BRG01 / Biosyngen - LARVOL DELTA

Safety and efficacy of chimeric antigen receptor (CAR)–T cell therapy (BRG01) targeting the Epstein-Barr virus (EBV) envelope protein in EBV+ lymphoproliferative disease patients. (ASCO 2025) - P=N/A, P1 | "A single dose of EBV CAR-T cells (BRG01) were infused after a lymphodepletion regimen (cyclophosphamide 250-350 mg/m2/day, fludarabine 25-30 mg/m2/day for three days). BRG01 is well tolerated and expanded in all treated patients. The durabler efficacy in all treated patients supports its further clinical investigation in various subtypes of EBV+ lymphomas and LPD."

Clinical • IO biomarker • Epstein-Barr Virus Infections • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Biosyngen's first-in-class CAR-T asset targeting solid tumors has entered pivotal phase II trial, Phase I trial data debut at ESMO 2024 Annual Congress (PRNewswire) - P1 | N=14 | NCT05864924 | Sponsor: BioSyngen Pte Ltd | "In terms of efficacy, disease control and response rates exhibited a clear dose-dependent relationship. Higher doses led to more significant effects, with 75% of patients experiencing a sustained reduction in tumor burden and diminished metabolic activity, and several lesions achieving complete response (CR) with 100% tumor reduction. Patients treated with BRG01 have shown a progression-free survival exceeding six months post-infusion, demonstrating significantly extended antitumor effects compared to the current standard treatment, checkpoint inhibitors like PD-1 antibodies....As previously reported, BRG01 has received regulatory approvals for Phase II clinical trials in July (China) and August (U.S.) with patient enrollment now underway."

P1 data • Trial status • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Safety and efficacy of a novel CAR-T cell therapy (BRG01) targeting the Epstein-Barr Virus envelope glycoprotein in advanced metastatic nasopharyngeal cancer patients (ESMO 2024) - P1 | "A single dose of BRG01 was infused after a lymphodepletion regimen (cyclophosphamide 250-350 mg/m2/day, fludarabine 25-30 mg/m2/day for three days). BRG01 is well tolerated and expanded in patients with no dose-limiting toxicity. Its dose-dependent antiviral and antitumor efficacy support further clinical investigation in a phase II trial."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Biosyngen's BRG01 Receives FDA Approval for Phase II Clinical Trial (PRNewswire) - "Biosyngen is proud to announce that the U.S. Food and Drug Administration (FDA) has approved its BRG01, an EBV-specific CAR-T cell therapy, to proceed with a pivotal Phase lI clinical trial. This marks the first cell therapy to enter Phase lI trials in both the U.S. and China for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma, demonstrating a breakthrough in solid tumor treatment."

IND • New P2 trial • Nasopharyngeal Carcinoma

Biosyngen's BRG01 enters Phase II clinical trial, a first-in-kind autologous EBV-Specific CAR-T Therapy for Solid Tumors on Recurrent/Metastatic Nasopharyngeal Carcinoma (PRNewswire) - P1 | N=14 | NCT05864924 | Sponsor: BioSyngen Pte Ltd | "The Phase l clinical trial of BRG01 in China and the U.S. has completed patient enrollment in January this year...The Phase l study has successfully completed assessments of dose-limiting toxicity (DLT) and preliminary efficacy in nine patients with advanced nasopharyngeal carcinoma who had previously been treated with at least one immune checkpoint inhibitor, such as a PD-1antibody...Initial data from the study have demonstrated excellent safety and encouraging signs of clinical activity, with 75% of high-dose patients experiencing local tumor shrinkage and reduced metabolic activity on PET-CT scans, and some patients achieving complete remission of their tumor lesions. Additionally, BRG01 has shown potent anti-EBV activity, with significant reductions in peripheral blood EBV viral load observed following treatment."

Enrollment closed • P1 data • Nasopharyngeal Carcinoma

Biosyngen's BRG01 enters Phase II clinical trial, a first-in-kind autologous EBV-Specific CAR-T Therapy for Solid Tumors on Recurrent/Metastatic Nasopharyngeal Carcinoma (PRNewswire) - "Biosyngen...announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has approved the initiation of a pivotal Phase ll clinical trial evaluating BRG01, the company's autologous Epstein-Barr virus (EBV) specific chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of patients with recurrent or metastatic EBV-positive nasopharyngeal carcinoma."

