HONG KONG, July 20, 2026
Akeso, Inc. has announced a significant milestone in its oncology pipeline with the first patient dosed in the Phase II AK146D1-201 clinical trial, evaluating its novel TROP2/Nectin-4 bispecific antibody-drug conjugate (ADC) AK146D1 in combination with ivonescimab, the company’s proprietary PD-1/VEGF bispecific antibody, for the treatment of advanced non-small cell lung cancer (NSCLC). The study is designed to assess the safety, efficacy, and therapeutic potential of the combination therapy, with a primary focus on the first-line treatment setting. This development marks another major advancement in Akeso’s innovative oncology strategy, combining next-generation ADC 2.0 technology with its IO 2.0 immuno-oncology platform to address unmet medical needs in one of the world’s most challenging cancers.
Phase II Trial Advances Akeso’s Next-Generation Oncology Strategy
The initiation of the AK146D1-201 Phase II study represents an important step in Akeso’s long-term vision of developing innovative cancer therapies capable of improving patient outcomes while minimizing treatment-related toxicity. The advancement of AK146D1 alongside AK138D1 into Phase II clinical development further validates the company’s IO2.0 + ADC2.0 strategy, which integrates proprietary bispecific antibody technology, advanced ADC engineering, and next-generation immunotherapy platforms. According to Akeso, the company’s expanding portfolio is designed to overcome many of the limitations associated with conventional antibody-drug conjugates, including narrow therapeutic windows and safety concerns. The company has now advanced several innovative ADC candidates into clinical development, including AK146D1, AK138D1, AK157D1, and AK158D1, strengthening its competitive position in the rapidly evolving global oncology market.
Combination Therapy Targets Improved Outcomes for NSCLC Patients
The investigational combination of AK146D1 and ivonescimab brings together two complementary therapeutic mechanisms that may significantly enhance anti-tumor activity. Ivonescimab, recognized as a first-in-class PD-1/VEGF bispecific antibody, has already demonstrated clinically meaningful advantages over conventional PD-1 inhibitor-based therapies across multiple Phase III clinical trials. Meanwhile, AK146D1, a next-generation TROP2/Nectin-4 bispecific ADC, has shown promising anti-tumor efficacy and a favorable safety profile during earlier-stage development. Researchers believe that combining these two agents could improve treatment responses, reduce toxicity, and expand the number of patients eligible for effective immunotherapy. By simultaneously targeting multiple cancer pathways, the regimen aims to overcome resistance mechanisms that frequently limit the effectiveness of existing immunotherapies and conventional ADC treatments in patients with advanced NSCLC.
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Growing Pipeline Reinforces Global Biopharma Leadership
Founded in 2012, Akeso has rapidly evolved into one of the leading innovative biopharmaceutical companies focused on discovering, developing, manufacturing, and commercializing first-in-class and best-in-class biologic medicines. The company has established an integrated research ecosystem supported by proprietary platforms including Tetrabody antibody technology, AI-powered drug discovery, Dual-Shield ADC technology, Dual-Lock T-cell engager technology, siRNA/mRNA platforms, and advanced cell therapy technologies. Akeso currently maintains a pipeline of more than 50 innovative drug candidates spanning oncology, autoimmune diseases, inflammatory disorders, and metabolic diseases. To date, 27 candidates have entered clinical development, including 15 bispecific or multispecific antibodies and bispecific ADCs, while eight innovative medicines have already reached commercialization. With global interest in ivonescimab and cadonilimab continuing to grow as preferred combination therapy partners, the successful initiation of this Phase II study further reinforces Akeso’s ambition to redefine cancer treatment through next-generation biologics and establish itself as a global leader in biopharmaceutical innovation.
Source: Akeso press release
