Phanes Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for spevatamig to treat patients with advanced and metastatic biliary tract carcinoma (BTC).

The company is evaluating spevatamig in Phase II clinical studies for various gastrointestinal cancers.

Spevatamig is a bispecific antibody targeting claudin 18.2 and cluster of differentiation 47 (CD47), designed to function as an innate immunity enhancer (I₂E).

The fast track designation for BTC follows other recent regulatory milestones for spevatamig.

In 2024, the antibody received the designation for metastatic claudin 18.2-positive pancreatic adenocarcinoma, and orphan drug status for metastatic pancreatic cancer in 2022.

Phanes Therapeutics expanded a clinical trial partnership with Merck & Co (MSD) last month to examine spevatamig in combination with pembrolizumab as a first-line treatment for BTC.

The companies began their collaboration in 2023 to study this combination therapy.

Phanes Therapeutics CEO Ming Wang said: “Spevatamig has the potential to be a transformational treatment option for patients with BTC.

"Following the successful completion of enrolment in our Phase II clinical trial of spevatamig in combination with chemotherapy for the front-line treatment of metastatic pancreatic ductal adenocarcinoma, we are making significant progress in the Phase II study of the molecule in BTC.”

The company is conducting three separate Phase II studies of its pipeline assets, notably spevatamig, peluntamig, and mavrostobart.

Both spevatamig and peluntamig are described as first-in-class bispecific antibodies and secured fast track and orphan drug status from the FDA.

The company’s pipeline is built using its PACbody, SPECpair and ATACCbody technology platforms, with the aim of addressing significant unmet needs in cancer treatment.