Chipscreen NewWay Biosciences Initiates Phase I Clinical Trial

Chengdu Chipscreen NewWay Biosciences Co., Ltd. (NewWay) has marked a significant milestone with the initiation of the phase I clinical trial for NWY001, the world's first PD-1/CD40 bispecific antibody to enter clinical trials. The dosing of the first patient occurred on January 5, 2024, at Sun Yat-Sen University Cancer Center in China.

NWY001 aims to transform "cold" tumors into "hot" tumors, potentially enhancing cancer patients' sensitivity to PD-(L)1 immune checkpoint inhibitors, particularly those resistant to PD-(L)1 antibody monotherapy.

NWY001's unique mechanism involves the synergistic targeting of PD-1 and CD40 pathways, activating the CD40 pathway in a PD-1 dependent manner. This approach is designed to mitigate the common toxicities associated with CD40 agonistic monoclonal antibodies. The phase I clinical trial is a multi-center, non-randomized, open-label study focusing on evaluating safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors.

Dr. Bin Liu, Scientific Director of Chipscreen NewWay, expressed gratitude to Sun Yat-Sen University Cancer Center, Chipscreen's clinical and related teams, and the enrolled patients and their families. The initiation of the trial is expected to address the ineffectiveness or toxicity challenges posed by PD-(L)1 immune checkpoint inhibitor monotherapy and combination therapies involving CD40 agonists.

In a related development, on February 27th, 2023, Biocytogen Pharmaceuticals' subsidiary, Eucure (Beijing) Biopharma Co., Ltd., entered an exclusive licensing agreement with Chipscreen NewWay Biosciences for the clinical development and commercialization of bispecific antibody YH008 (NWY001) in Greater China, encompassing Mainland China, Hong Kong, Macau, and Taiwan.

Chipscreen NewWay, a biotech company affiliated with Chipscreen, is dedicated to developing large molecules and novel therapeutic modalities, with a focus on oncology and autoimmunity. The company has built an extensive molecular R&D center in Chengdu Hi-Tech Zone, employing an experienced team for antibody and ADC R&D projects. Chipscreen, established in 2001, is a biopharmaceutical company specializing in original drug development across various disease areas, including oncology, metabolic diseases, autoimmune diseases, central nervous system disorders, and antiviral therapies.

As the world eagerly awaits the results of the NWY001 phase I clinical trial, this groundbreaking PD-1/CD40 bispecific antibody represents a promising advancement in cancer treatment, offering hope for enhanced therapeutic outcomes in patients with advanced solid tumors.