On January 16, 2024 Chengdu Chipscreen NewWay Biosciences Co., Ltd. (NewWay) reported that on January 5, 2024, the dosing of the first patient for a phase I clinical trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001, at Sun Yat-Sen University Cancer Center in China, the trial-leading institution (Press release, Shenzhen Chipscreen Biosciences, JAN 16, 2024, View Source [SID1234639275]). The trial is a multi-center, non-randomized, open-label, multi-dose phase I clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors.
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NWY001 is world’s first PD-1/CD40 bispecific antibody entering clinical study. Mechanistically, the bsAb targets two targets synergistically and can activate the CD40 pathway in a PD-1 dependent manner, reducing the potential toxicity commonly associated with CD40 agonistic monoclonal antibody (mAb). It is expected that this bsAb can transform "cold" tumors into "hot" tumors, thereby increasing cancer patients’ sensitivity to PD-(L)1 immune checkpoint inhibitors, especially PD-(L)1 antibody resistant cancer patients.
Dr. Bin Liu, Scientific Director of Chipscreen NewWay, said:
"Dosing of the first patient marks a significant milestone for the clinical development of NWY001. Its unique mechanism is expected to circumvent the ineffectiveness or toxicity caused by PD-(L)1 immune checkpoint inhibitor monotherapy, CD40 agonists, or their combination therapy, therefore benefiting more cancer patients. We thank the experts at Sun Yat-Sen University Cancer Center for their great support, the clinical and related teams at Chipscreen for their efforts, and the patients enrolled in this NWY001 clinical trial and their families."
February 27th, 2023 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd., has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences, a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences", SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 (NWY001) in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).