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Akeso Initiates Phase II Trial for Bispecific ADC in Lung Cancer

Akeso has dosed the first patient in a Phase II clinical study evaluating the combination of its novel TROP2/Nectin-4 bispecific antibody-drug conjugate, AK146D1, with the PD-1/VEGF bispecific antibody ivonescimab. This trial focuses on advancing first-line treatment options for patients diagnosed with advanced non-small cell lung cancer.

Akeso Initiates Phase II Trial for Bispecific ADC in Lung Cancer
Photo: Bio & News

The study, designated AK146D1-201, represents a strategic move to integrate the company’s IO2.0 portfolio with its next-generation ADC2.0 pipeline. By pairing the potent antitumor activity of AK146D1 with the clinical benefits of ivonescimab, researchers aim to address the safety limitations and narrow therapeutic windows often associated with conventional antibody-drug conjugates. This combination therapy is designed to reduce treatment-related toxicity while potentially broadening the pool of eligible patients for targeted lung cancer intervention.

This development reinforces Akeso’s current position in the immuno-oncology market, where it remains the only company globally with two approved bispecific antibodies. The company’s broader strategy involves moving multiple candidates, including AK138D1, AK157D1, and the bispecific ADC AK158D1, through clinical development. By utilizing its proprietary Tetrabody and Dual-Shield ADC technology platforms, Akeso is positioning these agents as a cross-generational competitive solution intended to elevate the global standard of care for complex tumor types.

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