Bristar Immunotech's Novel LILRB4-Targeting STAR-T Cell Therapy YTS104 Receives IND Approval from China NMPA

On November 3, 2023, the Investigational New Drug (IND) application for "YTS104 Cell Injection," a product developed by Huaxia Yingtai (Beijing) Biotechnology Co., Ltd. ("Huaxia Yingtai") using the innovative STAR-T platform, was officially accepted by the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2300757). As a STAR-T cell therapy exploring new targets for hematologic tumors, the successful acceptance of this IND application marks another milestone breakthrough in the development of Huaxia Yingtai's differentiated STAR-T therapies, bringing new hope for the treatment of acute myeloid leukemia (AML) and other indications with STAR-T cell drugs.

 The website of the Center for Drug Evaluation of the National Medical Products Administration showsYTS104 Cell Injection Accepted for Review

Previously, Huaxia Yingtai's investigational product LILRB4-specific STAR-T (pipeline code: YTS104) was presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting. YTS104 also received "Orphan Drug" designation from the U.S. FDA in December 2022.

The declared indications for YTS104 include relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), etc. AML is one of the most common malignant tumors of the hematopoietic system and can occur in any age group; it progresses rapidly and is highly aggressive, with a lack of effective clinical treatments. CMML is a clonal and heterogeneous blood tumor that exhibits both myelodysplastic and myeloproliferative features, with a high risk of transformation into AML. It is one of the most aggressive chronic myeloid leukemias, with a short median overall survival and a high risk of transformation into acute leukemia.

YTS104 targets LILRB4 (also known as ILT3, CD85k), an immunosuppressive receptor that is highly expressed on monocytic AML blasts (FAB M4 and M5 AML subtypes), making it an ideal therapeutic target for monocytic AML. Meanwhile, the LILRB4 target represents a differentiated exploration from the current CD19, BCMA, and other targets that are more concentrated in CAR-T cell therapy research for hematologic malignancies.

YTS104 is an innovative development based on the Synthetic T Cell Receptor and Antigen Receptor (STAR)-T technology platform jointly developed by Huaxia Yingtai (Beijing) Biotechnology Co., Ltd. and Tsinghua University. STAR, based on the TCR structure, utilizes the specific recognition mechanism of antibodies for tumor target antigens in its recognition region, while incorporating the T-cell cascade amplification signaling method. This combines the high-sensitivity signaling advantages of the natural TCR complex to achieve efficient, safe, and long-lasting tumor killing. Therefore, STAR-T is an innovative structure that integrates the comprehensive advantages of CAR-T and TCR-T, offering significant development potential in dual-target products and solid tumors.

Huaxia Yingtai's IND Application: YTS104 Cell InjectionHuaxia Yingtai(Beijing)Biotechnology Co., Ltd.'s YTS104 Cell Injection submitted for this IND application is an autologous cell therapy drug targeting LILRB4, developed based on the innovative STAR-T platform. It uses lentiviral gene transduction to introduce the STAR gene targeting LILRB4 into autologous T cells. After in vitro cell expansion, preparation, and functional and quality control testing, this innovative cell therapy drug is obtained. The product’s advantage lies in using two independently screened nanobodies targeting different epitopes, which are respectively linked to the α and β chains of the STAR structure, expected to exhibit better antigen recognition and cytotoxic effects. In early studies, this product has shown promising data and can effectively kill target-positive tumor cells. The development of this drug will bring hope to a large number of patients with advanced AML and CMML in China and globally.

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