Allogeneic CAR-NK Therapy IND Accepted

In May 2022, Qihan Biotech announced for the first time an open-label phase I study of QN-019a, an allogeneic CAR-NK cell targeting CD19, as a clinical trial for relapsed/refractory B acute lymphoblastic leukemia (B -ALL) monotherapy, and combined with rituximab in the treatment of relapsed/refractory B-cell lymphoma, this clinical study aims to evaluate the efficacy of QN-019a in relapsed/refractory B-cell lymphoma or B-cell lymphoma - Safety, tolerability and preliminary efficacy in ALL patients. Among them, the "3+3" enrollment plan will be adopted in the dose-escalation phase, and 24-36 patients will be recruited.

CAR-NK cell therapy

Due to the limitations of tumor heterogeneity and immunosuppressive tumor microenvironment, CAR-T cells have been more brilliant in the treatment of hematological malignancies in recent years, and have a significant inhibitory effect on the inhibition of MHC, but their efficacy in solid tumors is limited. The use of CAR-T immunotherapy still has some limitations, including the quality heterogeneity of T cells, high cost, and the limited number of available CAR cells.

NK cells generated from induced pluripotent stem cells (iPSCs) are expected to be safe and effective cell therapy drugs, which are potentially effective in targeting solid tumors, and have broad-spectrum anticancer activity without significant inhibition of MHC. Inhibition, and safe and stable. However, NK cells are not very effective due to reflux damage, and CAR-NK cells can make up for this shortcoming, effectively reducing the damage of NK cells, and also have the advantages of low cost and low toxicity. Qihan Biotech was previously committed to the research of xenotransplantation. Through CRISPR and transposon gene editing technology, "Pig 3.0" was born, eradicating porcine endogenous retrovirus (PERV), with 13 independent gene modifications, changing The incompatibility of immunity and blood coagulation between pigs and humans marks an important step in xenotransplantation, opening up new directions for tumor immune cell therapy and regenerative medicine. potential.

Founded in 2017 by Yang Luhan, a top doctor in the field of gene editing, Qihan Biotechnology is located in Hangzhou. It is a biotechnology company that masters multiple gene editing and transplantation immune compatibility. As the leader of the new generation of CRISPR gene editing technology in China, it has proved for the first time that human and other mammalian cells can perform genome editing, broke the record of multiple gene knockout, and realized the controllable expression of multiple genes.

In 2020, Qihan Biotechnology began to make in-depth research and development in cell therapy products, and independently developed natural killer cells (NK Cells) derived from gene-edited induced pluripotent stem cells (iPSCs), which have great potential to become the next generation of cell therapy . Its CD19-targeting CAR-NK product QN-019a has started clinical research in 2022, and completed the acceptance of clinical trial applications on May 6, 2023.

The field of NK cell therapy has attracted the attention of domestic and foreign pharmaceutical companies in recent years. In July 2022, Celularity Biotechnology announced that the phase 1/2a clinical trial of its NK cell therapy CYNK-101 has completed the first patient administration. Leading the next step in cellular medicine by investigating CYNK-101 as a treatment for multiple cancer indications - multiple myeloma (MM), acute myeloid lymphoma (AML) and glioblastoma multiforme (GBM) Development, for various cancer, infectious and degenerative disease indications.

Compared with CAR-T therapy, CAR-NK has the advantages of low toxicity and low cost. Allogeneic CAR-NK cells can solve some problems faced by autologous CAR-T cells. There is considerable potential in the field of CAR-NK cell therapy, and excellent technology companies continue to emerge. The "off-the-shelf" cell therapy products that are ready to use have broad prospects in cancer treatment.