- Mipletamig achieves an 85% remission rate in AML patients, with no cytokine release syndrome observed.
- Aptevo expands its CD3 portfolio with the preclinical candidate APVO455, targeting solid tumors.
- The CRIS-7 platform demonstrates effectiveness in developing tumor-specific immunotherapies.
Aptevo Therapeutics (APVO, Financial), a clinical-stage biotechnology company, has announced an expansion of its CD3-directed portfolio with the addition of a new preclinical candidate, APVO455, targeting Nectin-4+ cancers. This development marks a strategic shift from hematologic to solid tumors, leveraging Aptevo's proprietary CRIS-7 derived CD3 binding domain.
The company's portfolio now includes three CD3-engaging molecules: mipletamig (CD123 x CD3), APVO442 (PSMA x CD3), and the new APVO455 (Nectin-4 x CD3). Mipletamig is currently in a Phase 1b/2 trial for acute myeloid leukemia (AML) and has shown an 85% remission rate without cytokine release syndrome in initial RAINIER trial cohorts. APVO442 targets prostate cancer and remains in preclinical development.
APVO455, the latest preclinical addition, is designed to target solid tumors such as bladder, breast, non-small cell lung cancer (NSCLC), and head and neck cancers, where Nectin-4 is highly expressed. Unlike other T-cell engagers, APVO455 aims to activate immune responses only in the presence of Nectin-4 positive tumor cells, potentially offering a broader therapeutic window.
Aptevo’s strategic portfolio expansion is based on its CRIS-7 platform's successful clinical validation, which promises tumor-specific immune activation with limited systemic toxicity. The company plans to continue enhancing its CD3 suite in pursuit of innovative cancer therapies.
