase 1 trial demonstrated that LY007 was well tolerated at the dose levels up to 5.0 x 10 6 cells/ kg and showed a favorable dose-response relationship for the treatment of r/r B-NHL."

CAR T-Cell Therapy • Clinical • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

China Biotech Services (08037.HK) announced the results of a Phase I clinical study of LY007 cell injection in patients with relapsed and refractory B-cell non-Hodgkin's lymphoma (B-NHL) at the 2024 ASCO Annual Meeting in the United States [Google translation] (new.qq.com) - P1 | N=18 | NCT06279611 | Sponsor: Shanghai Longyao Biotechnology Inc., Ltd. | "China Biotech Services...announced the results of a Phase I clinical study on the use of LY007 cell injection...for patients with relapsed and refractory B-cell non-Hodgkin lymphoma (B-NHL) in the form of a poster presentation at the 2024 Annual Meeting of the American Society of Clinical Oncology...The Phase I study showed that LY007 cell injection was well tolerated at a dose level of up to 5.0x106 cells/kg and showed a good dose-response relationship in the treatment of relapsed and refractory B-cell non-Hodgkin's lymphoma....9 patients have received a single LY007 cell injection at 3 dose levels, with a median follow-up of 5.09 (range 0.92 to 18.10) months. 89% (8/9) of patients had extranodal involvement, and 78% (7/9) had an International Prognostic Index (IPI) score ≥ 2. 44% (4/9) had a maximum tumor length ≥ 5 cm, and two patients had a maximum tumor length > 8 cm."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

An Evaluation of LY007 Cell Injection for r/r B-NHL (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Ruijin Hospital

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

ANNUAL RESULTS ANNOUNCEMENT FOR THE YEAR ENDED 31 DECEMBER 2023 (HKEXnews) - "As at the date of this announcement, the screening of qualified subject patients in the low, medium, and high dose groups has been completed. Currently, a total of nine (9) individuals with B-NHL successfully received reinfusion of LY007 Injection and completed dose limited toxicity ('DLT') observation. The subjects in the maximum tolerated dose ('MTD') group are undergoing enrollment and cell infusion, and the cell infusion of one subject in the MTD dose group has been completed. It is expected to complete the comprehensive registration of the trial for total thirteen (13) subject patients by April 2024. The preparation work for Phase II clinical trial has been initiated and is currently underway."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

An Evaluation of LY007 Cell Injection for r/r B-NHL (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Shanghai Longyao Biotechnology Inc., Ltd.

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

China Biotech Services LY007 Cell Injection Obtained Clinical Trial Approval Letter (ACROFAN) - "China Biotech Services Holdings Limited...non-wholly-owned subsidiary Shanghai Longyao Biotechnology Co., Ltd...received an approval letter from the National Medical Products Administration for a clinical trial of the Company's LY007...used for the treatment of non-Hodgkin lymphoma. It is currently the first and only CD20-targeted CAR-T product whose application for a registered clinical trial has been approved in China."

Non-US regulatory • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Shanghai Longyao Biotechnology Inc., Ltd.

New P1 trial