On October 1, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) ("Aktis" or the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, reported the initiation of the Phase 1b BActinium-2 trial of AKY-25191 in patients with NSCLC and other B7-H3 expressing solid tumor types. The BActinium-2 trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in several B7-H3 expressing tumors. In May 2026, Aktis initiated the Phase 1b BActinium-1 trial of AKY-2519 in mCRPC patients, with preliminary data expected in 2027.
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"AKY-2519 has the potential to be a differentiated therapeutic option for patients with B7-H3 expressing solid tumors, as demonstrated by the first-in-human clinical imaging and dosimetry data presented at ASCO (Free ASCO Whitepaper) earlier this year," said Akos Czibere, MD, PhD, Chief Medical Officer at Aktis. "With both Phase 1b trials of AKY-2519 now underway, we are efficiently generating indication-relevant data in several cancers with large patient populations to evaluate where AKY-2519 can be most effective."
The first-in-human clinical imaging and dosimetry data for AKY-2519 across mCRPC, NSCLC and other B7-H3 expressing tumor types presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2026 demonstrated robust tumor uptake and retention of AKY-2519 with limited normal tissue exposure, suggesting the potential for a wide therapeutic window and differentiated profile compared to approved radiopharmaceuticals.
The Phase 1b, multicenter, open-label BActinium-2 trial will enroll patients with NSCLC and other B7-H3 expressing solid tumors. The study will explore three dose levels. Per protocol, Aktis has the ability to expand enrollment at selected dose levels to generate additional clinical data while dose escalation continues.
In addition to the AKY-2519 BActinium-1 and BActinium-2 trials, Aktis is also currently enrolling patients in an ongoing Phase 1b NECTINIUM-2 trial of its most advanced program, AKY-1189, a miniprotein radioconjugate targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027.
About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anticancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end clinical supply chain built for resiliency and scalability, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.
(Press release, Aktis Oncology, OCT 1, 2026, View Source [SID1234671220])