July , 2022, Shanghai, China: Maxinovel Pharmaceuticals Co., Ltd. (“Maxinovel” hereafter) announced dosing of first patient with MAX-40279, a novel multi-tyrosine kinase inhibitor developed by Maxinovel, in the multi-center Phase II study (MAX-40279-006, NCT05395780) of 2^nd line or above therapy for advanced gastric cancer or gastroesophageal junction cancer, at the Nanjing Drum Tower Hospital (also named as the Affiliated Hospital of Nanjing University Medical School), Jiangsu, China.

This study will evaluate the safety, tolerance, PK and efficacy of MAX-40279 in patients diagnosed with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have previously received standard chemotherapy combined with or without a monoclonal antibody. Prior to initiating this trial, Maxinovel has conducted multiple dose-escalation Phase I studies in Australia and China. Additionally, Maxinovel has reached agreement with Junshi Biosciences and Alphamab Oncology to collaborate on two Phase I studies, evaluating MAX-40279 combined with immune checkpoint inhibitor, Toripalimab (anti-PD-1 monoclonal antibody) or KN046 (anti-PD-L1/CTLA4 bispecific antibody) in solid tumors.

MAX-40279 is the first new molecular entity (NME) from the pipeline of Maxinovel to proof-of-mechanism/concept stage of clinical development. Multi-mechanisms are implicated in the antitumor effect of MAX-40279. Preclinical studies have shown that MAX-40279 can inhibit varieties of receptor tyrosine kinases. Additionally, MAX-40279 can inhibit hematopoietic progenitor kinase 1 (HPK1) and relieve the negative regulation of HPK1 on T cell receptor (TCR) pathway. Furthermore, through translational research, Maxinovel scientists identified a potential biomarker, an adaptor protein that can bind to multiple tyrosine kinases, may be predictive of response to MAX-40279 treatment.                        

Professor Jia Wei, Principle investigator, from the Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, commented: "We appreciate the Sponsor’s trust and selection of the Nanjing Drum Tower Hospital as the leading site to conduct this study, together with other cancer centers in China. MAX-40279 is a multi- tyrosine kinase inhibitor and showed very intriguing potential based on previous clinical data from advanced gastric cancer and other solid tumors. Through conducting of this study, we aim to generating solid evidence of its clinical utility as the late line option in treating patients with advanced gastric cancer. At the same time, we are also looking forward to seeing whether the biomarker hypothesis in this study can provide new ideas for precise medicine and combination therapy strategy of MAX-40279 in patients with gastric cancer. I would love to see that the study may bring hope to more patients in need! "

Dr. Michelle Zhi Xu, Medical Director of ICON Plc, commented: "We are honored to be the CRO partner of Maxinovel to carry out the clinical trial of MAX-40279 in gastric cancer. I would be thrilled to see the success of this study which is already a milestone for the first clinical collaboration between ICON and Maxinovel. Twenty years ago, it was Nanjing University School of Medicine and the Drum Tower Hospital that led me to the road of medical oncology.  It was of special significance for me to return to the place where my career took off by participating in the clinical study of MAX-40279. We look forward to working closely and collaboratively with the team of Professor Jia Wei, other investigators and Maxinovel to conduct high quality yet innovative trial, making continuous efforts toward improving the quality of life for patients! "

The medical lead of this study, Dr Yijun Wu, commented: "With the establishment of chemotherapy combined with or without monoclonal antibodies as the standard 1^st line, the survival of patients with advanced gastric cancer or gastroesophageal junction cancer has been greatly improved. However, currently, options for the 2^nd line or above treating advanced gastric cancer are very limited, and the clinical benefits need to be improved. Based on the results of our previous study, MAX-40279 may have the potential to be a viable option as late line treatment."

Chen Lu, data management lead of this study, commented: "Thank everyone’s efforts from the clinical team to ensure that the clinical database is established in a timely fashion for screening. In clinical trials, data management is a key process. Aiming for true and reliable data for the final statistical analysis, we will use strict and high standard data management to ensure the reliability, integrity and accuracy of the data obtained in the clinical trial. "

"We thank Professor Jia Wei, the PI of Nanjing Drum Tower Hospital and her study team for their great support; thank the clinical team, CRO ICON and SMO Med-Tech Development for their joint efforts, which overcame various difficulties caused by the COVID-19 lockdown, ensured the timely execution of this study, and triggered the milestone of dosing the first patient in China. We will continue to closely cooperate and communicate with the investigators of all centers and partners to efficiently promote this clinical study." Said Duorui Xia, the operation lead of the MAX-40279-006 study from Maxinovel.