Longyao Biotech and Ruijin Hospital Forge Strategic Collaboration to Advance CD20-Targeted CAR-T Therapy LY007

Sep 04, 2023 17:20 CST Updated 17:20

Longyao Biotechnology

Developer of Tumor Immune Cell Technologies and Products

Shanghai Longyao Biological Technology Co., LTD. (hereinafter referred to as “Longyao Biological"") in China, produced in China, nationwide in China"Recently, Shanghai Longyao Biological Technology Co., LTD. signed a cooperation agreement on technical development with Ruijin Hospital, affiliated to Shanghai Jiaotong University School of Medicine (hereinafter referred to as "Ruijin Hospital"). The two parties will jointly carry out the research project titled "Exploration of LY007 Cell Injection in Treating Relapsed and Refractory B-cell Non-Hodgkin Lymphoma: Mechanism of Tumor Microenvironment and Novel CAR-T Translation" in China.

This collaboration is based on the Phase 1 clinical study of LY007, further exploring the clinical efficacy mechanisms of LY007, screening key clinical indicators that affect efficacy, guiding patient selection and stratification before treatment, and exploring the clinical medication mechanisms of LY007, among others.This study is of great significance for the phase II clinical trial of LY007 and its post-marketing transformation and application.

LY007, developed by Shanghai Longyao Biological Technology Co., LTD, is the first and only CAR-T therapy targeting the CD20 antigen to be approved for registrational clinical trials in China. It is primarily used to treat relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL).Since being approved for clinical trials, LY007 has garnered relatively high market attention. This is because patients with relapsed or refractory B-NHL undergoing CD19 CAR-T treatment still experience non-responsiveness and recurrence, while CD20 CAR-T treatment is expected to address this issue.

Since the CD20 target is expressed on the surface of B cells at all stages of differentiation, except for early pre-B cells and plasma cells, its role is to optimize the immune response of B cells. Therefore, CD20 is an important therapeutic target for B-NHL. For B-NHL patients who have lost the CD19 antigen or for whom CD19 CART has failed, CD20 CAR-T is an excellent choice.

AndLongyao BiologicalLY007 utilizes a lentiviral vector for genetic modification and incorporates a unique design independently developed by Shanghai Longyao Biological Technology Co., LTD. This design introduces an independent costimulatory signal receptor, OX40, into the CAR structure, thereby creating a novel CAR-T construct.。

This novel structure not only enhances the killing ability of CAR-T cells but also reduces the expression of exhaustion molecules on the cell surface, better maintaining the function of CAR-T cells in the tumor immunosuppressive microenvironment. It is expected to prevent tumor recurrence and thus demonstrates favorable safety and efficacy.

As early as April 7, 2022, the first subject of LY007's Phase 1 clinical trial project had successfully completed the cell reinfusion at Shanghai Ruijin Hospital, and the subject has remained in good condition to date. As of June 30, 2023, subjects in the low-dose group and medium-dose group have received cell reinfusions.

Based on the aforementioned clinical trials and the favorable safety and efficacy demonstrated by LY007, Ruijin Hospital has collaborated withLongyao BiologicalSigned a technical development cooperation agreement, jointly launching this transformation exploration research, which also indicates Ruijin Hospital's recognition and expectation of LY007's future commercialization potential.

Notably, the value of the CD20 target has become increasingly prominent in recent years for two main reasons. First, while there are currently numerous CAR-T therapy developers, their indications are mainly concentrated in hematological tumors, with targets "crowding" around CD19 and BCMA, leading to intense drug competition for these targets.

Secondly, the clinical research results of CD20-targeted CART drugs are also beginning to show promise. In August this year, Mustang Bio announced the latest data from the multi-center Phase 1/2 clinical trial of MB-106 (CD20-targeted autologous CAR-T cell therapy). The overall response rate (ORR) reached 95%, with a complete response (CR) rate of 80%. The longest CR duration in a patient has exceeded three years. In the Waldenström's macroglobulinemia (WM) cohort (n=6), one patient achieved a sustained CR for over 22 months. CiboCell Biotech has entered into a global exclusive collaboration with Janssen to co-develop C-CAR039 (targeting CD19/CD20) and C-CAR066 (targeting CD20), receiving an upfront payment of $245 million along with multiple potential milestone payments and royalties.

And this timeLongyao BiologicalThe collaboration with Ruijin Hospital is of great significance for the future Phase II clinical trials of LY007, as well as its post-marketing transformation and application. This partnership lays a solid foundation for advancing the clinical progress of LY007 and exploring its future commercial potential.

About Shanghai Longyao Biological Technology Co.,LTD

Shanghai Longyao Biological Technology Co., LTD. is dedicated to the research and development, technology transfer, product registration, clinical application research, and application promotion of tumor immunocyte counting. The company’s scientific team, led by Professor Yang Xuanming from Shanghai Jiao Tong University, has established 14 product pipelines in areas such as CAR-T, TCR-T, and other immune effector cells, immune activation cells, and immune regulation cell therapies for malignant hematological tumors and solid tumors. They have accumulated numerous original achievements and filed multiple patents for key technologies. In July 2018, China Biotech Services Holdings Limited (stock code: 8037.HK) signed an agreement to acquire 67% of Longyao Biological Technology. The listed company, focusing on precision detection and precision treatment, aims to build a future biotechnology platform and will provide full support for Longyao Biological Technology’s development in terms of funding and resources.

On January 21, 2021, the clinical trial application for Shanghai Longyao's CAR-T product targeting the CD20 antigen was officially approved. The National Medical Products Administration approved the clinical trial application for Shanghai Longyao's LY007 Cell Injection, classified as a Category I new drug, demonstrating Shanghai Longyao's R&D capabilities in the field of immune cell drugs. Subsequently, on January 27, 2021, Eastern Time, an article on CD20-CART-OX40 was successfully published in *Science Translational Medicine*. The authors included Shanghai Longyao Biological Technology Co., LTD (referred to as "Longyao"), a subsidiary of China BioTech Services (08037), and Professor Yang Xuanming, Longyao’s chief scientist. Under the leadership of the scientific team headed by Yang Xuanming, Longyao Biological Technology has developed profound expertise in constructing advanced CAR-T laboratory preparation techniques, creating CAR-T cells with stronger tumor-killing efficacy and more durable self-expansion capabilities.

Source: Zhitong Finance

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