LioCyx-M
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September 15, 2025
Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations
(The Manila Times)
- "This approval represents the third major regulatory milestone for the same product candidate, which previously received both Fast Track and Orphan Drug Designations for the treatment of hepatitis B virus-related hepatocellular carcinoma (HBV-HCC)."
Fast track • Orphan drug • Hepatitis B • Hepatocellular Cancer
September 15, 2025
Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B
(The Manila Times)
- "Lion TCR...announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate phase1b/2 clinical trials for its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB)."
IND • New P1/2 trial • Hepatitis B
July 24, 2025
HBV-Specific TCR-T Cell Therapy Combining mRNA Electroporation and Lentiviral Transduction: Treatment Regime for Recurrent HBV-Related HCC Post-Liver Transplantation.
(PubMed, Clin Cancer Res)
- P1 | "This study preliminarily suggests that the combination of mRNA-HBV-TCR-T cells and lenti-HBV-TCR-T cells could be a safe and potentially effective approach for treating patients following liver transplantation in the context of lifelong immunosuppression drug administration. Further studies are needed to refine treatment strategies and assess long-term safety and efficacy in this special patient population."
Journal • Hepatocellular Cancer • Oncology • Transplantation
April 23, 2025
HBV-TCR T cell therapy: Preclinical and clinical insights into specificity, safety and efficacy for treating HBV-related HCC.
(ASCO 2025)
- P1 | "Preclinical and clinical data demonstrate the specificity, safety and efficacy of multiple LioCyx-M infusions. LioCyx-M treatment reprograms patient's immunity from exhausted status to immune active status, implying its potential in cancer immunotherapy. Reference Tan et al."
Preclinical • Hepatitis B • Hepatocellular Cancer • CCR7 • CXCL10 • CXCL9 • HAVCR2 • HLA-A • IFNG
May 08, 2025
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
(clinicaltrials.gov)
- P1 | N=10 | Recruiting | Sponsor: Lion TCR Pte. Ltd.
New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor
March 08, 2025
Association of T cell epitope spreading with the clinical efficacy of HBV-TCR T cell therapy for HBV-related HCC
(EASL 2025)
- "We provided preliminary evidences that clinical efficacy of TCR-T cell therapy in patients with HBV-related HCC is not directly proportional to the quantity and persistence of infused TCR-T cells but to their ability to induce inflammation and trigger a T cell response against novel T cell epitopes through a possible process of T cell epitope spreading."
Clinical • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatocellular Cancer • CD8 • CXCL10
January 04, 2025
A rapid method to assess the in vivo multi-functionality of adoptively transferred engineered TCR T cells
(APASL 2025)
- "These findings support the utility of the whole blood cytokine release assay in monitoring the in vivo function and quantity of engineered T cell products following adoptive transfer."
Preclinical • Hepatocellular Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor
January 04, 2025
Association of T cell epitope spreading with the clinical efficacy of HBV-TCR T cell therapy for HBV-related HCC
(APASL 2025)
- "We provided preliminary evidences that clinical efficacy of TCR-T cell therapy in patients with HBV-related HCC is not directly proportional to the quantity and persistence of infused TCR-T cells but to their ability to induce inflammation and trigger a T cell response against novel T cell epitopes through a possible process of T cell epitope spreading."
Clinical • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatocellular Cancer • CD8 • CXCL10
March 20, 2025
HBV-Specific TCR-T Cell Therapy Combined with Nucleos(t)ide Analogues in Chronic Hepatitis B Patients
(clinicaltrials.gov)
- P1 | N=20 | Recruiting | Sponsor: Changhai Hospital
New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation
March 10, 2025
Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC
(clinicaltrials.gov)
- P2 | N=55 | Not yet recruiting | Sponsor: Lion TCR Pte. Ltd. | Phase classification: P1b/2 ➔ P2 | Trial completion date: May 2027 ➔ Dec 2028 | Trial primary completion date: Feb 2026 ➔ Dec 2026
Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor
February 11, 2025
Lion TCR's Liocyx-M004 Receives FDA Clearance to Launch Global Multicenter Phase 2 Clinical Trial in HBV-Related Hepatocellular Carcinoma
(PRNewswire)
- "On 12 Feb 2025 (Singapore Time), Lion TCR announced that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial. This significant progress further solidifies Lion TCR's leading position in the mRNA-based TCR-T field and brings new hope to patients with hepatocellular carcinoma (HCC)....The FDA-approved international multicenter Phase 2 clinical trial will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib."
IND • New P2 trial • Hepatocellular Cancer
October 07, 2024
A rapid method to assess the in vivo multi-functionality of adoptively transferred engineered TCR T cells.
(PubMed, Immunother Adv)
- "The amount of cytokines secreted also showed an infusion-dose-dependent association. These findings support the utility of the whole blood cytokine release assay in monitoring the in vivo function and quantity of engineered T cell products following adoptive transfer."
Journal • Preclinical • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor
January 06, 2024
Mrna Based HBV-Specific Tcr T-Cell infusions Can induce Broad HBV T-Cell Response in HBV-Related HCC
(APASL 2024)
- P1 | "Our findings shed light on the safety and immunological responses to LioCyx-M, indicating its potential to trigger a broader immune response targeting various facets of HBV-related HCC."
Hepatitis B • Hepatocellular Cancer • Hepatology • Inflammation • CXCL10 • CXCL9 • GZMB • IFNG • IL2 • IL4
November 18, 2023
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
(clinicaltrials.gov)
- P1 | N=10 | Recruiting | Sponsor: Lion TCR Pte. Ltd. | Trial completion date: Jul 2024 ➔ Jul 2028 | Trial primary completion date: Jul 2023 ➔ Jul 2026
Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Solid Tumor • HLA-A
August 28, 2023
Lytic efficiency of immunosuppressive drug-resistant armoured T cells against circulating HBV-related HCC in whole blood.
