On October 31, 2022 Eucure Biopharma, a China-based clinical-stage biotechnology company focused on the development of antibody therapeutics, reported 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 (Press release, Eucure, OCT 31, 2022, View Source [SID1234622649]).

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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."

About YH003

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.