Akeso initiates first‑in‑human trial of its HER3‑targeted ADC combined with Ivonescimab in lung cancer, advancing its IO2.0+ADC2.0 pipeline
Executive summary: Akeso dosed the first patient in a Phase Ib/II clinical study evaluating its HER3‑directed ADC AK138D1 in combination with the PD‑1/VEGF bispecific antibody Ivonescimab for lung cancer. The trial tests a novel HER3 ADC together with a dual‑action immunotherapy, potentially offering a new treatment avenue for lung cancer and supporting Akeso’s integrated IO2.0+ADC2.0 strategy.
Who is involved: Akeso, Inc. (9926.HK) as trial sponsor; clinical investigators at participating sites; Ivonescimab supplied by its partner.
Likely next: The study will continue to enroll patients, assess safety and pharmacokinetics, and gather preliminary antitumor activity data.
The dosing of the first patient marks a concrete step in Akeso’s strategy to pair next‑generation antibody‑drug conjugates with its bispecific immunotherapy Ivonescimab. By targeting HER3, a protein implicated in resistance to existing EGFR/HER2 therapies, the trial explores a novel mechanism in non‑small cell lung cancer. Success could diversify Akeso’s oncology portfolio and validate the combination approach amid a crowded ADC landscape.
Timeline
- — Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer (PR Newswire)
- — Kelun-Biotech Receives a Clinical Trial Notice for Its First Dual-payload ADC SKB565 (PR Newswire)
- — Akari Therapeutics CEO Explains Why Growing Industry Demand for Next-Generation ADC Payloads Positions the Company at the Center of a Major Oncology Opportunity (GlobeNewswire)
- — Akeso Doses First Patient in Phase II Study of Novel TROP2/Nectin-4 Bispecific ADC (AK146D1) in Combination with Ivonescimab for Advanced NSCLC (PR Newswire)
Analysis — what this means
Sectors affected
- Oncology therapeutics
- Biotechnology
- Pharmaceutical R&D
Historical parallels
- FDA approval of ado‑trastuzumab emtansine (Kadcyla) for HER2+ breast cancer, 2013
- FDA approval of sacituzumab govitecan (Trodelvy) for metastatic triple‑negative breast cancer, 2020
- FDA approval of trastuzumab deruxtecan (Enhertu) for HER2‑low breast cancer, 2022
Key entities
Sources
- Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer — PR Newswire
- Kelun-Biotech Receives a Clinical Trial Notice for Its First Dual-payload ADC SKB565 — PR Newswire
- Akeso Doses First Patient in Phase II Study of Novel TROP2/Nectin-4 Bispecific ADC (AK146D1) in Combination with Ivonescimab for Advanced NSCLC — PR Newswire
- Akari Therapeutics CEO Explains Why Growing Industry Demand for Next-Generation ADC Payloads Positions the Company at the Center of a Major Oncology Opportunity — GlobeNewswire
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- Henlius and Sandoz partner to co‑develop up to ten biosimilar mAb and ADC assets, aiming to accelerate global market access and revenue generation
- Akeso advances its IO2.0/ADC2.0 strategy with first patient dosed in Phase II trial of AK146D1 combined with ivonescimab for breast cancer
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- Mabwell's ESMO 2026 oral presentation of clinical data for its Nectin-4-targeting ADC 9MW2821 highlights potential progress in triple-negative breast cancer therapy and could affect oncology investment sentiment