Innovent Biologics and Eli Lilly's PD-1/PD-L1 Bispecific Antibody IBI318 Granted IND Approval in China for Relapsed or Refractory Extranodal NK/T-cell Lymphoma, Nasal Type

According to the latest announcement on the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration, Innovent Bio’s investigational PD-1/PD-L1 bispecific antibody IBI318 has received implicit approval for a new clinical trial, intended for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma, nasal type.

Source: CDE Official Website

According to public information, IBI318 is a recombinant fully human IgG1 bispecific antibody targeting PD-1/PD-L1, jointly developed by Innovent Bio and Eli Lilly and Company. It restores T-cell activation and anti-tumor function by blocking the PD-1/PD-L1 and PD-1/PD-L2 signaling pathways, as well as inhibiting the binding of PD-L1 to CD80.

IBI318, through its bispecific capability, bridges PD-1-expressing T cells and PD-L1-expressing tumor cells, facilitating the formation of an immunological synapse between them, thereby potentially enhancing anti-tumor activity and therapeutic efficacy.

Previously, IBI318 was approved in China to conduct clinical studies targeting hematologic malignancies and solid tumors. At the ASCO meeting in June 2020, researchers announced preliminary results from the Phase 1a clinical trial of IBI318 for the treatment of advanced malignant tumors. The results showed that IBI318 had an acceptable safety profile: no dose-limiting toxicities (DLTs) were observed in the treatment groups ranging from 0.3 mg to 300 mg; among the nine patients who received doses ≥10 mg, three achieved partial response.

The new indication for IBI318 recently approved for clinical trials is relapsed or refractory extranodal NK/T-cell lymphoma, nasal type.

Publicly available data indicate that extranodal NK/T-cell lymphoma (ENKTL) is a lymphoma subtype with distinct characteristics in China. Pegasparase-based chemotherapy regimens are the primary treatment modality; however, 20%–40% of ENKTL patients experience relapse after receiving pegasparase-containing chemotherapy, and those with relapsed disease have a very poor prognosis. Therefore, there is an urgent need for new therapeutic options.

Notably, bispecific antibodies have become one of Innovent Bio’s key R&D focus areas. In addition to IBI318, Innovent Bio has received clinical trial approvals for multiple bispecific antibody therapies, including IBI323 (a novel LAG-3/PD-L1 bispecific antibody), IBI322 (a CD47/PD-L1 bispecific antibody), IBI315 (a PD-1/HER2 bispecific antibody), and IBI319. Among these, IBI319 is a bispecific antibody that incorporates an anti-PD-1 backbone derived from sintilimab.

In addition, Innovent Bio has several bispecific antibody products in the preclinical research stage, including IBI321 and IBI327. Among them, IBI321 is a bispecific antibody targeting PD-1 and another undisclosed target, while IBI327 is an anti-PD-L1/OX40 bispecific antibody.

References:

[1] Center for Drug Evaluation (CDE), National Medical Products Administration of China. Retrieved Dec 1, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=21#

[2] Innovent Bio Official Website and Public Information

Source: Medicine Overview

▽Follow [WuXi AppTecDe】WeChat Official Account