The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Phanes Therapeutics’ spevatamig for the treatment of patients with advanced and metastatic biliary tract carcinoma (BTC).
Spevatamig is an investigational immuno-oncology treatment being developed by Phanes, a clinical-stage biotechnology company focused on developing new cancer therapies. The FDA’s Fast Track designation is intended to speed the development and review of medicines that address serious conditions with an unmet medical need.
The latest designation adds to the regulatory support already received for spevatamig. In 2024, the FDA granted the drug Fast Track designation for patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma. In 2022, spevatamig also received orphan drug designation for metastatic pancreatic cancer.
Phanes is currently studying spevatamig in clinical trials for pancreatic and biliary cancers. The company recently expanded its clinical trial collaboration with Merck to evaluate spevatamig in combination with pembrolizumab as a first-line treatment for biliary tract carcinoma.
“Spevatamig has the potential to be a transformational treatment option for patients with BTC,” said Ming Wang, PhD, MBA, CEO of Phanes Therapeutics. He said the company is making progress in its Phase 2 study of spevatamig in biliary tract carcinoma after completing enrollment in another Phase 2 trial of the drug combined with chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma.
Spevatamig belongs to a newer class of immuno-oncology treatments known as immune-to-effector (I2E) agents. These therapies are designed to activate immune cells, including macrophages and dendritic cells, so they can recognize and attack cancer cells.
The approach could complement immune checkpoint inhibitors (ICIs), which work by helping the immune system recognize and fight tumors. Phanes believes I2E therapies may be particularly useful against “cold tumors,” which often have limited immune activity and may respond poorly to checkpoint inhibitors.
Biliary tract cancer includes cancers that develop in the bile ducts and other parts of the biliary system. Advanced and metastatic disease can be difficult to treat, creating a need for new treatment options.
Phanes is evaluating whether spevatamig can improve treatment outcomes by using the body’s immune system to target cancer cells through a mechanism that differs from existing immunotherapies.
The Fast Track designation allows the FDA to work more closely with drug developers during the development process and may support more frequent communication and faster review of applications when eligibility requirements are met.
Spevatamig remains an investigational treatment, and its safety and effectiveness have not yet been established by the FDA.