China's First mRNA Personalized Neoantigen Cancer Vaccine XH001 Enters Phase I Clinical Trial
NeoCura
RNA Innovative Drug Developer
On October 15, 2025, XH001, the mRNA personalized tumor neoantigen vaccine independently developed by NeoCura using AI technologyLaunched at Peking Union Medical College HospitalPhase Ⅰ Clinical StudyThis is the first Chinese mRNA personalized tumor neoantigen vaccine to enter the clinical stage. Globally, no similar products in this field have been approved for marketing.
This progress not only verifies NeoCura's technical breakthrough capabilities but also marks an important milestone in China's personalized tumor immunotherapy field, offering cancer patients an efficient and precise cutting-edge treatment option.
This study, led jointly by Peking Union Medical College Hospital and Peking University Cancer Hospital, is a multi-center, open-label, single-arm Phase I clinical trial (Clinical Trial Registration Number: CTR20253775), aiming to evaluate the safety, tolerability, and preliminary efficacy of XH001 in adjuvant therapy for patients with high-risk solid tumors after curative surgery.The trial design focuses on the prevention of recurrence in solid tumors after surgery, filling the gap in personalized immunotherapy in this field in China.
XH001 is an AI-driven mRNA personalized tumor neoantigen vaccine. Using NeoCura's proprietary NeoCura AI ALPINE tumor neoantigen prediction platform, it rapidly analyzes the unique tumor mutation profile and HLA typing data of patients, precisely selecting the most immunogenic neoantigens from a vast pool of candidate antigens. The mRNA vaccine encoding the corresponding neoantigens is synthesized in vitro and efficiently delivered into the patient's body.Thereby inducing persistent and potent CD8+And CD4+T cell immune response, achieving precise killing of tumor cells.
Previously, data from investigator-initiated clinical research (IIT) confirmed that XH001 has good safety, can efficiently activate patients' anti-tumor specific immune responses, and precisely eliminate tumor cells.
Compared with the limitation of traditional postoperative adjuvant therapy, which is often described as "killing a thousand enemies at the cost of eight hundred of one’s own," the unique value of XH001 lies in its "precise targeting" — tumor neoantigens are only specifically expressed on tumor cells, enabling it to lock onto tumor cells with precision like a "guided missile," thereby reducing the risk of collateral damage to healthy tissues. This makes it an ideal choice for postoperative adjuvant treatment of tumors.
On this basis, the customized strategy of "one patient, one vaccine" further enhances vaccine efficacy. The "exclusive vaccine" developed based on the patient's own tumor can not only efficiently induce specific T-cell immunity to precisely eliminate residual micro-metastases post-surgery, but also ensures the strength and durability of the immune response, continuously monitoring and attacking recurrent tumor cells, fundamentally resolving the clinical challenge of postoperative recurrence in solid tumors.
After the project launch, informed consents from multiple patients have been efficiently completed, further validating the innovative value of NeoCura's "AI+RNA" dual-engine R&D platform. Breaking through the limitations of traditional single-point R&D models, NeoCura has established a full-chain closed-loop system from neoantigen prediction, nucleic acid modification, sequence optimization, vector engineering, and delivery system development to GMP production, with AI deeply integrated throughout the entire process.
Among them, the self-developed tumor neoantigen prediction system NeoCura AI ALPINE has improved the accuracy of neoantigen prediction to over 75% through iterative upgrades, continuously enhancing the precision of neoantigen prediction and the efficiency of vaccine development, comprehensively shortening the R&D cycle, and accelerating the clinical transformation of ongoing pipelines.
The successful launch of the XH001 clinical trial marks not only a key breakthrough in China's tumor immunotherapy field but also an innovative exploration addressing the global challenge of post-surgical recurrence in solid tumors.
We are full of anticipation that this "smart vaccine," with its unique personalized killing mechanism and immune protection efficacy, will achieve outstanding results in future research, and bring hope to cancer patients as soon as possible, reshaping a new era of life span and quality.
