BST02 / Biosyngen - LARVOL DELTA

A phase I study of adoptive tumor-infiltrating lymphocyte (TIL, BST02) therapy in patients with advanced liver cancer. (ASCO 2025) - P1 | "Patients received lymphodepletion chemotherapy (cyclophosphamide, 250 mg/m2 × 3 days and fludarabine, 25 mg/m2 × 3 days) before BST02 administration (cohort 1: 5 × 109 viable cells, 3 patients; cohort 2: 2 × 1010 viable cells, 6 patients) followed by IL-2 infusion (total dose: 120 million IU, ≤ 12 doses, q12h). BST02 is well tolerated in advanced LC patients and demonstrates a robust anti-tumor efficacy at the dose of 5 × 109 viable cells , which supports the further clinical investigation."

Clinical • Metastases • P1 data • Tumor-infiltrating lymphocyte • Liver Cancer • Melanoma • Oncology • Solid Tumor • Thrombosis • CD8 • IFNG

Biosyngen Presents Pioneering"Conditional Activation + Armor Enhancement" SUPER-T technology at ESMO 2024 (PRNewswire) - "The highly anticipated 2024 European Society for Medical Oncology (ESMO)...Biosyngen...is presenting its groundbreaking 'Conditional Activation + Armor Enhancement' T-cell technology at this year's ESMO conference...the first patients have been enrolled in the Phase I trials for our other groundbreaking therapies, BST02 and BRL03, with completion of Phase I trials anticipated later this year....To overcome this technical challenge and balance safety with efficacy in solid tumor immune cell therapies, Biosyngen has developed the SUPER-T T cell safety optimization platform and created the Conditional Activation CAR-T cell BTRP003L. This technology allows CAR-T cells to activate only under hypoxic conditions typical of the tumor microenvironment (0.3% ~ 2.0% O2), while remaining inactive in normal tissues (3.4% ~ 6.8% O2)....Toxicology studies using the SUPER-T platform showed no weight loss or other adverse effects in mice injected with BTRP003L or BTRP011L,..."

Enrollment open • Preclinical • Trial completion date • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Biosyngen Announces FDA Fast Track Designation for BST02 in Treatment of Liver Cancer (PRNewswire) - "Biosyngen...has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma."

Fast track designation • Cholangiocarcinoma • Hepatocellular Cancer • Liver Cancer

Investigator-initiated Phase I Exploratory Clinical Study of the Safety, Tolerability, and Efficacy of BST02 Injection in the Treatment of Locally Advanced/Metastatic Liver Cancer (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: BioSyngen Pte Ltd

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Biosyngen's BST02, the World's First TIL Therapy for Liver Cancer, is Granted an IND Approval by FDA (PRNewswire) - "On October 26, 2023, Biosyngen's TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA....The approval of the BST02 (TIL therapy) is another significant achievement for Biosyngen, as it marks the fourth first-in-class product in the company's pipeline that secured IND."

IND • New trial • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Biosyngen's BST02, the World's First TIL Therapy for Liver Cancer, is Granted an IND Approval by FDA (PRNewswire) - "On October 26, 2023, Biosyngen's TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. BST02, a breakthrough product in the field of cell and gene therapy, represents the world's first TIL therapy designed for the treatment of all types of liver cancer to progress into the clinical stage."

IND • Liver Cancer