December 23, 2021
December 23, 2021
SINGAPORE and GUANGZHOU, CHINA and LOS ANGELES，USA, December 23, 2021 - 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 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. This designation was granted based on 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.
The FDA Fast Track Designation is designed for sponsors to gain access to expedited drug approval, via eligibility for Accelerated Approval and Priority Review, for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need through early and frequent meetings with the FDA to discuss drug development plans . The purpose is to get important new drugs to the patient earlier.
In earlier phase 1 study, LioCyx-M004 has shown a well-tolerated safety profile and promising prolonged overall survival. In September 2021, FDA Investigational New Drug (IND) Clearance for a Phase 1b/2 multi-center study has been obtained . This is the first ongoing clinical trial that uses HBV-specific TCR T cell therapy to target HBV-related HCC.
“HBV-related HCC occurs in over 420,000 people every year worldwide and majority of advanced HCC patients relapse quickly after initial treatment. However, existing treatments are very limited especially on improving overall survival. We believe that our innovative TCR-T therapy can fill this urgent and important unmet medical needs. With this Fast Track designation, we look forward to having more frequent communication with the Agency in the hope to attain a more expedited drug approval for our product for patient access. Efforts for patient recruitment for the Phase 1b/2 study in the U.S. and Asia are underway.” said Dr Tina Tingting Wang, COO and CMO of Lion TCR.
“The field of T-cell therapy is highly dynamic and competitive. Innovative therapies are released faster than ever through expediated programs like Fast Track. Together with our Orphan Drug Designation obtained for the use of HBV-specific TCR T cell therapy in HCC, we believe this Fast Track approval can drive forward the accelerated regulatory approval our proprietary first-in-class TCR T cell therapy.” said Dr Peng Xiaoming, CEO of Lion TCR.
1. U.S. Food and Drug Administration (FDA). Fast Track. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track/
About Lion TCR Pte Ltd
Lion TCR is a clinical-stage biotech company specialized in the development and commercialisation of its proprietary engineered T Cell Receptor (TCR) products against infectious disease and its associated cancers. As global leader in HBV-specific TCR redirected T cell therapy against HCC, the company is a biotech spin-off from Singapore’s Agency for Science, Technology and Research (A*STAR) and has global exclusive licenses of the technologies from A*STAR. Lion TCR has developed various TCR technology platforms including the TCR discovery as well as the autologous and allogeneic TCR that incorporate gene editing.
About the Agency for Science, Technology and Research (A*STAR)
The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector R&D agency. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry. A*STAR’s R&D activities span biomedical sciences to physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis. For ongoing news, visit www.a-star.edu.sg.
About Lead Product LioCyx-M004
LioCyx-M, including several well-established product derivatives, are autologous T cells modified to express HBV-specific TCR. These modified T cells have been shown to be able to lyse HBV-infected HCC cells upon target recognition in in-vivo pre-clinical studies and in patients.
Lion TCR contact
Dr Regina Wong
Manager, Business Development
Great China contact
Dr Zhou Yi
Associate Director, Strategy & Business Development
Phone: +86 15994719201
Lion TCR Secures USD 40 million Series B2 Financing, Revolutionizing Solid Tumor Treatment with mRNA-Encoding TCR-T Cell Therapy
Lion TCR Clinched The "Outstanding Innovative Award" At The 2023 Cell And Gene Therapy (CGT) Asia Innovation Summit.
Lion TCR Announces Poster Presentation of Phase 1 Study for Lead Product LioCyx-M at AASLD The Liver Meeting 2022
Lion TCR Receives FDA Fast Track Designation for its HBV-specific TCR T Cell Therapy for Hepatocellular Carcinoma
Scientific Founder & Chairman, Professor Antonio Bertoletti Has Been Placed on Highly Cited Researchers 2021 List
Lion TCR Announces FDA Clearance of its IND Application for its Lead Investigational Product, LioCyx-M004, for Hepatocellular Carcinoma
Scientific Founder, Prof Antonio Bertoletti Appointed as Cellular Immunotherapy Infectious Diseases Lead for Singhealth Duke-NUS Cell Therapy Centre
Lion TCR Licenses and Duke-NUS Medical School ink an exclusive IP licensing agreement for Immunosuppressive Drug Resistant Anti-Cancer T-cells
Dr Wai Lu-En, Director of R&D, represented Lion TCR to share the latest developments to the Minister for Manpower and Second Minister for Trade and Industry Tan See Leng.
Scientific Founder, Prof Antonio Bertoletti Appointed in Cell and Gene Therapy Workgroup in Singapore
Lion TCR Announces Data Presentation for its lead T-cell product, LioCyx-M at EASL Digital Liver Cancer Summit 2021
HSA approval for clinical trial for Lion TCR’s lead product LioCyx-M to characterize changes in liver cancer tumor microenvironment
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
Companion diagnostic assay for personalised immunotherapy for HBV-related liver cancer featured in A*STAR GIS website
Singapore’s first clinical trial approval for T cell engineered (TCR) immunotherapy for treatment of Liver cancer
Lion TCR receives US$ 20 million to fund its personalized T cell therapy clinical trials against Liver cancer
Scientific Founder, Prof. Antonio Bertoletti and Scientific Consultant, Dr Anthony Tanoto Tan of Lion TCR were awarded the SingHealth Duke-NUS Research Award 1st Prize 2018
US FDA grants Lion TCR two orphan drug designations of T cell therapy against Hepatocellular Carcinoma
Immunotherapy of HCC metastases with autologous T cell receptor redirected T cells, targeting HBsAg in a liver transplant patient