ZhiKang Hongyi and AstraZeneca Announce Collaboration on TIM-3 mAb (BC3402) in Combination with PD-L1 mAb (Imfinzi) for Advanced Hepatocellular Carcinoma

Sep 26, 2023 10:00 CST Updated 10:00

AstraZeneca

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On the afternoon of September 25, 2023, at the R&D headquarters of Wuxi Zhikang Hongyi Biotechnology Co., Ltd. located in Huaxi Rongchuang Center on the Huangpu Riverbank in Shanghai,Wuxi Zhikang Hongyi Biotechnology Co., Ltd.AndAstraZenecaBoth parties held a signing ceremony regardingWuxi Zhikang Hongyi TIM-3 Monoclonal Antibody(Development Code:BC3402`) Combined`AstraZeneca's PD-L1 monoclonal antibody Imfinzi(General name: Durvalumab) AstraZeneca signed a cooperation agreement for the treatment of advanced liver cancer. Both parties are jointly committed to evaluating the safety and efficacy of BC3402 combined with Imfinzi for the treatment of patients with advanced hepatocellular carcinoma (HCC) through a Phase Ib/II clinical study. According to the agreement, Wuxi Zhikang Hongyi Biotechnology Co., Ltd. will lead this clinical study conducted in China.

Previously, this clinical research had received the tacit approval for clinical trials from the National Medical Products Administration. This study has been rapidly initiated at Zhongshan Hospital, with Professor Fan Jia, academician of the Chinese Academy of Sciences, liver tumor surgeon, and president of Fudan University's Zhongshan Hospital, serving as the principal investigator.

Giovanni Melillo, Vice President of Global Medical Affairs at AstraZeneca, Head of Gastrointestinal Oncology and New Products; Haiying Yang, Vice President of China & Head of Medical Affairs; Yongjiang Hei, Co-CEO of Wuxi Zhikang Hongyi Biotechnology Co., Ltd.; Yiwei Wang, Co-founder and Executive Vice President, and other key members of both teams attended the signing ceremony.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd.Co-founder and Executive Vice President Ms. Wang Yiwei

AstraZenecaMs. Yang Haiying, Vice President of China and Head of Medical Affairs

On behalf of both parties signed the cooperation agreement

Wuxi Zhikang Hongyi Biotechnology Co., Ltd.Co-CEOHei YongjiangMr. (second from the left),

Ms. Su Rong (first from the left), Executive Director of Clinical Medicine and Medical Affairs Department

AstraZenecaGlobal Vice President of Medical Affairs, Head of Gastrointestinal Oncology and New Products

Giovanni MelilloMr. (second from the right),

Ms. Su Zheng (right), Head of the Hepatobiliary Tumor Medical Team

Witness on Stage

BC&AZ

Hector Black, Co-CEO of the company, stated in his welcome speech:"Warmly welcome the arrival of the AstraZeneca team, and thank both teams for their joint efforts, allowing us to reach a cooperation agreement in just six months at an extremely fast pace. TIM-3 is a very promising cancer target with great potential in co-development. Our team is ready, and we believe that this first clinical collaboration will achieve good results, benefiting patients in China.

"I also hope that this cooperation is a good start, and subsequently, both parties will be able to carry out broader cooperation in other molecules and fields."

In the subsequent report and discussion, Wang Yiwei, co-founder and executive vice president of the company, introduced the company's pipeline layout in the field of oncology, with a particular focus on the BC3402 project. Wang Yiwei pointed out"In tumors resistant to PD-1/PD-L1, such as liver cancer and lung cancer, TIM-3 is highly expressed. Based on the company's extensive translational medicine research results, BC3402, by optimally selecting binding epitopes and immune phenotypes, can block the binding of CEACAM1 and TIM-3 proteins at low concentrations, effectively restoring T-cell function and preventing T-cell exhaustion. This advantage gives it the potential to become a BIC molecule."

Meanwhile, in preclinical efficacy studies, BC3402 demonstrated strong synergy with PD-1 and CTLA-4.

HCC poses a serious threat to the survival of patients in China, with a 5-year survival rate of only 7% for advanced patients. Through this collaboration, both parties are committed to exploring new treatment options to further extend patient survival time and improve their quality of life. BC3402 has completed Phase I clinical studies and demonstrated good safety. We believe this research will better help achieve our shared goals.”

Giovanni Melillo, Vice President of Global Medical Affairs at AstraZeneca and Head of Gastrointestinal Oncology and New Products, presented AstraZeneca's oncology pipeline with a particular focus on the company’s layout in the GI field. Giovanni pointed out："AstraZeneca is continuously exploring different treatment modalities to meet the unmet needs of various patients, such as CAR-T and other cell therapies, ADC drugs, immune checkpoint inhibitors, and personalized chemotherapy."

The company is committed to developing therapeutic drugs for gastrointestinal tumors in Asia, especially in China. Currently, this field is highly competitive (particularly for liver cancer), and AstraZeneca is exploring multiple potential combination therapies for liver cancer. Among these, we are very optimistic about the combination of PD-L1 and TIM-3, and hope this collaboration will be successful."

Starting from this collaboration, the two parties will continue to actively explore more possibilities for cooperation, support innovation in China, and benefit more patients.

About Wuxi Zhikang Hongyi Biotechnology Co., Ltd.

"Better Medicine for Better Life"Wuxi Zhikang Hongyi Biotechnology Co., Ltd.The Lofty Mission.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd.Founded in December 2017, the company focuses on patients and diseases, highly values the fundamental role of disease biology in new drug development, and prioritizes the research, clinical trials, and commercialization of "BIC/FIC" innovative drugs for diseases such as cancer and nephropathy.

Since its establishment, the company has developed pipelines in various technological fields such as small molecule chemicals, monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADC). With an efficient R&D and operational model, seven novel drugs are currently in Phase I/II clinical trials, all led by top experts in the field as principal investigators (PIs). The quality and progress of these clinical trials continue to reflect the advantages demonstrated during preclinical development, placing them at a globally leading level. BC3195, the company’s globally exclusive ADC targeting CDH3, has entered clinical trials simultaneously in China and the U.S., further strengthening the company’s leading position in the global oncology pipeline. Additionally, the company has several first-in-class (FIC) ADCs and bispecific antibody products in preclinical development and Pre-IND stages.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd.A core management team with multidisciplinary backgrounds has been formed to lead the company’s full lifecycle R&D operations. At the same time, an operational team familiar with the market environments of both China and the U.S. has been put in place to systematically ensure the quality and efficiency of the company’s entire R&D process. The company will further strengthen the layout of new technologies and global commercialization to consolidate its leading comprehensive R&D capabilities and support the expansion into overseas markets.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd.Aiming to "quickly grow into a leading biopharmaceutical company in China, with continuous innovation capabilities, core combination products, diversified innovative therapies, and deep commercialization abilities," it is committed to benefiting more patients globally and contributing to the new round of development in China's biopharmaceutical industry.

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