CAR-T-19 injection / Immunotech Biopharm - LARVOL DELTA

Today!...new domestic drugs have been granted Breakthrough Therapy Designation by CDE, namely cell therapy, oncolytic virus... [Google translation] (bydrug.pharmcube.com) - "On December 4, the official website of CDE showed that three innovative drugs, anti-CD19 single-chain antibody chimeric antigen receptor T cell injection (CAR-T therapy, Yongterike), JL15003 injection (oncolytic virus product, JIKE Biotech)...are proposed to be included in breakthrough therapies. Anti-CD19 single-chain antibody chimeric antigen receptor T cell injection (aka CAR-T-19) is a cellular immunotherapy drug that integrates single-chain antibodies that recognize CD19-specific B-cell antigens into the patient's own T cells by means of genetic engineering, and the T cells have the ability to kill CD19-expressing B-cell tumors after reinfusion, so as to achieve the purpose of treating B-cell malignant hematologic diseases. According to public information....phase I clinical trial for the treatment of glioblastoma is currently underway."

Breakthrough therapy • CNS Tumor • Glioblastoma • Hematological Malignancies • Oncology • Solid Tumor

Immunotech Biopharm Receives Investigational New Drug Application Approval for Phase I Clinical Trial from Drug Evaluation Center of National Medical Products Administration for aT19 Injection [Google translation] (Zonebourse) - "The board of directors...announced that the Company has received approval from the Center for Drug Evaluation (the 'CDE') of the National Medical Products Administration for injection of aT19 (the 'aT19 Injection') in the Phase I Clinical Trial. The aT19 Injection is an injection of chimeric antigen receptor T cells targeting CD19 ('CAR-T cells') for sequential use after treatment of refractory B-cell-derived acute lymphoblastic leukemia ('B-ALL') for the prevention of CD19-positive relapses in patients younger than 25 years of age. The aim of this injection is to resolve the problem of possible CD19-positive relapse after CD19-targeting CAR-T cell treatment for B-ALL....The Group submitted the IND application to the CDE in November 2023. The Phase I clinical trial for aT19 Injection is expected to begin at the end of 2024."

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

FIRST PATIENT ENROLLED IN THE PHASE II CLINICAL TRIAL FOR CAR-T-19 INJECTION (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that the Company has completed the first patient enrolment for its Phase II clinical trial for CAR-T-19 injection ('CAR-T-19 Injection') in the PRC, which marked a key milestone of the Group’s development in its product pipeline. CAR-T-19 Injection is indicated for the treatment of pediatric and young adult patients up to and including the age of 25 with relapsed/refractory B cell acute lymphoblastic leukaemia ('B-ALL'). Based on the progress of clinical trial for CAR-T-19 Injection, it is expected that the target patient enrolment would complete by the end of 2025 and the preliminary analysis and results would be published in the first half of 2026."

Enrollment status • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

The CAR-T cell therapy pipeline takes the first step in IND approval, Yongtai Bio-B (06978) shows its mid- to long-term investment value [Google translation] (Eastmoney.com) - "T-19 injection has been approved by the National Center for Drug Evaluation and New Drug Clinical Trial ('IND') application for clinical trials. The company expects CAR-T-19 clinical trials to begin in 2021."

New trial • Non-US regulatory • Acute Myelogenous Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Immunotech’s CAR-T-19 therapy gains clinical approval in China (GBI Health) - "China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (06978.HK) announced receipt of the go-ahead from the Center for Drug Evaluation to conduct a clinical study for its CAR-T-19. The anti-CD19 targeted cell therapy is now set to enter the clinic in 2021."

Non-US regulatory • Hematological Malignancies • Oncology