On January 19, 2021 Lion TCR reported that Health Sciences Authority (HSA) has granted approval for our local open label, single-arm, single center Phase 1 Investigational New Drug (IND) clinical trial application to further analyze liver cancer tumor microenvironment (TME) (Press release, Lion TCR, JAN 19, 2021, View Source [SID1234574089]).

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Study name: Phase 1 Safety and Tolerability Study of Redirected HBV-Specific T-Cells in Patients with Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
Protocol No.: LTCR-HCC-3-3
Certificate number: CTC2100001
Approval date: 04 January 2021
Product: LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen-specific TCR)

Lion TCR has pioneered the use of mRNA to engineer T cells as an anti-tumor therapy. Our lead product LioCyx-M consists of a preparation of autologous T-cells transfected with mRNA encoding HBV antigen-specific TCR. These HBV-TCR engineered T cells are able to transiently recognize and lyse HBV-expressing hepatocellular carcinoma cells. We have previously studied the safety and preliminary efficacy of LioCyx-M both in patients with recurrent HBV-related hepatocellular carcinoma (HCC) post liver transplant [1] and in patients with advanced primary HBV-related HCC [2].

In this new study, we aim to determine, in unresectable patients with HBV-related primary HCC, the capability of LioCyx-M to not only directly lyse HCC cells expressing HBV antigens but also to alter HBV-related HCC microenvironment. Safety, HCC tumor volume reduction and alteration of tumor microenvironment will be sequentially monitor in treated patients. Preliminary results have suggested that LioCyx-M therapeutic efficacy might be linked to its ability to alter the tumor microenvironment (convert "cold tumours" to "hot tumours"). Hot tumours are characterized by the proinflammatory cytokines production and T-cell infiltration and are linked to longer survival. With a better understanding of the mechanism of action of LioCyx-M, we might be able to exploit LioCyx-M treatment to favor a more durable therapeutic efficacy in combination with other immunotherapy strategies such as immune checkpoint inhibitors.

This trial will be conducted at Singapore General Hospital (SGH) in collaboration with SGH Senior Consultant, Dr Thinesh Lee Krishnamoorthy and Professor Antonio Bertoletti from Duke-NUS Medicine School.

References
1. Chen W, Cheng J, Zheng X, et al 273 Phase I study of LioCyx-M, autologous hepatitis B virus (HBV)-specific T cell receptor (TCR) T-cells, in recurrent HBV-related hepatocellular carcinoma (HCC) post-liver transplantation. Journal for ImmunoTherapy of Cancer 2020;8:doi: 10.1136/jitc-2020-SITC2020.0273
2. Wang F, Meng F, Jin J, et al 272 Use of LioCyx-M, autologous hepatitis B virus (HBV)-Specific T cell receptor (TCR) T-cells, in advanced HBV-related hepatocellular carcinoma (HCC). Journal for ImmunoTherapy of Cancer 2020;8:doi: 10.1136/jitc-2020-SITC2020.0272