Biocytogen's self-developed bispecific antibody was approved by the FDA to enter clinical trials

Biocytogen (Beijing) Pharmaceutical Technology Co.
, Ltd.
("Biocytogen", stock code 02315.
HK) announced that its IND application for its self-developed bispecific antibody YH008 (PD-1 x CD40) has been approved
by the US FDA.
The IND application was completed
by Yuwa Pharmaceutical, a wholly-owned subsidiary of Biocytogen.

The approved clinical trial, an open-label, Phase I dose-escalation study (protocol number: YH008101), will evaluate the safety, tolerability, and pharmacokinetics of YH008 monotherapy in patients with PD-(L)1-resistant advanced solid tumors and hematological tumors; At the same time, the effectiveness
of the drug will be preliminarily assessed.

YH008 is a bispecific antibody with both antagonistic and agonist activity of PD-1 x CD40, and its target combination is the first in the world
.
In vitro and in vivo experimental results show that the activation of the CD40 pathway by YH008 must depend on the cross-linking effect
of PD-1.
Therefore, YH008 can conditionally activate the CD40 signaling pathway in the tumor microenvironment rich in tumor-specific T cells, avoiding systemic non-specific activation
.
In addition, YH008 adopts the IgG1 subtype of ineffective response function, which avoids non-specific activation
mediated by Fc receptors.
In the allotransplant model, YH008 showed better antitumor activity
than maternal monoclonal antibody and combination.
At the same time, the antitumor activity of YH008 in vivo was also significantly better than that of PD-1 monoclonal antibody and PD-L1 x CD40 dual antibody
.
In vivo pharmacological studies have shown that YH008 can effectively activate tumor-infiltrating DC cells and T cells
.
In addition, in vivo experiments and GLP toxicological studies have shown that YH008 has a better safety profile
than CD40 monoclonal antibody.

Dr.
Yi Yang, Chief Scientific Officer (CSO) of Biocytogen, said: "YH008 has PD-1-dependent CD40 agonist activity and immune synergy of the two targets
.
This makes YH008 almost hepatotoxic even at very high doses, while showing good efficacy with high clinical potential
.
”

Dr.
Chen Zhaorong, CEO and Chief Medical Officer of Biocytogen and Deputy General Manager of Biocytogen, said: "YH008 is an excellent combination of Biocytogen through a large number of in vivo efficacy screening, even in cold tumor models
.
With the approval of YH008's IND, the company will have more diversified products into the clinic in the future to benefit patients
.
”