Aktis Oncology, Inc.

Aktis Oncology Initiates Second Phase 1b Clinical Trial for AKY-2519, a Miniprotein Radioconjugate Targeting B7-H3

Aktis Oncology initiated the Phase 1b BActinium-2 trial of AKY-2519, a B7-H3-targeting miniprotein radioconjugate, in NSCLC and other B7-H3 expressing solid tumors. The trial explores three dose levels with the option to expand enrollment, and joins the ongoing BActinium-1 trial in mCRPC, which began in May 2026 with preliminary data expected in 2027. First-in-human imaging and dosimetry data presented at ASCO in May 2026 showed robust tumor uptake with limited normal tissue exposure. The company's lead program, AKY-1189, is in a Phase 1b NECTINIUM-2 trial with data expected in Q1 2027.

•1mo ago

Aktis Oncology Reports Financial Results and Business Highlights for the Second Quarter 2026

Aktis Oncology reported a cash position of $517.3 million as of June 30, 2026, bolstered by net proceeds from its January IPO, which extends the company's runway into 2029. The company disclosed positive first-in-human clinical imaging and dosimetry data for AKY-2519 at ASCO, demonstrating robust tumor uptake and limited normal tissue exposure, while initiating Phase 1b trials for both AKY-2519 and AKY-1189. Collaboration revenue rose to $3.4 million driven by the Eli Lilly partnership, while R&D expenses increased to $25.3 million to support advancing clinical programs.

•2mo ago

Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors

Aktis Oncology reported first-in-human imaging and dosimetry data for AKY-2519, a B7-H3-targeted miniprotein radioconjugate, showing robust tumor uptake and limited normal tissue exposure in patients with mCRPC and other solid tumors. The data, to be presented at ASCO 2026, demonstrate a favorable therapeutic index with low predicted doses to critical organs like salivary glands compared to approved radiopharmaceuticals, supporting the advancement of Phase 1b trials. Aktis plans to initiate a second Phase 1b trial of AKY-2519 in various B7-H3 expressing tumor types in the second half of 2026, expanding its clinical-stage pipeline beyond its lead asset AKY-1189.

•5mo ago

Aktis Oncology Reports Financial Results and Business Highlights for First Quarter 2026

Aktis Oncology announced a two-trial clinical development strategy for AKY-2519, enabling evaluation in multiple patient segments. The company initiated a Phase 1b clinical trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC) and expects preliminary data in 2027. Aktis also plans to present clinical imaging and dosimetry data for AKY-2519 at the upcoming ASCO Annual Meeting, which will provide initial insights into the drug's biodistribution and absorbed doses. Aktis' cash position increased to $538.5 million as of March 31, 2026, from $226.8 million as of December 31, 2025, primarily due to the initial public offering in January 2026.

•5mo ago

Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, a B7-H3 Miniprotein Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Aktis Oncology initiated a Phase 1b clinical trial for AKY-2519, a B7-H3 targeting miniprotein radioconjugate, in patients with metastatic castration-resistant prostate cancer. The two-trial strategy includes an mCRPC-dedicated study and a separate basket trial for lung, colorectal, and other solid tumors slated for the second half of 2026. Preliminary data for AKY-2519 is expected in 2027, marking the second program from Aktis' platform to enter the clinic in the past year.

•5mo ago

Aktis Oncology Announces Presentation of First Clinical Imaging and Dosimetry Data for AKY-2519 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Aktis Oncology announced that clinical imaging and dosimetry data for AKY-2519 will be presented in two poster presentations at the 2026 ASCO Annual Meeting. The data facilitate the initial understanding of biodistribution and predicted absorbed doses in tumors and normal tissues, supporting the initiation of a Phase 1b clinical trial in mid-2026. AKY-2519 is the company’s second clinical-stage miniprotein radioconjugate targeting B7-H3, while its lead program AKY-1189 is currently enrolling patients in a Phase 1b trial.

•6mo ago