Phanes Therapeutics Inc, a California-based, clinical-stage biotech company involved in innovative drug discovery and development in immuno-oncology, announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma (BTC).

Spevatamig was also granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and orphan drug designation for metastatic pancreatic cancer in 2022. Recently, Phanes has expanded its clinical trial collaboration with Merck to study spevatamig in combination with pembrolizumab for the frontline (1L) treatment of BTC.

According to Phanes, Spevatamig is an I2E, an emerging class of IO agents. I2Es are expected to activate macrophages and dendritic cells to recognize and destroy cancer cells, providing a mechanism complementary to immune checkpoint inhibitors (ICIs) to leverage the immune system to attack tumours, especially 'cold tumors' that are less likely to respond to ICIs.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the safety, tolerability and efficacy of spevatamig in combination with chemotherapy in patients with PDAC in the first-line setting. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. According to the company, it has the potential to become the first I2E for a solid tumour indication and is combinable with various anti-cancer therapies.