- Source : Press Release
- Date : 2020-12-23
- Event type : Phase 1
- Companies : Bayer AG
Bayer's New Anti-Tumor Drug BAY 2416964 Receives Approval for Clinical Use in China
The Center for Drug Evaluation (CDE) accepted Bayer's clinical application for BAY 2416964 tablets submitted in category 1 of chemical drugs on October 16th. On December 17th, it has given permission to two clinical trials intended to evaluate the drug for advanced malignant tumors. This is the first time the product has been approved for clinical use in China, which means that this drug candidate is about to start clinical studies in patients with advanced malignant tumors in China.
The Aryl Hydrocarbon Receptor (AHR) is a protein in immune cells, which can play an immunomodulatory role according to the integrated signals of microorganism and amino acid metabolism in the human body. Because AHR is highly expressed in a variety of tumors and has immunomodulatory effects, modulators targeting AHR are considered to be one of the new types of immunotherapy. At the same time, this type of therapy is expected to be combined with other drug categories to improve the therapeutic effect.
BAY 2416964 is a potent, highly selective, and cross-reactive AHR inhibitor that can exert a variety of anti-tumor immunomodulatory effects. It can block the transcription of CYP1A1 mediated by different AHR agonistic ligands, and can directly interact with AHR, and can inhibit ligand-induced AHR transport to the nucleus. Studies have shown that BAY 2416964 with different doses and different dosing frequencies can inhibit specific tumor models.
Bayer is currently carrying out an exploratory study on the human dose of BAY 2416964 in patients with advanced cancer. This is an open-label, Phase 1, dose-escalation, and expansion study conducted for the first time in humans to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and efficacy of the AHR inhibitor, its kinetics and tumor response profile, etc.
In the 2016 Cancer Development Report, Senator Roy Blunt of the United States wrote, “When a family is healthy, there may be many conflicts and problems. But if one of them has cancer, you have only one problem to deal with, and that's cancer itself. I hope that the follow-up clinical development of this product will progress smoothly and bring a new treatment option to cancer patients as soon as possible”.