On August 14, 2019, a discussion panel regarding the phase I clinical trial protocol of the TY-9591 program, which was independently developed by TYK Medicines, a local small molecule drug discovery, and development company, was held in Shanghai. Under the chairmanship of Baohui Han MD from Shanghai Chest Hospital, other experts and scholars including Lin Wu MD from Hunan Cancer Hospital and Yanqiu Zhao MD from Henan Cancer Hospital were invited to participate in the meeting. This marks that TYK Medicines has officially entered the clinical and higher development stages.

Dr. Han said “With Osimertinib widely used after its launch, its safety has gradually drawn the attention of physicians and patients. It is urgent to improve the safety and accessibility of Chinese patients. The revolutionary TY-9591 is a boon for a wide range of lung cancer patients. We hope to proactively accelerate the clinical trial process and look forward to exciting clinical trial results.”

As an innovative pharmaceutical development company, we are very honored to cooperate with Dr. Han and invited Dr. Wu, and Dr. Zhao to participate in this research. This meeting is an important milestone in TYK Medicines’ innovative drug development process,” Dr. Yusheng Wu, CEO of TYK Medicines, said in his speech, “We believe that under the leadership of Baohui Han MD, we will be able to actively proceed with the clinical trial of the TY-9591 project with high quality. TYK Medicines will also continue to adhere to a rigorous science attitude and innovative spirit, actively prepare for the upcoming clinical research of TY-9591, develop more and better new drugs that are accessible to Chinese patients, and find the cure for the disease.”

Dr. Jun Li, the CSO of TYK Medicines, introduced the TY-9591 program, “TY-9591 is an ATP-competitive irreversible third-generation selective EGFR-TKIs independently developed by TYK Medicines. The preclinical studies have shown that it has good target activity against EGFR-sensitive mutations DEL19 and L858R, as well as T790M drug-resistant mutations, and has demonstrated excellent target specificity and mutation selectivity at the molecular level, in vitro assay, and in vivo animal models, compared with similar drugs, it has a better anti-tumor effect. Compared with the marketed Osimertinib, TY-9591 has different in vivo pharmacokinetic characteristics with enhanced exposure and reduced toxicity. It is expected to improve its efficacy and have a better safety profile clinically.”

Under Dr. Han, after 4 hours of heated discussion, the participating experts agreed on inclusion criteria, dose escalation design, efficacy, safety profile characterization, etc., which clarified the research direction and the research ideas for the phase I clinical research protocol of TY-9591 tablets and laid a solid foundation for the subsequent smooth development of the project.

About TY-9591

TY-9591 is an irreversible ATP-competitive third-generation selective EGFR-TKIs independently developed by TYK Medicines Inc. preclinical studies have shown that the drug has a better anti-tumor effect than similar drugs. Moreover, it has different in vivo pharmacokinetic characteristics, which can significantly increase the exposure in vivo and reduce the toxic metabolites.