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 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.

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[1]. The purpose is to get important new drugs to the patient earlier.

In earlier phase 1 study, LioCyx-M004 has showed the 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[2]. 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.

References

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/

https://finance.yahoo.com/news/lion-tcr-announces-fda-ind-072300134.html

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 allergenic 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.

Source: Lion TCR