On August 13, 2025 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported the strategic importance of its preclinical asset APVO442-an investigational CD3-engaging bispecific antibody designed to treat prostate cancer (Press release, Aptevo Therapeutics, AUG 13, 2025, View Source [SID1234655211]). APVO442 is built on Aptevo’s next-generation ADAPTIR-FLEX platform and is engineered to selectively activate T cells within the PSMA-expressing tumor microenvironment, offering potential for precision targeting and reduced systemic toxicity.
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APVO442 is built on the same CRIS-7-derived anti-CD3 binding domain as clinical candidate mipletamig but is specifically engineered for solid tumors, with lower binding affinity and a monovalent format that reduce the risk of immune activation outside the tumor. This design helps ensure that T cells are activated only within the tumor microenvironment, improving safety while maintaining anti-tumor potency. Preclinical data show that APVO442 effectively localizes to PSMA-expressing prostate tumors, triggering a targeted immune response while potentially sparing healthy tissue. The same solid tumor-optimized architecture has also been applied to newly added pipeline candidate APVO455.
"With mipletamig performing as designed in the clinic and the addition to the pipeline of APVO455 for multiple solid tumors, we’re confident in the strength of our CD3-based bispecific approach," said Marvin White, President and CEO of Aptevo. "APVO442 is engineered for the same balance-potent immune activation precisely where it’s needed – in the tumor. It represents yet another high-conviction opportunity to expand into solid tumors, a market where the need is large and growing."
Prostate cancer is the second most common cancer in men, with over 300,000 new cases annually* in the U.S. The global treatment market-currently valued at $14 billion-is projected to reach $24 billion within the next decade**. APVO442 is differentiated in this space as a tumor-specific immunotherapy designed for combination potential and scalable manufacturing. (*American Cancer Society, **Global Data)
APVO442 is currently in preclinical studies, and supports the Company’s goal of expanding its clinical pipeline and driving long-term value through modular, platform-based innovation. The Company continues to leverage insights from its CD3 bispecific programs to accelerate future development and partnership opportunities.