PrimeLink Bio Achieves ADC Pipeline Breakthrough: First Patient Dosed in Phase I Trial of PLB-002

PrimeLink Bio, an innovative biopharmaceutical company focused on the development of next-generation Antibody-Drug Conjugates (ADCs), recently announced that the first subject has been dosed in the Phase I clinical trial of its independently developed Category 1 innovative drug PLB-002 (anti-Claudin 6 ADC).

This phase I, open-label, multicenter, dose-escalation and expansion study will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of PLB-002 in adults with advanced solid tumors.

PLB-002 is independently developed by PrimeLink Bio based on its proprietary next-generation flexible modular technology platform named ENHANMIX^®. The drug targets Claudin 6 with significant differentiation advantages. Its indications in ovarian cancer, non-small cell lung cancer, and other tumors represent areas of urgent unmet clinical needs. Currently, only a handful of ADCs with the same target have entered Phase I/II clinical trials globally. Through PrimeLink Bio's custom screening platform, PLB-002 has demonstrated significant Best-in-Class potential in preclinical studies. In animal models, its antitumor efficacy and PK properties are superior to the benchmark ADC. The safety profile of this pipeline has also been validated in non-human primate toxicology studies, with a therapeutic index over 19. Also, PLB-002 has already shown the potential for better tolerability compared to ADCs with the same payload.

Dr. Yin, founder of PrimeLink Bio, stated: "The successful first-subject dosing of PLB-002 marks the entry of the company's core ADC pipeline into the clinical stage, and we are full of anticipation for the good results. Moving forward, we will continue to increase R&D investment to accelerate clinical development, and bring this therapy to patients as soon as possible. Leveraging our proprietary, highly hydrophilic, modular next-generation ENHANMINX^®, PrimeLink Bio is simultaneously advancing novel ADC pipelines such as dual-payload and bispecific ADCs. We remain committed to a proactive and open approach in both pipeline development and technology collaboration."

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. PLB-002, developed on PrimeLink Bio's proprietary platform ENHANMIX^®, offers a broad therapeutic window and favorable 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

PrimeLink Bio, founded in July 2021 by Dr. Yin Mao, is an innovative biopharmaceutical enterprise dedicated to developing next-generation antibody-drug conjugates (ADCs). Guided by the core philosophy of "tailoring the optimal ADC structure for each target," the company has independently developed a flexible, modular technology platform named ENHANMIX^®. Featuring high hydrophilicity, compatibility, and flexibility, ENHANMIX^® provides a novel approach to addressing safety and resistance challenges in ADC therapeutics.

Leveraging its innovative ENHANMIN^® and differentiated product pipeline, PrimeLink Bio has established a robust portfolio encompassing single-target ADCs and novel modalities such as bispecific ADCs and dual-payload ADCs. The company has secured investments from leading domestic and international institutional investors including Vertex Ventures, Fosun Pharma, Kaitai Capital, and Shenzhen Mangrove Capital, raising a total of RMB 150 million. PrimeLink Bio has also been honored with multiple prestigious awards, including the "Top 100 Chinese Pharmaceutical Innovation Value Discovery Companies 2022-2023," National "Technology-based SME," Shenzhen "Innovative SME," "Specialized and Innovative SME," and "Seed Unicorn Enterprise" designations, as well as "Outstanding Enterprise" at the 13th China Innovation and Entrepreneurship Competition.

Moving forward, PrimeLink Bio will continue to evolve its platform technology and advance its product pipeline to benefit cancer patients worldwide.