FDA Greenlights PrimeLink Bio’s Clinical Trial of PLB-002

Recently, PrimeLink Bio, an innovative biopharma focused on the development of next-generation antibody-drug conjugates (ADCs), announced that its first pipeline candidate, PLB-002 (an anti-Claudin6 ADC), has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA).

PrimeLink Bio will initiate a multi-center, open-label, dose escalation and expansion clinical trial to evaluate the safety and efficacy of PLB-002 in adults with advanced solid tumors.

Dr. Yin, Founder of PrimeLink Bio, remarked: “FDA IND clearance for PLB-002 is a major milestone for the company. PLB-002 is an anti-CLDN6 ADC generated on our flexible, modular ADC technology platform and has the potential to be best-in-class. It has demonstrated remarkable efficacy in preclinical models and could become a new option for cancer patients. As our first program to reach the clinic, PLB-002 also marks the start of our clinical journey. We will continue advancing additional pipeline candidates into human studies.”

About PLB-002
PLB-002 is an anti-Claudin 6 ADC, a tight junction protein specifically expressed in solid tumors—most notably ovarian, non-small-cell lung, endometrial and testicular cancers—while barely expressed in healthy adult tissues. Discovered and advanced using PrimeLink Bio’s proprietary technology platform, PLB-002 has a much broader therapeutic window and great PK profile. Pre-clinical data has shown that PLB-002 is highly promising for the treatment of ovarian cancer, non-small cell lung cancer (NSCLC) and other CLDN6-positive solid tumors.

About PrimeLink Bio

Founded in July 2021, PrimeLink Bio is an innovative biopharmaceutical company dedicated to the development of next-generation antibody–drug conjugates (ADCs). Guided by the principle of “tailoring optimal ADC structures for specific targets,” the company has developed a flexible, modular platform with high hydrophilicity, compatibility, and flexibility that enables novel strategies to overcome the safety liabilities and resistance mechanisms limiting current ADC therapies. PrimeLink Bio has built the pipeline spanning single-target ADCs and novel modalities such as bispecific ADCs and dual-payload ADCs. Three programs have already reached the PCC stage. Backed by its innovative technology platform and differentiated product pipelines, PrimeLink Bio has raised a total of RMB 150 million from leading domestic and international investors, including Vertex Ventures, Fosun Pharma, KAITAI Capital and Shenzhen Hongshulin Venture Capital. The company will continue to advance its platform and accelerate pipeline development to bring life-changing benefits to cancer patients worldwide.