chiorencel (HR001) / Hrain Biotech - LARVOL DELTA

…blockbuster new drugs expected to be approved for marketing in China in 2025 [Google translation] (Sohu.com) - "Hengrun Dasheng's Runda Chiorencel (CD19-targeted CAR-T therapy): This is a CD19-targeted CAR-T therapy used to treat relapsed/refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. The drug's marketing application has been accepted by the CDE and is expected to be approved in 2025."

China approval • Diffuse Large B Cell Lymphoma • Follicular Lymphoma

Novel CAR T-Cell Therapy HR001 Demonstrates Efficacy in R/R Non-Hodgkin Lymphoma (OncLive) - P2 | N=100 | NCT05436223 | Sponsor: Hrain Biotechnology Co., Ltd. | "At the May 16, 2023, data cutoff, patients treated with HR001 (n = 81) achieved a best objective response rate (ORR) of 74.1% (95% CI, 63.1%-83.2%); the 3- and 6-month ORRs were 53.1% (95% CI, 41.7%-64.3%) and 45.7% (95% CI, 34.6%-57.1%), respectively. The best, 3-, and 6-month complete response rates were 49.4% (95% CI, 38.1%-60.7%), 32.1% (95% CI, 22.2%-43.4%), and 29.6% (95% CI, 20.0%-40.8%), respectively. The median time to best response was 30 days (range, 28-358)....Additional findings from the study revealed that the median DOR was 339 days (95% CI, 149-not estimable [NE]), and the median PFS was 176 days (95% CI, 91-NE). Notably, the median OS was not yet reached."

P2 data • Non-Hodgkin’s Lymphoma

Preclinical study of DASH CAR-T cells manufactured in 48 hours (ESMO 2022) - "Strikingly, 4 out 5 mice treated with one million anti-CD19 DASH CAR-T cells survived beyond 60 days. In contrast, 1 or 2 out of 5 mice treated with one million or 5 million anti-CD19 CAR-T cells survived. Conclusions DASH CAR-T cells manufactured in two days expanded significantly better in vivo and more effective than conventional CAR-T cells. Clinical trials are planned to use DASH CAR-T platform to rapidly generate CAR-T cells to treat patients with ALL or r/r B-ALL."

CAR T-Cell Therapy • IO biomarker • Preclinical • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCR7 • PTPRC