Strong Collaboration with Ruijin Hospital Positions China Biotech Services' CD20 CAR-T Therapy LY007 for Breakthrough Success

According to the Zhisheng Finance APP, Shanghai Longyao Biological Technology Co., LTD. (hereinafter referred to as "Longyao Bio"), a subsidiary of China Biotech Services (08037), recently signed a technology development cooperation agreement with Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (hereinafter referred to as "Ruijin Hospital"). Both parties will jointly conduct research in China on "The Mechanism of Tumor Microenvironment and Novel CAR-T Transformation Exploration for LY007 Cell Injection in the Treatment of Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma."

This collaboration is based on the Phase 1 clinical study of LY007, further exploring its clinical efficacy mechanisms, screening key clinical indicators that affect efficacy, guiding patient selection and stratification before treatment, and investigating the clinical medication mechanism of LY007.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 receiving approval for clinical trials, LY007 has garnered significant market attention due to the fact that some patients with relapsed or refractory B-NHL treated with CD19-targeted CAR-T therapies experience either no response or relapse, while CD20 CAR-T therapy holds promise to address this issue.

Since the CD20 target is expressed on the surface of B cells at all stages of differentiation, except for early precursor 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.

LY007 from Shanghai Longyao Biological Technology Co., LTD utilizes a lentiviral vector for genetic modification and incorporates a unique design independently developed by Longyao Biological. It introduces the independent costimulatory signal receptor OX40 into the CAR structure, thereby forming a novel CAR-T construct.

This novel structure not only enhances the cytotoxic ability of CAR-T cells but also reduces the expression of exhaustion molecules on the cell surface, better maintaining the functionality of CAR-T cells within the immunosuppressive tumor microenvironment. This presents promising safety and efficacy, with the potential to prevent tumor recurrence.

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 the medium-dose group have received cell reinfusion.

Based on the aforementioned clinical trials and the favorable safety and efficacy demonstrated by LY007, Ruijin Hospital signed a technology development and cooperation agreement with Longyao Bio, jointly embarking on this translational exploratory study, which also signifies Ruijin Hospital’s recognition and anticipation of LY007’s future commercial 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 patients 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.

The collaboration between Longyao Biological Technology and Ruijin Hospital is of great significance for the future Phase II clinical trials, post-marketing transformation, and application of the LY007 product. It lays a solid foundation for advancing the clinical progress of LY007 and exploring its future commercial potential, which will also enhance the intrinsic value of China's biotechnology service CAR-T business sector.

Founded in 2003, China Biotech Services is committed to building an advanced biotechnology platform for integrated cancer diagnosis and treatment. The company has established a presence in three key areas: precision diagnostics, CAR-T cell therapy, and BNCT boron neutron capture therapy, gaining regional or international leading advantages. Currently, the products across all three business segments have either entered commercialization or are on the verge of doing so. This latest acceleration in the development of the CAR-T cell therapy business not only propels the company toward becoming a leading technology service platform for cancer diagnosis and treatment but also ensures its clinical progress remains at the forefront of the industry. This signifies that China Biotech Services could become the first company in China to go public with a CD20-targeted CAR-T product. At that point, the intrinsic value of China Biotech Services will experience a transformative leap.