Biocytogen Announces FDA Clearance of IND Application for Bispecific Antibody YH008

BEIJING

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) today announced that the US FDA has approved the Investigational New Drug (IND) application for a phase I study of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (bsAb). The IND application was completed by Biocytogen’s wholly owned subsidiary Eucure Biopharma.

The trial is an open-label, dose-escalation study (No. YH008101) that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH008 monotherapy in patients with PD-(L)1-resistant advanced solid tumors or hematological malignancies.

YH008 exerts antagonistic and agonistic activities on PD-1 and CD40, respectively. In vitro and in vivo studies indicate that activation of the CD40 signaling pathway is dependent on PD-1 expression. Therefore, YH008 can conditionally activate CD40 pathway in the tumor microenvironment where tumor specific PD-1⁺ T cells are enriched, without systemic CD40 non-specific activation. Additionally, YH008 was engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated non-specific immune activation. YH008 demonstrated superior anti-tumor activity than parental monoclonal antibodies (mAbs) or combination therapy in vivo. Moreover, the anti-tumor activity of YH008 was also superior to benchmark PD-1 mAbs and PD-L1 x CD40 bsAbs in syngeneic models. In vivo pharmacodynamic studies indicate that YH008 can activate tumor-infiltrating DCs and T cells. In addition, both in vivo studies and GLP toxicology studies indicate improved safety of YH008 compared with benchmark CD40 mAbs.

“The CD40 agonistic activity of YH008 is PD-1-dependent, which allows for more targeted immune cell activation and synergies,” said Dr. Yi Yang, Chief Scientific Officer (CSO) of Biocytogen. “These characteristics prevent occurrence of liver toxicity, even at high doses, while enhancing anti-tumor activity, giving YH008 high clinical potential.”

“YH008 is a first-in-class bispecific antibody discovered through large-scale in vivo efficacy screening, where it demonstrated excellent anti-tumor activity, even in cold tumors,” said Dr. Rong Chen, CEO and CMO of Eucure Biopharma, VP of Biocytogen. “With this IND clearance for YH008, the company will have more products with diversified modalities entering the clinic to benefit patients.”

About Eucure Biopharma

As a wholly owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team and extensive clinical development experience, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets, with two products in launched phase II multi-regional clinical trials (MRCT) and two in phase I. For details, please visit https://www.eucure.com/en/index.

About Biocytogen

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^TM /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 antibody drugs for more than 1000 targets, known as Project Integrum. This project has resulted in 28 drug co-development agreements and 16 RenMice^TM 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.

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