Chipscreen NewWay: First Patient Dosed in Phase 1 Trial of the Bispecific Antibody NWY001, a Next-generation Tumor Immunotherapy in Patients with Advanced Solid Tumors

CHENGDU, China, Jan. 16, 2024 /PRNewswire/ -- Chengdu Chipscreen NewWay Biosciences Co., Ltd. (NewWay) announced 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. 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.

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).

About Chipscreen NewWay

Chipscreen Newway, affiliated with Chipscreen, is an innovative and R&D-driven biotech company dedicated to developing large molecules and other novel therapeutic modalities, including antibodies/ADC-centered large molecules, and nucleic acid drugs.

It develops innovative drugs that meet clinical needs and novel mechanisms of action in multiple therapeutic areas such as oncology and autoimmunity while providing patients with innovative mechanisms and globally leading-based new therapeutic approaches and options.

Chipscreen Newway has built a large molecular R&D center of over 3,000 square meters in Chengdu Hi-Tech Zone and has established an experienced antibody and ADC R&D team from the discovery to the early process development, with a number of in-house and cooperation projects in continuous and rapid advancements.

About Chipscreen

Chipscreen is a modern biopharmaceutical company founded in 2001 by a seasoned team of professionals who returned to China after studying in the United States. The company specializes in the development of original new molecular entity drugs and is committed to providing innovative drugs with revolutionary therapeutic effects that are affordable for patients worldwide and are in high clinical demand.

Leveraging its independently created state-of-the-art "Chemical Genomics-Based Integrated Drug Discovery and Early Evaluation Platform", Chipscreen has developed multiple original drug product lines in five significant disease areas, including oncology, metabolic diseases, autoimmune diseases, central nervous system disorders, and antiviral therapies. These product lines include chidamide (Tucidinostat marketed), chiglitazar (Carfloglitazar marketed), chiauranib (Ibcasertib in pivotal phase III clinical trial), and CS12192 (phase I clinical trial currently underway).

Currently, Chipscreen has established a global presence through its headquarters and R&D center in Shenzhen, with a wholly-owned subsidiary "Shenzhen Chipscreen Pharmaceuticals Co., Ltd." serving as a GMP production base. Additionally, it has a regional headquarters/R&D center/innovative drug production base - "Chengdu Chipscreen Pharmaceuticals Co., Ltd." focusing on the field of small-molecule innovative drugs, and a subsidiary "Chengdu Chipscreen Newway Biosciences Co., Ltd." dedicated to the development of large molecules and other novel therapeutic technologies. The company also maintains branches in Beijing (Clinical Research Center) and Shanghai (Business Center). Furthermore, Chipscreen extends its global footprint, with Chipscreen Biosciences (United States) Limited set up for global clinic development in the United States, embodying a comprehensive globalization strategy.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® (RenMab™/RenLite^®/RenNano^®/RenTCR-mimic^™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg).