Spevatamig

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. Aug. 14, 2026 -- 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. 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. 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. The content above comes from the network. if any infringement, please contact us to modify.

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. The expansion of the clinical trial collaboration, originally entered in 2023, now includes spevatamig in combination with KEYTRUDA® and chemotherapy for the frontline (1L) treatment of biliary tract cancer (BTC). SAN DIEGO, July 21, 2026 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, has expanded their clinical trial collaboration with Merck (known as MSD outside of the US and Canada) to study spevatamig in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and chemotherapy in 1L BTC. "We are very pleased to expand the clinical trial collaboration and supply agreement to include BTC, a devastating cancer with high unmet medical needs," said Ming Wang, PhD, MBA, CEO of Phanes. "This reflects our vision of leveraging the combination of innate immunity enhancers (I2Es) with other therapies to target hard-to-treat cancers." 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 potential complementary mechanism to leverage the immune system to attack tumors, especially the so-called "cold tumors" that are less likely to respond to immune checkpoint inhibitors (ICIs). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 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 of 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 efficacy of spevatamig in combination with chemotherapy in first-line PDAC patients. Spevatamig is a novel immunotherapy which 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 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 . For business development or media inquiries, please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics, Inc. 21% more press release views with Request a Demo