New P2 trial • Nasopharyngeal Carcinoma

A Phase 1 Study of BRG01 in Subjects With Relapsed/Metastatic Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: BioSyngen Pte Ltd | Trial completion date: Jan 2028 ➔ Apr 2024 | Trial primary completion date: Jan 2028 ➔ Apr 2024 | Not yet recruiting ➔ Completed

Metastases • Trial completion • Trial completion date • Trial primary completion date • Epstein-Barr Virus Infections • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Biosyngen's First-in-class Cell Therapy BRG01 Receives FDA Fast Track Designation (PRNewswire-Asia) - "On July 6, 2023, Biosyngen received an official notification from the U.S. Food and Drug Administration (FDA) granting Fast Track Designation (FTD) to its revolutionary first-in-class immunotherapy, BRG01, for the treatment of relapsed/metastatic nasopharyngeal carcinoma."

Fast track designation • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Biosyngen's Cell Therapy BRG01 Granted Orphan Drug Designation by the U.S. FDA for Treatment of Nasopharyngeal Cancer (PRNewswire-Asia) - "Jun. 1st, 2023, Biosyngen Pte. Ltd....announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) has granted to its application, for immune cell therapy BRG01 for the treatment of nasopharyngeal cancer, the status of Orphan Drug Designation (ODD)."

Orphan drug • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Phase 1 Study of BRG01 in Subjects With Relapsed/Metastatic Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: BioSyngen Pte Ltd

Metastases • New P1 trial • Epstein-Barr Virus Infections • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma (PRNewswire-Asia) - "April 15, 2023, Biosyngen Pte Ltd...announced that the Company received IND approval for its second product in the pipeline, a T-cell redirection therapy for the treatment of EBV-positive lymphoma. A week prior to this, the IND application of the same therapy has just been approved by China NMPA....Following this IND approval to initiate the phase I/II clinical trials, Biosyngen makes a significant first-step towards the goal to gaining marketing authorization in the US and China. At present, Biosyngen's IND application filing to Health Sciences Authority (HSA) is under review. Within 2023, the Company made plans for other IND applications to carry out phase I/II clinical trials for other therapies such as lung cancer, liver cancer and digestive track cancers across key regions – Singapore, the US and China."

New P1/2 trial • Gastrointestinal Cancer • Hematological Malignancies • Liver Cancer • Lung Cancer • Lymphoma • Oncology • Solid Tumor

Biosyngen received China NMPA IND approval for its T-cell redirection therapy targeting EBV-positive Lymphoma (PRNewswire-Asia) - "April 7th, 2023, Biosyngen Pte Ltd...was granted IND approval by China NMPA for the company's first-in-class T-cell redirection therapy, it is an autologous T cell therapy for EBV-positive lymphoma. The principle of autologous T cell therapy is to genetically modify patients' own T cells to express additional receptors for Epstein-Barr virus (EBV) antigen recognition and T cell activation upon EBV+ tumor cell engagement, targeting cancer indications....Within 2023, the company made plans for IND applications for other therapies such as lung cancer and liver cancer across key regions - Singapore, the US and China."

New trial • Gastrointestinal Cancer • Hematological Malignancies • Liver Cancer • Lung Cancer • Lymphoma • Oncology • Solid Tumor • Thoracic Cancer

Biosyngen has obtained FDA IND clearance of BRG01 for Phase I/II clinical trials against Nasopharyngeal Cancer (PRNewswire-Asia) - "Biosyngen Pte Ltd...was granted approval by US FDA for the company's IND application for BRG01 cell therapy, path the way for Phase I/II clinical trial....Prior to this approval from the US FDA, Biosyngen's BRG01 was granted IND by China CDE on December 14th, 2022. In addition, China CDE has acknowledged the company's IND submission for another indication, targeting EBV+ Lymphoma....Following this milestone, other products in Biosyngen's portfolio are projected to enter IIT/Phase I in 2023, across Singapore, China and the US. The indications targeted are hepatocellular cancer, colorectal cancer, gastric cancer, esophageal cancer and pancreatic cancer."

IND • New P1/2 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Lymphoma • Nasopharyngeal Carcinoma • Oncology • Pancreatic Cancer • Solid Tumor

IND Application of Biosyngen’s Cell Therapy (BRG01) for Nasopharyngeal Cancer Approved by China NMPA (PRNewswire-Asia) - "On Dec. 14th, 2022, Guangzhou Biosyngen...made an announcement on the approval granted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the company's IND application for BRG01 Therapy. BRG01 Therapy is an autologous T cell therapy for relapsed/metastatic nasopharyngeal cancer (NPC) treatment....Following this milestone, based on the company's pipeline, Biosyngen has begun planning for multiple sponsor-initiated clinical trials which will lead to IND applications in China, the US and Singapore in the course of 2023."

IND • New trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor