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ASCO 2024 | Biocytogen/Eucure Biopharma to Present Two Phase II Clinical Studies of CD40 Agonistic Antibody YH003

Biocytogen’s wholly owned subsidiary Eucure Biopharma today announced that the company will present two phase II clinical studies of YH003, a humanized anti-CD40 agonistic monoclonal antibody, at the American Society of Clinical Oncology (ASCO) annual meeting, taking place in Chicago, US, from May 31-June 4, 2024.

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Presentations details are as follows:

Poster Session:

Title: A phase II, multi-center, open-label study to evaluate the safety and efficacy of YH003 in combination with Toripalimab (anti-PD-1 mAb) in patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC)

Clinical Trial Registration Number: NCT05031494

Abstract Number: 4146

Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track: Pancreatic Cancer - Advanced/Metastatic Disease

Poster Bd #: 126

Date and Time: 13:30-16:30 CDT, June 1, 2024

Location: Hall A

Publication Only:

Title: A multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of YH003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma

Clinical Trial Registration Number: NCT05420324

Abstract Number: e21520

Track: Melanoma/Skin Cancers

Sub Track: Advanced/Metastatic Disease

About YH003

YH003 is a humanized IgG2 agonistic anti-CD40 monoclonal antibody independently developed by Biocytogen/Eucure Biopharma. Based on the safety, efficacy and PK data from the previous phase I study, the recommended phase II dose (RP2D) of YH003 was identified as 0.3 mg/kg. The combination of YH003 and Toripalimab has shown encouraging anti-tumor activity in patients with advanced solid tumors.

Preclinically, YH003, whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, demonstrated strong anti-tumor effects in multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicate that YH003 significantly increased the infiltration of anti-tumor T cells into tumors.

At AACR2024, our collaborator Syncromune revealed initial clinical data of SYNC-T SV-102, which includes YH003 and our clinical-stage CTLA-4 monoclonal antibody YH001. SYNC-T SV-102 demonstrated a very high 85% overall response rate in patients with metastatic castrate-resistant prostate cancer (mCRPC).

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMabTM/RenLite®/RenNano®/RenTCR-mimicTM) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologicsTM, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of December 31, 2023, 103 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 47 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMiceTM, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit

Biocytogen Contacts

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