Vaccines for tumors? CDE publishes a draft for comments on clinical trials

On October 9, the official website of the Center for Drug Evaluation (CDE) of the State Medical Products Administration released the "Technical Guidelines for Clinical Trials of Tumor Therapeutic Vaccines (Draft for Comments)" to further standardize and guide the clinical development of tumor therapeutic vaccine drugs and provide technical specifications
for reference.

According to the Center for Drug Evaluation of the National Medical Products Administration, the mechanism of action of tumor therapeutic vaccines is to process and present antigens to T cells through antigen-presenting cells (APCs), thereby inducing the production or amplification of existing antigen-specific T cell responses, which takes a long time
to process.
There are many different considerations
in the clinical trial design of therapeutic oncology vaccines compared to traditional cytotoxic drugs, targeted therapies or other immuno-oncology drugs.

"Our understanding of the concept of vaccines mainly refers to the prevention of infectious diseases, such as HPV vaccines, new crown vaccines, etc.
, but for tumors, there is currently no tumor that can be directly prevented by vaccines, only vaccines for treatment, which is very critical, which is also the reason why
tumor therapeutic vaccines emphasize the qualifier of treatment.
" 。 Professor Chen Xiaobing, chief physician of the Department of Internal Medicine of Henan Provincial Cancer Hospital, told the People's Daily health client reporter that after the successful development of tumor therapeutic vaccines, it is mainly used directly for the treatment of tumors, and after the vaccine is directly injected into the patient's body, it will induce or enhance the specific immunity to tumor antigens, thereby controlling and killing tumor cells, which can not only directly kill tumor cells, but more importantly, it can eliminate tiny residual lesions
。 Therefore, tumor therapeutic vaccine, its best response is not advanced tumor patients, but early tumor patients after surgery, it can remove tiny residual lesions, and finally establish anti-tumor immune memory effect
.

According to the official website of the Center for Drug Evaluation of the State Medical Products Administration, this guideline is led by the Clinical Department of Biological Products and included in the "2022 Guideline Formulation and Revision Plan of the Drug Review Center"
.
These guidelines are divided into two main chapters and references
.
The first chapter provides an overview of the background, purpose and scope of application of the drafting of these technical guidelines, and clarifies that these guidelines are recommendatory rather than mandatory, and the ideas therein are
staged.
The second chapter is the overall R&D strategy for clinical trial design, divided into general considerations, early exploratory clinical trials, and confirmatory clinical trials
.
It focuses on the considerations of clinical trial design of oncology therapeutic vaccines, covering the overall design of the trial design, the selection of clinical efficacy endpoints, safety evaluation, and special considerations for
personalized or autologous vaccines.

"The release of the "Technical Guidelines for Clinical Trials of Tumor Therapeutic Vaccines (Draft for Comments)" is of great significance for the development of clinical trial technology for tumor therapeutic vaccines, because from the perspective of the industry, the research and development of tumor therapeutic vaccines has been a long time, but the process has troughs and exciting moments, because before this, there was no national-level normative principle, so it would take some detours, and now with unified normative principles, relevant principles will be strictly studied.
It will also promote research and development progress more efficiently and rapidly, and ultimately be better used for the treatment of
tumor patients.
Chen Xiaobing said
.

(Operation: Liu Yuxin)