NWY001 Bispecific Antibody Phase 1 Trial Initiated for Advanced Solid Tumors

On January 5, 2024, a significant step was taken in the field of cancer treatment with the commencement of a phase I clinical trial for a groundbreaking bispecific antibody, NWY001. This trial, led by the Sun Yat-Sen University Cancer Center, marks the first time a PD-1/CD40 bispecific antibody has entered clinical study. The innovative drug is designed to target two pathways simultaneously, potentially reducing toxicity and transforming the way cancer is treated.

The clinical trial is structured as a multi-center, open-label, and non-randomized study that will assess the safety, tolerability, and preliminary efficacy of NWY001, along with its pharmacokinetics and possible biomarkers. This approach is crucial for patients with advanced solid tumors who have limited treatment options, especially those resistant to PD-(L)1 immune checkpoint inhibitors.

Dr. Bin Liu, the Scientific Director at Chipscreen NewWay, highlighted the importance of this milestone, stating that the unique mechanism of NWY001 could overcome the limitations of existing therapies, offering hope to a broader range of cancer patients. The support from the Sun Yat-Sen University Cancer Center and the dedication of the clinical teams at Chipscreen were acknowledged, along with gratitude towards the participating patients and their families.

In February 2023, Biocytogen Pharmaceuticals announced an exclusive licensing agreement with Chipscreen NewWay for the development and commercialization of NWY001 in Greater China. This collaboration signifies a strategic move to expand the reach of this pioneering treatment.

Chipscreen NewWay, a subsidiary of Chipscreen Biosciences, is an innovative biotech firm focused on developing novel therapeutics, including large molecules and nucleic acid drugs. The company's R&D center in Chengdu's Hi-Tech Zone houses a seasoned team working on antibody and ADC development, with several projects progressing rapidly.

Chipscreen Biosciences, established in 2001, is a biopharmaceutical company with a mission to develop original drugs that are both innovative and accessible. The company has created a state-of-the-art drug discovery platform and has a portfolio of original drugs targeting significant disease areas such as oncology and autoimmune diseases.

Biocytogen, a global biotech firm listed on the Hong Kong Stock Exchange, is known for its gene editing technology and platforms for antibody discovery. The company has a vast library of human antibody sequences and has established numerous partnerships for the development and licensing of therapeutic antibodies.

This collaboration and the ongoing clinical trial represent a significant advancement in the quest for more effective cancer treatments, with the potential to benefit patients globally.