【Product for Licensing】CLDN6 X 4-1BB bispecific antibody

Product Brief Summary

• Product Name: CLDN6 X 4-1BB bispecific antibody
• Modality: Bispecific antibody
• Target/MOA: T-cell engager killing tumor cells through CLDN6-dependent conditional T-cell activation by 4-1BB.
• Therapeutic Area: I/O
• Indication: CLDN6 positive tumors: ovarian cancer, testicular cancer, lung cancer, gastric cancer, endometrial cancer, and rare tumors.
• Current Stage: IND ready
• Rights Available: Global rights ex-China
• Collaboration Mode: License out

Patient Population and Market Size

• Ovarian cancer: 308k worldwide, 160k Asia, 28k (North America) new cases in 2023

Unmet Medical Needs

• Treatment for platinum-resistant/refractory ovarian cancer is largely palliative, and patients currently have very limited treatment options, although Elahere has been approved in the US for the treatment of folate receptor α-high platinum-resistant patients.

Competitive Landscape

• New drugs are being developed to target CLDN6-positive tumors using diversed modalities, including bispecific antibodies, ADCs, CAR-T, vaccines, CAR-NK, and mAbs.
• The most advanced new drug (BNT211, CAR-T plus CARVac, BioNTech) is currently in the Phase I/II stage.

Pathway / MOA

• The 4-1BB portion of BsAb is conditionally clustered and activated in the context of CLDN6 binding in the tumor microenvironment.
• The activation of 4-1BB in T cells delivers a costimulatory signal mediated through the TRAF1 and TRAF2 trimers, which recruit the ubiquitin ligases, cellular inhibitors of apoptosis 1 or 2 (cIAP1/2), that activate the downstream signaling pathways: NF-κB, ERK, MAPK, and JNK pathways.
• The activation of these pathways results in the costimulatory signals that further augment CD4+ and CD8+ T cell proliferation, differentiation, and effector functions.

Product Highlights, Differentiation, Advantages

• Potent T-cell engager with strong efficacy for CLDN6 expression-specific tumors.
• Strong killing of tumor cells and 4-1BBhi-Treg cells with intact Fc function.
• Conditional T-cell activation demonstrates an extended safety window with no evidence of systemic 4-1BB activation, indicating no liver toxicity.

Preclinical Results

Clinical Results

• NA

Development Plan

• IND ready and Phase I clinical trial is planned in both China and US in 2025

Contact

• If interested, please contact DrugTimes BD Team at BD@drugtimes.cn. Many thanks!