Sinobioway Submits IND Application for Novel LILRB4-Targeting STAR-T Cell Therapy YTS104 in Relapsed/Refractory AML and CMML

Nov 06, 2023 10:54 CST Updated 10:55

BriSTAR Immunotech

Cellular Immunotherapy Product Developer

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On November 6, Huaxia Yingtai (Beijing) Biotechnology Co., Ltd. announced that its innovative STAR-T platform has been used to developYTS104 Cell InjectionThe Investigational New Drug (IND) application has been officially accepted by the China National Medical Products Administration (NMPA). According to the press release from Huaxia Yingtai (Beijing) Biotechnology Co., Ltd., this is the company'sAutologous cell therapy targeting LILRB4, including indications for relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), etc.

Acute Myeloid LeukemiaIt is one of the common malignant tumors of the hematopoietic system, with rapid progression and high aggressiveness, and there is a lack of effective clinical treatment methods.SlowSexGranulocyte-MonocyteBlastic Plasmacytoid Dendritic Cell NeoplasmIt is a clonal and heterogeneous hematological tumor with both myelodysplastic and myeloproliferative features. LILRB4（Also known as ILT3、CD85k）It is an immune inhibitory receptor that is highly expressed on monocytic AML blasts, thus serving as a marker for monocytes.Acute Myeloid LeukemiaThe ideal therapeutic target.

Huaxia Yingtai's YTS104 Cell Injection, submitted for this IND application, is developed based on the innovative STAR-T platform.Autologous cell therapy targeting LILRB4, using a lentiviral gene transduction method to introduce the STAR gene targeting LILRB4 into autologous T cells. After in vitro cell expansion, preparation, functional and quality control testing, an innovative cell therapy drug is obtained.The product utilizes two independently screened nanobodies with different epitopes, each linked to the α and β chains of the STAR structure, respectively, and is expected to exhibit enhanced antigen recognition and killing effects.In early studies, the product demonstrated positive data, effectively killing target-positive tumor cells.

Huaxia Yingtai(Beijing)Biotechnology Co., Ltd. announced in a press release that,YTS104 is a synthetic T-cell receptor antigen receptor jointly developed by the company and Tsinghua University.（STAR）-Innovative development of the T technology platform.STAR is based on the TCR structure, with its recognition domain adopting the specific recognition mechanism of antibodies targeting tumor antigens, while integrating the signal transduction cascade of T cells. It leverages the high-sensitivity signal transduction advantage of the natural TCR complex to achieve efficient, safe, and long-lasting tumor killing.Therefore,STAR-T is an innovative structure that combines the comprehensive advantages of CAR-T and TCR-T, demonstrating significant development potential in dual-target products and solid tumors.。

References:

[1] Good News! Huaxia Yingtai(Beijing)Biotechnology Co., Ltd.'s New Target STAR-T Cell Drug IND Application Accepted. Retrieved Nov 6， 2023. From https://mp.weixin.qq.com/s/G80onGxkmXn18hg5T8bHwg

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