Phanes Therapeutics Inc, a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced on Monday that the first patient has been dosed in the clinical study of spevatamig in combination with chemotherapy for the treatment of biliary tract carcinoma (BTC).

Phanes says that Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024.

In 2023, Phanes entered into a clinical collaboration agreement with US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, to study spevatamig in combination with Merck's anti-PD-1 therapy, pembrolizumab.

The multi-center Phase I/II clinical trial of spevatamig, known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas.

The Phase I and Phase II clinical trials of spevatamig in China are currently recruiting patients.