Biocytogen Announces FDA Clearance of IND Application for Bispecific Antibody YH008


The US FDA has approved the Investigational New Drug (IND) application for a phase I study of YH008, an internally created first-in-class PD-1 x CD40 bispecific antibody, according to a statement from Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (bsAb). Eucure Biopharma, a subsidiary of Biocytogen, finished the IND application.

The YH008 monotherapy trial, with the study number YH008101, is an open-label, dose-escalation study that will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effectiveness in patients with advanced solid tumours or haematological malignancies that are PD-(L)1-resistant.

YH008 affects PD-1 and CD40 in a negative and positive way, respectively. Studies conducted in vivo and in vitro show that PD-1 expression is necessary for the activation of the CD40 signalling pathway. Due to the enrichment of tumor-specific PD-1+ T cells in the tumour microenvironment, YH008 can conditionally activate the CD40 pathway there without causing systemic CD40 non-specific activation. Additionally, an Fc-silent IgG1 isotype was added to YH008 in order to prevent Fc-receptor-mediated non-specific immune activation.

In vivo, YH008 outperformed parental monoclonal antibodies (mAbs) or combination therapy in terms of anti-tumor activity. Additionally, in syngeneic models, YH008’s anti-tumor effectiveness outperformed benchmark PD-1 mAbs and PD-L1 x CD40 bsAbs. YH008 has been shown in in vivo pharmacodynamic experiments to stimulate T cells and DCs that infiltrate tumours. Additionally, investigations conducted in vivo and GLP toxicity studies show that YH008 is safer than standard CD40 mAbs.

“The CD40 agonistic activity of YH008 is PD-1-dependent, which allows for more targeted immune cell activation and synergies”, “These characteristics prevent occurrence of liver toxicity, even at high doses, while enhancing anti-tumor activity, giving YH008 high clinical potential.”

Dr. Yi Yang, Chief Scientific Officer (CSO) of Biocytogen

“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”, “With this IND clearance for YH008, the company will have more products with diversified modalities entering the clinic to benefit patients.”

Dr. Rong Chen, CEO and CMO of Eucure Biopharma, VP of Biocytogen

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