Ovarian cancer is one of the most common gynecological malignant tumors, ranking third in incidence among female reproductive tract malignant tumors, yet it has the highest mortality rate. Despite the improvement in surgical skills and the clinical application of paclitaxel, platinum, and other targeted drugs over the past 20 years, which have significantly improved the prognosis of ovarian cancer patients, the five-year survival rate for advanced patients remains below 30%. Therefore, there is an urgent need to find new effective drugs for better therapeutic outcomes.

RR-M01 injection is a third-generation CAR-M cell therapy drug developed for HER2-positive solid tumors. In 2023, Kunshi Biotech, in collaboration with Xuzhou Medical University Affiliated Hospital, initiated an Investigator Initiated Trial (IIT) to assess the safety and efficacy of CAR-M cell therapy for HER2 highly expressed recurrent and refractory ovarian cancer.

The first clinical study subject was a 65-year-old female with a two-year history of ovarian malignancy, who underwent surgery to remove the ovaries and uterus. Despite various first-line treatment plans, multiple metastases occurred one year after surgery, and pathological testing showed HER2++. In December 2023, she was selected for the trial, completed apheresis blood collection and CAR-M preparation and quality control in the middle of the month, and completed cell infusion treatment at the end of the month. After the procedure, the subject's vital signs were stable, she felt comfortable, her general condition was good, and there were no serious adverse reactions during the entire follow-up observation period, demonstrating the good safety profile of the cell drug. At the same time, the subject's clinical symptoms gradually eased compared to before treatment, and tumor markers and other indicators were effectively controlled. The patient will continue regular follow-ups according to the clinical protocol after discharge.

Dr. Yin Xiushan, CEO of Kunshi Biotech, stated: CAR-M is a highly promising targeted solid tumor immunocyte therapy that uses non-integrating viral transduction of macrophages, which will not lead to the risk of secondary cancer. During the treatment process, there is no need for lymphodepletion, which greatly facilitates the patient, and since other immune cells are not cleared, they can play a synergistic role, enhancing the therapeutic effect. Kunshi Biotech is a biotechnology company specializing in macrophage drugs targeting solid tumors and is currently in the first tier internationally. The smooth discharge of the first subject marks the official entry of Kunshi Biotech's pipeline research into the clinical stage. We would like to express our gratitude to all Kunshi employees for their hard work, to the team led by Director Chen Buze at Xuzhou Medical University Affiliated Hospital, and to our strategic partner, Jiangsu Jucuo JuChuang Biotechnology Co., Ltd. (i.e., the National Biopharmaceutical Technology Innovation Center Cell Therapy Drug Clinical Research Center) for their strong support. Kunshi Biotech will accelerate the clinical trial registration of this pipeline to benefit more cancer patients as soon as possible.

The principal investigator of this clinical study, Director Chen Buze from Xuzhou Medical University Affiliated Hospital, said: "The subject showed very stable performance after dosing, and tumor markers and other indicators were effectively controlled, indicating that RR-M01 has good safety and potential efficacy for the treatment of recurrent and refractory ovarian cancer, which brings great confidence to the entire clinical research team. Subsequently, we will actively carry out dose-escalation and expanded indication clinical studies. At the same time, we would like to thank the subjects involved in the study, their families, and their clinical and nursing staff, as well as all researchers, for their efforts in advancing ovarian cancer research."