China-based Chengdu Chipscreen NewWay Biosciences Co., Ltd has announced that the first patient has been dosed in a Phase I clinical trial for its investigational PD-1/CD40 bispecific antibody (BsAb) candidate, NWY001. The multi-center, non-random, open-label trial is conducted under the leadership of Sun Yat-Sen University Cancer Center, with objectives to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors.
Chipscreen NewWay, a subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), highlights that NWY001 is a potential first-in-class global molecule, marking the first PD-1/CD40 targeted BsAb to enter the clinical stage. The molecule is designed to activate the CD40 pathway synergistically in a PD-1 dependent manner, which is expected to mitigate the toxicity issues typically associated with CD40 agonistic antibodies. This innovative approach aims to convert ‘cold’ tumors to ‘hot’, thereby increasing patient sensitivity to PD-(L)1 inhibition, particularly for cancer patients who have developed resistance to PD-(L)1 antibody treatment.
NewWay previously entered into an exclusive licensing agreement with Eucure (Beijing) Biopharma Co., Ltd, a subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd, granting clinical development and commercialization rights for NWY001 (YH008) to Eucure for the Greater China region, including Mainland China, Hong Kong, Macau, and Taiwan.- Flcube.com