Seagen and Sanofi Initiate Phase 1 Clinical Trial of CEACAM5-Targeting ADC SGN-CEACAM5C in Advanced Solid Tumors

Induced in 4 CRC PDX modelsEffective Dose-Dependent Antitumor Activity。

In a single-mouse trial involving 16 CRC PDX models, with one animal per treatment group for each PDX model, the results showed a disease control rate of 95% and an overall response rate of 50% after a single ADC dose of 10 mg/kg.

CEACAM5 (CEA) is a glycosylphosphatidylinositol-anchored glycoprotein that is highly expressed on the cell surface of various epithelial tumors.Including colon cancer, stomach cancer, pancreatic cancer, ovarian cancer, and lung cancer,Among which it is highly expressed in approximately 90% of colorectal cancers.

Earlier, SeagenSanofi引进自ImmunogenThrough OneCEACAM5 ADC（Tusamitamab ravtansine), followed by Innovent BiologicsIntroduce its clinical development and exclusive commercial rights in China. This is also the only CEACAM5-targeted drug currently in Phase 3.

Tusamitamab ravtansine is composed of a humanized monoclonal antibody (SAR408377) and DM4, conjugated via a cleavable linker (SPDB) developed by ImmunoGen, with a DAR of 3.8.

At this year's European Lung Cancer Conference (ELCC), Sanofi presented the latest Phase II data for its treatment of nsq NSCLC.

Among 25 patients treated at any regimen and dose level, the ORR was 52% (95% CI: 31.3%-72.2%), with all responders (n=13) achieving confirmed partial responses (PR). The stable disease rate was 36% (9/25), and the progressive disease rate was 12% (2/25). The disease control rate (DCR) was 88% (95% CI: 68.8%-97.5%).

In the T2 cohort, which studied TUSA + pembrolizumab treatment, the ORR and DCR were both 100% in patients receiving 150 mg/m² TUSA (n=3).

According to publicly available data, there are currently approximately nine CEACAM5-targeted drugs in clinical trials, involving ADCs, antibodies, and CAR-T therapies. In China, BeiGene, Limin, and Promab are all developing related antibody drugs.

Gimma Biotech provides ready-to-use CEACAM5 overexpression cells/antibodies and related customization services, meeting the needs for early drug screening and activity testing. (For more information, contact 18916119826, same number on WeChat.)