Drugs / LioCyx-M
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06885710 | Dec 2024 → Dec 2027 expected | chronic hepatitis B virus infection | Changhai Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06961617 | Jun 2024 → Dec 2027 expected | hepatocellular carcinoma | Lion TCR Pte. Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05195294 | Mar 2025 → Dec 2026 expected | hepatocellular carcinoma | Lion TCR Pte. Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2022-11-09 | Lion TCR Pte. Ltd. | Results Lion TCR Announces Poster Presentation of Phase 1 Study for Lead Product LioCyx-M at AASLD The Liver Meeting 2022 liontcr.com ↗
Patients with clinical response showed larger degree of reversible localized liver inflammation and larger anti-viral response, suggesting the on-target effects of LioCyx-M. |
| 2021-12-23 | Lion TCR Pte. Ltd. | Regulatory Lion TCR Receives FDA Fast Track Designation for its HBV-specific TCR T Cell Therapy for Hepatocellular Carcinoma liontcr.com ↗
This Fast Track Designation provides Lion TCR with an expedited path towards the regulatory approval for its leading investigational product, LioCyx-M004, which is being developed as a potential first-in-class drug for HBV-related HCC. |
| 2021-09-23 | Lion TCR Pte. Ltd. | Regulatory Lion TCR Announces FDA Clearance of its IND Application for its Lead Investigational Product, LioCyx-M004, for Hepatocellular Carcinoma liontcr.com ↗
Lion TCR Pte Ltd, a clinical-stage biotech company specialized in T Cell Receptor (TCR) T cell therapy today announced that it has received clearance from U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR. |
| 2021-02-08 | Lion TCR Pte. Ltd. | Results Lion TCR Announces Data Presentation for its lead T-cell product, LioCyx-M at EASL Digital Liver Cancer Summit 2021 liontcr.com ↗
The median overall survival was 33.57 months with a follow-up period of 47.9 months and an objective response rate of 16.7%, as compared to a median OS of 10.7 months achieved by FDA-approved first-line drug sorafenib (Llovet et al, N Engl J Med, 2008). |
| 2021-01-18 | Lion TCR Pte. Ltd. | Regulatory HSA approval for clinical trial for Lion TCR’s lead product LioCyx-M to characterize changes in liver cancer tumor microenvironment liontcr.com ↗ |
| 2020-12-09 | Lion TCR Pte. Ltd. | Results Lion TCR COO Dr Tina Wang’s sharing at Phar-East Asia's Pharma & Biotech Festival 2020 liontcr.com ↗
This presentation covered key clinical safety data of Lion TCR’s lead product, LioCyx-M, autologous HBV-specific TCR T cells, inpatients with advanced HCC (NCT03899415) and HCC relapse post liver transplantation (NCT02719782). |
| 2020-11-10 | Lion TCR Pte. Ltd. | Results Lion TCR presents two abstracts of Phase 1 clinical trial data for lead product LioCyx-M at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting liontcr.com ↗
Each of these abstracts highlights the good safety profile and efficacy of LioCyx-M and the promising use of HBV-specific TCR-T therapy in HBV-related HCC. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LioCyx-M | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05195294 ↗ |
| Modality | Cell therapy | “autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR)” NCT05195294 ↗ |
| Route | Intravenous | “Via intravenous (IV) infusion” NCT06961617 ↗ |