SAN DIEGO, June 22, 2026
Phanes Therapeutics, Inc. has announced the completion of patient enrollment in its Phase 2 clinical trial evaluating spevatamig in combination with standard-of-care chemotherapy as a first-line (1L) treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). The milestone marks a significant advancement for the company’s TWINPEAK basket study, which is investigating the safety, tolerability, and efficacy of spevatamig, a first-in-class bispecific antibody targeting CLDN18.2 and CD47, across multiple gastrointestinal (GI) cancers. Topline Phase 2 results are expected by the end of 2026, positioning the program as one of the most closely watched immuno-oncology developments for pancreatic cancer, a disease with limited therapeutic options and persistently poor survival outcomes.
Phase 2 Enrollment Milestone Advances Pancreatic Cancer Program
The completion of enrollment represents an important step toward evaluating whether spevatamig combined with chemotherapy can improve outcomes for patients with previously untreated metastatic PDAC, one of the deadliest solid tumors worldwide. The Phase 2 trial is investigating two dose levels—2 mg/kg and 3 mg/kg— alongside standard chemotherapy in frontline treatment. Earlier findings presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated a promising efficacy signal at the 2 mg/kg dose while also reporting encouraging initial safety and tolerability data at the higher 3 mg/kg dose level. These preliminary findings provided clinical support for continuing patient enrollment and reinforced the therapeutic potential of the investigational antibody. The completion of enrollment now enables the study to progress toward comprehensive efficacy and safety analyses, with topline clinical results anticipated later this year.
First-in-Class Bispecific Antibody Targets Hard-to-Treat Solid Tumors
Spevatamig is designed as a native IgG-like bispecific antibody that simultaneously targets CLDN18.2, a tumor-associated antigen frequently expressed in gastrointestinal cancers, and CD47, a key immune checkpoint that enables cancer cells to evade destruction by the immune system. By combining these targets, the investigational therapy functions as an Innate Immunity Enhancer (I2E), stimulating macrophages and dendritic cells to recognize and eliminate tumor cells while potentially avoiding the hematologic toxicities previously associated with conventional CD47-targeting therapies. Unlike traditional immune checkpoint inhibitors that primarily activate T cells, this novel mechanism seeks to enhance the body’s innate immune response, making it particularly attractive for treating “cold tumors” such as pancreatic cancer that generally respond poorly to existing immunotherapies. To date, more than 200 patients worldwide have received spevatamig across multiple clinical studies, supporting its continued development in gastrointestinal malignancies.
Advertisement
Regulatory Momentum Supports Future Clinical Development
Phanes Therapeutics has continued to build strong regulatory momentum for the program. Spevatamig received FDA Orphan Drug Designation in 2022 for pancreatic cancer and was subsequently granted Fast Track Designation in 2024 for patients with metastatic CLDN18.2-positive pancreatic adenocarcinoma, highlighting the significant unmet medical need in this indication. The company also established a clinical collaboration with Merck to evaluate spevatamig in combination with pembrolizumab (KEYTRUDA®) alongside chemotherapy in gastrointestinal cancers, further expanding its development strategy. Leveraging its proprietary PACbody®, SPECpair®, and ATACCbody® technology platforms, Phanes continues advancing a pipeline of innovative bispecific antibodies designed to improve outcomes for patients with difficult-to-treat cancers. With enrollment now complete in the PDAC Phase 2 study, the upcoming topline data will play a critical role in determining the next stage of clinical development and the future potential of this first-in-class immuno-oncology therapy.
Source: Phanes Therapeutics Press release
