Phanes Therapeutics Announces Promising Phase II Clinical Data of Spevatamig, a CLDN18.2/CD47 Bispecific Antibody, in First-Line Metastatic Pancreatic Ductal Adenocarcinoma

January 9, 2026, San Diego, California

• At the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium（ASCO GI 2026）The published data shows that spevatamig(A bispecific antibody targeting CLDN18.2/CD47)Combination chemotherapy GnP has the potential to become a treatment for CLDN18.2-positive metastatic pancreatic ductal adenocarcinoma.（mPDAC）Effective first-line treatment options for patients.

•Spevatamig's unique molecular design reduces blood toxicity and improves gastrointestinal tolerance.(Nausea and Vomiting), which was supported by the TWINPEAK study(More than 100 patients enrolled in the United States)Data support.

• Compared with previously published data on the GnP regimen for first-line treatment of mPDAC, spevatamig 2 mg/kg once weekly + GnP regimen demonstrated encouraging efficacy, while data for spevatamig 3 mg/kg once weekly + GnP regimen are still maturing.

•Spevatamig is a novel immunotherapy with the potential to become the first "innate immunity" enhancer for solid tumor indications and can be combined with various cancer therapies.

Phanes Therapeutics, Inc.（Phanes）Phanes Therapeutics, a clinical-stage biotechnology company focused on the discovery and development of innovative drugs in the field of oncology, announced the evaluationSpevatamig Combined with Chemotherapy for First-Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma（mPDAC）The First Clinical Data. The data was presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium（ASCO GI 2026）Published on; Abstract Number #709. This is the first time Phanes Therapeutics Inc. has publicly released data from its ongoing multi-center clinical trial of spevatamig in the United States.

TWINPEAK Study（NCT05482893）Is an ongoing multi-cohort Phase I dose-escalation study of single-agent therapy for patients with gastrointestinal tumors, as well as a Phase II combination expansion and dose optimization study. The combination expansion cohorts include combinations with chemotherapy and/or immune checkpoint inhibitors. As of December 12, 2025, 107 patients in the United States have received either single-agent or combination therapy with spevatamig. Forty-two patients with mPDAC received first-line treatment with various dosing regimens of spevatamig + GnP. At the ASCO GI 2026 conference, the company presented data on the 2 mg/kg spevatamig once-weekly dosing regimen + GnP. Data for the >2 mg/kg spevatamig once-weekly dosing regimen + GnP are still maturing. Notably:

•Spevatamig has demonstrated a good safety profile. In monotherapy, no cytokine release syndrome was observed.（CRS）Or Dose-Limiting Toxicity（DLT）. The maximum tolerated dose has not been reached in either monotherapy or combination therapy.（MTD）No adverse events of ≥3 grade anemia, neutropenia, or thrombocytopenia were observed during the study period.（TEAE）。

• At the dose level of 2 mg/kg spevatamig administered weekly + GnP, the incidence rates of anemia, neutropenia, and thrombocytopenia were comparable to those observed in the GnP treatment group in key clinical trials. No ≥Grade 3 nausea or vomiting events occurred during treatment, and there were no dose reductions or treatment discontinuations due to nausea or vomiting. No cytokine release syndrome was observed.（CRS）。

• In the regimen of 2 mg/kg spevatamig administered weekly + GnP as first-line treatment for mPDAC（n=15）, Disease Control Rate（DCR）93%, Objective Response Rate（ORR）For 40%(6/15 achieved partial response, with 1 patient pending confirmation)。

• Median Progression-Free Survival（mPFS）was 7.3 months, with a 6-month PFS rate of 59%. Median overall survival（mOS）At 13.2 months and still maturing, the 6-month OS rate was 93%.

• Treatment responses were observed in patients with CLDN18.2 scores ≥10% (≥2+ staining). Notably, 85% of screened patients met this CLDN18.2 threshold requirement.

Data for Phanes Therapeutics' spevatamig presented at ASCO GI 2026 can be accessed here: https://www.phanesthera.com/our-science/

About SPEVATAMIG

Spevatamig is a first-in-class bispecific antibody with a native IgG structure that targets Claudin 18.2 and CD47. In 2022, Spevatamig was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. In 2024, it received Fast Track Designation from the FDA for the treatment of metastatic Claudin 18.2-positive pancreatic cancer patients. In 2023, Phanes Therapeutics partnered with Merck.(known as MSD outside the United States and Canada)Reach a clinical trial collaboration agreement to study the combination of spevatamig and Merck's anti-PD-1 therapy, pembrolizumab.

Multicenter Phase I/II Clinical Trial of Spevatamig（NCT05482893）, namely the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal, or biliary tract adenocarcinoma. The Phase II clinical study of Spevatamig has been initiated in China.

About PHANES THERAPEUTICS

Phanes Therapeutics, Inc. is a clinical-stage biotechnology company focused on the discovery and development of innovative drugs in the field of oncology. The company is currently conducting three Phase I/II clinical trials, including the MORNINGSTAR study evaluating mavrostobart, a best-in-class monoclonal antibody, the TWINPEAK study evaluating spevatamig, and the SKYBRIDGE study evaluating peluntamig. Both spevatamig and peluntamig are first-in-class bispecific antibodies and have received Orphan Drug Designation and Fast Track Designation from the FDA.

Phanes Therapeutics, Inc. is developing novel bispecific antibodies with enhanced stability, manufacturability, and tunable immune activity through its proprietary technology platforms PACbody®, SPECpair®, and ATACCbody®.

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