Phanes Therapeutics Announces Updated Phase 2 Clinical Trial Results of Spevatamig (PT886) in Combination with Chemotherapy in Frontline Treatment of Metastatic PDAC at the ...

Phanes Therapeutics announced updated Phase 2 clinical trial results for spevatamig (PT886), an anti-CLDN18.2/CD47 bispecific antibody, in combination with chemotherapy for frontline treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026, the data demonstrated promising efficacy with a 2 mg/kg weekly dose, achieving a 52.4% objective response rate (ORR) and 90.5% disease control rate (DCR) in patients with metastatic PDAC. More than 90% of patients at this dose level had de novo metastatic disease, aligning with Phase 3 trial populations. Median progression-free survival (mPFS) was 7.3 months, and median overall survival (mOS) reached 14.7 months in US patients, with a median follow-up time of 14.7 months. The combination therapy showed no significant additive toxicity compared to chemotherapy alone, with optimized anti-CD47 design improving gastrointestinal tolerability and reducing hematological toxicity. Phanes noted that spevatamig, an innate immunity enhancer (I2E), targets 'cold tumors' resistant to immune checkpoint inhibitors (ICIs) by activating macrophages and dendritic cells. The company is rapidly enrolling patients for the 3 mg/kg dose level, with efficacy data expected in the second half of 2026, potentially leading to a Phase 3 trial shortly afterward. Spevatamig, a first-in-class bispecific antibody, received orphan drug designation from the FDA in 2022 for pancreatic cancer and Fast Track designation in 2024 for metastatic claudin 18.2-positive PDAC. Phanes also collaborates with Merck to study spevatamig in combination with pembrolizumab. The drug’s novel mechanism distinguishes it from traditional ICIs, offering an alternative for patients with aggressive PDAC, where treatment options remain limited. CEO Ming Wang emphasized the significance of targeting PDAC, a 'cold tumor' unresponsive to ICIs, and expressed confidence in advancing spevatamig as the first innate immunity enhancer for solid tumors. The company aims to accelerate development to deliver an innovative immunotherapy for metastatic PDAC patients. Clinical trials are ongoing across multiple cancer indications, reinforcing Phanes’ focus on pioneering oncology treatments.