FDA greenlights PrimeLink Bio’s clinical trial of PLB-002

CAR-T Digest - August 2020

09 October 2025: FDA greenlights PrimeLink Bio’s clinical trial of PLB-002

The FDA has granted IND clearance for PrimeLink Bio’s first ADC candidate, PLB-002, an anti-Claudin 6 antibody-drug conjugate, enabling the start of clinical trials
PLB-002 will be evaluated in a multi-center, open-label, dose escalation and expansion trial for adults with advanced solid tumors
The ADC targets Claudin 6 (CLDN6), a tight junction protein highly expressed in tumors such as ovarian, NSCLC, endometrial, and testicular cancers, but minimally in normal tissues
Developed using PrimeLink Bio’s modular ADC technology platform, PLB-002 has shown strong preclinical efficacy, a broad therapeutic window, and favorable pharmacokinetics
The IND clearance marks PrimeLink Bio’s first clinical milestone, with plans to advance additional ADC candidates into human studies