On April 19 2022, the first patient has been infused and treated with PA3-17, a CAR-T product developed by Persngen Biotherapeutics, in the Phase I study initiated in the First Affiliated Hospital of Zhengzhou University.

    Dr. Lin Yang, Chairman and CEO of PersonGen, commented that, “the infusion of the first patient enrolled in the initial Phase I trial evaluating PA3-17, our first project entering clinical stage, marks a significant milestone both for PersonGen and our immune-oncology program ‘PA3-17’. Persongen’s team has made extraordinary efforts in the face of challenges caused by the pandemic. The progress of PA3-17 is dependent on the joint efforts of PersonGen’s team and our clinical partner. We hope that PersonGen could make considerable progress and meet the unmet medical needs as soon as possible. 

    As of the date of the announcement, PA3-17 is the first CD-7-targeted CAR-T cell product candidate globally that is being studied in clinical trials. There are five centers for the trial and the principal investigators are Prof. Xiaojun Huang from the People's Hospital of Peking University, Prof. Mingzhi Zhang from the First Affiliated Hospital of Zhengzhou University, Heng Mei (MD) from Wuhan Union Hospital, Dehui Zou (MD) from Hematology Hospital of Chinese Academy of Medical Sciences and He Huang (MD) from the First Affiliated Hospital of Zhejiang University. The infusion was successfully completed with the efforts of Prof. Mingzhi Zhang and clinical experts in the department.

About CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies

    Most of CD7-positive Malignancies are high aggressive lymphomas or leukaemias, including T-lymphoblastic leukemia/lymphoma(T-ALL/LBL), Early T-cell precursor acute lymphoblastic leukemia(ETP-ALL), Extranodal NK/T cell lymphoma and other rare diseases. The disease progresses rapidly with poor prognosis and relapse occurs in most cases within a short period of remission after chemotherapy. Nelarabine is the only drug that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapse/refractory T-ALL/LBL in the world while it has yet to be launched in China. The CR (complete response) rate of nelarabine was 20%-30%. The median survival was 8 months with the drug alone. For refractory patients, the survival period of single drug therapy is only 4 months. Thus, there is an urgent medical need for the treatment of CD7-positive diseases, such as relapse/refractory T-ALL/LBL, and the advent of CD7-CAR T-cell therapy represents a promising solution to this urgent clinical need.

About PA3-17 Injection

    Different from traditional CD19-CAR T and BCMA-CAR T, the development and clinical application of CD7-CAR T cells face great challenges, including: Co-expression of CD7 by tumor T cells and normal T cells leads to the fact that conventional preparation processes make CAR-T cells unavailable due to the fratricide, the presence of tumor T cells in CAR-T cells leads to the failure of product release, and temporary reduction of T cells increases the risk of infection.  Therefore, numerous teams are trying to prepare UCAR-T cells from healthy donors based on gene editing strategies that knock out CD7 and TCR. PersonGen’s autologous CD7-CAR T cells with non-gene editing strategies demonstrated remarkable efficacy and safety data in pharmacokinetic and pharmacodynamic studies.  Moreover, due to the successful development of highly optimized automatic preparation process with significantly reduced cost, it would be delivered as an affordable innovative drug for ordinary patients.  

    PersonGen has been developing single-domain antibodies against CD7 since 2012, successively developing CD7 immunotoxin and CD7-CAR-NK, and finally successfully developing the first autologous CD7-CAR-T cells with first-in-class potential globally. PA3-17 received IND approval from CDE on August 6, 2021, and was granted ODD by US FDA on November 10, 2021, ranking first in the research and development progress in the world. 

About PersonGen

    PersonGen's vision is to be a pioneer in the research and development of innovative cell drugs. The mission of PersonGen is to develop innovative drugs to address unmet medical needs. PersonGen is a domestic high-tech enterprise focusing on the development of ground-breaking immunotherapy technology and cellular drug products against oncology. We are dedicated to develop globalal-leading first-in-class and best-in-class CAR-T cell drugs to deliver excellence to cancer patients.

    Autologous CD7-CAR T cells, developed by PersonGen, demonstrates high clinical value for the treatment of refractory and recurrent T cell and NK cell malignancies. Its IND application has been approved by CDE in August 2021, and the ODD has been granted by US FDA in November 2021. We are initiating the Phase I trial in five centers, the People's Hospital of Peking University, the First Affiliated Hospital of Zhengzhou University, Tianjin Hematology Hospital, Wuhan Union Hospital and the First Affiliated Hospital of Zhejiang University.

    In the first half of 2021, PersonGen completed the A round of financing led by Yuansheng Venture Capital, with Puen Guoxin Equity Investment and Xiantong Capital. In January 2022, we completed B round of financing jointly led by Zhongjin Qide and Huatai Zijin, with Panyi Capital and Huatong Capital. PersonGen has built a fully automated CAR-T cell manufacture center of 10,000 square meters in compliance with GMP standards, laying a solid foundation for the commercialization of CAR-T cells.