Phanes Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of Spevatamig in Combination with Chemotherapy for the Frontline Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
- Two dose levels of spevatamig in combination with standard of care chemotherapy are being evaluated as frontline (1L) treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) in the Phase 2 study.
- Initial data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the efficacy signal at the 2 mg/kg dose level and initial safety and tolerability data at the 3 mg/kg dose level.
- Completion of the PDAC enrollment represents a significant milestone for the TWINPEAK study, which is a basket trial assessing the safety, tolerability and potential efficacy of spevatamig in combination with various standard of care agents indicated for gastrointestinal (GI) cancers.
- Topline results from the PDAC Phase 2 study are expected by 2026 year-end.
SAN DIEGO, June 22, 2026 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology (IO), today announced the completion of enrollment in its Phase 2 study of spevatamig in combination of standard of care chemotherapy for metastatic PDAC in the 1L setting.
"This marks an important milestone in our mission to advance innovative therapies that help improve outcomes for patients with hard-to-treat cancers," said Ming Wang, PhD, MBA, CEO of Phanes. "PDAC is the first cancer type we are targeting with spevatamig; there is more to come."
Spevatamig is a bispecific antibody targeting CLDN18.2 and CD47 that functions as an innate immunity enhancer (I2E), an emerging class of IO agents. I2Es are expected to activate macrophages and dendritic cells to recognize and destroy cancer cells, providing an alternative immune-stimulating mechanism complementary to immune checkpoint inhibitors (ICIs) to attack tumors, especially "cold tumors" that are less likely to respond to ICIs.
Spevatamig is being evaluated in various GI cancers, including 1L metastatic PDAC, and has been dosed in over 200 patients globally. PDAC is a devastating cancer, and treatment has been largely limited to systemic chemotherapy which only offers a short duration of benefit due to development of resistance and cumulative toxicity. The impact on society is only expected to increase, as incidence of PDAC is rising. Thus, novel approaches capable of producing more durable responses are urgently needed. Although immunotherapies such as agents targeting PD-1/PD-L1 or CTLA-4 have been explored in many PDAC trials, few have demonstrated meaningful therapeutic benefit.
"Spevatamig was discovered in our lab in San Diego; its unique molecular design enables targeting solid tumors without causing significant hematological toxicity, an issue that has been seen with other CD47-targeting agents in the past," said Phanes' CEO. "We believe our approach can be applied to other tumor types. This could be a new frontier for targeting solid tumors."
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 [email protected] or [email protected], respectively.
SOURCE Phanes Therapeutics, Inc.
Share this article