Drugs / BST02
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06173726 | Dec 2023 → Dec 2026 expected | liver cancer | BioSyngen Pte Ltd | Not yet recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT06526832 | Jul 2024 → Jul 2025 | carcinoma of liver and intrahepatic biliary tract | BioSyngen Pte Ltd | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-11-13 | BioSyngen Pte Ltd | Results SITC 2024 (II): Biosyngen Unveils Next-Generation TIL Development Results – Achieving a Significant Breakthrough in the Treatment of All Types of Liver Cancer biosyngen.com ↗
The low-dose cohort has been successfully enrolled and infused, showing promising safety and efficacy with over patient achieving a 60% partial response (PR) 48 days post-infusion. |
| 2024-02-01 | BioSyngen Pte Ltd | Regulatory Biosyngen Announces FDA Fast Track Designation for BST02 in Treatment of Liver Cancer biosyngen.com ↗
February 1, 2024 - Biosyngen is proud to announce that its latest groundbreaking product, BST02, 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. |
| 2024-01-24 | BioSyngen Pte Ltd | Regulatory Biosyngen was granted an IND approval for its BST02, the world’s first TIL cell therapy for liver cancer to enter clinical trial biosyngen.com ↗
On January 23, 2024, Biosyngen announced that its independently developed TIL therapy BST02 has been granted an IND approval by the Center for Drug Evaluation (CDE), NMPA, China for the treatment of all types of liver cancer. |
| 2023-10-27 | BioSyngen Pte Ltd | Regulatory Biosyngen's BST02, the World's First TIL Therapy for Liver Cancer, is Granted an IND Approval by FDA biosyngen.com ↗
On October 26, 2023, Biosyngen’s TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-13 | BioSyngen Pte Ltd | SITC 2024 (II): Biosyngen Unveils Next-Generation TIL Development Results – Achieving a Significant Breakthrough in the Treatment of All Types of Liver Cancer biosyngen.com ↗ |
| 2024-02-01 | BioSyngen Pte Ltd | Biosyngen Announces FDA Fast Track Designation for BST02 in Treatment of Liver Cancer biosyngen.com ↗ |
| 2024-01-24 | BioSyngen Pte Ltd | Biosyngen was granted an IND approval for its BST02, the world’s first TIL cell therapy for liver cancer to enter clinical trial biosyngen.com ↗ |
| 2023-10-27 | BioSyngen Pte Ltd | Biosyngen's BST02, the World's First TIL Therapy for Liver Cancer, is Granted an IND Approval by FDA biosyngen.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BST02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06526832 ↗ |
| Known as | BST02 Injection | “Biological: BST02 Injection” NCT06173726 ↗ |
| Modality | Cell therapy | “this product is unmodified autologous T lymphocytes” NCT06173726 ↗ |