China-based Nanjing Leads Biolabs Co., Ltd has revealed that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial for its pipeline candidate, LBL-033. This anti-MUC16/CD3 bispecific antibody (BsAb) is set to be investigated as a potential treatment for ovarian cancer and other tumor types, marking a significant step forward in the development of this first-in-class BsAb, with no MUC16-targeted therapy approved globally to date.
Design of the Phase I/II Clinical Trial
The upcoming trial is designed as a multi-center, open-label, dose escalation and expansion study. The primary objective is to establish the dosage for Phase II before assessing the efficacy of LBL-033. This approach will provide crucial data on the safety, tolerability, and optimal dosing of the drug candidate.
MUC16’s Role in Malignant Tumors
MUC16 (Mucin16, mucin 16) is a highly glycosylated type I transmembrane protein typically found in epithelial cells, where it provides a protective lubricating barrier against infection. However, MUC16 is also highly expressed in a variety of malignant tumors, including ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, pancreatic cancer, non-small cell lung cancer, and gastric cancer. Its overexpression is involved in the regulation of immune escape, tumor cell proliferation, and metastasis, making it a promising target for cancer therapies.
LBL-033’s Potential Impact on Cancer Treatment
LBL-033’s potential to target MUC16 could offer a new avenue for treating a range of cancers, particularly those that are highly aggressive and have limited treatment options. The clinical trial’s results will be instrumental in determining the efficacy and safety of this innovative approach to cancer therapy.-Fineline Info & Tech
