Kunstone Biotech Unveils First Clinical Data of Third-Generation CAR-M Therapy RR-M01 at ESMO 2025, Demonstrating 71.4% Disease Control Rate in HER2-Positive Solid Tumors
Rock Roc Biotechnology
Macrophage Chimeric Antigen Receptor Therapy Developer
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From October 17 to 21 local time, at the 2025 European Society for Medical Oncology (ESMO) Annual Congress,ROC ROCK Biotechnology, as the only company that has advanced macrophage drugs to the clinical stage,Announce the first clinical trial results of its third-generation CAR-M cell therapy (RR-M01) targeting the HER2 site.
RR-M01 is a third-generation chimeric antigen receptor macrophage drug independently developed for HER2-positive solid tumors, targeting human epidermal growth factor receptor 2 (HER2). Its indications include recurrent and refractory solid tumors such as HER2-positive ovarian cancer, gastric cancer, breast cancer, cervical cancer, endometrial cancer, lung cancer, and pancreatic cancer.
(Third-generation CAR-M Structure)
Title: Preliminary Clinical Results of CAR-Macrophages in Metastatic HER2 Low-Expressing and HER2-Positive Solid Tumors
Final Publication Number (FPN): 1556P
Reporters: Han Zhengxiang, Chen Buze (Affiliated Hospital of Xuzhou Medical University)
Main Conclusion: This report summarizes and analyzes data from 7 patients with advanced HER2 solid tumors as of October 2025.
l Under repeated and continuous dosing regimens of up to 1.0×10⁹ cells per single dose in each patient, RR-M01 was well-tolerated.
l RR-M01 monotherapy demonstrated a favorable efficacy signal,Disease Control Rate (DCR) Reached 71.4%。
lFor patients previously treated with trastuzumab deruxtecan, RR-M01 still demonstrated significant efficacy. RR-M01 shows potential therapeutic effects for patients with a HER2 expression level of 2+.
AboutROC ROCK Biotechnology
ROC ROCK Biotechnology is a clinical-stage company focusing on the development of macrophage-based drugs for cancer and chronic diseases. The company was incubated in Berlin, Germany, and is a biomedicine strategic high-tech enterprise founded by Professor Yin Xiushan, a Chinese scientist who returned to China from Europe, based on over two decades of cutting-edge scientific research. Driven by gene editing, cell programming, and targeted delivery technologies, ROC ROCK Biotechnology has completed a multi-body layout in Suzhou and Berlin, Germany, and pioneered the creation of a closed-loop industrial chain centered on macrophages.
Source: ROC ROCK Biotechnology
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