Business Wire India
YH003 in combination with PD-1 are being dosed in phase II multi-regional clinical trials sponsored by Eucure Biopharma for pancreatic cancer and melanoma in Australia, the US and China.
ISU ABXIS intends to deploy YH003 sequence to develop tri-specific antibody for the treatment of multiple tumor types.
Eucure Biopharma, a China-based clinical-stage biotechnology company focused on the development of antibody therapeutics, announced today that it has entered into a collaborative agreement with ISU ABXIS Co., Ltd. (KOSDAQ: 086890), a Korea-based clinical stage company developing immuno-oncology drugs.
Under the terms of the agreement, ISU ABXIS will utilize the sequence of YH003, Biocytogen’s humanized agonistic anti-CD40 antibody currently in phase II clinical trials, to construct a few groups of tri-specific antibodies and develop cancer drugs for multiple indications using its technology platform. Eucure Biopharma will receive an upfront payment, milestone payments and royalties.
“Biocytogen utilized its unique evidence-based in vivo drug screening platform to obtain YH003, which has demonstrated a good preclinical safety and efficacy profile,” said Dr. Rong Chen, Vice President of Biocytogen and CEO/CMO of Eucure Biopharma. “Further, YH003’s phase I clinical trials indicate good tolerability and safety profiles, as well as encouraging antitumor activities against several tumor types, including malignant melanoma and pancreatic cancer.”
“CD40 is a key co-stimulator in adaptive immune responses,” said Yeob Hwang, CEO of ISU ABXIS. “We are glad for the opportunity to utilize Biocytogen/Eucure Biopharma’s anti-CD40 antibody (YH003), as it has outstanding efficacy and safety profiles, both preclinically and clinically. These favorable properties will undoubtedly accelerate our tri-specific antibody development against tumors.”
YH003 is a humanized IgG2 agonistic CD40 antibody. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. The phase I dose escalation study carried out in Australia indicated that YH003 combined with PD-1 mAb (toripalimab) had excellent safety and antitumor activity in patients with advanced solid tumors. Currently, YH003 is undergoing phase II multi-regional clinical trials (MRCTs) for the treatment of patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC) and melanoma.
As a wholly owned subsidiary of Biocytogen, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. Relying on a strong clinical development team with extensive experience, Eucure Biopharma develops innovative drugs to meet clinical needs for patients worldwide. The company has established a product pipeline for more than 10 targets, with two in phase II MRCTs and two in phase I clinical trials. For more information, please visit https://www.eucure.com/en/index.
Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab™ /RenLite® mice platforms for fully human monoclonal and bispecific antibody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum. This project has resulted in 28 drug co-development agreements and 16 RenMice™ licensing agreements with companies around the world, including several partnerships with multinational pharmaceutical companies (MNCs). Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany. For more information, please visit http://en.biocytogen.com.cn.
About ISU ABXIS
ISU ABXIS is a biotechnology company dedicated to the development of new and novel bio-therapeutics. Founded in 2001 with the goal of developing innovative antibody-based therapeutics to treat cancer and rare diseases, for the first time in South Korea, it succeeded in developing a therapeutic antibody in 2006. ISU ABXIS has a pipeline of systematic research and management for developing treatments for intractable diseases from cancer to rare diseases, through that it has successfully developed a new drug candidate for refractory cancer and Hemophilia B, etc. Its technology advances in antibody-based platform for the treatment of human disease.
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