(PubMed, Immunother Adv)
- "The assay was then used to quantify the efficacy of IDRA HBV-TCRs to lyse free-floating HBV-HCC cells in the presence of Tacrolimus and Mycophenolate Mofetil (MMF)...In conclusion, IDRA HBV-TCR T cells can lyse free-floating HBV-HCC cells in whole blood in the presence of Tacrolimus and MMF. The quantity of IDRA-HBV TCR T cells required can be achieved by the adoptive transfer of 5 × 10 IDRA-HBV TCR-T cells/kg, supporting the utilisation of IDRA HBV-TCR T cells to eliminate CTCs as prophylaxis against recurrence after LT."
Journal • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Solid Tumor • Transplant Rejection • Transplantation • GPC3 • PTPRC • VIM
April 18, 2023
Messenger RNA electroporated hepatitis B virus (HBV) antigen-specific T cell receptor (TCR) redirected T cell therapy is well-tolerated in patients with recurrent HBV-related hepatocellular carcinoma post-liver transplantation: results from a phase I trial.
(PubMed, Hepatol Int)
- P1 | "This study has demonstrated that multiple infusions of mRNA electroporated HBV-specific TCR T cells were well-tolerated in patients with HBV-positive recurrent HCC post-liver transplant."
Journal • P1 data • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Solid Tumor • Transplantation • HLA-A • HLA-B • HLA-C
November 02, 2022
ANALYSIS OF BIOCHEMICAL AND IMMUNOLOGICAL ALTERATIONS IN DISEASE CONTROL GROUP VS DISEASE PROGRESSION GROUP AFTER HEPATITIS B VIRUS (HBV)-SPECIFIC TCELL RECEPTOR (TCR) T CELL THERAPY FOR PRIMARY HBV-RELATED HEPATOCELLULAR CARCINOMA
(AASLD 2022)
- P1 | "These data collectively depict the differential liver function, viral and immune alterations in patient with and without clinical response, highlighting the importance of secondary immune response activation via the cancer-immunity cycle for durable anti-tumor effects of LioCyx-M. 1) Meng et al. Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial."
IO biomarker • Late-breaking abstract • Gastrointestinal Cancer • Hematological Malignancies • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor • CD4 • CD8 • CXCL10 • CXCL9 • ENTPD1
July 01, 2022
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
(clinicaltrials.gov)
- P1 | N=10 | Recruiting | Sponsor: Lion TCR Pte. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Jul 2024 | Trial primary completion date: Jul 2022 ➔ Jul 2023
Enrollment open • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • HLA-A
July 01, 2022
A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
(clinicaltrials.gov)
- P1 | N=13 | Completed | Sponsor: Lion TCR Pte. Ltd. | Unknown status ➔ Completed | N=10 ➔ 13 | Trial completion date: Nov 2020 ➔ Sep 2021 | Trial primary completion date: Nov 2017 ➔ Sep 2021
Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • Transplantation
December 24, 2021
Immunological alterations after immunotherapy with short lived HBV-TCR T cells associates with long-term treatment response in HBV-HCC.
(PubMed, Hepatol Commun)
- "In contrast, signs of transient localized liver inflammation, activation of the T-cell compartment, and/or elevations of serum chemokine (C-X-C motif) ligand (CXCL) 9 and CXCL10 levels were detected in patients with long-term clinical benefit. We show that despite the reduced in vivo half-life (3-4 days), adoptive transfer of mRNA HBV-TCR T cells into patients with HBV-HCC show long-term clinical benefit that was associated with transient immunological alterations."
IO biomarker • Journal • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor • CXCL10
December 23, 2021
Lion TCR Receives FDA Fast Track Designation for its HBV-specific TCR T Cell Therapy for Hepatocellular Carcinoma
(PRNewswire)
- "Lion TCR Pte Ltd today announced that it has received Fast Track Designation from United States Food and Drug Administration (U.S. FDA) for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR, for the treatment of HBV-related hepatocellular carcinoma (HBV-related HCC)....This designation was granted based on that the efficacy of LioCyx-M004, as demonstrated by an improvement in the overall survival in patients with HBsAg-positive HCC relapsed or refractory to prior systemic treatment."
Fast track designation • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor
December 02, 2021
Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial.
(PubMed, Hepatol Int)
- P1 | "The adoptive transfer of HBV-TCR-T cells into advanced HBV-HCC patients were generally safe and well-tolerated. Observations of clinical efficacy support the continued development and eventual application of this treatment strategy in patients with advanced HBV-related HCC."
Journal • P1 data • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor • Transplantation
September 23, 2021
Lion TCR Announces FDA IND Clearance for its LioCyx-M004 for Hepatocellular Carcinoma
(PRNewswire)
- P1, N=NA; "Lion TCR Pte Ltd...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...Lion TCR intends to initiate a Phase 1b/2 multi-center study for its lead investigational product, LioCyx-M004, for patients with advanced Hepatitis B Virus (HBV)-related hepatocellular carcinoma....The use of LioCyx-M004 has been tested in Phase 1 study in primary HBV-related HCC. LioCyx-M004 infusions were well-tolerated with no occurrence of cytokine release syndrome (CRS) nor neurotoxicity. Disease control rate was 60% and partial response (PR) as per RECIST 1.1 was observed with a duration of response of 27.7 months."
IND • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology
September 25, 2021
"#LionTCR Announces #FDA #IND Clearance for its #LioCyxM004 for #HepatocellularCarcinoma https://t.co/vkYRYjxM6D"
(@1stOncology)
Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor
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