Phanes Therapeutics Announces First-in-Class Claudin 18.2/CD47 Bispecific Antibody PT886 Doses First Patient in Phase I Clinical Trial in China
Phanes China
Antibody New Drug Developer
On July 12, Phanes Therapeutics, Inc. announced today that its self-developed, world's first bispecific antibody (dual antibody)PT886 has completed the first patient dosing in the Phase I clinical study in China。PT886 is a world-first bispecific antibody targeting claudin 18.2 and CD47, used for treatment.Gastric cancer, gastroesophageal junction cancer, and pancreatic cancer。
PT886, constructed through Phanes' proprietary bispecific antibody technology platforms PACbody® and SPECpair®, features a natural IgG structure. PT886 was granted FDA approval in June 2022 for the treatment of pancreatic cancer.Orphan Drug DesignationDetermined, and received FDA designation in March 2024Fast Track Designation, for the treatment of patients with metastatic claudin 18.2 positive pancreatic cancer.
The Phase I clinical trial launched in China aims to evaluate the safety, tolerability, PK/PD, and preliminary efficacy of PT886 in adult subjects with advanced gastric cancer, gastroesophageal junction cancer, and pancreatic cancer (CTR20241655), marking a critical step for Phanes in accelerating the transformation of innovative achievements to benefit patients in China.
PT886 in the U.S. multicenter Phase I/II clinical trial (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and pancreatic cancer.
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