August 8, 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, combined with toripalimab (Anti-PD-1 monoclonal antibody) in the multi-center Phase I study (NCT05369286) for advanced solid tumor at the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
About MAX-40279-008
This study will evaluate the safety, tolerance, PK and efficacy of MAX-40279 combined with toripalimab in patients diagnosed with advanced solid tumor. Under the premise of mutual benefit, Maxinovel Pharmaceuticals and Junshi Biosciences will jointly promote the clinical development of combination therapy of MAX-40297 and toripalimab in solid tumors.
Prior to initiating this trial, Maxinovel has conducted multiple dose-escalation Phase I studies in Australia and China. Additionally, Maxinovel has reached agreement with Alphamab Oncology to collaborate on one Phase I study, evaluating MAX-40279 combined with KN046 (anti-PD-L1/CTLA4 bispecific antibody) in solid tumors.
About MAX-40279
MAX-40279 is the first new molecular entity (NME) from the pipeline of Maxinovel to proof-of-mechanism/concept (POM/POC) 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.
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in 2018 (approved in China as TUOYI®). Currently, there are five approved indications for toripalimab in China.
Comments from Study Team Members and Partners:
Professor Yanhong Deng, Principle Investigator, from the Sixth Affiliated Hospital of Sun Yat-sen University, commented:
"We appreciate the trust of Maxinovel Pharmaceuticals and Junshi Biosciences and the selection of the Sixth Affiliated Hospital of Sun Yat-sen University as the leading site to conduct this study, together with other cancer centers in China. Small molecule TKIs have become the new treatment standards for patients with a variety of advanced solid tumors. Monotherapy with immune checkpoint inhibitors such as anti-PD-(L)1 and anti-CTLA4 is not ideal for solid tumors with strong immune tolerance. Thus the combination of targeted therapy and immune therapy has become a very important strategy at present and in the future. Through the conduct of this study, we will jointly investigate the development of MAX-40297/toripalimab combo in potential indications, with the vision of bringing new treatment options to serve the patient need! "
Lan Jiang, Senior Medical Director of Junshi Biosciences commented:
“Cancer immunotherapy has entered the era of multimodal combination treatment. We are proactively developing drug combination strategy based on toripalimab, the PD-1 inhibitor as a cornerstone, expected to improve the effectiveness of immunotherapy, break through the limitations of drug resistance, and expand its usage to benefit more cancer patients. MAX-40279 is a dual-target drug with multiple tumor suppressive mechanisms. We will collaborate with Maxinovel to advance the trial with the combination therapy of MAX-40279 and toripalimab to bring more treatment options to patients!
Linda Wang, General Manager of Kuntuo, VP of IQVIA commented:
"MAX-40279 is a distinctive TKI with multiple tumor suppression mechanisms and potential immunomodulatory mechanisms. As a clinical research organization focusing on the development of China-born innovative medicine in China, Kuntuo is honored to participate in the clinical study of MAX-40279 combined with toripalimab (the first domestically approved anti-PD-1 monoclonal antibody, independently developed by Junshi Biosciences). With the joint efforts from the clinical team of Maxinovel, investigators, Kuntuo and other partners, the project has achieved the first important milestone of first patient in! In the future, we will continue to deliver fast and high-quality clinical service to facilitate the development work of Maxinovel to benefit more patients ultimately."
The medical lead of this study, Dr Jinfang Su, commented:
"In addition to surgery, chemotherapy, targeted therapy and radiotherapy, immunotherapy has become the cornerstone of cancer treatment. As monotherapy of immune modulators brings mediocre efficacy and covers limited patient population, there is huge unmet medical need for new medicines/combination therapies. MAX-40279, a multi-target tyrosine kinase inhibitor, may play as an important combination partner of immunotherapy. We expect the combination of MAX-40279 and toripalimab may ameliorate immunotherapy resistance and provide effective treatment option for patients with malignancies."
Jianhang Fu, the operation lead of the MAX-40279-008 study from Maxinovel
" We appreciate the great support of Professor Yanhong Deng, the leading PI of the Sixth Affiliated Hospital of Sun Yat-sen University and the Junshi team! The COVID-19 situation has brought great challenge to the project. Thanks to our clinical team, CRO Kuntuo and SMO ClinPlus, everyone worked together to overcome the difficulties and hit the goal of enrolling the first patient on time! I believe that with the strong support from Team Professor Deng and the study teams of other PIs, the study can be conducted in high quality with a timely fashion. We look forward to dedicating our effort toward providing new treatment options to patients with advanced solid tumors." Said Jianhang Fu, the operation lead of the MAX-40279-008 study from Maxinovel.
About MaxiNovel Pharmaceuticals
MaxiNovel Pharmaceuticals Co.,Ltd. is a China based biotech company founded in 2016 to focus on the innovative drug research with the global intellectual property rights.
We carry out first-in-class small molecule drug discovery in the areas of targeted therapy and immunotherapy. Our rapidly expanding product pipeline is mainly composed of programs that target both blood tumors and solid tumors as well as autoimmune diseases. Company’s research platforms encompass oral therapy, radiotherapy, imaging and transdermal therapy.
We have our R&D and operation centers in China (Shanghai, Guangzhou, Shenzhen), the United States and Australia. Our management team members all have extensive previous working experiences in global pharmaceutical companies and capital markets, more importantly global vision of our company’s future development.
Our mission is to conduct pharmaceutical innovation to save lives and bring hopes to patients and their families.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.
In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (“EUA”) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.
Junshi Biosciences has more than 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).
About Kuntuo
Kuntuo, founded in 2011, has offices in Beijing, Shanghai, Guangzhou, Chengdu and Hangzhou, with nearly 900 employees nationwide. Kun Tuo, as the Contract Research Organization (CRO) specially set up in Chinese market by IQVIA, is dedicated to provide high-quality and reliable clinical study services for pharmaceutical, medical device and IVD companies, including site management service (CRC), clinical delegation FSP, clinical monitoring, project management, medical affair, biological statistics, data management, regulatory affair, pharmacovigilance, medical translation, quality management and quality assurance etc. Kun Tuo has provided more than 1000 professional clinical study services for many famous domestic and overseas pharmaceutical as well as medical device companies with customized solutions developed to help these companies to register new products in China successfully.
