Chinese biopharmaceutical company Chengdu Chipscreen NewWay Biosciences has dosed the first subject in a Phase I trial of the antibody NWY001 for solid tumours.

The trial aims to assess the safety, tolerability and preliminary efficacy of the PD-1/CD40 bispecific antibody in patients with advanced solid tumours.

It is being conducted at Sun Yat-Sen University Cancer Center in China.

NWY001 is understood to be the world’s first bispecific antibody to enter clinical studies.

It is designed to synergistically target two pathways and activate the CD40 pathway in a PD-1 dependent manner. This approach may reduce the toxicity often associated with CD40 agonistic monoclonal antibodies.

The treatment has the potential to convert ‘cold’ tumours into ‘hot’ tumours, enhancing the effectiveness of PD-(L)1 immune checkpoint inhibitors, particularly for patients resistant to PD-(L)1 antibodies.

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By GlobalData

Chipscreen NewWay scientific director Dr Bin Liu 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 benefitting 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.”

Chipscreen Newway is a subsidiary of Chipscreen, a biopharmaceutical company that focuses on developing original new molecular entity drugs.

In February last year, Biocytogen Pharmaceuticals’ subsidiary Eucure Biopharma signed an exclusive licensing agreement with Chipscreen NewWay for the development and commercialisation of YH008 (NWY001) in Greater China.

The agreement covers the territories of Mainland China, Hong Kong, Macau and Taiwan.

YH008 (NWY001) is a bispecific antibody indicated for the treatment of solid tumours.