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.

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^® (RenMab^TM/RenLite^®/RenNano^®/RenTCR-mimic^TM) 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, RenBiologics^TM, 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, BioMice^TM, 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 http://en.biocytogen.com.cn.

Biocytogen Contacts

Antibody assets and platforms: BD-Licensing@biocytogen.com

Media: pr@bbctg.com.cn