SAN DIEGO, April 7, 2026
Phanes Therapeutics, Inc. has announced the initiation of the dose expansion phase in its clinical study of spevatamig, a novel bispecific antibody, in combination with chemotherapy for the treatment of biliary tract cancer (BTC), following successful dose-limiting toxicity (DLT) clearance at two dose levels. This milestone marks a critical advancement in the company’s oncology pipeline and highlights the growing role of next-generation biologics in addressing hard-to-treat cancers with high unmet medical need.
Dose Expansion Signals Clinical Progress and Safety Validation
The transition into the dose expansion phase represents a key clinical milestone, indicating that spevatamig has demonstrated an acceptable safety profile during earlier dose-escalation stages. With DLT clearance achieved, the study now progresses to evaluate the therapy in a larger patient population to further assess efficacy, tolerability, and optimal dosing strategy.
Spevatamig is being investigated in combination with chemotherapy, reflecting a combination therapy approach increasingly used in oncology to enhance treatment outcomes. Biliary tract cancer remains a challenging and aggressive malignancy with limited treatment options, making this advancement particularly significant. The expansion phase will provide deeper insights into how the therapy performs in real-world clinical settings and whether it can deliver meaningful clinical benefits for patients.
Innovative Bispecific Antibody Targets Dual Cancer Pathways
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Spevatamig is a first-in-class native IgG-like bispecific antibody designed to simultaneously target claudin 18.2 and CD47, two critical pathways involved in tumor growth and immune evasion. This dual-targeting mechanism enables the therapy to directly attack tumor cells while enhancing the immune system’s ability to recognize and eliminate cancer, offering a potentially more effective and durable treatment strategy.
The drug has already received Orphan Drug Designation (ODD) from the U.S. FDA for pancreatic cancer and Fast Track Designation for metastatic claudin 18.2-positive pancreatic adenocarcinoma, underscoring its potential to address serious conditions with unmet medical needs. These regulatory designations also support accelerated development and review pathways, highlighting the therapy’s promise within the oncology landscape.
Phanes has further strengthened its development strategy through a clinical collaboration with Merck, evaluating spevatamig in combination with pembrolizumab, an anti-PD-1 immunotherapy, demonstrating a commitment to exploring multi-modal treatment approaches that integrate immunotherapy with targeted biologics.
Expanding Clinical Pipeline and Global Development Efforts
Phanes Therapeutics continues to advance a robust pipeline of innovative biologics targeting cancer, leveraging its proprietary platforms such as PACbody®, SPECpair®, and ATACCbody® to develop next-generation therapies. The company is currently conducting multiple Phase 2 clinical trials across various oncology indications, including pancreatic ductal adenocarcinoma (PDAC) and other solid tumors.
As of March 2026, more than 160 patients have been dosed globally with spevatamig, both as a monotherapy and in combination settings, providing a growing body of clinical data to support its development. Additionally, the company is set to present three clinical posters at the American Association for Cancer Research (AACR) Annual Meeting 2026, further highlighting its scientific progress and commitment to advancing oncology research.
These developments position Phanes as a key player in the biopharmaceutical innovation space, particularly in the field of bispecific antibodies and targeted cancer therapies, where precision medicine is rapidly transforming treatment paradigms.
The initiation of the dose expansion phase for spevatamig marks a significant step forward in clinical development, reinforcing its potential as a novel, first-in-class bispecific antibody for the treatment of biliary tract cancer and other malignancies. With strong clinical momentum, regulatory support, and innovative technology platforms, Phanes Therapeutics is well-positioned to contribute to the next generation of cancer therapeutics, offering new hope for patients facing limited treatment options.
Source: Phanes Therapeutics press release
