Clinical TrialMay 21, 2026, 05:23 PM
Aktis AKY-2519 shows robust tumor uptake, low normal tissue exposure
AI Summary
Aktis Oncology reported positive first-in-human clinical imaging and dosimetry data for AKY-2519, a miniprotein radioconjugate targeting B7-H3 expressing tumors. The data, to be presented at the 2026 ASCO Annual Meeting, demonstrated robust tumor uptake and retention across various solid tumors, including mCRPC, lung, and colorectal cancers, with limited normal tissue exposure. These findings suggest a potentially differentiated therapeutic profile compared to approved radiopharmaceuticals and support the advancement of a broad clinical development program for AKY-2519. The company will host a conference call on May 27, 2026, to discuss the results.
Key Highlights
- AKY-2519 showed robust tumor uptake and retention for at least 6 days in mCRPC patients.
- Predicted absorbed doses in normal tissues (bone marrow, liver, kidneys, salivary glands) were favorable.
- Predicted salivary gland dose was lower compared to approved radiopharmaceuticals.
- Robust uptake (SUVmax) observed across prostate (33.9-37.4), NSCLC (17.5-21.5), SCLC (15.4), and rectal cancer (15.3).
- Low uptake in critical normal tissues (adrenal, bone marrow, kidneys, liver, salivary glands, spleen).
- Phase 1b trial for mCRPC is ongoing, with preliminary data anticipated in 2027.
- A second Phase 1b trial for other B7-H3 tumors is expected to initiate in H2 2026.
- Aktis will host a conference call on May 27, 2026, to discuss the results.
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