XinhE Biologics Launches Clinical Trial of Neoantigen Cancer mRNA Vaccine at Peking Union Medical College Hospital

On July 14, 2022, the clinical trial initiation meeting for Xinhe Bio’s neoantigen tumor vaccine project was held at Peking Union Medical College Hospital. The theme of this clinical trial is “"A Study on the Safety and Efficacy of Neoantigen Tumor Vaccines in Advanced Solid Tumors". The safety and tolerability of the neoantigen tumor vaccine in subjects will be evaluated by recruiting patients with advanced solid tumors aged 18 to 75 years (inclusive), and the efficacy of the neoantigen tumor vaccine as monotherapy and in combination with PD-1 monoclonal antibody will be explored.

 Representatives of the Project Research Team and the Sponsor

Professor Bai Chunmei, Director of the Department of Medical Oncology at Peking Union Medical College Hospital, attended and presided over the meeting as the principal investigator of the project. Dr. Cheng Yuejuan, Attending Physician in the Department of Medical Oncology; Ms. Zhou Yanping, Assistant Researcher and Study Coordinator; Dr. Wang Yi, Co-founder and CEO of Xinhe Bio; and Dr. Long Jianjing, Head of Clinical Medicine, among others, participated in the meeting as representatives of the investigative site and the sponsor.

At the meeting, Dr. Long Jianjing from Xinhe Biologics provided a detailed introduction to the research protocol and design rationale for this clinical trial. The attendees engaged in thorough discussions on the trial procedures, inclusion and exclusion criteria for participants, and evaluation criteria, while also reviewing key considerations for the implementation of the clinical trial.

Professor Bai Chunmei, the principal investigator of the project, stated that neoantigen tumor vaccines hold promising application prospects. The research team will adhere to a rigorous and scientific approach, strictly comply with Good Clinical Practice (GCP) regulations, ensure trial quality, and strive to achieve the study objectives. It is hoped that this research will explore a novel therapeutic strategy and provide more treatment options for patients with advanced-stage cancer in China.

 Principal Investigator: Professor Chunmei Bai

Elaborate on the Background and Significance of This Clinical Trial

Neoantigen Tumor VaccinesNeoantigen tumor vaccines are an emerging form of cancer immunotherapy that target specific antigens generated by tumor mutations. These vaccines are designed and manufactured to stimulate immune responses, thereby killing tumor cells. Compared with other immunotherapeutic approaches, neoantigen tumor vaccines offer several advantages, including a high safety profile, strong tumor specificity, ease of eliciting immune responses, and compatibility with combination therapies.

In this clinical trial, Xinhe Biologics will sequence tumor tissue samples from participants and analyze the data using AI algorithms to identify high-quality neoantigen fragments derived from cellular mutations. mRNA vaccines corresponding to the amino acid sequences of these neoantigens will be synthesized in vitro and administered to participants to induce natural immune responses, thereby inhibiting and promoting the regression of tumor growth.

The successful convening of this kick-off meeting marks the official commencement of the clinical research on Xinhe Bio’s neoantigen tumor vaccine at Peking Union Medical College Hospital. It is anticipated that this clinical trial will pave the way for the practical application of neoantigen tumor vaccines in the immunotherapy of solid tumors, bringing new hope to more patients with advanced-stage cancer.