• Spevatamig is Phanes’ anti-CLDN18.2/CD47 bispecific antibody that functions as an innate immunity enhancer (I₂E), an emerging class of immuno-oncology (IO) agents. Spevatamig is currently in Phase 2 studies for the treatment of multiple forms of gastrointestinal cancers.
• This designation highlights the unmet need for novel treatments for patients living with biliary tract cancer (BTC) and the potential of spevatamig for this indication.

SAN DIEGO, Aug. 14, 2026 /PRNewswire/ — Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology, announced that the U.S. Federal and Drug Administration (FDA) has granted Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma. 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.

“Spevatamig has the potential to be a transformational treatment option for patients with BTC,” said Ming Wang, PhD, MBA, CEO of Phanes. “Following the successful completion of enrollment in our Phase 2 clinical trial of spevatamig in combination with chemotherapy for the frontline treatment of metastatic pancreatic ductal adenocarcinoma, we are making significant progress in the Phase 2 study of the molecule in BTC.”

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 tumors, especially “cold tumors” that are less likely to respond to ICIs.

ABOUT SPEVATAMIG

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 Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

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. It has the potential to become the first I₂E for a solid tumor indication and is combinable with various anti-cancer therapies.

ABOUT PHANES THERAPEUTICS

Phanes Therapeutics, Inc. is a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology. Currently, it is conducting three Phase 2 clinical trials with spevatamig, peluntamig, and mavrostobart. Both spevatamig and peluntamig are first-in-class bispecific antibodies and have been granted orphan drug and Fast Track designations by the FDA.

The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody^®, SPECpair^® and ATACCbody^® to develop novel biologics that address high unmet medical needs in cancer.

For more information about Phanes Therapeutics, please visit www.phanesthera.com.

For business development or media inquiries, please contact bd@phanestx.com or media@phanestx.com, respectively.

View original content to download multimedia:https://www.prnewswire.com/news-releases/phanes-therapeutics-receives-fda-fast-track-designation-for-spevatamig-in-advanced-and-metastatic-biliary-tract-carcinoma-302851460.html

SOURCE Phanes Therapeutics, Inc.